Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

开始日期2024-10-14

申办/合作机构

SK Life Science, Inc.

NCT05572255

/ Completed临床1期

A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally As a Crushed Tablet or a Crushed Tablet Via a Naso-gastric Tube Compared with an Intact 200 Mg Cenobamate Tablet

This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3-period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg, intact (whole) 200 mg and crushed 200 mg tablet via NG tube of cenobamate. All treatments will be administered under fasting conditions.

开始日期2022-09-27

申办/合作机构

SK Life Science, Inc.

NCT05388435

/ Terminated临床1/2期

A Phase 1/2, Open-Label, Multicenter, Dose-Finding Study of SKL27969 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumors

Primary Objective of Part 1 (Dose Escalation Phase): Evaluate the safety and tolerability of SKL27969, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of SKL27969
Primary Objective of Part 2 (Dose Expansion Phase): Evaluate the preliminary anti-tumor activity of SKL27969

开始日期2022-09-12

申办/合作机构

SK Life Science, Inc.

100 项与 SK Biopharmaceuticals Co., Ltd. 相关的临床结果

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项与 SK Biopharmaceuticals Co., Ltd. 相关的文献（医药）

2025-11-01·SEIZURE-EUROPEAN JOURNAL OF EPILEPSY

New onset of comorbidities in people with epilepsy in a national healthcare claims database

Article

作者: Faught, Edward ; Kerr, Wesley T ; Stern, Sean ; Klatte, Emily ; Wade, Clarence T

PURPOSE:

This study evaluated the rate of new occurrence of select comorbidities in adults after events of uncontrolled epilepsy versus controlled epilepsy.

METHODS:

The HealthVerity Marketplace Inovalon healthcare claims database was used. Adults (≥18 years) with an epilepsy diagnosis (ICD-10-CM G40*) prescribed at least one antiseizure medication (ASM) between January 1, 2015, and December 31, 2021, were included. Patients were categorized as having either a first-filled or third-filled ASM. The first ASM filled was defined as no ASMs filled for at least 1 year of enrollment. Uncontrolled epilepsy events within 1 year of new ASM initiation were: seizure-related inpatient or emergency room visit or initiation of subsequent ASM. Patients with uncontrolled and controlled epilepsy were propensity score matched. Time to first new comorbidity was measured for cardiac/metabolic, neuropsychiatric, and neurologic disorders.

RESULTS:

First-filled ASM start date was identified for 78,714 patients with epilepsy, 64,031 of whom received a third ASM. Most patients had an uncontrolled epilepsy event within the first year after first-filled (57%) ASM initiation and after third-filled (56%) ASM initiation. The rate of most neuropsychiatric and neurologic comorbidities was higher among patients with uncontrolled epilepsy during first-filled and third-filled ASM. The rate of most cardiac/metabolic comorbidities was higher among patients with uncontrolled epilepsy after third-filled ASM initiation; however, these comorbidities were more common in controlled epilepsy during first-filled ASM.

CONCLUSION:

Patients with uncontrolled epilepsy had a higher rate of new-onset comorbidities. These results indicated that seizure control may influence the non-seizure impacts of epilepsy.

2025-08-01·Epilepsy Currents

Inclusivity in Epilepsy Care: Navigating the Complex Nature of Seizure Disorders in People Undergoing Gender-Affirming Care

Review

作者: Kerr, Wesley T. ; Zeigler, Gwen ; L’Erario, Z Paige ; Lane, Chadrick E. ; Abramowitz, Jessica ; Alick-Lindstrom, Sasha ; Falco-Walter, Jessica J. ; Gidal, Barry E. ; Weingarten, Mindl M.

There is a paucity of information to rely on when caring for transgender and gender diverse (TGD) individuals with epilepsy. Clinicians must be aware of the mechanisms of antiseizure medications, potential unique side effects, and medication interactions that require monitoring. This principle is central to the clinical care of the TGD population, specifically for those pursuing gender-affirming care via hormone treatment and/or surgical interventions. This resource aims to support the delivery of quality healthcare with a comprehensive approach for TGD individuals living with epilepsy. This article discusses diverse topics, including antiseizure medications, drug–drug interactions, surgical and neuromodulation techniques, as well as general considerations for managing complex cases of medication-resistant epilepsy in TGD individuals. It also aims to make neurologists familiar with the basics of medical and surgical care for the same population and highlight potential reciprocal effects between comprehensive gender-affirming and epilepsy care.

2025-07-03·EXPERT OPINION ON PHARMACOTHERAPY

Potential of cenobamate as a broad-spectrum antiseizure medication

Review

作者: Melnick, Susan M. ; Ferrari, Louis ; Glenn, Kelli J. ; Misra, Sunita N ; Kamin, Marc

INTRODUCTION:

The process of diagnosing patients with epilepsy and selecting the optimal drug remains a significant challenge. Broad-spectrum antiseizure medications (ASMs) treat focal and generalized seizures without worsening other seizure types, making them the drug of choice when the exact seizure classification for patients is unknown. Cenobamate, an ASM approved for the treatment of adult focal seizures, has demonstrated strong efficacy, including high rates of seizure freedom. Evidence suggests that cenobamate has potential to be a broad-spectrum ASM.

AREAS COVERED:

Considerations for the selection of broad- versus narrow-spectrum ASMs are discussed and an overview of preclinical, clinical, and real-world evidence relating to cenobamate as a potential broad-spectrum ASM is presented.

EXPERT OPINION:

Combined evidence from preclinical data, clinical study data, and real-world evidence may indicate that cenobamate may be a broad-spectrum ASM. Evidence is accumulating regarding the utility of cenobamate in treating primary generalized tonic-clonic (PGTC) and seizures associated with developmental epileptic encephalopathies such as Lennox-Gastaut syndrome and Dravet syndrome. Results from the ongoing cenobamate trial in patients with idiopathic generalized epilepsy will determine the efficacy of cenobamate for the treatment of PGTC seizures.

137

项与 SK Biopharmaceuticals Co., Ltd. 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

2026-01-21

·百度百家

AI智能体独立运营实验室，2026年科学家或可告别重复劳动，AI如何加速新药研发？

旧金山湾区一处高度保密的实验室内，机械臂不知疲倦地在培养皿与检测仪间移动，AI模型实时调整着实验参数——这里没有科学家值守，却正在以人类十倍的速度探索着下一代减肥药的合成路径。 2026年1月，全球制药巨头礼来与英伟达宣布了一项震撼行业的合作：未来五年投资10亿美元，建立全球首个AI药物研发共创实验室。这个位于旧金山湾区的实验室将实现全天候AI辅助实验，将湿实验室与计算干实验室无缝连接。与此同时，清华大学团队在《科学》杂志发表的成果显示，他们开发的AI平台能将药物虚拟筛选速度提升百万倍。这些突破性进展标志着，2026年很可能成为AI从科研辅助工具转变为“科学合作者”的关键转折点。 01 研发范式革命，从人力驱动到AI主导的转变传统药物研发是典型的“三高”领域——高风险、高投入、高耗时。一款新药从发现到上市平均需要10-15年，耗资超过20亿美元，而成功率却低于10%。这种模式已持续半个世纪，成为制约医药创新的主要瓶颈。 AI的介入正在彻底改变这一范式。2026年1月13日，因美纳公司推出全球最大的“十亿细胞图谱”，这是构建“五十亿细胞图谱”计划的首批成果。这个图谱记录了超过200种疾病相关细胞系中，10亿个细胞对基因改变的响应，为AI模型提供了前所未有的训练资源。这种转变的核心是从“试错式”研究转向“预测式”研究。传统方法需要科学家基于有限知识和经验提出假设，然后通过大量实验验证。而AI能够分析海量数据，发现人类难以察觉的模式，直接预测哪些分子可能有效，大大减少了盲目实验。上海交通大学的研究团队提供了一个典型例证：他们使用专门的大语言模型寻找高效化学反应条件，仅进行了15次测试就取得了传统方法需要数百次实验才能获得的结果。这种效率提升不是线性增长，而是指数级飞跃。 02 三大核心技术，构成AI实验室的智能基石 AI驱动的新药研发建立在三大技术支柱之上，它们共同构成了智能药物发现系统的核心架构。首先是超高通量虚拟筛选技术。清华大学的DrugCLIP平台是这一领域的突破性成果，它创新性地将传统的分子对接方法，转化为蛋白口袋与小分子在向量空间中的高效语义检索。基于128核中央处理器和8张图形处理器的计算节点，该系统可在1天内完成10万亿次蛋白—配体打分。在实际验证中，针对去甲肾上腺素转运体这一抑郁症靶点，DrugCLIP从160万个候选分子中筛选出约100个高评分分子，实验证实其中15个为有效抑制剂，12个分子的结合能力优于当前常用抗抑郁药物。这种“从海量到精准”的筛选能力，彻底改变了早期药物发现的游戏规则。其次是自动化实验闭环系统。礼来与英伟达共建的实验室将实现“假设生成-实验验证-模型优化”的完整闭环。AI模型提出药物假设后，自动化实验平台进行验证，数据实时反馈至模型进行迭代优化，形成自主学习的科研循环。这种系统能够24小时不间断工作，不受人类生理限制。第三是多模态生物医学基础模型。英伟达的BioNeMo平台与因美纳的细胞图谱结合，正在构建能够理解生物学复杂性的下一代AI模型。这些模型不仅分析分子结构数据，还能整合基因组学、蛋白质组学、临床数据等多维度信息，形成对疾病机制更全面的理解。 03 效率跃升现实，从百万倍筛选到全天候实验 AI带来的效率提升不是理论预测，而是已经量化的现实成果。在药物发现最耗时的早期阶段，AI正展现出颠覆性的加速能力。虚拟筛选效率方面，传统方法可能需要数月甚至数年才能完成的工作，现在被压缩到几天甚至几小时。清华大学的DrugCLIP平台已完成覆盖约1万个蛋白靶点、2万个蛋白口袋的虚拟筛选，分析了超过5亿个类药小分子，构建了目前已知最大规模的蛋白—配体筛选数据库。实验自动化方面，加拿大多伦多大学2024年发布的机器人可将研究人员的工作时间缩短80%。这些机器人能够自主进行实验操作、数据收集和初步分析，使科学家从重复性劳动中解放出来，专注于更高层次的科学问题。礼来与英伟达的联合实验室则代表着更进一步的集成化方向。这个实验室不是简单的自动化设备集合，而是深度融合了AI计算与实验验证的智能系统。AI不仅控制实验过程，还能根据实时结果调整研究方向，实现真正意义上的“自主科研”。从研发管线进展来看，AI驱动的新药表现也十分亮眼。截至2023年12月底，全球共有24个AI发现的分子完成Ⅰ期临床试验，其中21个成功，成功率达87.5%，远高于传统制药行业平均水平。 04 科学家角色进化，从实验操作者到战略设计者随着AI和自动化技术接管越来越多的实验操作，科学家角色正发生深刻转变。他们不再是亲力亲为的实验操作者，而是转变为科研战略的设计者、AI系统的训练师和跨学科团队的协调者。 2026年1月的JP摩根健康大会上，SK Biopharmaceuticals首席执行官Lee Dong-hoon用了一个生动的比喻：“许多药物开发者就像纯种动物，存在遗传缺陷。现在是制药和生物技术行业大胆追求与AI‘杂交’的时候了，要超越近亲繁殖。” 这个比喻精准捕捉了行业需要的新思维方式。科学家们现在需要掌握的新技能包括AI模型训练、数据质量管理、跨领域知识整合等。他们更像电影导演，设定科研目标，指导AI“演员”执行任务，然后基于结果调整下一步策略。这种转变释放了科学家的创造潜力，使他们能够同时探索多个研究方向。上海创新药物研发中心首席科学家John Renger指出，未来AI甚至能够进行“逆向设计”——科学家直接告诉AI需要一种具有特定特性的药物，让机器去构建它。这将彻底改变从靶点发现到分子设计的传统流程。 05 行业生态重构，数据联盟与算力竞赛并行 AI制药的兴起正在重构整个医药研发生态系统。传统的封闭式研发模式逐渐被开放协作的数据联盟所补充，而算力则成为新的竞争壁垒。数据共享方面，因美纳的“十亿细胞图谱”是在与阿斯利康、美国默克公司和礼来公司等组成的联盟框架下构建的。这种行业级数据合作解决了AI训练中的数据短缺问题，打破了企业间的数据孤岛。阿斯利康基因组研究中心副总裁Slavé Petrovski表示：“将遗传信息转化为对疾病机制的清晰理解，并最终转化为药物，这仍然是研发领域的核心挑战。” 算力投入方面，大型药企正通过巨额投资建立竞争优势。礼来与英伟达的10亿美元联合实验室仅是冰山一角。这些投资不仅用于购买硬件，更重要的是构建专属的AI药物发现平台和模型，形成难以复制的技术护城河。对于中小企业而言，这种趋势带来了新的挑战。AI制药的高算力需求导致了明显的“马太效应”，只有少数有资金、有资源的大企业能持续投入。然而，清华大学的DrugCLIP平台提供了另一种可能——他们的筛选数据库已免费面向全球科研社区开放，截至论文发表时，已累计服务1400余名用户完成1.35万余次筛选。这种开源模式为资源有限的研究团队提供了参与AI药物发现的机会。 06 现实挑战犹存，从数据缺陷到临床转化瓶颈尽管前景广阔，但AI制药仍面临多重挑战，这些挑战横跨数据、算法、临床转化和算力四个维度。数据质量是首要难题。制药行业的数据分散在不同机构和平台，格式不统一，难以整合。更严重的是“成功偏见”——学界和工业界倾向于公布成功实验结果，而失败数据常被忽视。这就像只给AI看成功的菜谱，却不告诉它哪些食材搭配会失败，导致AI可能在错误方向上越走越远。算法“黑盒”问题则困扰着监管审批。AI在给出药物分子或靶点时，往往无法解释具体决策过程。监管部门难以评估其安全性和有效性，这成为了AI药物上市的重要障碍。临床转化是另一大瓶颈。即使AI在实验室表现出色，也难以完全模拟复杂的人体环境。药物进入人体后的吸收、代谢和潜在副作用，仍需传统临床试验验证。AI在患者招募和临床试验数据监测方面的辅助作用，也因医疗数据隐私和互通性问题而受限。东京科学大学教授冈崎直观的预测指出了方向：“未来将出现能够自主进行科学研究的AI。” 但要实现这一愿景，仍需跨越这些现实挑战。 07 未来展望，从辅助工具到科研伙伴的演进展望未来，AI在药物研发中的角色将继续深化，从当前的辅助工具演进为真正的科研伙伴，最终可能实现完全自主的科学发现。短期来看，AI将更深度地融入药物研发全流程。礼来与英伟达的合作已不仅限于早期分子发现，更扩展至临床试验设计、药品制造流程优化等领域。这种端到端的整合将最大化AI的价值。 2026年可能是AI制药商业化的重要节点。根据行业数据，目前全球共有102个AI驱动的药物管线获批临床试验，其中5个已处于Ⅲ期阶段。按照常规临床试验时间节奏，首个完全由AI驱动的药物有望在近期获批上市，这将标志着AI制药从技术验证转向商业化考量。从科研想象力角度看，AI甚至可能超越人类科学家。上海人工智能实验室教授欧阳万里团队测试发现，大语言模型能像化学家一样提出高质量研究想法。通过让大语言模型模拟不同领域专家团队进行讨论，AI可生成更具创新性的科研思路。长远而言，AI可能催生全新的药物研发范式。传统上，药物研发是线性过程：靶点识别、先导化合物发现、优化、临床前研究、临床试验。未来，AI可能使这一过程变得更加并行化和迭代化，不同阶段的信息流实时交互，大幅压缩研发时间。当礼来的科学家走进与英伟达共建的实验室，他们面对的不仅是自动化设备，更是能够自主提出假设、设计实验、分析结果的AI科研伙伴。这场变革的核心不是机器取代科学家，而是人类智慧与人工智能的深度融合，共同探索生命科学的未知领域。从百万倍加速的虚拟筛选到全天候运转的自动化实验室，AI正将药物研发从“艺术”转变为“工程”，从“试错”转变为“预测”。药物研发的速度提升意味着，未来十年我们可能看到的新药数量将超过过去五十年的总和，更多罕见病、疑难疾病有望找到治疗希望。

2026-01-20

·Boom Health

行业洞见｜麦肯锡：亚洲已成为全球生物制药创新的重要一极

由于近期公众号推送机制改变，欢迎您在公众号首页将Boom Health设为🌟“星标”🌟，第一时间获取数字医疗行业的最新趋势和专家洞见！本文约5000字，阅读需要11分钟本报告翻译自麦肯锡（McKinsey）发布的《The emerging epicenter: Asia’s role in biopharma’s future》，聚焦全球生物制药创新版图的结构性变化，通过系统分析亚洲主要市场在研发能力、产业生态、资本模式与全球化路径上的演进，揭示亚洲正从传统的制造与外包角色，跃迁成为全球生物制药创新的重要策源地。报告指出，亚洲在创新管线扩张、前沿治疗技术、跨境合作与成本效率等方面已形成不可忽视的综合优势，并正在重塑全球药物研发与商业化的组织方式。 01 亚洲崛起：从追随者到创新策源地长期以来，亚洲在全球生物制药体系中更多被视为制造基地或研发外包目的地，其核心价值集中在成本优势与执行效率层面。然而，报告指出，这一角色定位正在发生根本性改变。亚洲已从“快速追随者”跃迁为全球生物制药创新的重要策源地，并在多个关键指标上展现出领先态势。从创新产出看，亚洲在生物技术专利、创新管线以及新一代治疗平台方面的表现尤为突出。报告显示，2024年亚洲贡献了全球近三分之二的生物技术专利授权数量，约为欧洲的五倍；在全球对外授权交易中，亚洲企业已占据约四分之一的份额。这些指标反映出，亚洲在研发早期与中期阶段的创新活跃度已显著提升。尽管在FDA新分子实体批准数量上，亚洲目前仍仅占全球约十分之一，但报告认为，这一“滞后指标”并未充分反映真实创新能力。随着亚洲在药物发现、临床开发与监管体系方面的持续进步，这一差距有望在未来几年逐步缩小。报告进一步指出，亚洲创新能力的跃升并非偶然，而是多重结构性因素共同作用的结果。政府层面，多个亚洲国家已将生物制药明确列为战略性产业，通过长期财政投入、制度改革与产业政策提供持续支持；科研层面，亚洲在基础科学、转化研究及工程化能力上的积累不断加深；产业层面，临床试验、许可合作与跨境研发模式日益全球化，使亚洲能够更深度地嵌入全球创新网络。在亚洲内部，中国被视为最具代表性的领跑者（pacesetter）。报告指出，中国目前已占全球创新药管线的约29%，且在研发周期上显著快于行业平均水平。来自中国的对外授权交易首付款规模，也在短短数年间从不足1亿美元增长至8亿美元以上，足见中国的创新资产在全球市场上的认可度不断提升。与此同时，亚洲的创新崛起并非“中国单极现象”。韩国正在加速推进FDA审批与国际授权，新加坡逐步确立其生物医学研发枢纽地位，印度也在从仿制药强国向原创药研发转型。尽管各市场所处发展阶段不同，但其叠加形成的整体动能，正在重塑全球生物制药创新格局。亚洲主要市场进入生物制药创新的关键时间节点与制度演进路径 02 创新能力评估：价值链能力与生态要素的双重视角为系统评估亚洲生物制药创新的真实进展，报告从两个互补视角展开分析：一是价值链基础能力，二是创新生态的外部支撑要素。（1）价值链基础能力结构从价值链角度看，报告将生物制药创新拆解为基础研究、药物发现、临床开发、制造以及商业化等关键环节。分析结果显示，亚洲各国在这些环节上形成了差异化、但高度互补的能力分布。在基础研究与早期发现环节，日本长期积累的科研体系与学术传统，使其在高质量基础科学与转化研究方面持续发挥区域支点作用。中国与韩国则在发现与开发环节实现了规模化能力建设，依托密集的CRO与CDMO生态系统，显著压缩研发周期。在制造环节，印度在小分子药物与仿制药制造方面保持全球领先地位，并逐步向生物制剂与复杂制剂扩展；中国与韩国在生物制剂、抗体类药物及先进治疗平台制造方面快速提升能力。商业化方面，日本与部分中国企业已具备全球运营经验，而新加坡则在区域市场部署与早期商业化支持上形成优势。报告认为，亚洲并未形成单一集中式创新中心，而是构建了一种“分布式能力体系”（distributed capability system）。在这一体系中，不同国家在价值链不同环节形成专业化优势，企业可根据技术路径、治疗领域与项目阶段，灵活组合区域资源。亚洲主要国家在生物制药价值链各环节的规模与独特性分布（2）创新生态外部支撑要素除价值链能力外，报告还从政府政策、监管融合、资本供给、人才与文化以及数字与技术基础设施五个维度，评估亚洲创新生态的成熟度。在政府政策方面，中国、新加坡与韩国均通过国家级规划，将生物制药定位为战略性产业，并提供长期、系统性的财政与制度支持。监管层面，中国加入ICH、日本完善加速审批机制，使亚洲与全球监管体系的兼容性显著提升。资本环境方面，中国与韩国已形成相对活跃的IPO与私募融资市场，新加坡吸引了多家全球顶级风投设立区域总部；印度虽然资本市场相对滞后，但近年来政策激励与私募投资明显回升。在人才与文化层面，中国与印度均具备庞大的STEM人才储备，日本在高端科研人才质量上保持优势，而韩国与新加坡则通过国际化引才与创业激励机制，逐步改善创新文化。数字与技术基础设施方面，中国与印度在数据规模与数字化应用上具备显著优势，为AI辅助研发与数字健康提供了重要支撑。正是这些差异化的生态要素，使亚洲能够通过多条路径实现创新能力成熟，而非依赖单一模式复制。亚洲主要国家在五大创新支撑要素上的准备度比较 03 主要国家分析：多路径并行的创新格局（1）中国：规模、速度与广度报告指出，中国已成为亚洲乃至全球生物制药创新的最大单一贡献者，约占全球创新药管线的30%。其能力覆盖从药物发现到后期临床开发的完整流程，并在ADC、多特异性抗体、细胞与基因治疗等领域形成显著优势。中国最突出的特征在于研发速度。报告显示，其从早期发现IND申报的周期比全球平均水平快50%–70%，后期临床试验的患者招募速度也显著领先。这一效率来源于并行化研发流程、密集的CRO 生态以及高度执行导向的研发文化。监管改革进一步强化了这一优势。随着加入ICH 以及药审资源扩充，中国药品审批周期大幅缩短。与此同时，中国原创研究在顶级学术期刊中的发表数量持续增长，显示其正从“快速跟随”向“原创突破”转型。（2）韩国：技术积累与领域聚焦韩国在先进生物制剂领域，尤其是ADC 与细胞治疗方面，正快速提升全球影响力。报告提及多起数十亿美元级对外授权交易，反映出韩国创新资产在国际市场上的技术可信度不断增强。在政策层面，生物制药被列为国家战略技术之一，配套资本市场机制允许未盈利企业上市，为早期创新提供了重要融资渠道。科研产出、临床能力与全球化管理团队的同步提升，使韩国逐步成长为亚洲重要的“技术聚焦型创新中心”。（3）日本：质量、规范与全球合作日本在FDA 新分子实体批准数量上持续领先亚洲其他市场。日本长期积累的研发体系、成熟的监管机制以及高质量科研人才，使其在高标准创新与全球商业化方面保持稳定优势。通过“Sakigake designation”（先行审评）等制度，日本有效缩短了重点药物的上市周期。同时，日本企业在全球合作与跨国治理结构上的成熟经验，使其不仅是科研强国，也是全球生物制药体系中的重要合作伙伴。（4）新加坡：早期创新与区域枢纽新加坡将自身定位于早期生物制药创新与区域商业化平台。依托Biopolis 与A*STAR 等科研机构，其在科研成果转化、临床效率与数字基础设施方面形成协同优势。尽管新加坡本土市场规模有限，但其稳定的制度环境、强知识产权保护与国际化人才结构，使其成为全球企业进入亚洲的重要门户。（5）印度：从仿制走向科学驱动印度在全球制药制造领域长期占据核心地位。近年来，印度创新药管线规模显著扩张，逐步进入生物类似药、复杂制剂与新型疗法领域。在政策激励、资本投入与“人才回流”共同推动下，印度正从以成本效率为主导的制造中心，向创新驱动型生物制药体系演进。 04 全球化路径：亚洲生物制药的商业模式演化亚洲生物制药企业推进全球化的四类主要商业模式：首先是对外授权模式（Out-licensing）：对外授权是亚洲本土生物制药企业实现商业化的主要方式。在这一模式下，亚洲企业负责开发具有潜力的候选药物，并将相关权利授权给海外合作方，由后者主导后续的研发、生产以及市场上市工作。通过这种方式，亚洲生物制药企业可以在无需承担海外市场高资本投入基础设施建设成本的情况下，实现其科研与创新成果的商业化变现。目前，亚洲约占全球对外授权交易的25%。相关交易仍主要集中在肿瘤领域，同时在细胞与基因治疗、抗体药物偶联物（ADC）等新一代治疗技术方向上的授权活动正在增加。其次是战略合作模式（Strategic partnerships）：战略合作模式介于单纯的对外授权与完全自建全球能力之间。在这一模式下，亚洲生物制药企业通过与全球制药公司合作进入国际市场。合作形式可能包括联合开发、联合商业化或共同创建产品，合作双方在成本投入、风险承担以及潜在收益方面进行共享。目前，亚洲生物制药企业约占全球战略合作项目的30%。报告显示，这一模式在短期内仍有望进一步增长。第三是直接全球化的模式（Direct to global）：在直接全球化模式下，越来越多的亚洲生物制药企业选择不依赖合作伙伴，而是自主进入国际市场，独立承担监管审批、本地运营以及产品上市等相关工作。一些亚洲本土药企之所以采用这一模式，是因为其能够对资产保持更高的控制权，并获得更优的长期收入回报。目前，亚洲约占全球创新药管线的43%，这一数据表明，源自亚洲的创新正在日益直接参与全球竞争。在这一模式中，日本企业处于领先地位，拥有如武田制药（Takeda）和卫材（Eisai）等在全球市场活跃的企业。中国的百济神州（BeOne）是最早将自主研发资产直接推向国际市场的中国大型生物制药公司之一，涵盖海外监管申报、临床试验及商业化运营。与此同时，韩国的SK Biopharmaceuticals 和印度的Dr. Reddy’s Laboratories 也体现出亚洲企业在全球市场中的持续扩展。第四是近年来快速发展的NewCo模式（NewCo model）：该模式是一种近年来逐渐兴起的商业化路径。在该模式下，企业将一个或多个在研管线资产剥离出来，注入在海外新设立的公司实体中。新公司通过吸引独立投资者为资产后续开发提供资金，并聘请本地管理团队与专业人员负责产品的商业化运作。原亚洲生物制药企业通常会保留新公司的部分股权，并参与收入分成安排。过去一年中，已完成十余起NewCo 相关交易，该模式在亚洲及全球生物制药企业中逐渐受到关注。中国是亚洲NewCo活动最为集中的市场。例如，2025年初，中国的基石药业（KeyMed Biosciences）与美国Mountainfield Venture Partners 合作，成立了 Timberlyne Therapeutics。这家NewCo公司获得了基石药业CD38 靶向抗体CM313在大中华区以外市场的授权，用于肿瘤和自身免疫疾病的开发。通过NewCo模式，亚洲生物制药企业能够在保持一定战略控制权的同时，引入专业资本和本地化经验，从而加快资产开发进程并推动其进入全球市场。这些模式并非相互替代，而是构成一个可灵活组合的“战略工具箱”，使亚洲企业能够根据资产成熟度与战略目标选择最优路径。借助不同路径，亚洲企业正在加快全球扩展步伐，并在竞争激烈的全球生物制药市场中不断提升自身地位。 05 结语：亚洲崛起意味着什么亚洲正在加速形成的能力体系，决定了其将在全球生物制药创新的下一波浪潮中扮演核心角色。对于正在应对研发管线生产率挑战的制药企业管理层，以及寻求可规模化、高回报创新平台的投资者而言，信号已经非常清晰：亚洲不再只是一个值得关注的市场，而是将深刻影响整个行业演进方向的关键力量。在全球生物制药行业面临专利悬崖、新分子实体提交数量放缓的背景下，亚洲正逐步成长为一股重要的补充力量——成为弥合全球研发生产率缺口的重要引擎。同时，亚洲并非简单复制既有创新路径，而是在多个关键环节提供了新的增量能力。不同国家在这一过程中展现出各自独特的优势结构，各国生物制药价值链的持续演进，正在对全球药物发现与开发的组织方式产生结构性影响。与美国市场更倾向于聚焦高价格、突破性疗法不同，亚洲在“可负担创新”（affordable innovation）方面具备独特潜力。这类创新强调面向更广泛人群、具备规模化可行性的解决方案，并以更低成本实现临床价值。这种创新模式不仅有助于改善亚洲本土市场的药物可及性，也可能在东南亚、拉丁美洲、中东和非洲等其他新兴地区产生深远影响，为目前服务不足的数百万患者带来现代治疗方案。当前的战略问题已不再是是否进入亚洲，而是如何建立适配自身需求的合作与组织模式，以持续获取创新能力。这些模式既可以是单一资产层面的合作安排，也可以是包括NewCo或分布式开发体系在内的生态型结构。而能够超越传统合作模式、系统性整合这些能力的企业，将有望加快研发进程、拓展技术平台覆盖范围，并构建更加稳健的全球研发体系。在一个既要求研发能力、又强调运营效率的时代，亚洲已不再边缘，而是站在最核心的位置，成为全球生物制药创新的重要一极。整理：侯占才但誉乐点分享点点赞点在看

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