This phase II trial studies how well cixutumumab and temsirolimus work in treating patients with recurrent or refractory sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab and temsirolimus together may kill more tumor cells.

开始日期2012-06-18

申办/合作机构

National Cancer Institute

NCT00957853

/ Completed临床2期IIT

An Exploratory Study to Assess the Modulation of Biomarkers in Patients With Squamous Cell Carcinomas of the Head and Neck Randomized to Receive Preoperative Treatment With Cetuximab and/or IMC-A12, an Anti-insulin-like Growth Factor-1 Receptor Monoclonal Antibody

The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a reaction to study treatment.
The safety of the study treatments will also be studied.

开始日期2011-10-17

申办/合作机构

The University of Texas MD Anderson Cancer Center

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100 项与西妥木单抗相关的临床结果

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100 项与西妥木单抗相关的转化医学

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100 项与西妥木单抗相关的专利（医药）

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168

项与西妥木单抗相关的文献（医药）

2025-12-12·ACS Infectious Diseases

Identification and Characterization of a Small-Molecule Inhibitor of the Pseudomonas aeruginosa SOS Response

Article

作者: Ben Abderrazek, Rahma ; Tondi, Donatella ; Kavaliauskas, Povilas ; Vascon, Filippo ; Grybaite, Birute ; Petraitis, Vidmantas ; Polverino de Laureto, Patrizia ; Fongaro, Benedetta ; Cendron, Laura ; Pasquato, Antonella ; Mickevičius, Vytautas

The SOS response is among the most conserved pathways that promote antibiotic resistance onset in bacteria. This study aimed to identify and characterize small-molecule inhibitors of the SOS response in the opportunistic pathogen Pseudomonas aeruginosa. A library of 318 drug-like compounds was screened for inhibition of RecA-induced LexA autoproteolysis, a key step in SOS activation. One hit compound, 3-(2-sulfanylanilino)propanoic acid, showed dose-dependent inhibition with an IC₅₀ in the mid-micromolar. Differential scanning fluorimetry and isothermal titration calorimetry revealed that A12 binds to both RecA and LexA with a low micromolar affinity. Mass spectrometry analysis demonstrated that A12 covalently modifies RecA via condensation, while it forms a disulfide bond with Cys104 of LexA. Inhibition was diminished under reducing conditions, confirming that disulfide formation is crucial for A12 activity. A12 did not impair LexA's ability to bind SOS box DNA sequences, which is needed to keep the SOS genes repressed. Antimicrobial susceptibility testing of A12 on P. aeruginosa PAO1 showed no additive effect with tested antibiotics, but it impaired P. aeruginosa colonization of A549 lung epithelial cells and survival in THP-1-derived macrophages. While A12's potency requires optimization, it represents a promising scaffold for developing anti-SOS compounds targeting P. aeruginosa.

2025-08-01·PEST MANAGEMENT SCIENCE

Hit to lead optimization of carbothioate derivatives as novel succinate dehydrogenase inhibitors using a multistep virtual screening approach

Article

作者: Shao, Xusheng ; Sun, Xujuan ; Li, Zhong ; Xu, Xiaoyong ; Xu, Zhiping ; Cheng, Liangliang ; Zhou, Cong ; Wang, Cong ; Qian, Xuhong ; Cheng, Jiagao

Abstract:

BACKGROUND:

Succinate dehydrogenase inhibitors (SDHIs) represent one of the most important fungicide subclasses for the chemical control of plant diseases. The identification of novel SDHIs with innovative scaffolds through virtual screening is crucial for pathogenic fungi management and food security.

RESULTS:

A novel carbothioate hit compound was identified through a hierarchical virtual screening protocol with novel β‐ketonitrile fungicidal compound as query structure. The structural optimization resulted optimal compound A12 showed good in vitro broad‐spectrum fungicidal activities against Rhizoctonia solani, Sclerotiorum sclerotiorum, Botrytis cinerea and Fusarium graminearum, with EC50 values of 4.38, 10.76, 7.69, and 10.28 μg/mL, respectively. A12 also exhibited promising in vivo protective efficacy against rice sheath blight. Scanning electron microscopy (SEM) observation and SDH enzymatic assays revealed that A12 served as a potent SDH inhibitor, with an IC50 value of 4.53 μM. Computational binding mode research demonstrated that A12 formed H‐bonds, cation‐π and T‐π interaction with SDH.

CONCLUSION:

2025-08-01·Acta Pharmaceutica Sinica B

Bioisosterism-driven design of orally active, safe, and broad-spectrum biphenyl-DAPY derivatives as highly potent HIV-1 non-nucleoside reverse transcriptase inhibitors

Article

作者: Chen, Fen-Er ; De Clercq, Erik ; Pannecouque, Christophe ; Chen, Xiao-Mei ; Hao, Qing-Qing ; Wang, Shuai

This study aimed to identify ideal pharmaceutical candidates featuring strong anti-HIV-1 activity and desirable drug-like characteristics. Our endeavor involved the implementation of a bioisosterism strategy, leading to the discovery of an assemblage of halogen-containing biphenyl-diarylpyrimidines as potent HIV-1 non-nucleoside reverse transcriptase inhibitors. Notably, compound A12 demonstrated exceptional efficacy against both WT HIV-1 (EC₅₀ = 1.9 nmol/L) and seven mutant strains (EC₅₀ = 1.7-157 nmol/L), surpassing that of the lead compound 6 and comparable to etravirine. Furthermore, this analog exhibited minimal adverse effects with significantly reduced cytotoxicity (CC₅₀ = 195 μmol/L) and a high selectivity index (SI = 102,608), superior to those of etravirine (CC₅₀ > 4.6 μmol/L, SI > 1436) and rilpivirine (CC₅₀ = 3.98 μmol/L, SI = 3989). It displayed low inhibition of CYP (IC₅₀ = 6.99-25 μmol/L) and hERG (IC₅₀ > 40 μmol/L), indicating a safer profile compared to etravirine and rilpivirine. No acute toxicity or organ pathological damage was observed at a single dose of 2 g/kg. Additionally, A12 exhibited favorable oral bioavailability (F = 29.2%) and an extended elimination half-life (T _1/2 = 13.56 h), enabling convenient oral administration at minimal doses. These findings indicated that A12 could serve as a promising drug candidate for HIV treatment.

项与西妥木单抗相关的新闻（医药）

2026-01-31

·Pharm-Patent

索安非托研究进展

1、研究机构：SK Biopharmaceuticals、Axsome Therapeutics、贾兹制药、（非积极）、Aerial BioPharma、翼思生物医药（上海）有限公司、Pharmanovia 2、别名：ADX-N05、JZP-110、翼朗清 3、靶点：TAAR1/HTR1A 4、剂型及给药途径：普通片剂; 口服给药 5、结构式： 6、适应症及进展适应症进展最新进展日期发作性睡病、阻塞型睡眠呼吸暂停批准上市 2019-03-20 重度抑郁症 III期 2025-04-18 注意力缺陷多动障碍 III期 2025-04-04 暴饮暴食症 III期 2025-03-17 特发性嗜睡症 III期 2024-08-23 昼夜节律睡眠障碍 II期 2023-12-07 多发性硬化相关并发症 II期 2024-06-01 7、交易：交易名称交易类型转让方受让方交易时研发状态权益类型权益地区权益适应症交易金额交易时间 Pharmanovia announces exclusive distribution agreement with Er-Kim for Sunosi® in Eastern Europe 授权/许可 Pharmanovia Erkim Pharmaceuticals 批准上市商业化权其他 2025-02-21 Axsome Therapeutics Enters into License Agreement with Pharmanovia to Expand Commercialization and Further Develop Sunosi® (solriamfetol) in Europe 授权/许可 Axsome Therapeutics Pharmanovia 批准上市开发/商业化权欧洲，其他首付款：66百万美元里程碑付款：101百万美元 2023-02-22 Axsome Therapeutics to Acquire Sunosi® from Jazz Pharmaceuticals, Expanding Axsome’s Leadership in Neuroscience 转让/收购贾兹制药 Axsome Therapeutics 批准上市开发/商业化权美国，欧洲，其他首付款：53百万美元 2022-03-28 Ignis and SK Biopharmaceuticals jointly disclosed the signing of licensing agreements and a comprehensive long-term strategic collaboration for six innovative assets 授权/许可 SK Biopharmaceuticals 翼思生物医药（上海）有限公司批准上市开发/商业化权大中华区首付款：20百万美元里程碑付款：15百万美元其他交易额：150百万美元 2021-11-11 Axsome Therapeutics to Acquire Sunosi® from Jazz Pharmaceuticals, Expanding Axsome’s Leadership in Neuroscience 授权/许可 Aerial BioPharma 贾兹制药临床II期开发/商业化权美国，欧洲，其他首付款：125百万美元 2014-01-13 SK Biopharmaceuticals, the discoverer of the compound, out-licensed it to Aerial BioPharma in 2011 合作授权/许可 SK Biopharmaceuticals Aerial BioPharma 临床I期开发/商业化权美国，欧洲，其他 2011-12-31 8、专利布局公开（公告）号专利主题发明名称申请日法律状态 CN101217949B 用途治疗睡眠-清醒病症 2006-06-07 CN109906078B 制剂 (r)-2-氨基-3-苯丙基氨基甲酸酯的制剂 2017-09-05 CN120574152A 晶型 (R)-2-氨基-3-苯丙基氨基甲酸酯盐酸盐的溶剂化物形式的晶体、其制备方法、组合物及用途 2017-09-06 实质审查 CN121202730A 制备工艺 (R)-2-氨基-3-苯丙基氨基甲酸酯盐酸盐的制备方法、其组合物及用途 2017-09-06 实质审查 CN121202731A 晶型 (R)-2-氨基-3-苯丙基氨基甲酸酯盐酸盐的晶体、其组合物及用途 2017-09-06 实质审查 CN109996540A 晶型 (R)-2-氨基-3-苯丙基氨基甲酸酯的溶剂化物形式 2017-09-06 实质审查 9、研究历程上市信息 2019年03月20日，索安非托获得美国食品药品管理局FDA批准，由Axsome Therapeutics Ltd销售，商品名为Sunosi®。（NDA211230） 2020年01月16日，索安非托获得欧洲药品管理局EMA批准，由Atnahs Pharma Netherlands Bv销售，商品名为Sunosi®。（EMEA/H/C/004893） 2025年12月03日，索安非托获得中国国家药品监督管理局NMPA批准，由Axsome Malta Ltd销售，商品名为翼朗清®。（国药准字HJ20250139） 1) 发作性睡病 2019年03月20日，该药获得美国食品药品管理局FDA批准，由Axsome Therapeutics Ltd销售，商品名是Sunosi®，为一种口服片剂，规格是EQ 150MG BASE; EQ 75MG BASE。 2020年01月16日，该药获得欧洲药品管理局EMA批准，由Atnahs Pharma Netherlands Bv销售，商品名是Sunosi®，为一种片剂（薄膜包衣），规格是150 mg; 75 mg。 2) 阻塞性睡眠呼吸暂停综合征 2019年03月20日，该药获得美国食品药品管理局FDA批准，由Axsome Therapeutics Ltd销售，商品名是Sunosi®，为一种口服片剂，规格是EQ 150MG BASE; EQ 75MG BASE。 2020年01月16日，该药获得欧洲药品管理局EMA批准，由Atnahs Pharma Netherlands Bv销售，商品名是Sunosi®，为一种片剂（薄膜包衣），规格是150 mg; 75 mg。 3) 过度嗜睡 2019年03月20日，该药获得美国食品药品管理局FDA批准，由Axsome Therapeutics Ltd销售，商品名是Sunosi®，为一种口服片剂，规格是EQ 150MG BASE; EQ 75MG BASE。 2020年01月16日，该药获得欧洲药品管理局EMA批准，由Atnahs Pharma Netherlands Bv销售，商品名是Sunosi®，为一种片剂（薄膜包衣），规格是150 mg; 75 mg。 2025年12月03日，该药获得中国国家药品监督管理局NMPA批准，由Axsome Malta Ltd销售，商品名是翼朗清®，为一种口服片剂，规格是75mg（按C₁₀H₁₄N₂O₂计）。 2024年12月10日，由Axsome Malta Ltd向中国国家药品监督管理局NMPA提交上市申请，用于治疗过度嗜睡。（JXHS2400104） 2024年08月01日，由Axsome Therapeutics Inc在加拿大和美国开展临床三期试验，用于治疗过度嗜睡和行为障碍。（NCT06568367） 2024年06月01日，由Axsome Therapeutics Inc和约翰·霍普金斯大学在美国开展临床二期试验，用于治疗多发性硬化。（NCT06170970） 2024年04月26日，由Axsome Therapeutics Inc在美国开展临床三期试验，用于治疗狂饮-进食障碍。（NCT06878976; NCT06413433） 2024年04月01日，由Axsome Therapeutics Inc在美国开展临床三期试验，用于治疗神经性贪食症。（https://www.biospace.com/article/releases/axsome-therapeutics-initiates-engage-phase-3-trial-of-solriamfetol-for-the-treatment-of-binge-eating-disorder/?s=69） 2024年03月18日，由Axsome Therapeutics Inc在美国开展临床三期试验，用于治疗重度抑郁症。（NCT06360419） 2023年08月01日，由Andersonbrecon (Uk) Ltd、Siegfried Ag、Axsome Malta Ltd、翼思生物医药（苏州）有限公司和Siegfried Malta Ltd在中国大陆开展临床三期试验，用于治疗阻塞性睡眠呼吸暂停综合征和过度嗜睡。（NCT06103825; CTR20231397） 2023年07月06日，由Axsome Therapeutics Inc在美国开展临床三期试验，用于治疗注意力缺陷障碍伴多动。（NCT05972044） 2023年06月13日，由Andersonbrecon (Uk) Ltd、Siegfried Ag、Axsome Malta Ltd、翼思生物医药（苏州）有限公司和Siegfried Malta Ltd在中国大陆开展临床一期试验，用于治疗过度嗜睡。（CTR20231396） 2023年04月13日，由Axsome Malta Ltd和翼思生物医药（苏州）有限公司在中国大陆开展临床一期试验，用于治疗阻塞性睡眠呼吸暂停综合征。（JXHL2300018; JXHL2300017） 2023年02月22日，由Pharmanovia A/S开展临床前研究试验。（https://www.globenewswire.com/en/news-release/2023/02/22/2613017/33090/en/Axsome-Therapeutics-Enters-into-License-Agreement-with-Pharmanovia-to-Expand-Commercialization-and-Further-Develop-Sunosi-solriamfetol-in-Europe.html） 2023年02月03日，由Axsome Malta Ltd和翼思生物医药（苏州）有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗阻塞性睡眠呼吸暂停综合征。（JXHL2300018; JXHL2300017） 2021年11月11日，由Insignis Therapeutics Inc开展临床前研究试验。（https://www.sklifescienceinc.com/pdf/SK%20Biopharmaceuticals%20Enters%20Greater%20China%20Out-licensing%206%20Clinical%20Pipelines%20to%20CNS-focused%20Biotech%20Ignis%20Therapeutics.pdf） 2021年08月27日，由Axsome Therapeutics Inc在美国开展临床一期试验，用于治疗阻塞性睡眠呼吸暂停综合征、过度嗜睡、发作性睡病和产褥期疾病。（NCT05008341） 2020年01月03日，治疗过度嗜睡的研究暂无进展。（NCT02806908; NCT02806895） 2018年08月27日，治疗帕金森病的研究暂无进展。（NCT03037203） 2018年01月08日，治疗阻塞性睡眠呼吸暂停综合征和发作性睡病的研究暂无进展。（NCT02348593; NCT02348619; NCT02348632; NCT02348606） 2017年10月19日，治疗阻塞性睡眠呼吸暂停综合征的研究暂无进展。（NCT02348619） 2017年01月01日，由Jazz Pharmaceuticals Plc在美国开展临床二期试验，用于治疗帕金森病和过度嗜睡。（NCT03037203） 2016年07月05日，由Jazz Pharmaceuticals Plc在荷兰开展临床二期试验，用于治疗阻塞性睡眠呼吸暂停综合征。（NCT02806895） 2016年06月01日，由Jazz Pharmaceuticals Plc在荷兰开展临床二期试验，用于治疗过度嗜睡和发作性睡病。（NCT02806908; NCT02806895） 2015年05月01日，由Jazz Pharmaceuticals Plc在加拿大、芬兰和法国等国家和地区开展临床三期试验，用于治疗阻塞性睡眠呼吸暂停综合征和发作性睡病。（NCT02348593; NCT02348619; NCT02348632; NCT02348606） 2011年12月01日，由Jazz Pharmaceuticals Plc在美国开展临床二期试验，用于治疗发作性睡病。（NCT01485770; NCT01681121） 2009年08月28日，治疗重度抑郁症的研究暂无进展。（NCT00073203） 2003年11月17日，由Johnson & Johnson Pharmaceutical Research & Development LLC在美国开展临床二期试验，用于治疗重度抑郁症。（NCT00073203） 10、临床试验登记号试验标题适应症原始适应症申办/合作机构试验状态试验分期开始日期完成日期国家/地区 NCT06878976 An Open-Label Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder 暴食症 Binge-Eating Disorder Axsome Therapeutics, Inc. Enrolling by invitation 临床3期 2025-02-20 2026-12-01 美国 NCT06590662 A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. 特发性睡眠过度 Idiopathic Hypersomnia University Hospital of Montpellier Not yet recruiting 临床2期 2024-09-15 2027-06-01 法国 NCT06568367 A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder 特发性睡眠过度 | 日夜节律睡眠障碍 Excessive Sleepiness | Shift-work Disorder Axsome Therapeutics, Inc. Recruiting 临床3期 2024-08-01 2026-12-01 加拿大 | 美国 NCT06413433 A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED) 暴食症 Binge-Eating Disorder Axsome Therapeutics, Inc. Recruiting 临床3期 2024-04-26 2025-12-01 美国 NCT06413420 SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 Narcolepsy | Obstructive Sleep Apnea | Pregnant Women and Their Offspring Axsome Therapeutics, Inc. Recruiting N/A 2019-07-31 2029-09-01 美国 NCT06404086 RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) 新冠肺炎后遗症 | 过度嗜睡性障碍 Long COVID | Long COVID-19 | Hypersomnia | Sleep Disturbance Duke University Completed 临床2期 2024-07-31 2025-12-31 美国 NCT06360419 A Randomized, Double-Blind, Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder 重度抑郁症 Major Depressive Disorder Axsome Therapeutics, Inc. Completed 临床3期 2024-03-18 2025-03-26 美国 NCT06170970 Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness 疲劳 | 白天过度嗜睡 | 多发性硬化症 Multiple Sclerosis | Multiple Sclerosis Fatigue The Johns Hopkins University | Axsome Therapeutics, Inc. | The National Multiple Sclerosis Society Recruiting 临床2期 2024-06-01 2027-03-01 美国 NCT06103825 A Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Treatment with Solriamfetol in Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea Syndrome (OSA) with a 12-week Treatment Period 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 Sleep Apnea, Obstructive | Excessive Daytime Sleepiness 翼思生物医药（苏州）有限公司 Completed 临床3期 2023-08-01 2024-08-19 中国 NCT05972044 A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD. 注意缺陷障碍伴多动 ADHD Axsome Therapeutics, Inc. Completed 临床3期 2023-07-06 2025-03-14 美国 CTR20231396 一项在中国健康受试者中评价单次口服索安非托片的药代动力学特征、安全性、耐受性的I期、开放性临床研究阻塞性睡眠呼吸暂停综合征阻塞性睡眠呼吸暂停综合征（OSA）患者的日间过度思睡（EDS） Siegfried AG | Axsome Malta Ltd. | 翼思生物医药（苏州）有限公司 | AndersonBrecon (UK) Ltd. Completed 临床1期 2023-06-06 2023-06-29(国内) 中国 NCT05838430 The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia Disorder 入睡和睡眠障碍 | 疲劳 | 嗜睡 Insomnia University of Pennsylvania | Axsome Therapeutics, Inc. Active, not recruiting 临床4期 2023-07-31 2026-04-30 美国 NCT05008341 A Phase 4, Open-Label, Single-Dose Study to Evaluate Sunosi® (Solriamfetol) Pharmacokinetics in Breast Milk and Plasma of Healthy Postpartum Women Following Oral Administration of Sunosi® 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 Narcolepsy | Obstructive Sleep Apnea | Excessive Daytime Somnolence | Excessive Sleepiness | Postpartum Axsome Therapeutics, Inc. Completed 临床1期 2021-08-27 2022-04-15 美国 NCT04839562 Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study 注意缺陷障碍伴多动 Attention Deficit Hyperactivity Disorder The General Hospital Corp. Completed 临床2/3期 2021-08-06 2023-01-27 美国 NCT04788953 Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder 特发性睡眠过度 | 日夜节律睡眠障碍 Excessive Sleepiness | Shift-work Disorder The Brigham & Women's Hospital, Inc. | Axsome Therapeutics, Inc. Terminated 临床4期 2021-07-21 2024-04-19 美国 NCT04789174 Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function 认知 | 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 Excessive Daytime Sleepiness | Obstructive Sleep Apnea | Impaired Cognitive Function Axsome Therapeutics, Inc. Completed 临床4期 2021-05-17 2022-09-19 加拿大 | 荷兰 | 美国 | 英国 | 意大利 | 西班牙 NCT04622293 A Double-Blind, Randomized, Placebo-Controlled, Single-Center, Flexible Titration Study Evaluating the Efficacy of Solriamfetol in Treating Fatigue and Cognitive Symptoms in Adults Aged 18-65 Years With a Diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome 学习障碍 | 慢性疲劳综合征 | 疲劳 | 神经行为学表现 Chronic Fatigue Syndrome | Myalgic Encephalomyelitis Rochester Center for Behavioral Medicine Completed 临床4期 2021-04-27 2024-12-01 美国 NCT04602936 Solriamfetol in Binge Eating Disorder 暴食症 Binge Eating Disorder The Craig & Frances Lindner Center of Hope | Jazz Pharmaceuticals Plc Unknown status 临床4期 2021-06-15 2024-12-30 美国 EUCTR2019-003008-11-BE An Open-Label, Single Ascending Dose Study to Evaluate the Pharmacokinetics and Safety of Solriamfetol in Pediatric Subjects with Narcolepsy 发作性睡病 Narcolepsy | Idiopathic narcolepsy Jazz Pharmaceuticals, Inc. Completed 临床2期 2020-05-14 2022-02-04 比利时 NCT03868943 Open Label Safety Study of Solriamfetol to Promote Wakefulness and Improve Cognition and Quality of Life in Patients With Primary Gliomas 胶质母细胞瘤 Glioma | Glioblastoma Wake Forest School of Medicine | National Cancer Institute Terminated 临床2期 2021-01-27 2021-11-22 美国 NCT03037203 A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness 特发性睡眠过度 | 帕金森病 Excessive Sleepiness | Parkinson Disease Jazz Pharmaceuticals Plc Completed 临床2期 2017-01-01 2018-08-01 美国 NCT02806895 A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Obstructive Sleep Apnea 特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 Obstructive Sleep Apnea | Excessive Sleepiness Jazz Pharmaceuticals Plc Completed 临床2期 2016-07-05 2019-05-28 荷兰 NCT02806908 A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Narcolepsy 发作性睡病 | 特发性睡眠过度 Narcolepsy | Excessive Sleepiness Jazz Pharmaceuticals Plc Completed 临床2期 2016-06-01 2019-05-19 荷兰 NL-OMON47629 A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive Sleepiness Due to Obstructive Sleep Apnea - Effect of JZP-110 on driving performance in subjects with sleep apnea 阻塞性睡眠呼吸暂停综合征 Obstructive sleep apnea | temporary respiratory arrest | 10040998 Jazz Pharmaceuticals, Inc. Completed 临床2期 2016-07-05 - 荷兰 NCT02348606 A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA) 特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 Obstructive Sleep Apnea Jazz Pharmaceuticals Plc Completed 临床3期 2015-05-01 2016-12-01 加拿大 | 荷兰 | 美国 | 法国 | 德国 NCT02348593 A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy 发作性睡病 | 特发性睡眠过度 Narcolepsy Jazz Pharmaceuticals Plc Completed 临床3期 2015-05-01 2017-02-01 加拿大 | 荷兰 | 美国 | 芬兰 | 法国 | 德国 NCT02348632 A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea 发作性睡病 | 特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 Narcolepsy | Obstructive Sleep Apnea Jazz Pharmaceuticals Plc Completed 临床3期 2015-05-01 2017-12-01 加拿大 | 荷兰 | 美国 | 芬兰 | 法国 | 德国 NCT01681121 A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy 发作性睡病 | 白天过度嗜睡 Narcolepsy Jazz Pharmaceuticals Plc Completed 临床2期 2012-09-01 2013-08-01 美国 NCT01485770 A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness 发作性睡病 | 白天过度嗜睡 Narcolepsy Jazz Pharmaceuticals Plc Completed 临床2期 2011-12-01 2012-05-01 美国 NCT00073203 A 6- Week, Randomized, Double-Blind, Parallel-Group, Active-and Placebo-Controlled Trial to Assess the Efficacy of R228060 in Adult Subjects With Major Depressive Disorder (MDD) 中度重度抑郁症 | 重度抑郁症 Major Depressive Disorder Johnson & Johnson Pharmaceutical Research & Development LLC Completed 临床2期 - 2004-05-01 美国 CTIS2024-513365-39-00 A randomized, double-blind, placebo-controlled trial comparing the efficacy and tolerance of solriamfetol in patients affected with idiopathic hypersomnia. SOLR-IH 特发性睡眠过度 idiopathic hypersomnia | Idiopathic hypersomnia Centre Hospitalier Universitaire de Montpellier Not yet recruiting 临床2期 2024-07-15 2026-12-15 法国 11、临床结果标题登记号来源分期适应症评价人数用药方案结果评价发布日期申办/合作机构来源链接 Synapse链接 Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function NCT04789174 CTgov 临床4期认知 | 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 59 Solriamfetol(Solriamfetol) Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period(LS Mean) = 6.49 Point - 2026-01-26 Axsome Therapeutics, Inc. https://clinicaltrials.gov/ct2/show/results/NCT04789174 https://synapse.zhihuiya.com/clinical-result-detail/354dd2525ee02220d8d820a2a3344a23 Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function NCT04789174 CTgov 临床4期认知 | 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 59 Placebo(Placebo) Change From Baseline in the Average of the DSST RBANS Scores at the End of Each Double-blind Treatment Period(LS Mean) = 4.75 Point - 2026-01-26 Axsome Therapeutics, Inc. https://clinicaltrials.gov/ct2/show/results/NCT04789174 https://synapse.zhihuiya.com/clinical-result-detail/354dd2525ee02220d8d820a2a3344a23 Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment NCT04622293 Pubmed 临床4期慢性疲劳综合征 38 Solriamfetol 75 mg (titrated to 150 mg as needed) Behavioral Rating Inventory of Executive Function for Adults (BRIEF-A)(Week 8): P-Value = 0.012 积极 2025-11-01 Rochester Center for Behavioral Medicine https://pubmed.ncbi.nlm.nih.gov/40958377/ | https://doi.org/10.1177/02698811251368371 https://synapse.zhihuiya.com/clinical-result-detail/05542e2023d29aa255d25d824e245224 Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment NCT04622293 Pubmed 临床4期慢性疲劳综合征 38 Placebo Behavioral Rating Inventory of Executive Function for Adults (BRIEF-A)(Week 8): P-Value = 0.012 积极 2025-11-01 Rochester Center for Behavioral Medicine https://pubmed.ncbi.nlm.nih.gov/40958377/ | https://doi.org/10.1177/02698811251368371 https://synapse.zhihuiya.com/clinical-result-detail/05542e2023d29aa255d25d824e245224 Open Label Safety Study of Solriamfetol to Promote Wakefulness and Improve Cognition and Quality of Life in Patients With Primary Gliomas NCT03868943 CTgov 临床2期胶质母细胞瘤 2 Soliramfetol Proportion With Grade 3 or Higher Adverse Events = 0 Pts - 2025-10-21 Wake Forest School of Medicine | National Cancer Institute https://clinicaltrials.gov/ct2/show/results/NCT03868943 https://synapse.zhihuiya.com/clinical-result-detail/88e4e8e2482a3e042e52e032e9e8aa52 Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder NCT04788953 CTgov 临床4期特发性睡眠过度 | 日夜节律睡眠障碍 84 Solriamfetol Oral Tablet(Solriamfetol (Sunosi)) Change in Mean Sleep Latency(LS Mean) = 12.6 Minute (95%CI, 10.0 ~ 15.2) - 2025-09-24 The Brigham & Women's Hospital, Inc. | Axsome Therapeutics, Inc. https://clinicaltrials.gov/ct2/show/results/NCT04788953 https://synapse.zhihuiya.com/clinical-result-detail/2523e8520eea022252a0283558de5539 Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder NCT04788953 CTgov 临床4期特发性睡眠过度 | 日夜节律睡眠障碍 84 Placebo(Control) Change in Mean Sleep Latency(LS Mean) = 3.2 Minute (95%CI, 0.6 ~ 5.8) - 2025-09-24 The Brigham & Women's Hospital, Inc. | Axsome Therapeutics, Inc. https://clinicaltrials.gov/ct2/show/results/NCT04788953 https://synapse.zhihuiya.com/clinical-result-detail/2523e8520eea022252a0283558de5539 Axsome Therapeutics Announces FOCUS Phase 3 Trial of Solriamfetol in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Achieves Primary Endpoint NCT05972044 Company_Website 临床3期注意缺陷障碍伴多动 516 solriamfetol 150 mg AISRS(6-week) = -17.7 Point 达到积极 2025-03-25 Axsome Therapeutics, Inc. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-focus-phase-3-trial-solriamfetol https://synapse.zhihuiya.com/clinical-result-detail/0a8e2ad2a0e222e9254852aed32aa54a Axsome Therapeutics Announces FOCUS Phase 3 Trial of Solriamfetol in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Achieves Primary Endpoint NCT05972044 Company_Website 临床3期注意缺陷障碍伴多动 516 solriamfetol 300 mg - 积极 2025-03-25 Axsome Therapeutics, Inc. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-focus-phase-3-trial-solriamfetol https://synapse.zhihuiya.com/clinical-result-detail/0a8e2ad2a0e222e9254852aed32aa54a Results of the Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP) NCT04789174 Pubmed 临床4期认知功能障碍 | 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 59 Solriamfetol 75 mg/day for 3 days, then 150 mg/day TEAE = The most common treatment-emergent adverse events were nausea (7%) and anxiety (3%). 积极 2025-03-01 Axsome Therapeutics, Inc. https://pubmed.ncbi.nlm.nih.gov/39528111/ | https://doi.org/10.1016/j.chest.2024.10.050 https://synapse.zhihuiya.com/clinical-result-detail/0a822e9ee0a035d220480820a23203d3 Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm (P10-9.009) - AAN 临床3期发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 75mg ESS = 0.47 Cohen's d 积极 2024-04-09 Atrium Health, Inc. | Axsome Therapeutics, Inc. | Neurotrials Research, Inc. | Excel Hospital https://www.neurology.org/doi/full/10.1212/WNL.0000000000205312 https://synapse.zhihuiya.com/clinical-result-detail/8448a0a8a5298ee5d28a008348ee5e4d Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm (P10-9.009) - AAN 临床3期发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 150mg ESS = 0.8 Cohen's d 积极 2024-04-09 Atrium Health, Inc. | Axsome Therapeutics, Inc. | Neurotrials Research, Inc. | Excel Hospital https://www.neurology.org/doi/full/10.1212/WNL.0000000000205312 https://synapse.zhihuiya.com/clinical-result-detail/8448a0a8a5298ee5d28a008348ee5e4d SURWEY Study of Solriamfetol: Initiation, Titration, Safety, Efficacy, and Follow-up Experience for Patients with OSA in Germany (P9-9.010) - AAN N/A 阻塞性睡眠呼吸暂停综合征 83 Solriamfetol 37.5 mg/day AE = Common adverse effects were headache, insomnia, and irritability 积极 2024-04-09 - https://www.neurology.org/doi/full/10.1212/WNL.0000000000205163 https://synapse.zhihuiya.com/clinical-result-detail/a94928428558595a58a2eea43d55ae8e SURWEY Study of Solriamfetol: Initiation, Titration, Safety, Efficacy, and Follow-up Experience for Patients with OSA in Germany (P9-9.010) - AAN N/A 阻塞性睡眠呼吸暂停综合征 83 Solriamfetol 75 mg/day AE = Common adverse effects were headache, insomnia, and irritability 积极 2024-04-09 - https://www.neurology.org/doi/full/10.1212/WNL.0000000000205163 https://synapse.zhihuiya.com/clinical-result-detail/a94928428558595a58a2eea43d55ae8e Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study NCT04839562 CTgov 临床2/3期注意缺陷障碍伴多动 66 Solriamfetol 75 MG(Solriamfetol) Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score(Mean) = -7.6 Point (95%CI, -9.9 ~ -5.3) - 2024-03-04 The General Hospital Corp. https://clinicaltrials.gov/ct2/show/results/NCT04839562 https://synapse.zhihuiya.com/clinical-result-detail/0aa2ad0853aeade5e222a22e92529ae3 Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study NCT04839562 CTgov 临床2/3期注意缺陷障碍伴多动 66 Placebo(Placebo) Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score(Mean) = -2.1 Point (95%CI, -4.4 ~ 0.2) - 2024-03-04 The General Hospital Corp. https://clinicaltrials.gov/ct2/show/results/NCT04839562 https://synapse.zhihuiya.com/clinical-result-detail/0aa2ad0853aeade5e222a22e92529ae3 Effects of solriamfetol on cognition in participants with cognitive impairment associated with excessive daytime sleepiness in obstructive sleep apnea: SHARP study results - WSC N/A 白天过度嗜睡 - Solriamfetol 150 mg/day Adverse Event: anxiety = 3.4% - 2023-10-25 SleepMed, Inc. | Jazz Pharmaceuticals Plc | Axsome Therapeutics, Inc. https://ws2023.abstractserver.com/program/#/details/presentations/1559 https://synapse.zhihuiya.com/clinical-result-detail/a2232585e00828e5d9858a58e82e5aaa Effects of solriamfetol on cognition in participants with cognitive impairment associated with excessive daytime sleepiness in obstructive sleep apnea: SHARP study results - WSC N/A 白天过度嗜睡 - Placebo Adverse Event: anxiety = 3.4% - 2023-10-25 SleepMed, Inc. | Jazz Pharmaceuticals Plc | Axsome Therapeutics, Inc. https://ws2023.abstractserver.com/program/#/details/presentations/1559 https://synapse.zhihuiya.com/clinical-result-detail/a2232585e00828e5d9858a58e82e5aaa SURWEY Study of Solriamfetol: Initiation, Titration, Safety, Efficacy, and Follow-Up Experience for Patients with OSA in Germany - WSC N/A 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 37.5 mg/day Adverse Event: headache = Common adverse effects were headache - 2023-10-24 Jazz Pharmaceuticals Plc | Axsome Therapeutics, Inc. | ATNAHS PHARMA UK LIMITED https://ws2023.abstractserver.com/program/#/details/presentations/2240 https://synapse.zhihuiya.com/clinical-result-detail/523593a9e893849ee48a582aa4894dad SURWEY Study of Solriamfetol: Initiation, Titration, Safety, Efficacy, and Follow-Up Experience for Patients with OSA in Germany - WSC N/A 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 75 mg/day Adverse Event: headache = Common adverse effects were headache - 2023-10-24 Jazz Pharmaceuticals Plc | Axsome Therapeutics, Inc. | ATNAHS PHARMA UK LIMITED https://ws2023.abstractserver.com/program/#/details/presentations/2240 https://synapse.zhihuiya.com/clinical-result-detail/523593a9e893849ee48a582aa4894dad Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm - WSC 临床3期发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 75mg CGIC = 4 NNT 积极 2023-10-24 Axsome Therapeutics, Inc. https://ws2023.abstractserver.com/program/#/details/presentations/2247 https://synapse.zhihuiya.com/clinical-result-detail/ae8a28a28e8e0282a929202422929a20 Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm - WSC 临床3期发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 150mg CGIC = 3 NNT 积极 2023-10-24 Axsome Therapeutics, Inc. https://ws2023.abstractserver.com/program/#/details/presentations/2247 https://synapse.zhihuiya.com/clinical-result-detail/ae8a28a28e8e0282a929202422929a20 Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy. NCT02348632 Pubmed N/A 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 37.5 mg Adverse Event: weight-related treatment-emergent adverse events = No weight-related treatment-emergent adverse events were serious - 2022-08-14 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/36084494/ | https://doi.org/10.1016/j.sleep.2022.08.005 https://synapse.zhihuiya.com/clinical-result-detail/28a52359aa2a8899ae9245ede9e98889 Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy. NCT02348632 Pubmed N/A 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 75 mg Adverse Event: weight-related treatment-emergent adverse events = No weight-related treatment-emergent adverse events were serious - 2022-08-14 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/36084494/ | https://doi.org/10.1016/j.sleep.2022.08.005 https://synapse.zhihuiya.com/clinical-result-detail/28a52359aa2a8899ae9245ede9e98889 Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. NCT02348593 | NCT02348606 Pubmed 临床3期发作性睡病 | 白天过度嗜睡 - Solriamfetol 37.5 mg 焦虑 = 2.1 % - 2021-07-20 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/34283019/ | https://doi.org/10.5664/jcsm.9550 https://synapse.zhihuiya.com/clinical-result-detail/5522e8255a8258855895aa88ea2a9e25 Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. NCT02348593 | NCT02348606 Pubmed 临床3期发作性睡病 | 白天过度嗜睡 - Solriamfetol 150 mg 口干症 = 4.2 % - 2021-07-20 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/34283019/ | https://doi.org/10.5664/jcsm.9550 https://synapse.zhihuiya.com/clinical-result-detail/5522e8255a8258855895aa88ea2a9e25 A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness NCT01485770 CTgov 临床2期发作性睡病 | 白天过度嗜睡 33 ADX-N05(ADX-N05 300 mg) Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo(Mean) = 12.7 Minute - 2021-07-06 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT01485770 https://synapse.zhihuiya.com/clinical-result-detail/250503029588348a82adddade5282408 A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness NCT01485770 CTgov 临床2期发作性睡病 | 白天过度嗜睡 33 Placebo+ADX-N05(Placebo) Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo(Mean) = 0.9 Minute - 2021-07-06 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT01485770 https://synapse.zhihuiya.com/clinical-result-detail/250503029588348a82adddade5282408 Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. NCT03037203 Pubmed 临床2期白天过度嗜睡 66 Solriamfetol 300 mg/d Adverse Event: anxiety = 5.4% - 2021-06-30 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/34191352/ | https://doi.org/10.1002/mds.28702 https://synapse.zhihuiya.com/clinical-result-detail/45e8a882442ed32285ea2a9d5a252552 Solriamfetol Titration & AdministRaTion (START): Characteristics of Patients with Obstructive Sleep Apnea and Prescriber Rationale for Starting Treatment with Solriamfetol - ATS N/A 阻塞性睡眠呼吸暂停综合征 - Solriamfetol Obese = 50 % - 2021-05-03 Albert Einstein College of Medicine, Inc. | Stratevi LLC | Tri-Valley Sleep Center LLC | Jazz Pharmaceuticals, Inc. https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2021.203.1_MeetingAbstracts.A1624 https://synapse.zhihuiya.com/clinical-result-detail/2e2d3a048a0a5292ee455e82e54a20de Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in Obstructive Sleep Apnea: An Analysis of Subgroups Adherent or Nonadherent to Obstructive Sleep Apnea Treatment. NCT02348606 Pubmed 临床3期白天过度嗜睡 476 Solriamfetol 37.5 mg/d MWT sleep latency = 4.8 Minute (95%CI, 0.6 ~ 9.0) - 2021-02-22 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/33631141/ | https://doi.org/10.1016/j.chest.2021.02.033 https://synapse.zhihuiya.com/clinical-result-detail/884385d2424d522a280330e5ae820e58 Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in Obstructive Sleep Apnea: An Analysis of Subgroups Adherent or Nonadherent to Obstructive Sleep Apnea Treatment. NCT02348606 Pubmed 临床3期白天过度嗜睡 476 Solriamfetol 75 mg/d MWT sleep latency = 8.4 Minute (95%CI, 4.3 ~ 12.5) - 2021-02-22 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/33631141/ | https://doi.org/10.1016/j.chest.2021.02.033 https://synapse.zhihuiya.com/clinical-result-detail/884385d2424d522a280330e5ae820e58 A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Narcolepsy NCT02806908 CTgov 临床2期发作性睡病 | 特发性睡眠过度 24 Placebo(Placebo) Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)(Median) = 20.46 centimeter (cm) (Full Range, 14.4 ~ 28.6) - 2021-01-13 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT02806908 https://synapse.zhihuiya.com/clinical-result-detail/5aea0a420e2d9045aeea552e58e49238 A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Narcolepsy NCT02806908 CTgov 临床2期发作性睡病 | 特发性睡眠过度 24 JZP-110(JZP-110) Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)(Median) = 19.08 centimeter (cm) (Full Range, 13.2 ~ 25.0) - 2021-01-13 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT02806908 https://synapse.zhihuiya.com/clinical-result-detail/5aea0a420e2d9045aeea552e58e49238 Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a post hoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. NCT02348593 | NCT02348606 Pubmed 临床3期发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 37.5 mg ESS scores ≤10 = 30.5 % - 2020-11-23 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/33226332/ | https://doi.org/10.5664/jcsm.9006 https://synapse.zhihuiya.com/clinical-result-detail/25820220a00a992955ad3850983295da Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a post hoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. NCT02348593 | NCT02348606 Pubmed 临床3期发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 75 mg ESS scores ≤10 = 49.2 % - 2020-11-23 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/33226332/ | https://doi.org/10.5664/jcsm.9006 https://synapse.zhihuiya.com/clinical-result-detail/25820220a00a992955ad3850983295da Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. NCT02348632 Pubmed 临床3期阻塞性睡眠呼吸暂停综合征 417 Solriamfetol 75 mg/d Adverse Event: adverse events = Common adverse events (both subgroups): headache, nasopharyngitis, insomnia, dry mouth, nausea, anxiety, and upper respiratory tract infection - 2020-11-11 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/33179591/ | https://doi.org/10.5664/jcsm.8992 https://synapse.zhihuiya.com/clinical-result-detail/89e328a3dae95a5d5992ea4e55e2838e Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. NCT02348632 Pubmed 临床3期阻塞性睡眠呼吸暂停综合征 417 Solriamfetol 150 mg/d Adverse Event: adverse events = Common adverse events (both subgroups): headache, nasopharyngitis, insomnia, dry mouth, nausea, anxiety, and upper respiratory tract infection - 2020-11-11 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/33179591/ | https://doi.org/10.5664/jcsm.8992 https://synapse.zhihuiya.com/clinical-result-detail/89e328a3dae95a5d5992ea4e55e2838e Effects of Solriamfetol on Driving Performance inParticipants with Narcolepsy NCT02806908 ANA 临床2期发作性睡病 24 Solriamfetol 150 mg/d SDLP = 19.08 cm 积极 2020-09-25 Jazz Pharmaceuticals Plc https://onlinelibrary.wiley.com/doi/epdf/10.1002/ana.25865 https://synapse.zhihuiya.com/clinical-result-detail/5ee598e2392588922a22a98a8aee5528 Effects of Solriamfetol on Driving Performance inParticipants with Narcolepsy NCT02806908 ANA 临床2期发作性睡病 24 Solriamfetol 300 mg/d SDLP = 19.08 cm 积极 2020-09-25 Jazz Pharmaceuticals Plc https://onlinelibrary.wiley.com/doi/epdf/10.1002/ana.25865 https://synapse.zhihuiya.com/clinical-result-detail/5ee598e2392588922a22a98a8aee5528 Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. NCT02348593 Pubmed 临床3期发作性睡病 239 Solriamfetol 75 mg MWT = 1.6 Minute - 2020-07-01 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/32588401/ | https://doi.org/10.1007/s40263-020-00744-2 https://synapse.zhihuiya.com/clinical-result-detail/ed458a54d845a99e5ea9d28042a5543d Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. NCT02348593 Pubmed 临床3期发作性睡病 239 Solriamfetol 150 mg MWT = 6.1 Minute - 2020-07-01 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/32588401/ | https://doi.org/10.1007/s40263-020-00744-2 https://synapse.zhihuiya.com/clinical-result-detail/ed458a54d845a99e5ea9d28042a5543d A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Obstructive Sleep Apnea NCT02806895 CTgov 临床2期特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 34 Placebo(Placebo) Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)(LS Mean) = 19.92 centimeter (cm) - 2020-06-16 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT02806895 https://synapse.zhihuiya.com/clinical-result-detail/382932ae003de40a22e0ae24a588e53a A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Obstructive Sleep Apnea NCT02806895 CTgov 临床2期特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 34 JZP-110(JZP-110) Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)(LS Mean) = 18.83 centimeter (cm) - 2020-06-16 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT02806895 https://synapse.zhihuiya.com/clinical-result-detail/382932ae003de40a22e0ae24a588e53a Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea NCT02348632 Pubmed 临床3期发作性睡病 | 特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 - solriamfetol Epworth Sleepiness Scale [ESS] score(LS mean) = -1.6 Point 积极 2020-02-13 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/31691827/ | https://doi.org/10.1093/sleep/zsz220 https://synapse.zhihuiya.com/clinical-result-detail/598aa05248a805e922222925252aa288 Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea NCT02348632 Pubmed 临床3期发作性睡病 | 特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 - Placebo Epworth Sleepiness Scale [ESS] score(LS mean) = -5.3 Point 积极 2020-02-13 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/31691827/ | https://doi.org/10.1093/sleep/zsz220 https://synapse.zhihuiya.com/clinical-result-detail/598aa05248a805e922222925252aa288 A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness NCT03037203 CTgov 临床2期特发性睡眠过度 | 帕金森病 66 JZP-110(JZP-110 75mg) Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation = 1 Pts - 2020-01-09 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT03037203 https://synapse.zhihuiya.com/clinical-result-detail/3a5228820aad2e8e422a85e222a58d29 A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness NCT03037203 CTgov 临床2期特发性睡眠过度 | 帕金森病 66 JZP-110(JZP-110 150mg) Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation = 2 Pts - 2020-01-09 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT03037203 https://synapse.zhihuiya.com/clinical-result-detail/3a5228820aad2e8e422a85e222a58d29 INCIDENCE AND DURATION OF COMMON ADVERSE EVENTS IN 2 SOLRIAMFETOL PHASE 3 STUDIES FOR TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN OBSTRUCTIVE SLEEP APNOEA AND NARCOLEPSY - WSC 临床3期发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 37.5 mg Adverse Event: decreased appetite = decreased appetite, headache, and nausea, as well as anxiety, feeling jittery, and insomnia in participants with OSA, and dry mouth in participants with narcolepsy 积极 2019-09-20 Jazz Pharmaceuticals Plc | Neurotrials Research, Inc. | Jazz Pharmaceuticals, Inc. | Pulmonary Associates, Inc. https://worldsleepsociety.org/wp-content/uploads/2019/10/WS19-Poster-abstracts-by-author.pdf https://synapse.zhihuiya.com/clinical-result-detail/aae34a392e542d88025da22588e258ea INCIDENCE AND DURATION OF COMMON ADVERSE EVENTS IN 2 SOLRIAMFETOL PHASE 3 STUDIES FOR TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN OBSTRUCTIVE SLEEP APNOEA AND NARCOLEPSY - WSC 临床3期发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol 75 mg Adverse Event: decreased appetite = decreased appetite, headache, and nausea, as well as anxiety, feeling jittery, and insomnia in participants with OSA, and dry mouth in participants with narcolepsy 积极 2019-09-20 Jazz Pharmaceuticals Plc | Neurotrials Research, Inc. | Jazz Pharmaceuticals, Inc. | Pulmonary Associates, Inc. https://worldsleepsociety.org/wp-content/uploads/2019/10/WS19-Poster-abstracts-by-author.pdf https://synapse.zhihuiya.com/clinical-result-detail/aae34a392e542d88025da22588e258ea EFFECTS OF SHORT- AND LONG-TERM SOLRIAMFETOL TREATMENT ON ADHERENCE TO PRIMARY OBSTRUCTIVE SLEEP APNOEA THERAPY - WSC 临床3期阻塞性睡眠呼吸暂停综合征 474 Solriamfetol 37.5 mg/d Adverse Event: anxiety = Common adverse events (≥5%) with solriamfetol in the 12-week study were headache, nausea, decreased appetite, anxiety, nasopharyngitis, diarrhoea, and dry mouth, and in the OLE were headache, nasopharyngitis, insomnia, dry mouth, nausea, anxiety, and upper respiratory infection. 积极 2019-09-20 Jazz Pharmaceuticals Plc https://worldsleepsociety.org/wp-content/uploads/2019/10/WS19-Poster-abstracts-by-author.pdf https://synapse.zhihuiya.com/clinical-result-detail/48452d2e22aa55e5ea8832de5320a4e9 EFFECTS OF SHORT- AND LONG-TERM SOLRIAMFETOL TREATMENT ON ADHERENCE TO PRIMARY OBSTRUCTIVE SLEEP APNOEA THERAPY - WSC 临床3期阻塞性睡眠呼吸暂停综合征 474 Solriamfetol 75 mg/d Adverse Event: anxiety = Common adverse events (≥5%) with solriamfetol in the 12-week study were headache, nausea, decreased appetite, anxiety, nasopharyngitis, diarrhoea, and dry mouth, and in the OLE were headache, nasopharyngitis, insomnia, dry mouth, nausea, anxiety, and upper respiratory infection. 积极 2019-09-20 Jazz Pharmaceuticals Plc https://worldsleepsociety.org/wp-content/uploads/2019/10/WS19-Poster-abstracts-by-author.pdf https://synapse.zhihuiya.com/clinical-result-detail/48452d2e22aa55e5ea8832de5320a4e9 INDIRECT TREATMENT COMPARISON OF THE EFFICACY AND SAFETY OF SOLRIAMFETOL, MODAFINIL, AND ARMODAFINIL FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN OBSTRUCTIVE SLEEP APNOEA - WSC N/A 阻塞性睡眠呼吸暂停综合征 1714 Solriamfetol 150 mg TEAE = 11 % (95% CrI, 3% ~ 64%) 积极 2019-09-20 Pharmerit International LP | Jazz Pharmaceuticals Plc | Jazz Pharmaceuticals, Inc. https://worldsleepsociety.org/wp-content/uploads/2019/10/WS19-Poster-abstracts-by-author.pdf https://synapse.zhihuiya.com/clinical-result-detail/824e425282dad54289aa0085289e85ee A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA) NCT02348606 CTgov 临床3期特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 476 JZP-110(37.5 mg of JZP-110) Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12(LS Mean) = 4.74 Minute - 2019-07-23 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT02348606 https://synapse.zhihuiya.com/clinical-result-detail/2e254284d9432822d48a5323e4228802 A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA) NCT02348606 CTgov 临床3期特发性睡眠过度 | 阻塞性睡眠呼吸暂停综合征 476 JZP-110(75 mg of JZP-110) Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12(LS Mean) = 9.08 Minute - 2019-07-23 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT02348606 https://synapse.zhihuiya.com/clinical-result-detail/2e254284d9432822d48a5323e4228802 A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy NCT02348593 CTgov 临床3期发作性睡病 | 特发性睡眠过度 239 Placebo oral tablet(Placebo) Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12(LS Mean) = 2.12 Minute - 2019-07-23 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT02348593 https://synapse.zhihuiya.com/clinical-result-detail/2d4e9a9882a3e5223a8930edd58543aa A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy NCT02348593 CTgov 临床3期发作性睡病 | 特发性睡眠过度 239 JZP-110(75 mg of JZP-110) Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12(LS Mean) = 4.74 Minute - 2019-07-23 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT02348593 https://synapse.zhihuiya.com/clinical-result-detail/2d4e9a9882a3e5223a8930edd58543aa A Long-Term Study of the Safety and Maintenance of Efficacy of Solriamfetol (JZP-110) for Treatment of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea (S46.008) - AAN N/A 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 643 Solriamfetol ESS = sustained reductions Point - 2019-04-09 Jazz Pharmaceuticals Plc https://www.neurology.org/doi/full/10.1212/WNL.92.15_supplement.s46.008 https://synapse.zhihuiya.com/clinical-result-detail/e2222ae250ea5da0842022822a43229e A Long-Term Study of the Safety and Maintenance of Efficacy of Solriamfetol (JZP-110) for Treatment of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea (S46.008) - AAN N/A 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 643 Placebo ESS = 5.3 Point - 2019-04-09 Jazz Pharmaceuticals Plc https://www.neurology.org/doi/full/10.1212/WNL.92.15_supplement.s46.008 https://synapse.zhihuiya.com/clinical-result-detail/e2222ae250ea5da0842022822a43229e Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study NCT02348619 | EUCTR2014-005515-16-FI | EUCTR2014-005515-16-SE Pubmed 临床3期阻塞性睡眠呼吸暂停综合征 124 Solriamfetol ESS score(From weeks 4 to 6) = -0.1 Point (SE, 0.7) 积极 2019-02-01 Jazz Pharmaceuticals Plc | Jazz Pharmaceuticals, Inc. https://pubmed.ncbi.nlm.nih.gov/30471270/ | https://doi.org/10.1016/j.chest.2018.11.005 https://synapse.zhihuiya.com/clinical-result-detail/9223225432834e2835255a944a282ada Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study NCT02348619 | EUCTR2014-005515-16-FI | EUCTR2014-005515-16-SE Pubmed 临床3期阻塞性睡眠呼吸暂停综合征 124 Placebo ESS score(From weeks 4 to 6) = 4.5 Point (SE, 0.7) 积极 2019-02-01 Jazz Pharmaceuticals Plc | Jazz Pharmaceuticals, Inc. https://pubmed.ncbi.nlm.nih.gov/30471270/ | https://doi.org/10.1016/j.chest.2018.11.005 https://synapse.zhihuiya.com/clinical-result-detail/9223225432834e2835255a944a282ada A Randomized, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Solriamfetol (JZP-110) for the Treatment of Excessive Sleepiness (ES) in Participants with Narcolepsy Types 1 and 2 (NT1/2) (CT.003) - AAN 临床3期发作性睡病 | 嗜睡 236 Solriamfetol 75 mg MWT sleep latency = 4.7 Minute - 2018-04-10 Jazz Pharmaceuticals Plc https://www.neurology.org/doi/full/10.1212/WNL.90.15_supplement.CT.003 https://synapse.zhihuiya.com/clinical-result-detail/3d84530a058082d448ed8a5454e48289 A Randomized, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Solriamfetol (JZP-110) for the Treatment of Excessive Sleepiness (ES) in Participants with Narcolepsy Types 1 and 2 (NT1/2) (CT.003) - AAN 临床3期发作性睡病 | 嗜睡 236 Solriamfetol 150 mg MWT sleep latency = 9.8 Minute - 2018-04-10 Jazz Pharmaceuticals Plc https://www.neurology.org/doi/full/10.1212/WNL.90.15_supplement.CT.003 https://synapse.zhihuiya.com/clinical-result-detail/3d84530a058082d448ed8a5454e48289 Safety and Efficacy of JZP-110 for Treatment ofExcessive Sleepiness in Narcolepsy: Results of aRandomized, Placebo-Controlled, Phase 3 Study - ANA 临床3期发作性睡病 - JZP-110 150mg MWT = 9.8 Minute 积极 2017-10-15 Jazz Pharmaceuticals Plc https://onlinelibrary.wiley.com/doi/epdf/10.1002/ana.25024 https://synapse.zhihuiya.com/clinical-result-detail/a9a882323228888aaee2e3849e8a3255 Safety and Efficacy of JZP-110 for Treatment ofExcessive Sleepiness in Narcolepsy: Results of aRandomized, Placebo-Controlled, Phase 3 Study - ANA 临床3期发作性睡病 - JZP-110 300mg MWT = 12.3 Minute 积极 2017-10-15 Jazz Pharmaceuticals Plc https://onlinelibrary.wiley.com/doi/epdf/10.1002/ana.25024 https://synapse.zhihuiya.com/clinical-result-detail/a9a882323228888aaee2e3849e8a3255 RESULTS OF A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, 12-WEEK, MULTICENTER STUDY OF SOLRIAMFETOL (JZP-110) FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA NCT02348606 WSC 临床3期阻塞性睡眠呼吸暂停综合征 474 Solriamfetol 37.5mg MWT mean sleep latency = 4.7 Minute (LS mean (SE), 1.4) 积极 2017-10-07 Jazz Pharmaceuticals Plc https://worldsleepcongress.com/wp-content/uploads/2015/06/WS2017_by_author.pdf https://synapse.zhihuiya.com/clinical-result-detail/5de3522432e3ae988deaa95a5e34ae85 RESULTS OF A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, 12-WEEK, MULTICENTER STUDY OF SOLRIAMFETOL (JZP-110) FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA NCT02348606 WSC 临床3期阻塞性睡眠呼吸暂停综合征 474 Solriamfetol 75mg MWT mean sleep latency = 9.1 Minute (LS mean (SE), 1.4) 积极 2017-10-07 Jazz Pharmaceuticals Plc https://worldsleepcongress.com/wp-content/uploads/2015/06/WS2017_by_author.pdf https://synapse.zhihuiya.com/clinical-result-detail/5de3522432e3ae988deaa95a5e34ae85 TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA: EFFICACY AND SAFETY RESULTS OF A 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED-WITHDRAWAL TRIAL OF SOLRIAMFETOL (JZP-110) NCT02348619 WSC 临床3期阻塞性睡眠呼吸暂停综合征 174 Solriamfetol 75mg MWT = 31.7 Minute (95%CI, 9.2) 积极 2017-10-07 Jazz Pharmaceuticals Plc https://worldsleepcongress.com/wp-content/uploads/2015/06/WS2017_by_author.pdf https://synapse.zhihuiya.com/clinical-result-detail/23025559e4a3aa254e8ead352a85eda2 TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA: EFFICACY AND SAFETY RESULTS OF A 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED-WITHDRAWAL TRIAL OF SOLRIAMFETOL (JZP-110) NCT02348619 WSC 临床3期阻塞性睡眠呼吸暂停综合征 174 Placebo MWT = 29.0 Minute (95%CI, 9.9) 积极 2017-10-07 Jazz Pharmaceuticals Plc https://worldsleepcongress.com/wp-content/uploads/2015/06/WS2017_by_author.pdf https://synapse.zhihuiya.com/clinical-result-detail/23025559e4a3aa254e8ead352a85eda2 A RANDOMIZED, PLACEBO-CONTROLLED, PHASE 3 STUDY OF THE SAFETY AND EFFICACY OF SOLRIAMFETOL (JZP-110) FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH NARCOLEPSY NCT02348593 WSC 临床3期发作性睡病 239 Solriamfetol 75mg 焦虑 = TEAEs; generally, the incidence of the most common TEAEs was dose dependent 积极 2017-10-07 Jazz Pharmaceuticals Plc https://worldsleepcongress.com/wp-content/uploads/2015/06/WS2017_by_author.pdf https://synapse.zhihuiya.com/clinical-result-detail/d5e3ed982443a2ea484455e528a04023 A RANDOMIZED, PLACEBO-CONTROLLED, PHASE 3 STUDY OF THE SAFETY AND EFFICACY OF SOLRIAMFETOL (JZP-110) FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH NARCOLEPSY NCT02348593 WSC 临床3期发作性睡病 239 Solriamfetol 150mg 焦虑 = TEAEs; generally, the incidence of the most common TEAEs was dose dependent 积极 2017-10-07 Jazz Pharmaceuticals Plc https://worldsleepcongress.com/wp-content/uploads/2015/06/WS2017_by_author.pdf https://synapse.zhihuiya.com/clinical-result-detail/d5e3ed982443a2ea484455e528a04023 JZP-110, a Dopamine Norepinephrine ReuptakeInhibitor (DNRI), with Robust Wake-Promoting Effectsand Low Abuse Potential - ANA 临床2期 - - JZP-110 Adverse Event: anxiety = 11.4% vs 0% 积极 2016-10-14 Jazz Pharmaceuticals Plc https://onlinelibrary.wiley.com/doi/epdf/10.1002/ana.24759 https://synapse.zhihuiya.com/clinical-result-detail/a2525503428e3592ae5a938a55eda528 JZP-110, a Dopamine Norepinephrine ReuptakeInhibitor (DNRI), with Robust Wake-Promoting Effectsand Low Abuse Potential - ANA 临床2期 - - Placebo Adverse Event: anxiety = 11.4% vs 0% 积极 2016-10-14 Jazz Pharmaceuticals Plc https://onlinelibrary.wiley.com/doi/epdf/10.1002/ana.24759 https://synapse.zhihuiya.com/clinical-result-detail/a2525503428e3592ae5a938a55eda528 Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study NCT01681121 Pubmed 临床2期发作性睡病 | 嗜睡 93 JZP-110 CGIC(12-week) = 86 % 积极 2016-07-01 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/27166238/ | https://doi.org/10.5665/sleep.5968 https://synapse.zhihuiya.com/clinical-result-detail/ea2ea49d39834395e838954a8aed92ee Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study NCT01681121 Pubmed 临床2期发作性睡病 | 嗜睡 93 Placebo CGIC(12-week) = 38 % 积极 2016-07-01 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/27166238/ | https://doi.org/10.5665/sleep.5968 https://synapse.zhihuiya.com/clinical-result-detail/ea2ea49d39834395e838954a8aed92ee Definition of a Responder to NarcolepsyTreatment with JZP-110 - ANA 临床2期发作性睡病 - JZP-110 150 mg/day ESS score reduction = 25 % 积极 2015-09-25 Vanda Pharmaceuticals, Inc. | UCB Pharma GmbH | Xenon Corp. | Jazz Pharmaceuticals, Inc. | ApniCure, Inc. | Aerial BioPharma LLC | Merck & Co., Inc. | XenoPort, Inc. https://onlinelibrary.wiley.com/doi/epdf/10.1002/ana.24498 https://synapse.zhihuiya.com/clinical-result-detail/4542ea589e55e04a5ee4d0a220235242 Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy NCT01485770 Pubmed 临床2期发作性睡病 | 嗜睡 33 JZP-110 MWT: difference = 11.8, P-Value = 0.0002 积极 2015-09-01 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/26298786/ | https://doi.org/10.1016/j.sleep.2015.05.013 https://synapse.zhihuiya.com/clinical-result-detail/528058a5d29a55a5205582ae00425320 Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy NCT01485770 Pubmed 临床2期发作性睡病 | 嗜睡 33 Placebo MWT: difference = 11.8, P-Value = 0.0002 积极 2015-09-01 Jazz Pharmaceuticals Plc https://pubmed.ncbi.nlm.nih.gov/26298786/ | https://doi.org/10.1016/j.sleep.2015.05.013 https://synapse.zhihuiya.com/clinical-result-detail/528058a5d29a55a5205582ae00425320 Oral JZP-110 phase 2b study for the treatment of excessivesleepiness in adults with narcolepsy: Results of a randomized,double-blind, placebo-controlled trial - WSC 临床2期 - 93 JZP-110 150 mg/day Adverse Event: anxiety = 11.4% vs 0% 积极 2015-02-26 Jazz Pharmaceuticals, Inc. | Aerial BioPharma LLC https://worldsleepsociety.org/wp-content/uploads/2016/07/WASM-2015-Korea-Abstracts.pdf https://synapse.zhihuiya.com/clinical-result-detail/5e5aaa85282485258e5e3955e2aea290 Oral JZP-110 phase 2b study for the treatment of excessivesleepiness in adults with narcolepsy: Results of a randomized,double-blind, placebo-controlled trial - WSC 临床2期 - 93 Placebo Adverse Event: anxiety = 11.4% vs 0% 积极 2015-02-26 Jazz Pharmaceuticals, Inc. | Aerial BioPharma LLC https://worldsleepsociety.org/wp-content/uploads/2016/07/WASM-2015-Korea-Abstracts.pdf https://synapse.zhihuiya.com/clinical-result-detail/5e5aaa85282485258e5e3955e2aea290 A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy NCT01681121 CTgov 临床2期发作性睡病 | 白天过度嗜睡 93 ADX-N05(ADX-N05) Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) for ADX-N05 300 mg vs. Placebo at Last Assessment.(Mean) = 12.8 Minute - 2014-09-11 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT01681121 https://synapse.zhihuiya.com/clinical-result-detail/55a0ee9a08e9de282ad2a4e395592e5a A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy NCT01681121 CTgov 临床2期发作性睡病 | 白天过度嗜睡 93 Placebo(Placebo) Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) for ADX-N05 300 mg vs. Placebo at Last Assessment.(Mean) = 2.1 Minute - 2014-09-11 Jazz Pharmaceuticals Plc https://clinicaltrials.gov/ct2/show/results/NCT01681121 https://synapse.zhihuiya.com/clinical-result-detail/55a0ee9a08e9de282ad2a4e395592e5a 12、转化医学研究亮点主题期刊/会议出版日期适应症机构 Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment - 上市后研究 J Psychopharmacol 2025-11-01 慢性疲劳综合征 Rochester Center for Behavioral Medicine Post-marketing safety of solriamfetol: A retrospective pharmacovigilance study based on the us food and drug administration adverse event reporting system - 真实世界研究 PLoS One 2025-09-22 白天过度嗜睡扬州大学 Results of the Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-Controlled Study (SHARP) - 上市后研究 Pubmed 2025-03-01 阻塞性睡眠呼吸暂停综合征 Axsome Therapeutics, Inc. | Neurotrials Research, Inc. | Washington State University SURWEY real-world study of solriamfetol: initiation, titration, safety, efficacy, and follow-up experience for patients with obstructive sleep apnea in Germany - 真实世界研究 Sleep Breath 2025-02-27 阻塞性睡眠呼吸暂停综合征 Axsome Therapeutics, Inc. | Philipps University of Marburg | University of Saarland | Heilig Geist-Hospital Evaluation of pitolisant, sodium oxybate, solriamfetol, and modafinil for the management of narcolepsy: a retrospective analysis of the FAERS database - 真实世界研究 Front Pharmacol 2024-11-11 发作性睡病 Department of Pharmacy, University-Town Hospital of Chongqing Medical University, Chongqing, China. Post-marketing safety profile of solriamfetol: A real-world disproportionality analysis using FDA adverse event reporting system (FAERS) database - 真实世界研究 Heliyon 2024-10-01 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 Health Management Center, The First Affiliated Hospital of Fujian Medical University, NO.20 Chazhong Road, Fuzhou, 350001, Fujian, China. Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm (P10-9.009) 该研究旨在从两项关于solriamfetol注册研究中计算效应大小（ES）、需要治疗的人数（NNT）和需要伤害的人数（NNH），这些统计数据可以帮助临床医生做出治疗决策。研究结果显示，solriamfetol治疗因纳科雷普西或阻塞性睡眠呼吸暂停症而导致的过度日间嗜睡症（EDS）的效果显著，且耐受性良好。在维持清醒测试（MWT）和Epworth嗜睡量表（ESS）上，solriamfetol的效应大小与安慰剂相比均有显著差异。需要治疗的人数（NNT）显示，solriamfetol对改善患者的嗜睡症状具有显著效果。总体而言，该研究结果支持solriamfetol作为治疗因纳科雷普西或阻塞性睡眠呼吸暂停症而导致的过度日间嗜睡症的有效药物。 3期临床研究 AAN 2024 2024-04-09 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - SURWEY Study of Solriamfetol: Initiation, Titration, Safety, Efficacy, and Follow-up Experience for Patients with OSA in Germany (P9-9.010) 该研究旨在对德国医生开展索利安非托尔治疗的真实剂量/滴定策略以及患者治疗后的结果进行表征。研究发现，索利安非托尔通常以每天37.5毫克的剂量开始，并且常见进行滴定。患者的白天过度嗜睡症状得到了临床上的显著改善，大多数患者和医生都认为索利安非托尔对白天过度嗜睡症状有改善作用。常见的不良反应包括头痛、失眠和烦躁。总体而言，索利安非托尔在德国患者中的应用是安全有效的。真实世界研究 AAN 2024 2024-04-09 阻塞性睡眠呼吸暂停综合征 - Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm Solriamfetol (Sunosi ® )是一种多巴胺/去甲肾上腺素再摄取抑制剂，已被批准（美国和欧盟）用于治疗成人的嗜睡症（75-150 mg/天）或阻塞性睡眠呼吸暂停症（37.5-150 mg/天）。该药物在两项注册研究中显示出良好的效果大小、需要治疗人数（NNT）和需要伤害人数（NNH）的统计参数。对于嗜睡症和阻塞性睡眠呼吸暂停症患者，该药物在维持清醒测试（MWT）和 Epworth嗜睡量表（ESS）上显示出良好的效果大小和NNT值。在两项研究中，药物的不良事件发生率较低，NNH值大多大于10，表明其耐受性良好。这项后续分析证实了Solriamfetol在治疗嗜睡症和阻塞性睡眠呼吸暂停症方面的良好效果和耐受性。 3期临床研究 WSC 2023 2023-10-24 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - Solriamfetol for Attention-Deficit/Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study. - 2/3期临床研究 Pubmed 2023-10-09 注意缺陷障碍伴多动 Corresponding Author: Craig B. Surman, MD, 55 Fruit St, Warren 625, Boston, MA 02114, (csurman@mgh.harvard.edu). | Clinical and Research Program in Adult ADHD, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Preclinical Pharmacology of Solriamfetol: Potential Mechanisms for Wake Promotion (P4-13.005) - 药物发现/临床前 AAN 2023 2023-04-25 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 Eurofins-Cerep SA | Jazz Pharmaceuticals Plc | Axsome Therapeutics, Inc. | E-Phy-Science Solriamfetol Improves Chronic Sleep Fragmentation-Induced Adverse Effects on Novel Object Recognition in Mice 慢性睡眠碎片化对小鼠新物体识别的不良影响得到改善。阻塞性睡眠呼吸暂停是一种慢性高发病情况，其特征为慢性间歇性低氧和睡眠碎片化，可能导致心血管、代谢和神经行为功能等多种器官疾病。Solriamfetol（SOL）是一种新型去甲肾上腺素-多巴胺再摄取抑制剂，可减少阻塞性睡眠呼吸暂停和嗜睡症患者的白天嗜睡。Modafinil（MOD）是一种常用的唤醒药物，用于治疗睡眠障碍患者。然而，目前尚无实验研究评估SOL对暴露于睡眠碎片化小鼠的新物体识别表现的影响。研究结果显示，SOL显著改善了睡眠碎片化引起的新物体识别缺陷，但对焦虑行为无影响。药物发现/临床前 ATS 2022 2022-05-15 - University of Missouri | Marie M. and Harry L. Smith Endowed Chair, Univ of Missouri School of Med, Columbia, MO, United States. Cognitive Deficits in Mice Exposed to Chronic Intermittent Hypoxia: Effect of Solriamfetol 本研究旨在探讨慢性间歇性低氧对小鼠认知功能的影响以及Solriamfetol（SOL）和Modafinil（MOD）的药理作用。研究发现，暴露于间歇性低氧的小鼠在新物体识别测试中表现出认知缺陷和焦虑行为增加。药物治疗后，SOL显著改善了认知功能，对焦虑有一定效果，而MOD对认知功能和焦虑影响不明显。这些结果为SOL在临床上进一步评估其有利的认知效果提供了依据。药物发现/临床前 ATS 2022 2022-05-15 - University of Missouri Solriamfetol and Modafinil Ameliorate Excessive Sleepiness in Mice Exposed to Chronic Intermittent Hypoxia 本研究旨在评估Solriamfetol（SOL）和Modafinil（MOD）对暴露于慢性间歇性低氧（IH）的小鼠的过度嗜睡症状的影响。结果显示，慢性IH显著增加了小鼠在黑暗周期的睡眠时间百分比，而SOL和MOD的治疗显著减少了睡眠时间，并增加了清醒时间。因此，SOL和MOD对改善暴露于IH的小鼠的过度嗜睡症状具有相当的疗效。药物发现/临床前 ATS 2022 2022-05-15 - Marie | Child Health, University of Missouri, Columbia, MO, United States TRIAL DESIGN: SOLRIAMFETOL ’ S EFFECT ON COGNITIVE HEALTH IN APNEA PARTICIPANTS DURING A RANDOMIZED PLACEBO- CONTROLLED STUDY (SHARP) 本研究由Jazz Pharmaceuticals支持，旨在评估solriamfetol对伴有阻塞性睡眠呼吸暂停症（OSA）的过度日间嗜睡（EDS）患者的认知功能的影响。研究采用随机、双盲、安慰剂对照、交叉设计，招募OSA和EDS患者进行研究。初步结果显示，截至2022年1月10日，已有45名参与者在北美和欧洲的研究中心进行了随机分组。研究目标招募116名参与者，样本量可能根据中期分析增加至164人。研究结果将有助于评估solriamfetol对EDS患者认知功能的改善效果。上市后研究 WSC 2022 2022-03-11 - Jazz Pharmaceuticals Plc | CognitionMetrics LLC Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder 本研究旨在评估新型多巴胺和去甲肾上腺素再摄取抑制剂（DNRI）索利安非托尔在治疗暴食症（BED）中的疗效和耐受性。研究采用12周、64名门诊患者的随机（1:1比例）、安慰剂对照、双盲、平行组、2臂临床试验。主要观察指标为患者填写的暴食日频率。次要观察指标包括暴食发作频率以及耶鲁-布朗强迫症量表和临床全球严重程度量表的评分。这是首个关于索利安非托尔在BED中安全性和疗效的随机、双盲研究，对使用DNRI治疗BED进行了讨论。该研究已在ClinicalTrials.gov注册，识别号为NCT04602936。上市后研究 Pubmed 2021-11-01 暴食症 Lindner Center of HOPE, 4075 Old Western Row Road, Mason, OH 45040, United States of America | University of Cincinnati College of Medicine, Department of Psychiatry & Behavioral Neuroscience, Stetson Building, 260 Stetson Street, Suite 3200, Cincinnati, OH 45219, United States of America. Electronic address: anna.guerdjikova@lindnercenter.org. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea 该研究评估了长期使用索利安非托对患有嗜睡症或阻塞性睡眠呼吸暂停症的参与者的生活质量和工作生产力的影响。研究发现，长期使用索利安非托可显著改善患者的功能状态、工作生产力和生活质量，持续时间长达52周。索利安非托对嗜睡症和阻塞性睡眠呼吸暂停症患者的不良事件相似。这一研究结果为索利安非托在治疗嗜睡症和阻塞性睡眠呼吸暂停症患者的长期疗效提供了重要的临床证据。药物发现/临床前 Pubmed 2021-10-01 narcolepsy or obstructive sleep apnea Jazz Pharmaceuticals, Inc. | Philipps University of Marburg | College of Nursing, University of Illinois Chicago, Chicago, Illinois | Cleveland Sleep Research Center, Cleveland, Ohio Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. 该研究旨在分析随机对照试验中使用solriamfetol治疗阻塞性睡眠呼吸暂停和嗜睡症患者的常见早期不良事件的发生率和持续时间。研究对象包括474名阻塞性睡眠呼吸暂停患者和236名嗜睡症患者，分别接受12周的安慰剂或solriamfetol 37.5（仅限阻塞性睡眠呼吸暂停患者）、75、150或300毫克的治疗。结果显示，solriamfetol治疗的常见早期不良事件包括头痛、恶心、食欲减退、焦虑、失眠等，发生率最高的是头痛和恶心，但大多数不良事件在治疗的第一周内即可缓解。该研究结果有助于评估solriamfetol治疗的安全性和耐受性。 3期临床研究 J Clin Sleep Med 2021-07-20 发作性睡病 | 白天过度嗜睡 Jazz Pharmaceuticals Plc Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. 该研究是一项针对帕金森病患者的过度日间嗜睡症（EDS）的2期概念验证试验。研究评估了索利安非托对帕金森病患者EDS的安全性和有效性。研究结果显示，索利安非托在安全性和耐受性方面与已知的特征一致。在Epworth嗜睡量表（ESS）方面未见显著改善，但维持清醒测试（MWT）结果表明索利安非托可能对PD患者有益。研究结果发表在《Movement Disorders》杂志上。 2期临床研究 Mov Disord 2021-06-30 白天过度嗜睡 Jazz Pharmaceuticals Plc Solriamfetol Titration & AdministRaTion (START): Characteristics of Patients with Obstructive Sleep Apnea and Prescriber Rationale for Starting Treatment with Solriamfetol 该研究调查了使用Solriamfetol治疗阻塞性睡眠呼吸暂停综合征（OSA）患者的特征以及医生开展治疗的原因。研究发现，即使患者坚持使用主要的OSA治疗方法，如持续气道正压通气，白天过度嗜睡（EDS）仍可能持续存在。Solriamfetol是一种多巴胺/去甲肾上腺素再摄取抑制剂，已被批准用于治疗成人的EDS。研究结果显示，医生在选择Solriamfetol治疗时主要考虑了药物的疗效。研究还发现，大多数患者在使用Solriamfetol后病情稳定，而停药的原因主要是疗效不佳和副作用。这些结果有助于更好地了解在真实世界环境中，医生开展Solriamfetol治疗的策略和原因。真实世界研究 ATS 2021 2021-05-03 阻塞性睡眠呼吸暂停综合征 - Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in Obstructive Sleep Apnea: An Analysis of Subgroups Adherent or Nonadherent to Obstructive Sleep Apnea Treatment. 该研究是一项关于Solriamfetol治疗睡眠呼吸暂停综合征（OSA）引起的过度日间嗜睡的随机对照试验。研究发现Solriamfetol能够改善OSA患者的过度日间嗜睡，无论其是否坚持主要OSA治疗。Solriamfetol对主要OSA治疗的使用没有产生明显影响。研究结果表明Solriamfetol在改善OSA患者的过度日间嗜睡方面具有潜在的临床应用前景。 3期临床研究 Chest 2021-02-22 白天过度嗜睡 Jazz Pharmaceuticals Plc Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a post hoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. 該研究旨在評估solriamfetol在治療嗜睡癥的臨床相關性。對於患有小睡癥或阻塞性睡眠呼吸暫停症（OSA）的參與者進行後續分析的結果顯示，與安慰劑組相比，使用solriamfetol治療的參與者達到正常ESS分數（≤ 10）或臨床意義上的ESS改善的百分比更高。安全性方面，小睡癥和OSA患者的安全概況相似。 3期临床研究 J Clin Sleep Med 2020-11-23 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 Jazz Pharmaceuticals Plc Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. 该研究评估了多巴胺/去甲肾上腺素再摄取抑制剂solriamfetol在患有阻塞性睡眠呼吸暂停症（OSA）的参与者中的疗效，包括对于遵循或不遵循主要OSA治疗的人群。研究结果显示，solriamfetol对于长期治疗的患者无论是否遵循主要OSA治疗，其疗效和安全性均相似，并且不影响主要治疗的使用。这一研究为solriamfetol在阻塞性睡眠呼吸暂停症患者中的应用提供了重要的临床数据支持。 3期临床研究 J Clin Sleep Med 2020-11-11 阻塞性睡眠呼吸暂停综合征 Jazz Pharmaceuticals Plc Effects of Solriamfetol on Driving Performance inParticipants with Narcolepsy 该研究评估了索利安非托对嗜睡症患者驾驶表现的影响。结果显示，索利安非托（300 mg/d）在用药后2小时改善了SDLP，这是衡量驾驶表现的重要指标。研究包括24名参与者，结果表明索利安非托在用药后2小时显著降低了SDLP，表明其改善了驾驶表现。然而，在用药后6小时，索利安非托的SDLP与安慰剂组没有显著差异。常见不良事件包括头痛、食欲减退、嗜睡、睡眠障碍、焦虑、恶心和心悸。索利安非托可改善嗜睡症患者的驾驶表现，但需注意不良事件的发生。 2期临床研究 ANA 2020 2020-09-25 发作性睡病 Jazz Pharmaceuticals Plc Long-Term Effects of Solriamfetol on Functioningand Work Productivity in Participants with ExcessiveDaytime Sleepiness Associated with Narcolepsy 该研究评估了索利安非托对患有嗜睡症的参与者在长达一年的时间内对功能和工作生产力的影响。结果显示，索利安非托在改善功能和工作生产力方面表现持久。大多数不良事件的严重程度为轻度至中度。研究包括226名患有嗜睡症的参与者，结果显示索利安非托对功能和工作生产力的改善持续稳定，常见不良事件包括头痛、恶心、焦虑、鼻咽炎、食欲减退、失眠和口干。有6名参与者（2.7%）出现严重不良事件。索利安非托是一种多巴胺/去甲肾上腺素再摄取抑制剂，已在美国和欧盟获批用于改善嗜睡症或阻塞性睡眠呼吸暂停症成年患者的清醒度。药物发现/临床前 ANA 2020 2020-09-25 - University of Toronto | Jazz Pharmaceuticals Plc | University of California San Diego | Cleveland Sleep Research Center | Sahlgrenska University Hospital Effects of Solriamfetol on Quality-of-Life Measures from a 12-Week Phase 3 Randomized Controlled Trial 本研究旨在评估多巴胺/去甲肾上腺素再摄取抑制剂Solriamfetol对患有阻塞性睡眠呼吸暂停症和过度日间嗜睡症患者的日常功能、健康相关生活质量和工作生产力的治疗效果。研究结果显示，Solriamfetol 150mg和300mg剂量组在12周时相较于安慰剂组，能够显著提高功能状态、减少工作和活动受损，改善身体和心理健康总结分。常见不良事件包括头痛、恶心、食欲减退和焦虑。研究表明，Solriamfetol能够改善阻塞性睡眠呼吸暂停症和过度日间嗜睡症患者的功能、生活质量和工作生产力，且安全性与先前研究一致。该临床试验已在www.clinicaltrials.gov注册（NCT02348606）。 3期临床研究 Pubmed 2020-08-01 阻塞性睡眠呼吸暂停综合征 SleepMed, Inc. | CTI Clinical Research Center | Jazz Pharmaceuticals, Inc. | Sleep Therapy & Research Center LLC | Stanford Center for Sleep Sciences and Medicine, Palo Alto, California | University of Illinois at Chicago College of Nursing, Chicago, Illinois | FutureSearch Trials of Neurology LP, Austin, Texas Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. 该研究分析了多巴胺/去甲肾上腺素再摄取抑制剂Solriamfetol在嗜睡症患者中的疗效和安全性，结果显示Solriamfetol对嗜睡症患者的清醒度和白天过度嗜睡症状有显著改善，无论是否伴有肌无力发作。研究结果表明，Solriamfetol对嗜睡症患者的治疗效果显著，且安全性良好。 3期临床研究 CNS Drugs 2020-07-01 发作性睡病 Jazz Pharmaceuticals Plc Long-Term Effects of Solriamfetol on Functioning and Work Productivity in Participants With Excessive Daytime Sleepiness Associated With Narcolepsy (1388) 该研究评估了索利安非托对患有嗜睡症的参与者长期功能和工作生产力的影响。研究发现，索利安非托在约1年的时间内持续改善了嗜睡症患者的功能和工作生产力。安全性与先前的研究相似。研究对象包括完成先前索利安非托研究的嗜睡症或阻塞性睡眠呼吸暂停综合征（OSA）患者。结果显示，索利安非托对嗜睡症患者的功能和工作生产力有持续改善作用。常见不良事件包括头痛、恶心、焦虑、鼻咽炎、食欲减退、失眠和口干。有6名参与者（2.7%）出现≥1个严重不良事件。药物发现/临床前 AAN 2020 2020-04-14 发作性睡病 University of Toronto | Jazz Pharmaceuticals Plc | Cleveland Clinic Lerner College of Medicine | Cleveland Sleep Research Center Clinically Relevant Effects of Solriamfetol on Excessive Daytime Sleepiness: A Post-Hoc Analysis of the Magnitude of Change in a Clinical Trial of Adults With Narcolepsy (644) 该研究分析了索利安非托对嗜睡症患者过度日间嗜睡的临床影响。研究结果显示，索利安非托显著减少了参与者自报的嗜睡症状。在12周的研究中，索利安非托对嗜睡症的临床效果得到进一步证实。索利安非托治疗组中，有30.5%、40.0%和49.2%的参与者的嗜睡症状得到改善，相比之下，安慰剂组只有15.5%的参与者嗜睡症状得到改善。常见的治疗相关不良事件包括头痛、恶心、食欲减退、鼻咽炎、口干和焦虑，大多数不良事件的严重程度为轻度或中度。该研究结果表明，索利安非托对嗜睡症的临床治疗具有重要意义。 3期临床研究 AAN 2020 2020-04-14 发作性睡病 Jazz Pharmaceuticals Plc | Neurotrials Research, Inc. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy 本研究旨在评估多巴胺/去甲肾上腺素再摄取抑制剂solriamfetol对嗜睡症患者功能状态、健康相关生活质量和工作生产力的影响。研究结果显示，solriamfetol在150mg和300mg剂量下改善了功能状态、健康相关生活质量和工作生产力。大多数治疗相关不良事件为轻度或中度。常见不良事件包括头痛、恶心、食欲减退、鼻咽炎、口干和焦虑。该研究结果为solriamfetol在嗜睡症治疗中的应用提供了重要参考。ClinicalTrials.gov标识号NCT02348593，EudraCT号2014-005487-15。 3期临床研究 Pubmed 2020-03-01 发作性睡病 University of Toronto | Jazz Pharmaceuticals, Palo Alto, CA, USA; Stanford Center for Sleep Sciences and Medicine, Palo Alto, CA, USA. | Jazz Pharmaceuticals, Palo Alto, CA, USA. | The Center for Sleep & Wake Disorders, Chevy Chase, MD, USA; George Washington University Medical Center, Washington, DC, USA. Electronic address: sleepdoc@sleepdoc.com. | Jazz Pharmaceuticals, Palo Alto, CA, USA; University of Arkansas for Medical Sciences, Little Rock, AR, USA. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea 该研究旨在评估溴丙醇对嗜睡症和阻塞性睡眠呼吸暂停患者长期昼间过度嗜睡治疗的安全性和有效性。参与者通过逐渐增加药量的方法进行治疗，并在维持期（长达50周）内接受检测。结果表明，溴丙醇治疗能明显改善患者的嗜睡程度，而在安慰剂对照阶段，继续接受溴丙醇治疗的患者改善幅度明显优于转为安慰剂的患者。溴丙醇的常见不良事件包括头痛、恶心、鼻咽炎、失眠、口干、焦虑、食欲减退和上呼吸道感染。总体来看，该研究结论显示出溴丙醇在长期治疗下能够维持其有效性，并且安全性与以往研究结果一致，没有新的安全问题。这一研究为溴丙醇的长期治疗提供了有效的临床数据支持。 3期临床研究 Pubmed 2020-02-13 白天过度嗜睡 University of Toronto | Jazz Pharmaceuticals, Inc. | Philipps University of Marburg | Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego , La Jolla | Cleveland Sleep Research Center , OH Long-term efficacy of solriamfetol for excessive sleepiness in narcolepsy or obstructive sleep apnea 该研究评估了索利安非托治疗嗜睡症和阻塞性睡眠呼吸暂停症的长期安全性和有效性。研究结果显示，在长达50周的开放标签索利安非托治疗期间，患者的Epworth嗜睡量表（ESS）得分显著改善，且维持了治疗效果。在两周的安慰剂对照随机退出阶段，索利安非托组的患者相较于安慰剂组在ESS评分、患者和临床印象改变方面表现更好。该药物的常见不良事件包括头痛、恶心、上呼吸道感染等，且有4.2%的患者出现严重不良事件。总体而言，这些结果证明了索利安非托治疗嗜睡症或阻塞性睡眠呼吸暂停症的长期疗效和安全性。 3期临床研究 ERS 2019 2019-09-28 阻塞性睡眠呼吸暂停综合征 | 白天过度嗜睡 Grenoble Alpes University Hospital, Grenoble, France | Jazz Pharmaceuticals, Palo Alto, United States of America INCIDENCE AND DURATION OF COMMON ADVERSE EVENTS IN 2 SOLRIAMFETOL PHASE 3 STUDIES FOR TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN OBSTRUCTIVE SLEEP APNOEA AND NARCOLEPSY 两项3期研究中，治疗阻塞性睡眠呼吸暂停和嗜睡症的索利安非托尔引起的常见早发性治疗相关不良事件（TEAEs）包括头痛、食欲减退和恶心，阻塞性睡眠呼吸暂停患者还包括焦虑、神经过敏和失眠，嗜睡症患者还包括口干。在≤150 mg剂量下，头痛、恶心和神经过敏的中位持续时间≤10天；食欲减退、焦虑、失眠和口干的中位持续时间更长。阻塞性睡眠呼吸暂停患者中，早发性TEAEs占TEAE相关的中止的44%，嗜睡症患者中为11%。这一分析有助于医生和患者对索利安非托尔相关的常见早发性TEAEs的类型和持续时间有更清晰的认识。 3期临床研究 WSC 2019 2019-09-20 发作性睡病 | 阻塞性睡眠呼吸暂停综合征 - POOLED ANALYSES FROM 12-WEEK RANDOMISED, CONTROLLED STUDIES OF SOLRIAMFETOL IN THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS IN PARTICIPANTS WITH OSA OR NARCOLEPSY 这项研究总结了三项12周的随机对照研究，对排泄期间过度昼间嗜睡症的患者进行了研究，研究对象包括患有睡眠呼吸暂停综合症（OSA）或嗜睡症的患者。结果表明，索利安非托在改善患者症状方面的有效性与安全性与患者的基础诊断无关。索利安非托的美国批准剂量范围为每日一次75到150毫克，欧洲药品管理局正在审查其适应症的上市申请。研究汇总数据显示，索利安非托对改善睡眠觉醒维持试验中的平均睡眠潜伏期、Epworth嗜睡量表评分和患者自评改善比例具有明显效果，而且安全性相对较好。常见的不良事件包括头痛、恶心、食欲减退、焦虑、上呼吸道感染、腹泻和口干，而且在OSA和嗜睡症患者中发生率相当。" 3期临床研究 WSC 2019 2019-09-20 - Albert Einstein College of Medicine, Inc. | Neurotrials Research, Inc. | The George Washington University Medical Center | The Center for Sleep and Wake Disorders, Chevy Chase, | Jazz Pharmaceuticals, Palo Alto, United States, EFFECTS OF SHORT- AND LONG-TERM SOLRIAMFETOL TREATMENT ON ADHERENCE TO PRIMARY OBSTRUCTIVE SLEEP APNOEA THERAPY 该研究分析了使用solriamfetol治疗过度日间嗜睡症（EDS）对原发性阻塞性睡眠呼吸暂停（OSA）治疗设备使用的影响。研究结果表明，solriamfetol治疗并未影响参与者对原发性OSA治疗设备的使用，且安全性相似。研究数据来自一项为期12周的随机、双盲、安慰剂对照的第3期试验和一项持续52周的开放标签延伸试验。研究参与者在整个研究期间被要求保持相同水平的原发性OSA治疗设备使用。研究结果显示，solriamfetol治疗对原发性OSA治疗设备使用没有实质性影响，且常见不良事件包括头痛、恶心、食欲减退、焦虑等。感谢Jazz Pharmaceuticals提供支持，Peloton Advantage提供医学写作支持。 3期临床研究 WSC 2019 2019-09-20 阻塞性睡眠呼吸暂停综合征 - Safety and Efficacy of Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Parkinson’s Disease in a Four-Week Double-blind, Placebo-controlled Randomized Crossover Study (P3.8-036) 本研究旨在评估Solriamfetol治疗帕金森病患者过度日间嗜睡的安全性和有效性。研究采用双盲安慰剂对照、随机交叉设计，纳入66名35-80岁的帕金森病患者，持续4周。结果显示Solriamfetol在减轻EDS方面具有潜力，最终的安全性和有效性数据将在2019年AAN年会上公布。该药物对于PD患者的治疗具有重要意义，但仍需进一步研究。 2期临床研究 AAN 2019 2019-04-09 帕金森病 Jazz Pharmaceuticals, Inc. | Movement Disorders Unit and Division of Sleep Medicine, MGH Neurological Clinical Research Institute, Boston, MA Boston MA United States Solriamfetol for the Treatment of Excessive Sleepiness in OSA 该研究评估了索利安非托（JZP-110）对成人阻塞性睡眠呼吸暂停症（OSA）患者过度嗜睡症状的治疗效果。研究结果显示，使用索利安非托治疗的患者在维持清醒测试和 Epworth 嗜睡量表方面表现出改善，并且在6周内维持了治疗效果。与安慰剂相比，索利安非托组的患者在MWT和ESS上的改善幅度分别为11.2分钟和-4.6分。少数患者出现头痛、口干、恶心、头晕和失眠等不良事件。该研究结果表明，索利安非托在6周内的疗效和安全性得到了维持。这一研究为索利安非托在OSA患者中治疗过度嗜睡症状提供了有力的临床证据。 3期临床研究 Pubmed 2019-02-01 阻塞性睡眠呼吸暂停综合征 University of Turku | Jazz Pharmaceuticals Plc | PAB Clinical Research/Florida Sleep Disorder Center, Brandon, FL | From the University of Pittsburgh/Veterans Administration Pittsburgh Health System, Pittsburgh, PA A Randomized, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Solriamfetol (JZP-110) for the Treatment of Excessive Sleepiness (ES) in Participants with Narcolepsy Types 1 and 2 (NT1/2) (CT.003) 这是一项关于Solriamfetol（JZP-110）治疗嗜睡症的安全性和有效性的随机、安慰剂对照、3期研究（CT.003）。Solriamfetol是一种选择性多巴胺和去甲肾上腺素再摄取抑制剂，具有唤醒作用。研究结果表明，Solriamfetol显著改善了患有NT1/2的参与者的清醒度，并减少了嗜睡症状。安全性和耐受性与之前的研究一致。研究设计为12周的双盲、随机、安慰剂对照、平行组研究。结果显示，Solriamfetol显著增加了参与者的清醒时间，并减少了嗜睡症状。常见的治疗相关不良事件包括头痛、恶心、食欲减退、鼻咽炎、口干和焦虑。Solriamfetol在治疗NT1/2患者中显示出了良好的安全性和有效性。 3期临床研究 AAN 2018 2018-04-10 发作性睡病 | 嗜睡 Jazz Pharmaceuticals, Inc. Safety and Efficacy of JZP-110 for Treatment ofExcessive Sleepiness in Narcolepsy: Results of aRandomized, Placebo-Controlled, Phase 3 Study 该研究评估了JZP-110在治疗嗜睡症患者过度嗜睡症的安全性和有效性。研究结果显示，JZP-110是一种选择性多巴胺和去甲肾上腺素再摄取抑制剂，具有唤醒作用。在12周的随机、安慰剂对照的研究中，JZP-110 150mg和300mg剂量显著改善了患者的清醒维持测试和Epworth嗜睡量表得分，且患者对改善的自我评价也显著提高。与安慰剂相比，JZP-110的治疗剂量在安全性方面与2期试验一致。该研究结果支持了JZP-110作为治疗嗜睡症患者过度嗜睡症的潜在疗法。 3期临床研究 ANA 2017 2017-10-15 发作性睡病 - RESULTS OF A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, 12-WEEK, MULTICENTER STUDY OF SOLRIAMFETOL (JZP-110) FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA 本研究是一项随机、安慰剂对照、双盲、12周、多中心研究，旨在评估solriamfetol（JZP-110）治疗阻塞性睡眠呼吸暂停患者过度嗜睡的效果。研究结果显示，solriamfetol 75mg、150mg和300mg剂量组的治疗导致客观清醒度增加、主观嗜睡感减少，以及整体改善，分别通过MWT、ESS和PGI-C测量。耐受性与之前的solriamfetol纳科病研究一致。研究表明solriamfetol对阻塞性睡眠呼吸暂停患者的过度嗜睡具有潜在的治疗效果。 3期临床研究 WSC 2017 2017-10-07 阻塞性睡眠呼吸暂停综合征 Jazz Pharmaceuticals Plc FUNCTION, WORK PRODUCTIVITY, AND QUALITY OF LIFE MEASURES IN A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, 12-WEEK STUDY OF THE SAFETY AND EFFICACY OF SOLRIAMFETOL (JZP-110) FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA 本研究是一项为期12周的多中心、随机、安慰剂对照、双盲、3期研究，旨在评估Solriamfetol（JZP-110）治疗阻塞性睡眠呼吸暂停患者过度嗜睡的安全性和有效性。研究结果表明，Solriamfetol 150mg和300mg剂量改善了患者的功能、工作生产力和健康相关生活质量。安全性和耐受性与之前在纳科雷普症患者中进行的2期研究一致。研究结果对于生物医药领域的教授具有重要的临床意义。 3期临床研究 WSC 2017 2017-10-07 阻塞性睡眠呼吸暂停综合征 AND QUALITY OF LIFE MEASURES IN A PHASE 3, RANDOMIZED, PLACEBO - CONTROLLED, DOUBLE - BLIND, MULTICENTER A RANDOMIZED, PLACEBO-CONTROLLED, PHASE 3 STUDY OF THE SAFETY AND EFFICACY OF SOLRIAMFETOL (JZP-110) FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH NARCOLEPSY 本研究是一项随机、安慰剂对照的3期研究，旨在评估solriamfetol（JZP-110）治疗嗜睡症患者的安全性和有效性。研究结果表明，solriamfetol显著改善了嗜睡症患者的清醒度，减少了过度嗜睡。该药物的安全性和耐受性与之前在嗜睡症患者中进行的2期研究一致。研究采用了12周的双盲、随机、安慰剂对照、平行分组设计，结果显示solriamfetol在300mg和150mg剂量下显著增加了清醒度，减少了过度嗜睡。研究还发现，solriamfetol在所有剂量下均能提高患者的整体状况。在安全性方面，头痛、恶心、食欲减退、鼻咽炎、口干和焦虑是最常见的治疗相关不良事件，且发生率与剂量相关。总体而言，solriamfetol在治疗嗜睡症患者方面表现出良好的安全性和有效性。 3期临床研究 WSC 2017 2017-10-07 发作性睡病 Jazz Pharmaceuticals Plc TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA: EFFICACY AND SAFETY RESULTS OF A 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED-WITHDRAWAL TRIAL OF SOLRIAMFETOL (JZP-110) 本研究旨在评估Solriamfetol对阻塞性睡眠呼吸暂停综合征（OSA）患者过度嗜睡症状的疗效和安全性。研究结果显示，Solriamfetol治疗组在MWT、ESS和PGI-C评分上的改善明显优于安慰剂组。Solriamfetol突然停药未伴随停药相关不良事件。研究还发现，Solriamfetol治疗组在稳定剂量和随机停药期间的不良事件发生率均低于5%。因此，Solriamfetol对OSA患者的过度嗜睡症状具有显著疗效且安全性良好。 3期临床研究 WSC 2017 2017-10-07 阻塞性睡眠呼吸暂停综合征 Jazz Pharmaceuticals Plc JZP-110, a Dopamine Norepinephrine ReuptakeInhibitor (DNRI), with Robust Wake-Promoting Effectsand Low Abuse Potential JZP-110是一种多巴胺和去甲肾上腺素再摄取抑制剂(DNRI)，具有强大的唤醒作用和低滥用潜力。研究表明，JZP-110与传统兴奋剂相比，具有独特的作用机制和低滥用潜力。临床试验结果显示，JZP-110每日一次的用药可能对治疗嗜睡症和嗜睡症患者的清醒障碍具有治疗潜力。研究人员在研究中披露了与Jazz Pharmaceuticals的雇佣关系和股权持有情况。JZP-110的非临床研究结果显示，其对多巴胺和去甲肾上腺素的再摄取抑制作用更为选择性和较弱，不会引起滥用和反跳性嗜睡。临床试验结果显示，JZP-110每日一次的治疗显著增加了患者在整天9小时内保持清醒的能力。常见的不良事件包括失眠、头痛、恶心、食欲减退、腹泻和焦虑。该研究由Jazz Pharmaceuticals赞助。 2期临床研究 ANA 2016 2016-10-14 - - Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study 本研究旨在评估口服JZP-110对成年患有睡病的患者的清醒度和过度嗜睡症状的疗效和安全性。研究采用了随机、双盲、安慰剂对照的方法，结果显示，JZP-110显著改善了患者的清醒能力和过度嗜睡症状。在150-300 mg/天的剂量下，JZP-110耐受性良好，对成年患有睡病的患者具有显著疗效。常见的不良事件包括失眠、头痛、恶心、腹泻、食欲减退和焦虑。该研究结果表明JZP-110在睡病治疗中具有潜在的临床应用前景。 2期临床研究 Sleep 2016-07-01 发作性睡病 | 嗜睡 Jazz Pharmaceuticals Plc Patient and Clinician Global Impressions ofChange in Disease Status Were Correlated in a ClinicalTrial of JZP-110 Treatment for Narcolepsy 研究发现，JZP-110治疗嗜睡症的临床试验中，患者和临床医生对疾病状态改变的整体印象之间存在显著的一致性。JZP-110治疗组在12周时，临床医生评定的疾病改善比安慰剂组显著增加（86.0%对38.3%），患者自评的改善比例也显著增加（93.0%对38.3%）。患者自评和临床医生评定之间的相关性强且显著（Spearman r 5 0.868; P < 0.0001）。这项研究由Aerial BioPharma, LLC资助，JZP-110被证实是一种改善嗜睡症相关疲倦的唤醒药物。 2期临床研究 ANA 2015 2015-09-25 发作性睡病 Atlanta PT | Morrisville and Palo Alto | Dallas, TX | E. Aurora, Co ; Chevy Chase, MD | Redwood City Definition of a Responder to NarcolepsyTreatment with JZP-110 研究旨在定义对JZP-110治疗的纳科病患者的反应者。研究发现，基线至少25%的Epworth嗜睡量表（ESS）得分减少可能是对JZP-110治疗反应的最佳标准。研究由Aerial BioPharma，LLC资助。研究结果表明，对JZP-110的有意义反应可能是基线ESS得分减少25％，具有较高的敏感性（81.4％）和特异性（80.9％）。这项研究对于了解纳科病患者的治疗反应至关重要。 2期临床研究 ANA 2015 2015-09-25 发作性睡病 - Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy 本研究旨在探讨口服JZP-110（ADX-N05）对患有嗜睡症的成年人清醒和嗜睡状况的影响。研究结果表明，JZP-110在150-300 mg/天剂量下，能够显著延长患者清醒时间，改善嗜睡症状。在治疗1至2周后，患者的Epworth嗜睡量表（ESS）评分明显下降，且JZP-110相对于安慰剂更为有效。研究还发现，JZP-110在治疗过程中耐受性良好，常见不良事件包括恶心、非心脏胸部不适和头痛。因此，JZP-110可作为一种有效的改善清醒和嗜睡症状的治疗药物。 2期临床研究 Sleep Med 2015-09-01 发作性睡病 | 嗜睡 Jazz Pharmaceuticals Plc Oral JZP-110 phase 2b study for the treatment of excessivesleepiness in adults with narcolepsy: Results of a randomized,double-blind, placebo-controlled trial 这项研究旨在评估JZP-110对成年患有睡病的患者的治疗效果。研究结果显示，JZP-110在150和300毫克/天的剂量下，对睡病患者的过度嗜睡症状有显著改善，并且耐受性良好。在12周的研究中，JZP-110组的患者在多个评估指标上均表现出明显改善，包括睡眠延迟时间、睡眠质量和临床整体印象。研究资助方为Aerial BioPharma，Jazz Pharmaceuticals, Inc.已从Aerial BioPharma获得JZP-110的许可。研究中发现JZP-110的常见不良事件包括失眠、头痛、恶心、食欲减退、腹泻和焦虑，但大多数不良事件均为轻度。三名受试者因不良事件而退出研究，而JZP-110组中出现的两起严重不良事件与治疗无关。 2期临床研究 WSC 2015 2015-02-26 - - R228060, a new stimulant: strain and drug comparisons of the effects on EEG, sleep and transcriptome in mice 本研究测试了苯丙氨酸衍生物R228060（R22）作为一种新的唤醒促进药物，对三种小鼠品系的清醒脑电图（EEG）、恢复睡眠和基因表达的影响进行了对比。研究发现，R22是一种有效的唤醒促进药物，与两种常用的兴奋剂（d-安非他明和莫达非尼）相比，R22的清醒脑电图谱特征明显不同，表明激活了不同的神经通路来实现唤醒促进。此外，R22是唯一一种引起基因表达变化与正常睡眠剥夺非常相似的兴奋剂。因此，R22可能是一种潜在的治疗过度日间嗜睡的新药物。药物发现/临床前 SFN 2007 2007-11-07 - Ctr. for Integrative Genomics, Lausanne Univ., Lausanne, Switzerland

引进/卖出临床3期临床2期临床1期并购

2026-01-24

·药政时势

百利天恒2026 J.P. Morgan会议实录（文字稿）

English Jeff (Host):All right, thank you everyone. We will go to our next presentation given the timing. Nice to meet you all, and thank you for joining the J.P. Morgan Healthcare Conference. I'm Jeff, based in Hong Kong, the Senior Director in the China Healthcare team. We are very happy and honored to welcome our next presenting company,Sichuan Biokin Pharmaceutical Company. The company is listed in Asia and is an integrated pharmaceutical company spanning capabilities from early-stage research to development, with a focus on oncology. Today, we have the honor of having the CEO of SystImmune,Dr. Jie D'Elia, presenting the company. So Jie, over to you. Jie D'Elia (CEO, SystImmune/Biokin):Thank you, Jeff, and thank you to the J.P. Morgan Healthcare Conference for the invitation. My name is Jie D'Elia, and I am the CEO of SystImmune. SystImmune is the US subsidiary of Biokin Pharmaceutical. I will be presenting on behalf of Biokin. Let's start with Biokin's evolution. Biokin was founded about 30 years ago, in the mid-90s, initially as a generic company. Over the last 30 years, it has evolved into an innovation-driven leading biopharmaceutical company with a first-in-class and best-in-class pipeline. In 2023, Biokin was listed on the Shanghai Stock Exchange. Subsequently, later that year, Biokin entered into a strategic partnership with Bristol Myers Squibb to co-developIzalontamab, a first-in-class bispecific antibody. Since then, we have made significant progress in the development of Izalontamab as well as our wholly owned pipeline. In 2025 alone, we achieved a number of exciting clinical milestones, including the initiation of three pivotal global registration trials and three new Phase 3 trials in China. We also saw the first positive Phase 3 readout of Izalontamab in a controlled randomized trial in China, and I will share that data later in this presentation. In addition, we are very well capitalized. We have raised about 500 million US dollars through an A-share private placement. Additionally, we achieved a clinical milestone payment from our partner Bristol Myers Squibb in the amount of 250 million dollars. Another highlight of our pipeline progress is the initiation of two new INDs, including one for aradiopharmaceuticalproduct. I'm sure you have heard a lot about "China speed" and China innovation. Biokin and SystImmune are best positioned to take advantage of the best of both the China and US innovation ecosystems. We operate a fully integrated biopharma model with teams established in the United States as well as in China. In the US, we focus on innovation, leveraging novel biology concepts to develop novel therapeutics through hit generation and hit-to-lead optimization. Once the lead candidate is identified, our Biokin China team engages in rapid preclinical and process development. The team in China then files the IND and conducts first-in-human studies to generate initial safety data, as well as continued data generation across multiple tumors to establish proof of concept. This data from China enables the US team, where we have over 70 people in our clinical development organization, to quickly engage in an accelerated global development pathway and launch pivotal or registration-enabling trials. This fully integrated, seamless collaboration between the US and China teams has enabled us to advance our pipeline very quickly. Our long-term vision is to build SystImmune and Biokin into a multinational company with global capabilities and scale. We have already established capabilities in global discovery innovation and a global clinical development team. We are in the process of building manufacturing and supply chains both in and outside of China to ensure supply stability. Looking to 2026, we expect the first commercial launch of Izalontamab in China. In anticipation of that, we have established a China commercial team. In the next few years, we will look to establish a US commercial team as Izalontamab advances towards approval later in this decade. We believe we have the critical success factors to enable this long-term vision. We have a very exciting pipeline with 17 clinical-stage programs, supported by a global oncology leader, Bristol Myers Squibb. We also have access to capital markets as we continue to explore a potential IPO in Hong Kong. We are very well capitalized, thanks to approximately $1.5 billion in dilutive and non-dilutive financing raised since 2024. Additionally, as mentioned, we are exploring a Hong Kong IPO to raise about $500 million, which would bring our cash position to over $2 billion. Furthermore, we have received a committed credit facility from Chinese banks amounting to $3 billion, which we can deploy towards global clinical development. This means we have aggregate available funds of $5 billion to draw upon to advance our pipeline, grow our company, and ultimately become a leading biopharmaceutical multinational with global capabilities. Here is a brief overview of our pipeline. We have 17 clinical-stage compounds derived from three innovative platforms: our leading ADC platform with a Topo-1 payload (as well as next-generation novel payloads), our T-cell engager platform with four clinical-stage assets, and our recently initiatedradioligandtherapy platform. The first program from the latter has entered the clinic in China, and we expect to bring that program to the US in the near term. In the US, we currently have six assets in clinical development and two additional programs in IND preparation. By the end of the year, we should have at least eight clinical programs in development, and we expect to launch at least one or two global registrational trials this year. Now let's look at the recent development of Izalontamab, our lead asset. This is a first-in-class bispecific ADC targeting EGFR and HER3, developed in strategic collaboration with Bristol Myers Squibb. As of now, Izalontamab has initiated 13 registration-enabling trials in China and globally. We have dosed over 5,000 patients. This program has received Breakthrough Therapy Designation from the FDA in EGFR-mutant non-small cell lung cancer (NSCLC) and seven additional Breakthrough Designations from the Chinese NMPA in other tumor types. This allows us to seek accelerated regulatory pathways when feasible and maintain close communication with regulatory agencies in both China and the US. Last year, we reported two positive Phase 3 readouts in China. I will share the first one: Izalontamab as monotherapy versus chemotherapy in heavily pre-treated metastatic nasopharyngeal carcinoma patients. This is a China trial, and we have already submitted the BLA for approval. In this randomized controlled study, we saw a response rate of 54% with Izalontamab treatment compared to 27% in the chemotherapy arm. The median duration of response was 8.5 months for Izalontamab versus 4.8 months with chemotherapy. This result led to clinically meaningful improvement in progression-free survival (PFS). As you can see, patients treated with Izalontamab demonstrated a median PFS of 8.4 months compared to only 4.3 months for chemotherapy-treated patients. That is an improvement of over four months in median progression-free survival, with a hazard ratio of 0.44. This gives us great confidence that Izalontamab demonstrates clinically meaningful improvement over chemotherapy in a randomized controlled study, bolstering our confidence in its continued development across many additional indications. Based on this data, we submitted the first BLA in China and expect approval later this year. We also have data from Izalontamab tested as a monotherapy in metastatic EGFR-mutant non-small cell lung cancer patients. In a cohort of 50 patients who had been previously treated with TKIs (and were not chemo-naïve), these patients demonstrated a median PFS of 12.5 months. Overall survival was not reached; however, we observed a 12-month OS rate of 80%. This data demonstrated very promising efficacy in EGFR-mutant NSCLC patients and led to the launch of two Phase 3 trials. One is Izalontamab as a monotherapy in EGFR-mutant NSCLC as a second-line treatment. The other is Izalontamab in combination withOsimertinibin the frontline treatment of EGFR-mutant NSCLC patients. Both Phase 3 trials are ongoing in China. Now switching gears to our next exciting pipeline asset, potentially a best-in-class HER2 ADC, which we call "T-bren". This is a wholly owned asset. T-bren has been studied in 14 clinical trials, including six registration-enabling trials in China. The first registration-enabling trial in China is for second-line-plus HER2-positive breast cancer as a monotherapy. We expect a readout later this year, upon which we will make a data-driven decision to file for approval in China. T-bren is also in a Phase 1 dose escalation and expansion study in the United States, and we expect to continue its development both in China and the US. Looking forward, we have many catalysts through 2026. For Izalontamab in China, we expect to receive the first market approval in nasopharyngeal cancer as well as esophageal carcinoma. We also expect to submit regulatory approvals for additional indications of Izalontamab as a monotherapy in EGFR wild-type NSCLC, EGFR-mutant NSCLC, small cell lung cancer, as well as HR-positive/HER2-negative breast cancer and triple-negative breast cancer. These label expansion opportunities will further expand the commercial potential for Izalontamab in China. We also plan to read out data at ASCO and ESMO this year. In addition, we are initiating additional Phase 3 studies of Izalontamab both as a frontline treatment and as a monotherapy in late-line treatment in additional tumors. Globally, in partnership with BMS, we expect to initiate new global registration trials either as monotherapy or in combination with standard of care. In the US, we plan to present the Phase 1 expansion data in EGFR-mutant NSCLC at a major congress. Most excitingly, thanks to the partnership with BMS, we expect to explore the combination of Izalontamab and our PD-L1/VEGF bispecific antibody in multiple indications. This will further expand the opportunities for Izalontamab to bring clinical benefits to patients. Regarding T-bren, as I mentioned earlier, we expect a Phase 3 readout from China studies, which will enable us to submit the first BLA approval in China. We also expect to initiate the first global registration trial for T-bren in a solid tumor indication. The rest of our pipeline continues to advance as well. We expect to have at least three or four pipeline assets advancing into registrational trials in China. For one of those assets, we expect to initiate a global registration trial as well. We will continue to present early clinical data at major congresses to keep our investors and investigators up to date. With that, thank you very much. I really appreciate your interest in Biokin and SystImmune, and I am happy to answer any questions. Jeff:Okay, great. Thank you very much. 中文 Jeff (主持人):好的，谢谢大家。鉴于时间关系，我们将开始下一场演讲。很高兴见到各位，感谢大家参加摩根大通医疗健康大会。我是 Jeff，常驻香港，是中国医疗健康团队的高级总监。我们非常荣幸地欢迎下一家演讲公司——四川百利天恒药业（Sichuan Biokin Pharmaceutical）。这是一家在亚洲上市的综合性制药公司，具备从早期研究到开发的各项能力，并专注于肿瘤学领域。今天我们荣幸地邀请到 SystImmune 的 CEOJie D'Elia 博士来介绍公司。Jie，交给你了。 Jie D'Elia (SystImmune/百利天恒 CEO):谢谢 Jeff，也感谢摩根大通医疗健康大会的邀请。我叫 Jie D'Elia，是 SystImmune 的 CEO。SystImmune 是百利天恒的美国子公司。我将代表百利天恒进行演讲。让我们从百利天恒的发展历程开始。百利天恒成立于大约 30 年前，即 90 年代中期，最初是一家仿制药公司。在过去的 30 年里，它已发展成为一家创新驱动的领先生物制药公司，拥有同类首创（first-in-class）和同类最优（best-in-class）的产品管线。2023 年，百利天恒在上海证券交易所上市。随后在同年晚些时候，百利天恒与百时美施贵宝（Bristol Myers Squibb）达成战略合作伙伴关系，共同开发Izalontamab，这是一种同类首创的双特异性抗体。自那时以来，我们在 Izalontamab 以及全资管线的开发方面取得了巨大进展。仅在 2025 年，我们就实现了多项激动人心的临床里程碑，包括启动了三项关键的全球注册试验和三项在中国的新三期试验。我们还看到了 Izalontamab 在中国一项对照随机三期试验中的首次阳性读出，稍后我将分享这些数据。此外，我们的资金非常充裕。我们通过 A 股私募融资筹集了约 5 亿美元。此外，我们还从合作伙伴百时美施贵宝那里获得了一笔 2.5 亿美元的临床里程碑付款。我们管线进展的另一个亮点是启动了两项新的 IND（新药临床试验申请），其中包括一项放射性药物产品。我相信大家听过很多关于“中国速度”和中国创新的讨论。百利天恒和 SystImmune 处于最佳位置，能够利用中美两国创新生态系统的优势。我们拥有完全整合的生物制药运营模式，在美国和中国都建立了团队。在美国，我们专注于创新，利用新颖的生物学概念，通过苗头化合物生成和先导化合物优化来开发新型疗法。一旦确定了先导候选药物，百利天恒中国团队就会进行快速的临床前开发和工艺开发。随后，中国团队将提交 IND 并开展首次人体研究，以生成初步安全性数据，并在多种肿瘤中持续生成数据以建立概念验证。来自中国的数据使我们拥有 70 多名临床开发人员的美国团队能够迅速启动加速的全球开发路径，并开展关键试验或注册支持试验。美中团队之间这种完全整合、无缝的合作使我们能够非常迅速地推进管线。我们的长期愿景是将 SystImmune 和百利天恒打造成为一家具有全球能力和规模的跨国公司。我们已经建立了全球发现创新能力和全球临床开发团队。我们正在中国国内外建设生产和供应链，以确保供应的稳定性。展望 2026 年，我们预计将在中国首次商业上市 Izalontamab。为此，我们已经建立了中国商业团队。在接下来的几年里，随着 Izalontamab 在本十年后期迈向获批，我们将着手建立美国商业团队。我们相信我们具备实现这一长期愿景的关键成功要素。我们拥有令人兴奋的管线，包含 17 个临床阶段项目，并得到全球肿瘤学领军企业百时美施贵宝的支持。随着我们继续探索在香港 IPO 的可能性，我们也拥有进入资本市场的渠道。得益于自 2024 年以来筹集的约 15 亿美元的稀释性和非稀释性融资，我们的资金非常充裕。此外，如前所述，我们正在探索在香港 IPO 筹集约 5 亿美元，这将使我们的现金头寸增加到 20 亿美元以上。此外，我们还获得了中国银行提供的 30 亿美元承诺授信额度，可用于全球临床开发。这意味着我们总共有 50 亿美元的可用资金来推进管线、发展公司，并最终成为一家具有全球能力的领先跨国生物制药公司。以下是我们的管线概览。我们有 17 个临床阶段的化合物，源自三个创新平台：我们领先的 ADC 平台（配备 Topo-1 载荷以及正在开发的下一代新型载荷）、拥有四个临床阶段资产的 T 细胞接合器(TCE)平台，以及最近启动的放射性配体疗法平台。后者的第一个项目已在中国进入临床，我们预计近期将该项目引入美国。在美国，目前我们有六个处于临床开发阶段的资产，还有两个项目正在进行 IND 准备。到今年年底，我们应该至少有八个临床项目在开发中，并且预计今年将启动至少一到两项全球注册试验。现在让我们看看我们的核心资产 Izalontamab 的最新进展。这是一款靶向 EGFR 和 HER3 的同类首创双特异性 ADC，是与百时美施贵宝战略合作开发的。截至目前，Izalontamab 已在中国和全球启动了 13 项注册支持试验。我们已经给药超过 5000 名患者。该项目已获得 FDA 授予的 EGFR 突变非小细胞肺癌（NSCLC）突破性疗法认定，以及中国国家药品监督管理局（NMPA）在其他肿瘤类型中授予的七项突破性疗法认定。这使我们能够在可行的情况下寻求加速监管途径，并与中美两国的监管机构保持密切沟通。去年，我们报告了中国两项阳性三期试验结果。我将分享第一项：在经过多线治疗的转移性鼻咽癌患者中，Izalontamab 单药治疗对比化疗的研究。这是一项中国试验，我们已经提交了 BLA（生物制品许可申请）以寻求批准。在这项随机对照研究中，Izalontamab 治疗组的缓解率为 54%，而化疗组为 27%。Izalontamab 的中位缓解持续时间为 8.5 个月，而化疗组为 4.8 个月。这一结果带来了无进展生存期（PFS）具有临床意义的改善。正如大家所见，接受 Izalontamab 治疗的患者中位 PFS 为 8.4 个月，而化疗患者仅为 4.3 个月。中位无进展生存期改善了超过四个月，风险比为 0.44。这让我们非常有信心，证明 Izalontamab 在随机对照研究中显示出优于化疗的具有临床意义的改善，也增强了我们继续在更多适应症中开发该药物的信心。基于这些数据，我们提交了中国的首个 BLA，并预计今年晚些时候获得批准。我们还有 Izalontamab 单药治疗转移性 EGFR 突变非小细胞肺癌患者的数据。在一个由 50 名既往接受过 TKI 治疗（非化疗初治）的患者组成的队列中，中位 PFS 达到了 12.5 个月。总生存期尚未达到，但我们观察到 12 个月 OS 率为 80%。该数据展示了在 EGFR 突变 NSCLC 患者中非常有前景的疗效，并促成了两项三期试验的启动。一项是 Izalontamab 单药二线治疗 EGFR 突变非小细胞肺癌。另一项是 Izalontamab 联合奥希替尼（Osimertinib）一线治疗 EGFR 突变非小细胞肺癌。这两项三期试验均在中国进行中。现在转向我们下一个激动人心的管线资产，可能是同类最优的 HER2 ADC，我们称之为“T-bren”。这是全资资产。T-bren 已在 14 项临床试验中进行了研究，包括中国的六项注册支持试验。中国首个注册支持试验是针对二线及以上 HER2 阳性乳腺癌的单药治疗。我们预计今年晚些时候会有读出，届时我们将基于数据决定是否在中国提交批准申请。 T-bren 也在美国进行一期剂量递增和扩展研究，我们预计将在中国和美国继续其开发。展望未来，到 2026 年我们将迎来许多催化剂。对于中国的 Izalontamab，我们预计将获得鼻咽癌和食管癌的首个上市批准。我们还预计将提交 Izalontamab 单药治疗其他适应症的监管申请，包括 EGFR 野生型非小细胞肺癌、EGFR 突变非小细胞肺癌、小细胞肺癌，以及 HR 阳性/HER2 阴性乳腺癌和三阴性乳腺癌。这些适应症扩展机会将进一步扩大 Izalontamab 在中国的商业潜力。我们还计划在今年的 ASCO 和 ESMO 上公布数据。此外，我们正在启动更多 Izalontamab 的三期研究，包括作为一线治疗以及作为晚期治疗的单药疗法，覆盖更多肿瘤类型。在全球范围内，通过与 BMS 的合作，我们预计将启动新的全球注册试验，采用单药治疗或与标准疗法联合使用。在美国，我们计划在一个主要会议上展示 EGFR 突变非小细胞肺癌的一期扩展数据。最令人兴奋的是，得益于与 BMS 的合作关系，我们预计将探索 Izalontamab 与我们的PD-L1/VEGF 双特异性抗体在多种适应症中的联合用药。这将进一步扩大 Izalontamab 为患者带来临床获益的机会。关于 T-bren，正如我之前提到的，我们预计中国研究将有三期读出，这将使我们能够在中国提交 T-bren 的首个 BLA 批准。我们还预计将启动 T-bren 在实体瘤适应症中的首个全球注册试验。我们的其余管线也在继续推进。我们预计至少有三到四个管线资产将进入中国的注册试验。对于其中一个资产，我们预计也将启动全球注册试验。我们将继续在主要会议上展示早期临床数据，让我们的投资者和研究人员了解最新进展。谢谢大家。非常感谢各位对百利天恒和 SystImmune 的关注，我很乐意回答任何问题。 Jeff:好的，太棒了。非常感谢。

临床研究IPO

2026-01-23

·智汇新研-生物医学

免疫学与传染病20260123

自身免疫病 1. A single-cell atlas of bone marrow B cells reveals defective central B-cell tolerance in immune thrombocytopenia. 单细胞图谱揭示免疫性血小板减少症的B细胞耐受缺陷。ITP以抗血小板自身抗体产生为特征，但其早期B细胞发育中的耐受崩溃机制不明。通过单细胞RNA/BCR测序发现，ITP患者骨髓中未成熟B细胞存在受体编辑不足及耐受缺陷。该研究确定了ITP发病的关键阶段，为开发针对B细胞发育源头的精准疗法提供了依据。免疫性血小板减少症 (ITP) | B细胞中枢耐受, 受体编辑 | 单细胞RNA/BCR测序 Sheng Zi · … · Peng Jun · Blood · 2026/01/22 ⭐ 该研究由国家杰出青年基金获得者、长江学者彭军教授团队完成原文链接：https://doi.org/10.1182/blood.2025028960 2. Human genetics guides the discovery of CARD9 inhibitors with anti-inflammatory activity. 基于人类遗传学发现具有抗炎活性的CARD9抑制剂。CARD9变异与克罗恩病保护相关，但其作为药物靶点开发难度大。研究利用DNA编码库筛选和X射线晶体学，成功鉴定出能阻止CARD9信号转导复合物组装的小分子抑制剂。该研究展示了利用保护性遗传变异指导难成药靶点开发的策略，为炎症性疾病治疗提供了新方向。克罗恩病, 炎症性疾病 | CARD9蛋白, NF-κB通路 | DNA编码库筛选, 晶体结构分析 Rush Jason S · … · Xavier Ramnik J · Cell · 2026/01/16 ⭐ 该研究由美国国家科学院院士、Broad研究所Ramnik J Xavier团队完成原文链接：https://doi.org/10.1016/j.cell.2025.12.013 3. Endothelial Injury to Cognitive Decline: A 12-month Follow-up Using CT-Perfusion and Diffusion MRI in Immune-mediated Thrombotic Thrombocytopenic Purpura. iTTP康复者面临持续血管损伤与认知下降。免疫介导的血栓性血小板减少性紫癜（iTTP）虽急性期存活率提高，但长期认知障碍的病理机制尚不明确。研究通过12个月的随访发现，患者存在持续的血脑屏障功能障碍、脑容量减少及白质完整性受损。该发现强调了iTTP缓解期长期脑监测的必要性，并提示早期神经保护策略对改善预后的重要性。免疫介导的血栓性血小板减少性紫癜 (iTTP), 认知功能障碍 | 血脑屏障 (BBB) 损伤, 血管内皮损伤 | 磁共振成像 (MRI), CT灌注成像 Hannan Fahad · … · Susan Huang Shih-Han · Journal of thrombosis and haemostasis : JTH · 2026/01/19 原文链接：https://doi.org/10.1016/j.jtha.2025.12.021 4. Stratification of immunotherapy responses by adaptive immune receptor repertoires. 适应性免疫受体库助力免疫治疗反应分层。由于个体免疫受体库的独特性，免疫治疗的疗效在不同患者间存在显著差异。研究综述了利用二代测序结合机器学习分析免疫库特征，以实现癌症和自身免疫病患者精准分层的方法。该研究强调了数据标准化和共享在提升免疫治疗敏感性与特异性中的关键作用。免疫治疗分层 | 适应性免疫受体库(AIRR) | 二代测序, 机器学习 Biró Bálint · … · Standley Daron M · Trends in molecular medicine · 2026/01/20 ⭐ 该研究由大阪大学系统免疫学专家Daron M Standley团队完成原文链接：https://doi.org/10.1016/j.molmed.2025.12.007 5. Inflammation and pain as interconnected targets in axial spondyloarthritis. 轴性脊柱关节炎中炎症与疼痛的交互。许多患者在炎症受抑后仍经历持续疼痛，其背后的非炎症机制尚不完全清楚。本文探讨了中枢敏化、纤维肌痛及性别差异对疼痛感知的影响，强调了多模式治疗的重要性。该研究推动了从炎症中心向机制导向的疼痛管理模式转变。轴性脊柱关节炎, 慢性疼痛 | 中枢敏化, 神经病理性疼痛 | 临床评估工具, 生物标志物 Baraliakos Xenofon · … · Poddubnyy Denis · Nature reviews. Rheumatology · 2026/01/21 原文链接：https://doi.org/10.1038/s41584-025-01348-0 6. IL-21 mediates crosstalk between T cells and NK cells during the remission of type 1 diabetes. IL-21介导T1D免疫细胞对话。先天免疫系统在1型糖尿病中的作用，特别是NK细胞的功能仍不明确。研究通过单细胞测序发现CD226+ NK细胞亚群受IL-21调控并促进疾病进展。该发现揭示了连接适应性与先天免疫的新机制，为T1D免疫治疗提供了新靶点。 1型糖尿病 (T1D) | IL-21, CD226+ NK细胞 | 单细胞RNA测序, 免疫阻断 Lei Kang · … · Li Xia · Nature metabolism · 2026/01/21 ⭐ 该研究由国家代谢性疾病临床医学研究中心Li Xia团队完成原文链接：https://doi.org/10.1038/s42255-025-01439-y 7. Thrombophilia screening in patients with autoimmune hemolytic anemia: a single-center analysis. 自身免疫性溶血性贫血患者的易栓症筛查分析。AIHA患者发生血栓栓塞事件的风险较高，但常规筛查的价值仍有待评估。研究通过单中心分析探讨了AIHA患者中易栓症标志物的流行情况及其临床意义。该研究为AIHA患者的血栓风险管理提供了临床参考。自身免疫性溶血性贫血(AIHA), 易栓症 | 凝血功能 | 临床回顾性分析 Fattizzo Bruno · … · Capecchi Marco · Haematologica · 2026/01/22 原文链接：https://doi.org/10.3324/haematol.2025.288981 细菌感染 1. Transmission of carbapenemase-producing Enterobacter in Ontario, Canada: a retrospective genomic analysis. 加拿大安大略省产碳青霉烯酶肠杆菌的基因组传播分析。产碳青霉烯酶肠杆菌（CP-Ent）在全球范围内流行，但其在医院环境中的传播路径尚不明确。回顾性基因组分析发现，约35%的患者属于传播集群，且医院水槽等环境设施是重要储菌库。该研究强调了环境监测在防控耐药菌传播中的重要性，为医院感染控制提供了科学依据。产碳青霉烯酶肠杆菌 (CP-Ent) | 抗生素耐药性, 医院内传播 | 全基因组测序 (WGS), 流行病学监测 Izydorczyk Conrad · … · McGeer Allison · Emerging microbes & infections · 2026/01/22 ⭐ 该研究由多伦多大学微生物学专家Allison McGeer团队完成原文链接：https://doi.org/10.1080/22221751.2025.2595794 2. An activator of a two-component system controls cell separation and intrinsic drug resistance in Mycobacterium tuberculosis. 双组分系统激活因子控制结核杆菌细胞分离与耐药。分枝杆菌的极性生长与分裂协调机制是寻找新型抗结核药物靶点的重要领域。研究鉴定出TapA为关键调节因子，其缺失会干扰细胞分裂并显著增强细菌对多种抗生素的敏感性。该发现建立了细胞周期与内在耐药性的联系，为开发新型抗结核联合疗法提供了潜在靶点。结核分枝杆菌感染 | TapA, MtrB, 细胞分裂 | 遗传筛选, 药物敏感性实验 McDonough Liam D · … · Rego E Hesper · Proceedings of the National Academy of Sciences of the United States of America · 2026/01/16 原文链接：https://doi.org/10.1073/pnas.2519608123 3. A bacterial translation activator with an intrinsically disordered RNA-binding region. 细菌翻译激活因子PhaF调控铜绿假单胞菌生物膜形成。细菌RNA结合蛋白多为负调控因子，正调控机制尚不明确。本研究发现PhaF通过其内在无序区的KPAA基序结合mRNA上游，促进pslA翻译。该发现揭示了细菌中类真核生物的翻译激活机制，为控制病原菌感染提供新思路。铜绿假单胞菌感染, 生物膜形成 | PhaF蛋白, 翻译激活, RNA结合 | CLIP-seq, CLAP-seq Basu Pallabi · … · Dove Simon L · Proceedings of the National Academy of Sciences of the United States of America · 2026/01/16 ⭐ 该研究由哈佛医学院波士顿儿童医院Simon L Dove团队完成原文链接：https://doi.org/10.1073/pnas.2519770123 4. Global molecular epidemiology of Mycoplasma pneumoniae and its association with macrolide resistance and disease severity: a systematic review and meta-analysis. 全球肺炎支原体分子流行病学及其与耐药性和病情严重程度的关系。肺炎支原体基因型分布及其临床影响尚缺乏系统性全球分析。本研究通过荟萃分析发现P1-1和4572型在西太平洋地区占主导，且与大环内酯类耐药密切相关。该研究阐明了肺炎支原体的全球流行特征，为制定防控策略和临床管理提供了科学依据。肺炎支原体感染, 耐药性 | 基因型分布, 流行病学特征 | 系统评价, 荟萃分析 Zhu Xinyue · … · Liu Enmei · Emerging microbes & infections · 2026/01/16 ⭐ 该研究由重庆医科大学附属儿童医院刘恩梅团队完成原文链接：https://doi.org/10.1080/22221751.2026.2614742 5. Peptidoglycan architecture dictates protein interactions, tissue tropism, and arthritis in the Lyme disease spirochete Borrelia burgdorferi. 肽聚糖结构决定伯氏疏螺旋体的组织趋向性与关节炎。莱姆病关节炎是由病原体及其产物引起的炎症反应，其中肽聚糖被认为是关键介质。研究通过缺失dacA基因改变肽聚糖组成，发现其显著影响病原体的组织趋向性并减轻关节炎症状。该研究深化了对螺旋体细胞壁成分致病性的理解，为防治莱姆病关节炎提供了新靶点。莱姆病关节炎 | 肽聚糖, dacA基因 | 基因缺失, 组织趋向性分析 Ahmad Saadman S · … · Jutras Brandon L · PLoS pathogens · 2026/01/20 原文链接：https://doi.org/10.1371/journal.ppat.1013849 6. Inhaled nitric oxide at 300 ppm treats multidrug-resistant Pseudomonas pneumonia in swine and is safe in humans. 高剂量吸入一氧化氮治疗多重耐药铜绿假单胞菌肺炎。抗生素耐药性是呼吸道感染治疗的全球性难题。研究在猪肺炎模型中证实，300 ppm高剂量吸入一氧化氮（iNO300）可显著降低细菌负荷并改善肺功能。随后的一期临床试验确认了该疗法在健康人类及危重患者中的安全性与可行性。该研究为治疗多重耐药细菌引起的肺炎提供了一种极具潜力的新型抗菌方案。多重耐药菌肺炎 | 一氧化氮抗菌作用 | 吸入疗法, 猪模型, 一期临床试验 Yu Binglan · … · Berra Lorenzo · Science translational medicine · 2026/01/21 原文链接：https://doi.org/10.1126/scitranslmed.ady2646 7. Granuloma dual RNA-seq reveals composite transcriptional programs driven by neutrophils and necrosis within tuberculous granulomas. 双RNA测序揭示结核肉芽肿中中性粒细胞驱动的转录程序。结核肉芽肿是细菌存活的独特微环境，其坏死核心难以在传统模型中评估。研究利用成年鱼坏死肉芽肿模型进行双RNA测序，识别了细菌在坏死环境中的转录改变。发现中性粒细胞通过上调细菌devR调节子促进其生长，并识别了特定的细菌转录模块。该研究为理解结核杆菌的遗传适应和开发新疗法提供了重要靶点。结核病肉芽肿 | devR调节子, 中性粒细胞介导生长 | 双RNA测序, 斑马鱼模型 Viswanathan Gopinath · … · Tobin David M · Science advances · 2026/01/21 原文链接：https://doi.org/10.1126/sciadv.adw4619 8. Emerging advances in prokaryotic transposition: TnPedia as a promising tool. TnPedia为原核生物转座子研究提供新工具。原核转座元件（TEs）在抗生素耐药性传播中起关键作用，但缺乏系统化的知识框架。TnPedia整合了TEs的分类、机制及RNA引导转座等前沿进展，并总结了其在耐药基因传递中的作用。该工具为理解原核生物基因组动态及耐药性进化提供了重要参考。抗生素耐药性 | 转座元件, 基因水平转移 | 数据库, 生物信息学工具 Chandler Michael · … · Varani Alessandro · Trends in microbiology · 2026/01/20 原文链接：https://doi.org/10.1016/j.tim.2025.12.013 9. Phospholipid composition strongly affects the assembly of β barrel proteins into purified bacterial outer membranes. 磷脂成分显著影响细菌外膜蛋白的组装。革兰氏阴性菌外膜蛋白（OMP）的组装由BAM复合物催化，但膜脂环境的作用尚不完全清楚。研究通过优化纯化方法发现，外膜磷脂谱的改变会显著削弱BAM催化的OMP组装效率。该结果直接证明了磷脂在维持外膜稳态及蛋白质生物合成中发挥着比以往认知更重要的作用。革兰氏阴性菌感染 | 外膜蛋白(OMP)组装, BAM复合物 | 磷脂组分分析, 体外组装实验 Nilaweera Thushani D · … · Bernstein Harris D · Nature communications · 2026/01/21 ⭐ 该研究由美国国立卫生研究院(NIH)Harris D Bernstein团队完成原文链接：https://doi.org/10.1038/s41467-026-68743-3 10. Evolution of the tuberculin skin test reveals generalisable Mtb-reactive T cell metaclones. 结核菌素皮肤试验揭示了通用的Mtb反应性T细胞元克隆。T细胞在结核病免疫中至关重要，但多克隆反应的复杂性阻碍了生物标志物的发现。研究通过TCR测序建立了公共Mtb反应性HLA限制性T细胞元克隆目录。这些元克隆在人群中具有免疫优势，可为患者分层和疫苗开发提供重要参考。结核病, 免疫保护 | T细胞受体(TCR), 抗原特异性 | TCR测序, 计算生物学管线 Turner Carolin T · … · Noursadeghi Mahdad · Nature communications · 2026/01/21 原文链接：https://doi.org/10.1038/s41467-026-68678-9 过敏与炎症 1. De novo discovery of bicyclic cysteine-rich peptides targeting gasdermin D. 靶向Gasdermin D的双环富半胱氨酸肽的从头发现。GSDMD是细胞焦亡的关键执行者，与多种炎症疾病相关，但目前缺乏临床可用的特异性抑制剂。研究利用mRNA展示技术筛选并优化了高亲和力的双环肽，能有效抑制GSDMD切割及孔道形成。该研究开发的双环肽具有高代谢稳定性和强抑制活性，为炎症性疾病的药物开发提供了重要候选分子。细胞焦亡/炎症性疾病 | Gasdermin D (GSDMD) | mRNA展示技术, 双环肽筛选 Li Choi Yi · … · Suga Hiroaki · Proceedings of the National Academy of Sciences of the United States of America · 2026/01/16 ⭐ 该研究由沃尔夫化学奖得主Hiroaki Suga团队完成原文链接：https://doi.org/10.1073/pnas.2516051123 2. The ratio of circulatory levels of sphingolipids to steroids predicts asthma exacerbations. 鞘脂与类固醇比例可预测哮喘加重风险。临床上缺乏识别哮喘加重高风险个体的生物标志物，限制了患者预后的改善。研究通过分析三个队列的代谢组学数据，发现21种鞘脂与类固醇的比例能有效预测5年内的发病风险。该研究为开发低成本、实用的临床检测方法提供了依据，有助于优化哮喘患者的长期护理。哮喘加重 | 鞘脂代谢, 类固醇 | 质谱分析, 代谢组学 Chen Yulu · … · Lasky-Su Jessica A · Nature communications · 2026/01/19 原文链接：https://doi.org/10.1038/s41467-025-67436-7 3. Western lifestyle linked to maladaptive trained immunity. 西方生活方式与失调的训练免疫密切相关。训练免疫能提供生存优势，但失调的训练免疫会加剧炎症性疾病的发生。本综述探讨了西方饮食、慢性压力及环境污染物如何诱导先天免疫细胞发生有害的表观遗传重编程。强调了通过生活方式干预来预防或减轻失调训练免疫对健康负面影响的重要性。炎症性疾病, 西方生活方式 | 训练免疫, 表观遗传重编程 | 生活方式干预 Merbecks Aurelia Josephine · … · Latz Eicke · eLife · 2026/01/21 ⭐ 该研究由高被引学者Eicke Latz团队完成原文链接：https://doi.org/10.7554/eLife.105835 4. Fecal microbiota transplantation ameliorates radiation-induced lung injury by reshaping gut metabolic homeostasis to activate FAM134B-mediated ER-phagy. 粪菌移植通过重塑肠道代谢减轻放射性肺损伤。放射性肺损伤（RILI）是胸部放疗的严重并发症，目前缺乏有效的临床治疗手段。研究发现FMT通过调节肠-肺轴，激活PPARγ-FAM134B通路介导的内质网噬，从而修复肺部损伤。该研究确立了肠道代谢重塑作为RILI治疗的新靶点，为FMT的临床转化提供了机制依据。放射性肺损伤 | 粪菌移植, 内质网噬 | 多组学分析, 肠-肺轴调节 Pu Xiaoyu · … · Jiang Xin · PLoS pathogens · 2026/01/21 原文链接：https://doi.org/10.1371/journal.ppat.1013786 5. Therapeutic potential of targeting novel signaling pathways in regulating chronic inflammation in obstructive lung disorders. 靶向新信号通路治疗慢性阻塞性肺部疾病。COPD和哮喘是具有持续气道炎症的重大疾病，现有疗法在控制炎症和阻止肺功能下降方面仍有局限。本文综述了NF-κB、CXCR2及NLRP3等关键信号通路在维持慢性炎症中的作用，并评估了新型治疗靶点。该综述为开发更精准有效的呼吸系统炎症治疗策略提供了全面的理论参考。慢性阻塞性肺疾病 (COPD), 哮喘 | NLRP3炎性体, NF-κB通路, 趋化因子受体 | 靶向治疗, 信号通路分析 Li Dan · … · Schmidt Martina · Pharmacology & therapeutics · 2026/01/19 原文链接：https://doi.org/10.1016/j.pharmthera.2026.108983 6. Natural products modulating interleukin-mediated pathways for anti-allergic and immunomodulatory effects. 天然产物调控白介素通路抗过敏。过敏性疾病发病率上升，亟需开发针对白介素信号通路的新型免疫调节疗法。本综述总结了黄酮、多酚等天然活性物质通过抑制促炎细胞因子及调节Th2反应来发挥抗过敏作用的机制。该研究强调了天然产物在开发创新免疫控制药物方面的巨大潜力。过敏性疾病 | 白介素通路 | 药物综述 Shah Abdul Bari · … · Lee Ki Yong · Natural product reports · 2026/01/22 原文链接：https://doi.org/10.1039/d5np00074b 病毒感染 1. Plant rhabdovirus glycoprotein activates unfolded protein response-mediated antiviral ER-phagy in insect vectors. 植物弹状病毒通过激活内质网应激诱导昆虫媒介产生抗病毒内质网自噬。昆虫媒介中病毒触发内质网自噬的机制尚不清晰。研究发现RSMV糖蛋白G通过干扰BiP与PERK结合激活UPR通路，进而通过Sec62受体介导内质网自噬。该研究揭示了跨物种保守的抗病毒防御机制，深化了对病毒-媒介相互作用的理解。病毒感染, 抗病毒防御 | 内质网自噬, UPR通路, PERK/ATF4 | 基因敲降, 显微注射 Chen Siyu · … · Wei Taiyun · PLoS pathogens · 2026/01/16 ⭐ 该研究由国家杰出青年科学基金获得者、福建农林大学魏太云团队完成原文链接：https://doi.org/10.1371/journal.ppat.1013888 2. Cooperativity and communication between the active sites of the dimeric SARS-CoV-2 main protease. SARS-CoV-2主蛋白酶二聚体活性位点间的协同与通讯机制。Mpro是抗病毒药物的重要靶点，但其二聚体结构中两个活性位点如何相互作用尚不明确。研究通过构建异质二聚体发现，二聚化能显著提高单体切割效率，并鉴定出关键的通讯残基网络。该研究深入揭示了Mpro的催化循环机制，为开发新型二聚体抑制剂提供了结构基础。新冠病毒感染 | Mpro主蛋白酶, 二聚体协同 | 酶学分析, 晶体结构 Zvornicanin Sarah N · … · Yilmaz Nese Kurt · Science advances · 2026/01/16 ⭐ 该研究由马萨诸塞大学陈氏医学院Nese Kurt Yilmaz团队完成原文链接：https://doi.org/10.1126/sciadv.aeb0769 3. Nucleus softens during herpesvirus infection. 疱疹病毒感染导致细胞核显著变软。病毒感染会诱导细胞核结构重组，但其对细胞核力学性质的影响此前鲜为人知。研究发现HSV-1感染通过降低生物分子密度和改变细胞内外力，导致细胞核硬度大幅下降。这一发现揭示了病毒如何重塑宿主力学环境，为理解病毒复制与核输出提供了力学视角。疱疹病毒感染 | 细胞核力学, 病毒复制区 | 高级显微成像, 计算建模 Tervonen Aapo · … · Vihinen-Ranta Maija · PLoS pathogens · 2026/01/20 原文链接：https://doi.org/10.1371/journal.ppat.1013873 4. Discovery and Characterization of GLPG3808, a PAPD5/7 Inhibitor for Suppression of Hepatitis B Viral Infections. 新型PAPD5/7抑制剂GLPG3808可抑制乙肝病毒。慢性乙肝感染是严重的肝脏疾病，目前的治疗方法难以实现乙肝表面抗原（HBsAg）的持续清除。研究开发了强效抑制剂GLPG3808，在动物模型中显示出显著的HBsAg抑制效果，但因神经毒性中止。该研究为开发功能性治愈乙肝的药物提供了重要先导化合物及毒理学参考。慢性乙型肝炎 | PAPD5/7抑制剂, HBsAg抑制 | 药物筛选, 毒理学研究 Mammoliti Oscar · … · Andrews Martin · Journal of medicinal chemistry · 2026/01/20 原文链接：https://doi.org/10.1021/acs.jmedchem.5c01703 5. Cryo-electron tomography reveals coupled flavivirus replication, budding and maturation. 冷冻电子断层扫描揭示黄病毒复制与组装的耦合。黄病毒在内质网膜上进行基因组复制和病毒组装，但这些过程如何空间协调尚不明确。研究利用冷冻ET技术观察到复制细胞器与病毒颗粒出芽位点紧密耦合，并受RNA压力调节。该发现揭示了黄病毒生命周期的精细空间组织，为开发抗病毒策略提供了结构基础。黄病毒感染 | 病毒复制, 膜重塑 | 冷冻电子断层扫描 Dahmane Selma · … · Carlson Lars-Anders · Nature communications · 2026/01/20 原文链接：https://doi.org/10.1038/s41467-026-68483-4 6. Structural characterization of the HDV virion and its ribonucleoprotein. 冷冻电镜揭示丁型肝炎病毒及其核糖核蛋白结构。丁型肝炎病毒（HDV）依赖乙肝病毒包膜，其复制机制及组装过程尚不完全清楚。研究利用冷冻电子断层扫描和单颗粒冷冻电镜，重建了HDV病毒颗粒及RNP的结构。发现HDAg八聚体通过特定顶点与RNA结合，且该接触位点对病毒复制至关重要。这些结构信息为开发针对HDV复制的新型抗病毒药物提供了指导。丁型肝炎 | HDAg-RNA相互作用, 病毒组装 | 冷冻电子断层扫描, 单颗粒冷冻电镜 Itskanov Samuel · … · Lansdon Eric B · Proceedings of the National Academy of Sciences of the United States of America · 2026/01/21 ⭐ 该研究由吉利德科学公司（Gilead Sciences）结构生物学团队完成原文链接：https://doi.org/10.1073/pnas.2519809123 7. An ultra-long-acting dimeric bictegravir prodrug defined by a short pharmacokinetic tail. 超长效双体必妥维前药助力艾滋病治疗与预防。开发具有长效效力且药代动力学尾迹短的抗逆转录病毒药物是HIV治疗的重要方向。研究将必妥维转化为双体酯前药纳米悬浮液NMXBIC，在动物模型中实现了长达六个月的持续血药浓度及理想的安全性。该制剂为HIV的超长效治疗和预防提供了极具前景的候选方案。艾滋病(HIV-1) | 超长效药代动力学, 前药 | 纳米悬浮液, 药物递送 Nayan Mohammad Ullah · … · Edagwa Benson · Nature communications · 2026/01/21 原文链接：https://doi.org/10.1038/s41467-026-68501-5 8. Broad cross-T cell immunity between emerging SARS-CoV-2 serotypes waved by spike-signature mutations. SARS-CoV-2血清型间的跨T细胞免疫特征。随着病毒变异，针对不同血清型的T细胞反应特征及其免疫逃逸机制仍不清楚。研究评估了不同感染者对15种变异株的T细胞反应，识别了影响免疫识别的关键突变。该发现揭示了人群T细胞免疫屏障的作用模式，为通用疫苗开发提供了见解。 SARS-CoV-2, 免疫逃逸 | T细胞表位突变, 跨反应性 | T细胞反应评估, 突变分析 Guo Yuanyuan · … · Liu Jun · Emerging microbes & infections · 2026/01/21 ⭐ 该研究由广州国家实验室病毒学专家Liu Jun团队完成原文链接：https://doi.org/10.1080/22221751.2025.2610856 9. ZNRD2 Mediated Nucleoprotein Aggregation Impairs Respiratory Syncytial Virus Replication. 宿主蛋白ZNRD2通过介导核蛋白聚集抑制呼吸道合胞病毒复制。呼吸道合胞病毒（RSV）严重威胁婴幼儿健康，探索宿主限制因子对开发抗病毒策略至关重要。研究鉴定出ZNRD2能与RSV核蛋白结合并诱导其发生不溶性聚集，从而阻断病毒复制。该研究揭示了宿主与病毒间的一种新型拮抗机制，为RSV防治提供了潜在靶点。呼吸道合胞病毒(RSV)感染 | ZNRD2蛋白, 核蛋白聚集 | 免疫共沉淀-质谱(IP-MS) Zhou Haiwu · … · Chen Mingzhou · Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026/01/21 ⭐ 该研究由武汉大学/湖北大学教授、病毒学专家陈明周团队完成原文链接：https://doi.org/10.1002/advs.202508811 10. Discovery of Amino Acid-Functionalized Multisubstituted Pyrimidines as Novel Efficient Antiviral Agents Against Enteroviruses. 氨基酸功能化嘧啶类抗肠道病毒药物研发。肠道病毒感染威胁全球健康，但目前缺乏特异性治疗药物，亟需开发高效抗病毒制剂。研究合成了新型嘧啶衍生物，发现化合物8e能通过激活I型干扰素信号通路增强宿主防御，有效抑制CVB3复制。该发现为开发具有独特机制的新型抗肠道病毒药物提供了结构基础。肠道病毒感染 | I型干扰素通路 | 药物合成与筛选 Zheng Fuqiang · … · Wei Yanhong · Journal of medicinal chemistry · 2026/01/22 原文链接：https://doi.org/10.1021/acs.jmedchem.5c02792 其他免疫与传染病 1. Myxovirus resistance protein A to differentiate between viral and non-viral respiratory infections in adults: a prospective study. 粘病毒抗性蛋白A（MxA）可有效区分成人病毒性与非病毒性呼吸道感染。快速区分呼吸道感染病原体对于减少抗生素滥用至关重要。这项前瞻性研究显示，MxA在病毒感染者中显著升高，区分病毒与细菌/真菌感染的曲线下面积达0.83。该研究证实了MxA作为生物标志物的临床价值，有助于优化成人呼吸道感染的诊疗决策。呼吸道感染, 鉴别诊断 | MxA蛋白, 病毒感染标志物 | 前瞻性临床研究, 蛋白质定量 Yan Mengwei · … · Cao Bin · Emerging microbes & infections · 2026/01/16 ⭐ 该研究由中国工程院院士、中日友好医院曹彬团队完成原文链接：https://doi.org/10.1080/22221751.2026.2614734 2. α2-macroglobulin function of thioester-containing proteins guards Drosophila from a bacterial protease via two immune-induced peptides. 果蝇免疫诱导肽通过补体蛋白防御细菌蛋白酶。果蝇基因组中存在大量功能未知的免疫诱导基因。研究发现yulü和shenshu编码的肽虽无直接蛋白酶抑制活性，但能辅助补体蛋白Tep2和Tep4抑制铜绿假单胞菌的蛋白酶PrtA。这表明Tep蛋白在果蝇中具有类似α2-巨球蛋白的防御功能。该发现揭示了无脊椎动物免疫系统中一种新型的蛋白酶中和机制。细菌感染防御 | 补体蛋白, 蛋白酶抑制 | 突变体筛选, RNA测序 Cai Chuping · … · Ferrandon Dominique · Proceedings of the National Academy of Sciences of the United States of America · 2026/01/21 ⭐ 该研究由诺贝尔奖得主Jules Hoffmann所在的联合研究团队完成原文链接：https://doi.org/10.1073/pnas.2525580123 3. Multimodal hybrid nanozymes with antioxidant catalytic and antibiotic-free antibacterial activities for enhanced multi-target sepsis therapy. 混合纳米酶通过多靶点策略增强败血症治疗。败血症病理生理复杂，急需结合抗菌、免疫调节和器官保护的综合治疗手段。研究构建了铈-黄芩苷混合纳米酶，通过清除活性氧、抑制铁死亡及减轻线粒体功能障碍来缓解炎症。该纳米酶为败血症提供了一种无抗生素的多靶点治疗方案，具有重要的临床转化潜力。败血症, 炎症反应 | 铁死亡, 活性氧清除, 线粒体功能 | 纳米酶, 铈-黄芩苷复合物 Zhu Kai · … · Chen Gan · Cell reports. Medicine · 2026/01/20 ⭐ 该研究由军事医学研究院陈干团队完成。原文链接：https://doi.org/10.1016/j.xcrm.2025.102541 4. Engineering a multifunctional nanoplatform with cascade catalytic and bidirectional immunomodulatory capacities for integrating sepsis therapy. 多功能纳米酶通过双向免疫调节整合败血症治疗。败血症导致的免疫失调和器官损伤缺乏有效疗法，亟需开发能同时针对感染和炎症的新策略。研究设计了ARPB纳米酶，通过清除活性氧和抑制树突状细胞焦亡，在多种小鼠模型中显著提高了生存率。该纳米酶平台为重症败血症提供了一种协同治疗方案，在传染病领域具有广阔的应用前景。败血症, 免疫失调 | 活性氧清除, 细胞焦亡, NLRP3通路 | 纳米酶, 银-普鲁士蓝复合物 Xiao Yao · … · Chen Gan · Journal of advanced research · 2026/01/19 ⭐ 该研究由军事医学研究院陈干团队完成。原文链接：https://doi.org/10.1016/j.jare.2026.01.041 5. Multimodal analysis disentangles the genetic and microbial associations between inflammatory bowel disease and other immune-mediated diseases across a harmonized population framework. 多模态分析揭示炎症性肠病与其他免疫疾病的遗传与微生物关联。免疫介导炎症性疾病（IMID）与肠病关联复杂，遗传与环境因素的贡献难以区分。研究整合丹麦全国数据、GWAS及粪便微生物组，发现不同肠病亚型与其他免疫疾病间存在独特的遗传与微生物相关性模式。该发现强调了在诊断和治疗中采取分层方法的重要性。炎症性肠病(IBD) | 肠道微生物组, 遗传相关性 | 多模态分析, GWAS Vestergaard Marie Vibeke · … · Jess Tine · Nature communications · 2026/01/21 原文链接：https://doi.org/10.1038/s41467-026-68564-4 6. Spatiotemporal regulation of energetic charge dictates T cell function. 能量电荷的时空调节决定T细胞功能。免疫细胞分化调控代谢途径，但个体细胞能量电荷的时空变化及其对功能的影响尚不明确。研究利用SPICE-Met方法监测体内ATP:ADP比率，发现T细胞能量电荷受解剖位置和昼夜节律调节，并直接影响细胞因子产生。该发现揭示了营养可用性和能量状态是决定免疫细胞功能的关键时空因素。 T细胞功能 | 能量代谢, ATP:ADP比率 | SPICE-Met, 时空代谢监测 Chikina Aleksandra S · … · Bousso Philippe · Nature communications · 2026/01/21 ⭐ 该研究由巴斯德研究所著名免疫学家Philippe Bousso团队完成原文链接：https://doi.org/10.1038/s41467-026-68559-1 7. Endothelial cell responses in sepsis are attenuated by targeting truncated procalcitonin. 靶向截短型降钙素原可缓解脓毒症内皮损伤。脓毒症常伴随血管渗漏和微循环障碍，内皮细胞是关键治疗靶点。研究发现中和降钙素原能通过抑制IL-17通路保护血管屏障完整性并降低脓毒症严重程度。该发现为脓毒症引起的器官损伤提供了新的转录组水平干预策略。脓毒症, 血管渗漏 | 降钙素原, IL-17信号通路 | 转录组测序, 抗体中和实验 Brabenec Laura · … · Wagner Nana-Maria · Nature communications · 2026/01/21 原文链接：https://doi.org/10.1038/s41467-025-68199-x 8. Impact and cost-effectiveness of doxycycline post-exposure prophylaxis in Australian men who have sex with men. 多西环素暴露后预防在澳大利亚男男性行为者中具有显著成本效益。多西环素预防性用药（doxy-PEP）在降低性传播感染（STI）方面的最佳策略尚不明确。研究通过个体模型评估了五种策略，发现所有策略均能显著减少STI并节省成本。其中，针对梅毒诊断的策略在平衡预防效益与耐药风险方面表现最优。该研究为制定STI防控政策提供了重要的流行病学和经济学依据。性传播感染(STI), 梅毒 | 暴露后预防(PEP), 抗菌素耐药性 | 个体化建模, 成本效益分析 Lai Hao · … · Zhang Lei · Nature communications · 2026/01/21 ⭐ 该研究由西安交通大学张磊团队完成原文链接：https://doi.org/10.1038/s41467-026-68561-7 9. The transition from monocyte to tissue-resident macrophage requires DHPS. DHPS酶驱动单核细胞向组织驻留巨噬细胞转化。组织驻留巨噬细胞对维持组织稳态至关重要，但其发育转化的通用机制尚不明确。研究发现DHPS介导的eIF5A修饰是巨噬细胞分化所必需的，缺失会导致细胞粘附和信号传导缺陷。该发现揭示了驱动单核细胞向组织驻留巨噬细胞转化的细胞内源性通用通路。组织驻留巨噬细胞 | DHPS, eIF5A | 转录组学, 蛋白质组学 Carrizo Gustavo E · … · Pearce Erika L · Nature · 2026/01/21 ⭐ 该研究由国际知名免疫代谢专家Erika L. Pearce团队完成原文链接：https://doi.org/10.1038/s41586-025-09972-2 10. Fibroblastic reticular cells direct the initiation of T cell responses via CD44. 纤维母细胞网状细胞通过CD44引导T细胞免疫应答。次级淋巴器官中免疫细胞的相互作用对适应性免疫至关重要，但其分子机制尚不完全清楚。研究发现巨细胞病毒蛋白m11通过结合CD44干扰其与透明质酸的相互作用，从而阻断树突状细胞迁移和T细胞启动。该发现揭示了CD44在基质细胞支持免疫应答中的核心作用。抗病毒免疫 | CD44, 纤维母细胞网状细胞 (FRC) | 病毒蛋白干扰分析 Sng Xavier Y X · … · Degli-Esposti Mariapia A · Nature · 2026/01/21 原文链接：https://doi.org/10.1038/s41586-025-09988-8 11. Baby-to-baby strain transmission shapes the developing gut microbiome. 婴儿间的菌株传播塑造肠道微生物组发育。婴儿早期微生物组主要源自母亲，但社交互动对微生物组发育的影响尚不清楚。研究通过对托儿所婴儿的大规模宏基因组监测，发现婴儿间存在广泛的菌株传播，其贡献度在一年内可与家庭成员相当。该研究强调了早期社交互动是驱动婴儿微生物组发育的关键因素。肠道微生物组发育 | 菌株传播网络 | 宏基因组测序 Ricci Liviana · … · Segata Nicola · Nature · 2026/01/21 ⭐ 该研究由高被引学者、微生物组研究权威Nicola Segata团队完成原文链接：https://doi.org/10.1038/s41586-025-09983-z 12. How crosstalk at the immune synapse shapes T cell and dendritic cell biologys. 免疫突触处的双向对话塑造免疫功能。T细胞与抗原提呈细胞的相互作用曾被视为单向，但双向串扰的机制日益受到关注。本文综述了免疫突触处T细胞如何反向调节树突状细胞的“授权”过程及其分子基础。该综述深化了对免疫反应调节的理解，对免疫疗法开发具有指导意义。免疫突触 | T细胞-DC串扰, DC授权 | 免疫荧光显微镜, 信号通路分析 Martín-Cófreces Noa B · … · Sánchez-Madrid Francisco · Nature reviews. Immunology · 2026/01/21 原文链接：https://doi.org/10.1038/s41577-025-01262-2 13. Commensal microbe-derived butyrate enhances T follicular helper cell function to boost mucosal vaccine efficacy. 肠道菌群衍生丁酸盐提升疫苗效力。调节粘膜IgA反应的具体微生物代谢物尚不完全清楚。研究发现丁酸盐通过GPR43信号促进派氏结Tfh细胞分化，进而增强抗原特异性IgA产生。该发现建立了“菌群-代谢物-Tfh细胞”轴，为增强粘膜疫苗保护效果提供了新策略。粘膜免疫, 疫苗效力 | 丁酸盐, Tfh细胞, GPR43 | 粪便微生物移植, RNA测序 Ko Haeun · … · Im Sin-Hyeog · Microbiome · 2026/01/21 原文链接：https://doi.org/10.1186/s40168-025-02284-7 14. Engineering bacteriophages for gut health: precision antimicrobials and beyond. 工程化噬菌体在肠道健康中的精准应用。抗生素耐药性和菌群失调使得传统疗法在胃肠道疾病中效果有限。本文综述了利用合成生物学改造噬菌体以实现病原体精准打击和免疫调节的最新进展。该综述探讨了噬菌体疗法在临床转化中的挑战，为个性化医疗提供了新思路。肠道疾病, 抗生素耐药 | 精准抗菌, 免疫调节 | 噬菌体工程, 合成生物学 Xu Mengmeng · … · Zhang Yongsheng · Journal of nanobiotechnology · 2026/01/22 原文链接：https://doi.org/10.1186/s12951-026-04038-5 15. Macrophage-Derived Ferritin Exacerbates Silica-Induced Pulmonary Fibrosis via PIK3R2-Mediated Fibroblast Differentiation. 巨噬细胞源性铁蛋白加重矽肺纤维化。矽肺是一种因吸入二氧化硅导致的致命性肺部疾病，其致病机制尚不完全明确。研究发现矽肺患者肺组织中铁蛋白显著升高，且巨噬细胞分泌的铁蛋白通过PIK3R2/SMAD轴促进成纤维细胞分化。该发现为矽肺的临床监测和综合诊疗策略提供了新的理论基础。矽肺, 肺纤维化 | 铁蛋白, PIK3R2/SMAD信号通路 | 多组学分析, 细胞共培养 Wang Liqun · … · Yao Yuqin · Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026/01/21 原文链接：https://doi.org/10.1002/advs.202519191 16. Strategies to eliminate native T cell receptors for adoptive T cell therapies. 消除内源性T细胞受体提升过继性T细胞疗法效能。在TCR-T或异体T细胞疗法中，内源性TCR的竞争与错配会降低疗效并引发移植物抗宿主病。本文全面综述了在基因、转录及蛋白水平消除内源性TCR的多种策略，并对比了各方法的优缺点。该综述为优化过继性T细胞疗法的安全性与有效性提供了重要的技术参考。过继性T细胞疗法 | T细胞受体(TCR) | 基因编辑, TCR消除策略 Flumens Donovan · … · Lion Eva · Molecular therapy : the journal of the American Society of Gene Therapy · 2026/01/20 原文链接：https://doi.org/10.1016/j.ymthe.2026.01.017 17. Trained Immunity in Interorgan Communication and Vascular Inflammation. 训练免疫在器官间通讯及血管炎症中发挥核心驱动作用。缺血性卒中或心肌梗死后患者面临长期的多器官并发症风险。研究提出训练免疫通过重编程骨髓造血祖细胞，产生促炎单核细胞并靶向远端器官。该综述为开发干预病理性炎症记忆、缓解慢性血管炎症提供了新思路。血管炎症, 缺血性卒中 | 训练免疫, 造血祖细胞 | 文献综述 Liesz Arthur · Arteriosclerosis, thrombosis, and vascular biology · 2026/01/22 原文链接：https://doi.org/10.1161/ATVBAHA.125.323130 18. Chronic graft-versus-host disease in the era of post-transplant cyclophosphamide. PTCy预防下cGVHD临床特征分析。异基因造血干细胞移植后，PTCy预防方案下慢性移植物抗宿主病（cGVHD）的表型特征尚不明确。本研究通过前瞻性分析发现，PTCy预防后中重度cGVHD发生率较低，且口腔受累最常见，多数患者对激素反应良好。该研究揭示了现代预防策略下cGVHD的新特征，为优化移植后管理提供了重要参考。慢性移植物抗宿主病 | 免疫耐受 | 前瞻性临床研究 Cantò Pedro Asensi · … · Sanz Jaime · Haematologica · 2026/01/22 原文链接：https://doi.org/10.3324/haematol.2025.289266 真菌与寄生虫感染 1. Profound taxonomic and functional gut microbiota alterations associated with trichuriasis: cross-country and country-specific patterns. 鞭虫感染导致肠道微生物群发生显著的分类和功能改变。土源性蠕虫感染会破坏肠道微环境，但其跨地区的共性特征尚不明确。研究通过对三个国家的宏基因组分析，发现感染者普遍存在短链脂肪酸产生菌的减少和粘蛋白降解菌的增加。这些变化导致肠道屏障受损和免疫调节失衡，有利于寄生虫持续存在。该发现支持了通过益生菌或饮食干预辅助控制蠕虫感染的策略。鞭虫感染, 肠道微生物群 | 短链脂肪酸(SCFA), 粘蛋白降解 | 宏基因组测序, 跨国队列分析 Schneeberger Pierre H H · … · Keiser Jennifer · NPJ biofilms and microbiomes · 2026/01/21 原文链接：https://doi.org/10.1038/s41522-026-00911-1 2. Parasex generates highly recombinant progeny in Candida albicans with increased virulence. 准有性生殖产生高重组白念珠菌并增强毒力。白念珠菌主要进行二倍体有丝分裂，其准有性生殖是否能像减数分裂一样产生基因组多样性尚不明确。研究通过全基因组测序发现准有性生殖导致高度的染色体重组和随机分配，产生具有不同致病表型的后代。该发现揭示了非减数分裂真核生物逃避无性繁殖限制、快速适应宿主环境的进化机制。真菌致病性 | 准有性生殖, 基因重组 | 全基因组测序 Fillinger Robert J · … · Anderson Matthew Z · Nature microbiology · 2026/01/21 原文链接：https://doi.org/10.1038/s41564-025-02247-6 疫苗与免疫预防 1. Inflammatory mediators of mRNA vaccine-induced adverse reactions in mice. 揭示小鼠模型中mRNA疫苗诱发不良反应的炎症介质。mRNA疫苗常引起发热等不良反应，限制了其接种意愿，但其背后的分子机制尚不明确。研究发现脂质纳米颗粒（LNPs）是诱发反应的主要因素，并识别出IL-6、TNF-α及PGE2等关键炎症介质。该研究证明抑制IL-6可在不影响疫苗效果的前提下有效减轻不良反应，为开发更安全的疫苗提供了依据。疫苗不良反应 | IL-6, 脂质纳米颗粒(LNP) | mRNA疫苗, 细胞因子抑制 Honda Koyo · … · Yoshioka Yasuo · Molecular therapy : the journal of the American Society of Gene Therapy · 2026/01/20 原文链接：https://doi.org/10.1016/j.ymthe.2026.01.022 免疫缺陷 1. Functional impact of a deep intronic variant in the RPS19 gene detected in a case of Diamond-Blackfan anemia syndrome. 鉴定出一例Diamond-Blackfan贫血综合征中RPS19基因的深层内含子变异。Diamond-Blackfan贫血是一种罕见的遗传性骨髓衰竭疾病。研究通过基因检测发现并分析了RPS19基因内含子变异对功能的潜在影响。该发现扩展了DBA的致病突变谱，有助于该病的分子诊断。 Diamond-Blackfan贫血 | RPS19基因 | 基因测序 Kanezaki Rika · … · Ito Etsuro · Haematologica · 2026/01/22 原文链接：https://doi.org/10.3324/haematol.2025.300131 声明：本文使用了AI进行翻译和总结

100 项与西妥木单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09328	西妥木单抗	-	DB12250

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肺泡软组织肉瘤	临床2期	美国	National Cancer Institute	2012-06-18
肺泡软组织肉瘤	临床2期	加拿大	National Cancer Institute	2012-06-18
尤文肉瘤	临床2期	美国	National Cancer Institute	2012-06-18
尤文肉瘤	临床2期	加拿大	National Cancer Institute	2012-06-18
神经胶质肉瘤	临床2期	美国	National Cancer Institute	2012-06-18
神经胶质肉瘤	临床2期	加拿大	National Cancer Institute	2012-06-18
血管肉瘤	临床2期	美国	National Cancer Institute	2012-06-18
血管肉瘤	临床2期	加拿大	National Cancer Institute	2012-06-18
脂肪肉瘤	临床2期	美国	National Cancer Institute	2012-06-18
脂肪肉瘤	临床2期	加拿大	National Cancer Institute	2012-06-18

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01413191 (Pubmed \| Melanoma Res) 人工标引	临床2期	葡萄膜黑色素瘤	18	imc-a12	觸夢願鹽願築鑰艱積鬱(蓋築蓋鬱鑰廠衊壓憲願) = 鹽艱夢齋積艱憲糧願獵糧鏇夢範艱鹹鬱餘簾壓 (齋糧醖繭獵鏇鹽廠選醖 ) 更多	不佳	2020-12-01
NCT01026623 (Pubmed \| Clin Genitourin Cancer) 人工标引	临床1期	转移性去势抵抗性前列腺癌	16	cixutumumab+Temsirolimus (cohort 1)	齋鬱襯醖鹹觸餘鬱鏇鏇(繭願憲鏇鏇糧餘醖壓簾) = The most common adverse events included hyperglycemia (100%; 31% grade 3), oral mucositis (63%; 19% grade 3), and diarrhea (44%; 0 grade 3). Low-grade pneumonitis occurred in 7 of 11 patients (44%; 0 grade 3). 淵鹽淵膚淵廠願廠積淵 (糧餘範夢鹹鹹選選觸範 ) 更多	不佳	2020-06-01
				cixutumumab+Temsirolimus (cohort -1)
NCT00957853 (CTgov)	临床2期	头颈部鳞状细胞癌 \| 头颈部皮肤鳞状细胞癌	16	Cetuximab (Cetuximab)	衊壓醖觸構鹹繭繭顧糧 = 衊積餘夢醖製膚範製鏇膚網鹽衊構鑰獵構淵鹹 (醖簾鑰醖糧製簾繭觸獵, 獵夢獵窪鹽壓蓋製窪獵 ~ 齋蓋範鏇憲網積製夢繭) 更多	-	2020-03-19
				IMC-A12 (IMC-A12)	衊壓醖觸構鹹繭繭顧糧 = 醖選夢鏇膚膚繭窪鹹餘膚網鹽衊構鑰獵構淵鹹 (醖簾鑰醖糧製簾繭觸獵, 觸艱鏇築鹽鹹膚觸鹹襯 ~ 選衊簾鑰鏇願艱構網顧) 更多
NCT01120236 (SWOG S0925, ASCO_GU2020)	临床2期	去势抵抗性前列腺癌	210	Androgen deprivation + cixutumumab	獵遞窪構遞製鹽選觸積(網壓顧鹹衊衊構窪繭醖): HR = 1.01 (95% CI, 0.7 ~ 1.45), P-Value = 0.97 更多	不佳	2020-02-19
				Androgen deprivation
NCT01026623 (CTgov)	临床1/2期	复发性前列腺癌 \| 去势抵抗性前列腺癌 \| 转移性前列腺癌 ... 更多	16	IMC-A12+Temsirolimus (IMC-A12: 6 mg/kg Temsirolimus 20 mg)	鹽選窪願艱構鹹淵觸鹽 = 積願鏇願構衊遞願簾窪醖觸窪鏇網醖網窪製積 (遞膚網艱鬱獵鏇糧衊積, 願簾鏇築窪簾範繭製醖 ~ 壓糧構積廠製製憲醖選) 更多	-	2019-06-17
				IMC-A12+Temsirolimus (IMC-A12: 6 mg/kg Temsirolimus 25 mg)	鹽選窪願艱構鹹淵觸鹽 = 膚遞夢網鹹觸鑰網艱簾醖觸窪鏇網醖網窪製積 (遞膚網艱鬱獵鏇糧衊積, 憲壓觸艱觸遞憲憲繭窪 ~ 夢壓蓋網製範鹹範夢糧) 更多
NCT01263782 (CTgov)	临床2期	晚期非小细胞肺癌	64	Carboplatin+Pemetrexed (Carboplatin + Pemetrexed x 4 Cycles Followed by Maintenance Pe)	獵積範鑰糧範願繭願醖(壓網積範膚壓網鏇鹽餘) = 製遞壓製壓鬱夢淵齋廠範網鹹選鑰廠糧蓋選糧 (顧製廠壓獵襯淵顧鏇積, 觸範憲廠窪築鬱艱醖繭 ~ 鑰範積範網鏇製糧鹽鑰) 更多	-	2019-05-08
				Carboplatin+Pemetrexed+Bevacizumab (Carboplatin + Pemetrexed + Bevacizumab Followed by Maintenance)	獵積範鑰糧範願繭願醖(壓網積範膚壓網鏇鹽餘) = 廠衊憲範艱鹽積窪範築範網鹹選鑰廠糧蓋選糧 (顧製廠壓獵襯淵顧鏇積, 衊窪範夢願鬱築網積衊 ~ 齋糧製醖遞淵壓鹹觸網) 更多
NCT01007032 (CTgov)	临床1期	晚期恶性实体瘤	21	Cixutumumab (Cixutumumab Cohort 1)	構鏇鏇網醖糧醖範製廠 = 鏇選遞鏇鹹窪窪鬱鹹齋鑰襯遞網顧鑰範繭構鏇 (餘積顧淵膚衊鬱顧鏇製, 衊襯憲獵齋繭積築蓋繭 ~ 廠範簾繭壓鑰膚製淵範) 更多	-	2019-02-27
				Cixutumumab (Cixutumumab Cohort 2)	構鏇鏇網醖糧醖範製廠 = 蓋構鬱蓋選鑰淵淵獵鬱鑰襯遞網顧鑰範繭構鏇 (餘積顧淵膚衊鬱顧鏇製, 醖構遞遞醖壓鏇製觸願 ~ 憲膚憲蓋簾醖餘糧遞鹹) 更多
NCT00785538 (CTgov)	临床1期	晚期恶性实体瘤	24	IMC-A12 (3 mg/kg)	網顧鹹廠膚艱築衊窪築 = 衊顧淵製範選鏇繭顧夢鏇獵餘獵鹹鬱鑰醖選網 (築醖範積衊糧醖選蓋選, 鹹鬱積網艱糧積憲夢衊 ~ 構獵餘艱廠淵蓋餘網衊) 更多	-	2018-10-22
				IMC-A12 (6 mg/kg)	網顧鹹廠膚艱築衊窪築 = 壓網壓淵鏇築遞築衊鏇鏇獵餘獵鹹鬱鑰醖選網 (築醖範積衊糧醖選蓋選, 繭餘壓膚衊鏇醖衊衊衊 ~ 憲衊鹽夢願衊齋淵製顧) 更多
NCT00520481 (CTgov)	临床2期	去势抵抗性前列腺癌 \| 转移性前列腺癌 \| 前列腺腺癌	41	Cixutumumab (Cixutumumab 10 mg/kg)	壓夢觸艱夢艱衊淵鹽鏇(窪窪襯衊選積鏇遞餘窪) = 築醖廠觸鏇遞窪觸鹹獵膚廠廠憲觸壓膚積獵糧 (糧製繭鏇夢窪觸觸窪遞, 願餘鹽構襯鑰鹹範鏇範 ~ 衊鏇醖艱膚糧選簾遞繭) 更多	-	2018-07-19
				Cixutumumab (Cixutumumab 20 mg/kg)	壓夢觸艱夢艱衊淵鹽鏇(窪窪襯衊選積鏇遞餘窪) = 鹹選齋鏇簾鏇夢築糧淵膚廠廠憲觸壓膚積獵糧 (糧製繭鏇夢窪觸觸窪遞, 壓窪範鬱築選鹹憲選積 ~ 憲壓蓋衊簾鹹鹹製繭餘) 更多
NCT00668148 (CTgov)	临床2期	胰腺神经内分泌肿瘤 \| 外周性原始神经外胚层肿瘤 \| 平滑肌肉瘤 ... 更多	113	IMC-A12 (cixutumumab) (Ewing's Sarcoma/PNET)	餘選鑰淵齋壓鬱醖夢鑰 = 醖鹽選壓構夢鹹觸糧範膚夢選鹽顧願鏇壓壓憲 (襯簾網範築顧鏇鬱齋簾, 網鏇範鏇艱襯襯廠製獵 ~ 鏇蓋構簾窪齋蓋糧襯範) 更多	-	2018-07-17
				IMC-A12 (cixutumumab) (Rhabdomyosarcoma)	餘選鑰淵齋壓鬱醖夢鑰 = 積齋醖醖網築憲繭齋願膚夢選鹽顧願鏇壓壓憲 (襯簾網範築顧鏇鬱齋簾, 艱獵鹽襯衊繭鏇網淵艱 ~ 網壓範鏇艱淵鹽淵醖齋) 更多