A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Masupirdine (SUVN-502) for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type

This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

开始日期2022-11-01

申办/合作机构

Suven Life Sciences Ltd.

NCT02580305

/ Completed临床2期

A Phase 2a Multicenter, Randomized, Double-Blind, Parallel Group, 26-Week, Placebo-Controlled Study of SUVN-502 in Subjects With Moderate Alzheimer's Disease Currently Treated With Donepezil Hydrochloride and Memantine Hydrochloride

This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable doses of donepezil HCl and memantine HCl.

开始日期2015-09-01

申办/合作机构

Suven Life Sciences Ltd.

NCT03564964

/ No longer availableN/A

An Intermediate-Size, Expanded Access to SUVN-502 for the Treatment of Subjects With Alzheimer's Disease Who Have Completed the CTP2S1502HT6 Study

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to SUVN-502 for the treatment of Alzheimer's Disease. Investigator as well as the subject/caregiver must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria.
Subjects will not be evaluated for efficacy and safety during the expanded access.

开始日期-

申办/合作机构

Suven Life Sciences Ltd.

100 项与 Masupirdine(Suven Life Sciences Ltd.) 相关的临床结果

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项与 Masupirdine(Suven Life Sciences Ltd.) 相关的文献（医药）

2025-12-01·Alzheimers & Dementia

Clinical and Non‐clinical Evidence Supporting the Development of Masupirdine (SUVN‐502) for the Management of Agitation in Alzheimer’s Disease

Review

作者: Benade, Vijay ; Palacharla, Veera Raghava Chowdary ; Subramanian, Ramkumar ; Abraham, Renny ; Mohammed, Abdul Rasheed ; Goyal, Vinod Kumar ; Ravulu, Jyothsna ; Jayarajan, Pradeep ; Jetta, Satish ; Nirogi, Ramakrishna ; Shinde, Anil

Abstract:

Background:

Neuropsychiatric symptoms (NPS) commonly occur over the course of Alzheimer's disease (AD), with agitation being one of the most prevalent symptoms. Agitation results in caregiver distress, increased morbidity and mortality, and early institutionalization of patients with AD. Pharmacological agents used to manage agitation are limited to antipsychotics, benzodiazepines, antiepileptics, and antidepressants, for which efficacy and safety are not well established, except for brexpiprazole. The side effects associated with these agents are substantial, highlighting the need for effective and safe treatments. Serotonin‐6 (5‐HT 6 ) receptors are widely expressed in the brain regions involved in control of mood and behavior. Modulation of 5‐HT 6 receptors may have potential therapeutic implications in the management of agitation in AD.

Method:

Masupirdine, a pure, potent and selective 5‐HT 6 receptor antagonist was assessed for its effects on aggression like behaviors in rodent models like resident‐intruder task and dominant‐submissive assay. The effects of Masupirdine on cognitive and motor performances were studied in the alternating lever cyclic ratio schedule. Clinical evidence supporting the potential effectiveness of Masupirdine for treating agitation was generated from a subgroup analysis of a Phase‐2, 26‐week proof‐of‐concept clinical study in AD patients (NCT02580305).

Result:

Oral treatment with Masupirdine led to a significant and meaningful reduction in aggressive behaviors, as observed in both the resident‐intruder and dominant‐submissive assays. Performance on the alternating lever cyclic ration schedule demonstrated that Masupirdine did not induce any cognitive or motor impairments. Subgroup analysis of the agitation/aggression domains on the NPI‐12 scale revealed a statistically significant reduction in agitation/aggression scores (p<0.01) in patients treated with either 50 or 100 mg of Masupirdine at Week 13, with the effect remaining sustained through the end of 26‐week treatment period.

Conclusion:

The non‐clinical and clinical data support further evaluation of Masupirdine for the management of agitation in AD. A global Phase‐3, double‐blind, randomized, placebo‐controlled study to establish the efficacy, safety, tolerability, and pharmacokinetics of Masupirdine in patients with agitation in dementia of the Alzheimer’s type (NCT05397639 and EudraCT 2021‐003405‐22) is in progress.

2025-04-01·BIOORGANIC & MEDICINAL CHEMISTRY

Design, synthesis and activity evaluation of 4-(quinoline-2-yl)aniline derivatives as SARS-CoV‑2 main protease inhibitors

Article

作者: Tu, Gao ; Yao, Xiaojun ; Du, Zhenya ; Gong, Yaguo ; Ma, Chunhua ; Wu, Jianlin ; Ma, Qinhai ; Bao, Honglei ; Gong, Shilin ; Meng, Hui ; Wang, Yuwei

Since 2020, numerous compounds have been investigated for their potential use in treating SARS-CoV-2 infections. By identifying the molecular targets during the virus replication process, rationally designed anti-SARS-CoV-2 agents are developed. Among these targets, the main protease (M^pro) is a crucial enzyme required for virus replication, and its highly conserved characteristic make it an important drug target for the development of anti-SARS-CoV-2 drugs. Herein, we utilized warhead-based design strategy to conduct the structural optimization of M-1 developed through virtual screening, leading to a series of novel M^pro inhibitors with 4-(quinolin-2-yl)aniline scaffold. Among them, M-32 exhibited good SARS-CoV-2 M^pro inhibitory activity (IC₅₀ = 5.2 μM) with a nearly 25-fold increase. Isothermal titration calorimetry (ITC) directly proved that M-32 binds directly to SARS-CoV-2 M^pro in an entropy-driven manner. Mass spectrometry (MS) further confirmed the covalent binding ability of M-32 to M^pro. Meanwhile, M-32 effectively inhibited the replication of SARS-CoV-2 in Vero E6 cells (EC₅₀ = 5.29 μM).

2025-03-01·NEOPLASIA

Phase I clinical trial of a novel procaspase-3 activator SM-1 with temozolomide in recurrent high-grade gliomas

Article

作者: Li, Shenglan ; Li, Shangwei ; Xiao, Yantao ; Zhang, Botao ; Huang, Mengqian ; Li, Wenbin ; Kang, Zhuang

OBJECTIVE:

Despite a standard of care, the mortality of recurrent high-grade gliomas (HGGs) remains high. SM-1 is a novel molecular activator that has shown to target procaspase-3, which is overexpressed in HGGs. A phase I clinical trial was conducted to evaluate the safety, pharmacokinetics, and primary clinical efficacy of SM-1 plus TMZ. Participants received escalating doses of daily oral SM-1 (450, 600, and 800 mg) plus standard TMZ therapy.

METHODS:

In the preclinical study, the synergistic effects of SM-1 and temozolomide (TMZ) in rodent models were evaluated. In the clinical study, adult patients received SM-1 therapy in various doses in combination with a standard TMZ dosing. The tolerability and pharmacokinetics data of the combination therapy were tested. The primary efficacy was measured by tumor response in accordance with the RANO criteria.

RESULTS:

A total of 13 patients with recurrent HGG were enrolled, with 11 patients completed ≥ two cycles of therapy and received tumor assessment. Among them, one patient had complete response, whereas two patients had partial response for the best change from baseline. No dose-limited toxicities were observed, and no maximum tolerated dose was reached.

CONCLUSION:

SM-1 has the potential to enhance antitumor activity while alleviating the side effects of TMZ. SM-1 exhibited mild toxicity in patients with recurrent HGG. The combination of SM-1 and TMZ warrants further investigation, with promising clinical outcomes. The monotherapy phase and expansion phase of SM-1 are still ongoing. (ClinicalTrials.gov number, CTR20221641).

项与 Masupirdine(Suven Life Sciences Ltd.) 相关的新闻（医药）

2026-01-29

·阿尔茨海默病研究

2021-2026年全球AD药物研发管线分析

AD_Drug_Development_2021-2026.xlsx 关键词：阿尔茨海默病、药物、临床、研发、Phase 25年的AD药物统计还没看到，AI先做了一个汇总表阿尔茨海默病(AD)药物研发汇总报告 2021-2026年全球AD药物研发管线分析数据摘要已上市药物 3个 (Lecanemab, Donanemab, Aduhelm[退市]) Phase 3在研 18个 Phase 2/3在研 8个 Phase 2在研 22个 Phase 1在研 10个研发失败/终止 19个总计 80个药物说明本报告汇总了2021-2026年间全球阿尔茨海默病药物研发情况，包括已上市药物、在研药物（Phase 1-3）以及研发失败的药物。数据来源于ClinicalTrials.gov、PubMed、FDA等权威机构。涵盖Aβ靶向、tau靶向、神经炎症、老药新用等多种机制。 23/24年大佬整理的药物研发情况汇总：参考文献 ClinicalTrials.gov https://clinicaltrials.gov PubMed https://pubmed.ncbi.nlm.nih.gov FDA https://www.fda.gov Alzheimer's & Dementia (Journal) https://alz-journals.onlinelibrary.wiley.com Nature Reviews Drug Discovery https://www.nature.com/nrd New England Journal of Medicine https://www.nejm.org JAMA Neurology https://jamanetwork.com/journals/jamaneurology Lancet Neurology https://www.thelancet.com/neurology Cummings et al. 2025 Pipeline Report Alzheimer's Dement 2025;11:e70098 Alzforum https://www.alzforum.org Alzheimers Dement (N Y). 2023 May 25;9(2):e12385. Alzheimers Dement (N Y). 2024 Apr 24;10(2):e12465. 本文内容来自公开信息及研究文献，不代表临床建议。如需投稿、转载、商务合作后台留言，回复有一定延迟敬请谅解。辅助编辑：腾讯元宝or（GPT、Gemini、Claude等）扫码加入ima知识库，获取本公众号所有文献全文资料，AI问答了解更多信息，文献实时更新药品名称进展阶段临床试验编号所属公司/机构开发起始时间备注 GV-971 (Sodium Oligomannate) 中国已上市/全球Phase 3终止 NCT04520412 (Green Memory) Green Valley Pharma (China) 2019 中国2019年批准，国际III期2022年终止 Lecanemab (Leqembi) 已上市 (FDA 2023.1加速批准, 2023.7完全批准) NCT03887455 (Clarity AD) Eisai / Biogen / BioArctic 2020 抗Aβ原纤维抗体，减缓认知下降27% Donanemab (Kisunla) 已上市 (FDA 2024.7批准) NCT04437511 (TRAILBLAZER-ALZ 2) Eli Lilly 2020.6 抗Aβ抗体，低/中tau患者减缓下降60% Remternetug Phase 3 (进行中) NCT05463731 (TRAILRUNNER-ALZ1) Eli Lilly 2022.8 第三代抗Aβ抗体，皮下/静脉给药 ALZ-801 (Valiltramiprosate) Phase 3 (进行中) NCT04770220 (APOLLOE4) Alzheon 2021.5 口服Aβ寡聚体抑制剂，针对APOE4/4纯合子 Semaglutide Phase 3 (进行中) NCT04777396 / NCT04777409 (EVOKE/EVOKE+) Novo Nordisk 2021.5 GLP-1受体激动剂，老药新用 Nilotinib Phase 3 (进行中) NCT05143528 Novartis 2022.2 酪氨酸激酶抑制剂，老药新用 Masitinib Phase 3 (进行中) NCT05564169 AB Science 2022 酪氨酸激酶抑制剂，抗炎 KarXT (Xanomeline-Trospium) Phase 3 (进行中) NCT05511363 Karuna Therapeutics / Bristol-Myers Squibb 2022 毒蕈碱受体激动剂组合 Masupirdine (SUVN-502) Phase 3 (进行中) NCT05397639 Suven Pharmaceuticals 2022 5-HT6受体拮抗剂，用于激越症状 Nabilone Phase 3 (进行中) NCT04516057 University of Toronto 2020 大麻素受体激动剂，老药新用，用于激越 Dextromethorphan/Quinidine Phase 3 (进行中) NCT03389922 Otsuka / Avanir 2018 用于AD相关激越 NE3107 Phase 3 (进行中) NCT04669028 BioVie 2021 口服抗炎胰岛素增敏剂 AR1001 Phase 3 (进行中) NCT05531526 AriBio 2022 PDE5抑制剂，老药新用 ATH-1017 (Fosgonimeton) Phase 3 (进行中) NCT04488419 Athira Pharma 2020 肝细胞生长因子增强剂 AXS-05 (Dextromethorphan/Bupropion) Phase 3 (进行中) NCT05526968 Axsome Therapeutics 2022 用于AD相关激越 Trontinemab (RO7126209) Phase 3 (进行中) NCT06385072 Roche / Genentech 2024 Brainshuttle技术抗Aβ抗体，基于gantenerumab ALZ-801 (Long-term Extension) Phase 3扩展 (进行中) NCT06304883 Alzheon 2023 APOLLOE4试验长期扩展 Blarcamesine (ANAVEX 2-73) Phase 2/3 (完成) NCT03790709 Anavex Life Sciences 2019 Sigma-1受体激动剂，已提交欧洲上市申请 Piromelatine Phase 2/3 (进行中) NCT05267535 Neurim Pharmaceuticals 2022.5 褪黑素受体激动剂 Buntanetap Phase 2/3 (进行中) NCT05686044 Annovis Bio 2023 神经毒性聚集蛋白翻译抑制剂 Metformin Phase 2/3 (进行中) NCT04098666 University of Pennsylvania 2021.3 降糖药，老药新用 E2814 (Etalanetug) Phase 2/3 (进行中) NCT05269394 (DIAN-TU Tau NexGen) Eisai / UCL 2022.1 抗tau抗体，靶向MTBR，获FDA快速通道资格 Rotigotine + Rivastigmine Phase 2/3 (进行中) NCT04185099 University of California 2019 多巴胺激动剂+胆碱酯酶抑制剂 Lecanemab + E2814 Phase 2/3 (进行中) NCT05269394 (DIAN-TU-001) Eisai 2022 抗Aβ+抗tau组合疗法 ABBV-916 Phase 2 (进行中) NCT05291234 AbbVie 2022 抗Aβ抗体，靶向N3pG-Aβ CT1812 (Zervimesine) Phase 2 (进行中) NCT03507790 (SHINE) / NCT05531656 (START) Cognition Therapeutics 2018 Sigma-2受体调节剂 Bepranemab (UCB0107) Phase 2 (进行中) NCT04867616 Roche / UCB 2021 抗tau抗体，靶向tau中央区域 JNJ-63733657 Phase 2 (进行中) NCT04619420 (AUTONOMY) Janssen 2020 抗tau抗体，靶向p-tau217 LY3372689 Phase 2 (进行中) NCT05063539 Eli Lilly 2021.9 O-GlcNAcase抑制剂，小分子 BIIB080 (IONIS-MAPTRx) Phase 2 (进行中) NCT05399888 (CELIA) Biogen / Ionis 2022 Tau反义寡核苷酸 ACI-35 Phase 2 (进行中) NCT04445831 AC Immune / Janssen 2020 抗tau疫苗 Hydralazine Hydrochloride Phase 2 (进行中) NCT04842552 University of Colorado 2021 老药新用，激活Nrf2通路 Caffeine Phase 2 (进行中) NCT04570085 University of Miami 2020 腺苷受体拮抗剂，老药新用 Sildenafil Phase 2 (进行中) NCT05403764 Cleveland Clinic 2022 PDE5抑制剂，老药新用 Dasatinib + Quercetin Phase 2 (进行中) NCT04063124 Mayo Clinic 2019 衰老细胞清除剂，老药新用 Liraglutide Phase 2 (进行中) NCT05653675 Novo Nordisk 2023 GLP-1受体激动剂，老药新用 Foralumab Phase 2 (进行中) NCT06382623 Tiziana Life Sciences 2024 抗CD3单抗，鼻内给药，针对神经炎症 PRX005 Phase 2 (进行中) NCT06126686 Prothena 2023 抗tau抗体 Exenatide Phase 2 (进行中) NCT04269349 University of Oxford 2020 GLP-1受体激动剂，老药新用 Lixisenatide Phase 2 (进行中) NCT05837287 Sanofi 2023 GLP-1受体激动剂，老药新用，帕金森病 Tirzepatide Phase 2 (进行中) NCT06556289 Eli Lilly 2024 GLP-1/GIP双受体激动剂，老药新用 Dulaglutide Phase 2 (进行中) NCT05844971 Eli Lilly 2023 GLP-1受体激动剂，老药新用 Tadalafil Phase 2 (进行中) NCT05422885 University of California 2022 PDE5抑制剂，老药新用 Vardenafil Phase 2 (进行中) NCT05575076 University of Pennsylvania 2022 PDE5抑制剂，老药新用 Ibudilast Phase 2 (进行中) NCT05549530 MediciNova 2022 PDE4/PDE3抑制剂，抗炎 Saracatinib Phase 2 (进行中) NCT05256052 AstraZeneca 2022 Src/Fyn激酶抑制剂 AZD0530 Phase 2 (进行中) NCT05256052 AstraZeneca 2022 Src激酶抑制剂 Posdinemab (ACI-35-028) Phase 2 (进行中) NCT06126686 AC Immune / Janssen 2023 抗磷酸化tau抗体 AADvac1 Phase 2完成 (未达主要终点) NCT04170891 (ADAMANT) Axon Neuroscience 2020 抗tau疫苗，未达主要终点 ASN51 Phase 2终止 (2025) NCT05544431 Asceneuron 2022 tau靶向药物，战略调整终止 Lu AF87908 Phase 1 (完成) NCT04149860 Lundbeck 2019 抗磷酸化tau抗体 PNT001 Phase 1 (完成) NCT05059380 Pinteon Therapeutics 2021 抗cis-pT231 tau抗体 MK-2214 Phase 1 (进行中) NCT05544431 Merck 2022 抗tau抗体 APNmAb005 Phase 1 (进行中) NCT05575076 Applied NeuroSolutions 2022 抗tau寡聚体抗体 Denali TVD (Transferrin Receptor) Phase 1 (进行中) NCT05712223 Denali Therapeutics 2023 脑穿梭技术平台，抗体递送 DNL919 Phase 1 (进行中) NCT05544431 Denali Therapeutics 2022 TREM2激活剂，脑穿梭技术 AL101 (GSK4527226) Phase 1 (进行中) NCT05575076 Alector / GSK 2022 Progranulin增强单抗 NI006 Phase 1 (进行中) NCT05575076 University Hospital Zurich 2022 抗Aβ纳米抗体 ATN-101 Phase 1 (进行中) NCT05575076 Aton Pharma 2022 抗Aβ抗体 RG7345 Phase 1终止 (2015) NCT01952637 Roche / Genentech 2015 抗tau抗体 BIIB076 Phase 1终止 (2022) NCT03113815 Biogen / Neurimmune 2017 抗tau抗体 AL002 Phase 2 (失败) NCT04592874 (INVOKE-2) Alector 2020 TREM2激动剂抗体，INVOKE-2试验未达终点 Ponezumab Phase 2失败 NCT00960531 Pfizer 2012 抗Aβ抗体 Gosuranemab (BIIB092) Phase 2失败 (2021终止) NCT03352557 Biogen / Bristol-Myers Squibb 2018 抗tau抗体，未达主要终点 Tilavonemab (ABBV-8E12) Phase 2失败 (2021终止) NCT03413319 Bristol-Myers Squibb / AbbVie 2018 抗tau抗体，未达主要终点 Zagotenemab (LY3303560) Phase 2失败 (2021终止) NCT03518073 Eli Lilly 2018 抗tau抗体，未达主要终点 Varoglutamstat (PQ912) Phase 2失败 (2024终止) NCT03919162 (VIVA-MIND) / NCT04498650 (VIVIAD) Vivoryon Therapeutics 2019 QPCT抑制剂，VIVIAD试验失败，已转向糖尿病肾病 Semorinemab Phase 2失败 (TAURIEL/LAURIET) NCT03289143 (TAURIEL) / NCT03828747 (LAURIET) Genentech / Roche 2018 TAURIEL未达终点，LAURIET部分终点阳性但功能终点阴性 Idalopirdine Phase 3失败 NCT01955143 Lundbeck / Otsuka 2015 5-HT6受体拮抗剂 Intepirdine Phase 3失败 NCT02585934 Axovant 2017 5-HT6受体拮抗剂 Bapineuzumab Phase 3失败 NCT00575055 / NCT00574132 Pfizer / Janssen 2014 抗Aβ抗体，未达临床终点 Verubecestat (MK-8931) Phase 3失败 (2017终止) NCT01739348 Merck 2017 BACE1抑制剂，因无效提前终止 Lanabecestat (AZD3293) Phase 3失败 (2018终止) NCT02245737 AstraZeneca / Eli Lilly 2018 BACE1抑制剂 Atabecestat (JNJ-54861911) Phase 3失败 (2018终止) NCT02569398 Janssen 2018 BACE1抑制剂，肝毒性 Crenezumab Phase 3失败 (2019终止/2022发表) NCT02670083 (CREAD) / NCT03114657 (CREAD2) Roche / Genentech 2019 CREAD/CREAD2试验因无效提前终止 Gantenerumab Phase 3失败 (2022.11) NCT03444870 (GRADUATE I) / NCT03443973 (GRADUATE II) Roche / Genentech 2018 GRADUATE试验未达主要终点，未能减缓认知下降 Solanezumab Phase 3失败 (2023年A4研究失败) NCT02008357 (A4 Study) Eli Lilly 2014 EXPEDITION 1/2及A4研究均未达终点 Simufilam (PTI-125) Phase 3失败 (2024-2025) NCT04994483 (RETHINK-ALZ) / NCT05026177 (REFOCUS-ALZ) Cassava Sciences 2021.11 Filamin A抑制剂，两项Phase 3均未达终点，已停止开发 Aduhelm (Aducanumab) 已退市 (FDA 2021.6加速批准, 2024.1停产) NCT02484547 (EMERGE) Biogen / Neurimmune 2021.6 2024年1月Biogen宣布停产，非安全/疗效原因

临床3期上市批准抗体药物偶联物加速审批申请上市

2026-01-14

·天浚脑科学

2025年阿尔茨海默病药物研发管线综述

内华达大学医学院Jeffrey L. Cummings联合克利夫兰诊所、凯斯西储大学医学院，共同总结了2025年阿尔茨海默病（AD）药物研发管线。2025年全年共有182项临床试验评估138种药物；研发管线具有多样性：生物疾病靶向疗法（DTTs）占管线的30%，小分子DTTs占43%；认知增强药物占14%；改善AD患者神经精神症状的药物占11%。生物标志物在其中发挥了重要作用，是27%活跃试验的主要结局指标。再利用药物占管线药物的33%。该综述2025年发表在Alzheimer's & Dementia。一、数据采集与分析 1.所有数据来源于临床试验注册平台clinicaltrials.gov，该平台由美国国立卫生研究院（NIH）下属的美国国家医学图书馆维护。 2.数据分析解读在内华达大学拉斯维加斯分校临床试验观察站和克利夫兰诊所网络医学实验室进行。 3.索引日期为2025年1月1日。 4.纳排 4.1.包括1期、1/2期、2期、2/3期及3期临床试验；不包含0期或4期临床试验。 4.2.涵盖AD连续谱：临床前AD、MCI/前驱期AD、轻度至重度AD痴呆。 4.3.排除标准： 4.3.1.非药物治疗方案的临床试验，包括运动疗法、生活方式干预、认知行为疗法、照护者干预、膳食补充剂或医用食品等。 4.3.2.干细胞疗法的临床试验亦未纳入。 4.3.3.若无干预措施，则不包含生物标志物相关试验。 5.分析框架： 5.1.基于阿尔茨海默病研究通用本体论（CADRO）对药物靶点进行系统分类，包括：Aβ ；tau蛋白；载脂蛋白E（APOE）、脂质及脂蛋白受体；递质受体；神经发生；炎症；氧化应激；细胞死亡；蛋白质稳态/蛋白病；代谢与生物能量学；血管系统；生长因子与激素；突触可塑性/神经保护；肠-脑轴；昼夜节律；环境因素；表观遗传调控因子；多靶点；未知靶点；其他。 5.2.根据作用机制与靶点信息将药物按治疗目的分类为疾病靶向疗法（DTTs）或对症治疗 5.2.1.“DTT”优于“疾病修饰疗法（DMT）” 5.2.2.将DTTs分为生物制剂（如单克隆抗体、疫苗、反义寡核苷酸[ASOs]）和小分子药物（如通常口服给药且分子量小于500道尔顿的药物）。 5.2.3.将对症治疗药物分为具有潜在认知增强特性的药物和旨在改善神经精神症状（NPS）的药物，明确试验针对的NPS类型如激越、精神病、淡漠。二、主要结果 1.2025年新药管线概况（原文图1） 1.1.共182项临床试验评估138种AD管线药物 1.1.1.48项评估31种III期药物（原文图3） 1.1.2.86项评估75种II期药物（原文图4） 1.1.3.48项评估45种I期药物。 1.1.4.16/182项是既往试验的长期扩展研究。 1.2.与2024年相比 1.2.1.AD研发管线新增56项临床试验：3期临床试验新增10项，2期新增25项，1期新增21项。 1.2.2.仍在研发管线但现已退出的药物中，25项临床试验已完成，8项终止，8项状态未知（系统中无更新数据）。 1.3.涵盖的AD连续疾病阶段 1.3.1.8项（4%）试验针对认知功能正常但存在症状性AD风险的受试者； 1.3.2.64项（35%）试验纳入被归类为AD或前驱期AD的轻度认知障碍（MCI）患者（无论是否通过生物标志物确认AD病理改变）； 1.3.3.48项（26%）试验涉及早期AD患者（MCI或轻度AD痴呆）； 1.3.4.103项（57%）试验允许轻度AD痴呆患者参与； 1.3.5.75项（41%）试验包含中度或重度AD痴呆患者，以及任何严重程度的AD痴呆患者（这些类别并非互斥，部分试验同时纳入多个类别的受试者）。 1.4.临床试验的地域分布 1.4.1.67项（39%）仅在北美地区开展；47项（28%）仅涵盖北美以外地区； 1.4.2.56项（33%）同时包含北美与非北美地区的临床试验中心（即为“全球性”试验）。 2.基于治疗策略的分类体系 2.1.治疗目的分布: 2.1.1.DTT药物102种（74%）：旨在调控AD病理生理过程，延缓临床衰退 - 42种（30%）生物制剂：如单抗、疫苗、反义寡核苷酸 - 60种（43%）小分子药物：口服，分子量<500道尔顿 2.1.2.对症治疗药物35种（26%） - 认知增强剂：20种（14%） - 神经精神症状（NPS）药物：15种（11%） 2.2.基于 CADRO的靶点分类（原文图2） 2.3.药物种类对应各期临床试验总结如下表 2.4.各阶段在研管线药物靶点汇总如下表 3.生物标志物在2025年阿尔茨海默病（AD）药物研发管线的临床试验中发挥关键作用 3.1.104/182项（57%）临床试验将生物标志物作为入选标准 3.2.影像标志物作为纳排标准 3.2.1.47/182项（26%）使用Aβ—PET作为纳入标准：7项1期试验、29项2期试验和11项3期试验。 3.2.2.59/182项（32%）使用MRI作为排除标准：9项I期试验、32项II期试验和18项III期试验。 3.3.体液标志物 3.3.1.52/182项（29%）使用了体液（包括血液、血浆、血清、脑脊液）标志物作为纳入标准； 3.3.2.17项试验使用了 Aβ 测量指标；17项试验在液体样本中检测了过磷酸化tau蛋白（p-tau）。 3.4.50/182项（27%）以生物标志物作为主要结局指标 3.4.1.26项试验将影像学生物标志物作为主要结局指标，22项试验评估了体液样本。 3.4.2.1项I期试验、4项II期试验和4项III期试验将淀粉样蛋白PET作为结局指标。 3.4.3.MRI作为结局指标的应用包括3项I期试验、4项II期试验和2项III期试验。 3.4.4.作为主要结局指标，11项临床试验评估了 Aβ 变化，其中2项检测了体液样本中的分析物。 3.4.5.测量tau病理学时，1项试验采用tau PET，7项试验使用p-tau生物标志物。 3.4.6.总tau蛋白和神经丝轻链（NfL）分别有2项和3项试验将其作为主要结局指标。 4.联合用药试验：20/182项（11%） 4.1.药效学联合: 10项，靶向炎症或Aβ病理生理学。 - 其中2项采用达沙替尼+槲皮素清除衰老细胞，靶向神经炎症。 4.2.药代动力学联合 4.2.1.10项试验优化药物暴露 4.2.2.6项试验评估右美沙芬与CYP2D6抑制剂的药代动力学组合，旨在降低肝脏代谢、促进活性成分更有效地进入中枢神经系统（CNS）。 4.2.3.4项关于Xanomeline联合trospium的临床试验：阻断外周胆碱能副作用，治疗NPS。 5.2025年预期完成的临床试验 5.1.12种药物完成临床三期：dextromethorphan联合奎尼丁、纳比隆、司美格鲁肽、 simufilam, nilotinib、piromelatine、masupirdine、AR1001、Xanomeline联合trospium、valiltramiprosate、 5.2.Rotigotin联合卡巴拉汀、右美沙芬联合安非他酮。 5.3.29种药物完成临床二期：涵盖神经炎症、tau、突触可塑性等多元靶点。三、临床意义与结论 1.AD药物研发管线具有较高的活跃度 1.1.Phase 1试验的爆发式增长，增幅约两倍； 1.2.管线多样性（15个CADRO类别）降低了对单一靶点的过度依赖风险。 2.北美地区临床试验点2227个vs全球其他地区2302个试验点，数量大致相当。 2.1.可能加速受试者招募，加速试验进程； 2.2.扩大临床试验队列中受试者的人口统计学特征； 2.3.更深入地理解AD的生物学异质性，提高临床试验结果的普适性，并促进临床实践中精准医疗的实施。 3.生物标志物驱动的范式革命 3.1.影像和血液标志物更多作为药物临床试验的纳排标准和主要结局设定。 3.2.血液生物标志物异军突起 3.2.1.体液标志物已被作为药物开发工具应用于临床试验中的诊断、监测及药效学反应评估。 3.2.2.血液标志物在AD诊断中发挥更大作用。 3.2.3.血浆p-tau217在诊断准确性上与AD病理的脑脊液生物标志物相当。 4.结论 4.1.使用生物标志物来确定资格和作为临床试验的结局指标，显示了生物标志物在阿尔茨海默病药物开发中日益重要的作用。 4.2.生物标志物的发展势头使抗淀粉样蛋白疗法受益，活跃的科学与试验框架可能有助于开发针对更广泛患者群体其他靶点的治疗方案。 4.3.增加临床试验中心数量有助于扩大受试者招募规模，还能提升招募效率、优化运营效能并提高试验质量。本文仅代表编辑个人对原文献的翻译理解，不能作为直接引用证据。原文献可通过PubMed或杂志官网获取。

2023-05-16

·PRNewswire

Psychosis in Parkinson's and Alzheimer's Disease Market to Observe Stunning Growth at a CAGR of 15.6% in the US During the Study Period (2019-2032), Examines DelveInsight

The psychosis in Parkinson's and Alzheimer's disease market size shall grow during the forecast period (2023–2032). This increase will be due to rising disease awareness and improving diagnosis, besides the launch of emerging therapies by key companies, including Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, and others. LAS VEGAS, May 16, 2023 /PRNewswire/ -- DelveInsight's Psychosis in Parkinson's and Alzheimer's Disease Market Insights report includes a comprehensive understanding of current treatment practices, psychosis in Parkinson's and Alzheimer's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Psychosis in Parkinson's and Alzheimer's Disease Market Report As per DelveInsight analysis, the psychosis in Parkinson's and Alzheimer's disease market size in the 7MM was approximately USD 1.2 billion in 2022. According to the assessment done by DelveInsight, the estimated total diagnosed prevalent psychosis in Parkinson's and Alzheimer's disease cases in the 7MM were approximately 6.7 million in 2022. Leading psychosis in Parkinson's and Alzheimer's disease companies such as Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp & Dohme, and others are developing novel psychosis in Parkinson's and Alzheimer's disease drugs that can be available in the psychosis in Parkinson's and Alzheimer's disease market in the coming years. The promising psychosis in Parkinson's and Alzheimer's disease therapies in the pipeline include Ulotaront (SEP-363856), KarXT (xanomeline-trospium), FANAPT (iloperidone), Masupiridine (SUVN-502), ENT-01, ITI-1284, MK-8189 , and others. Discover which therapies are expected to grab the major psychosis in Parkinson's and Alzheimer's disease market share @ Psychosis in Parkinson's and Alzheimer's Disease Market Report Psychosis in Parkinson's and Alzheimer's Disease Overview Psychosis is a group of symptoms that affect the mind and indicate a loss of contact with reality. Individuals' ideas and perceptions are altered during a psychotic episode, making it difficult to distinguish between what is genuine and what is not. In Parkinson's disease and Alzheimer's disease, both exogenous and endogenous factors contribute to the development of psychosis. Old age, sleep difficulties, long-term neurodegenerative conditions, depression, cognitive impairment, and vision abnormalities are all risk factors for the disease. Parkinson's disease psychosis (PDP) is a prevalent occurrence in Parkinson's disease patients that is associated with significant morbidity and mortality. It is caused by anomalies in dopamine, serotonin, and glutamate neurotransmission induced by Lewy body deposition in the brain. Alzheimer's disease psychosis (ADP), which is common in Alzheimer's disease patients, is caused by increased excitatory neuron sensitivity and post-transcriptional mechanisms that alter synaptic protein in the brain. Due to the complexity of the aetiologies and physiological hypotheses, many diagnostic techniques, including neuroimaging, neurophysiological, genotypic, and serologic examinations, are used to diagnose psychosis in Parkinson's and Alzheimer's disease patients. Psychosis in Parkinson's and Alzheimer's Disease Epidemiology Segmentation DelveInsight estimates that there were approximately 6.7 million diagnosed prevalent cases of psychosis in Parkinson's and Alzheimer's disease in the 7MM in 2022. Among the 7MM, the US contributed to the largest diagnosed prevalent psychosis population in Parkinson's and Alzheimer's disease, acquiring ~34% in 2022. In contrast, the UK accounted for the least, with approximately 4% of the total population share in 2022. The psychosis in Parkinson's and Alzheimer's disease market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total diagnosed prevalent cases of Parkinson's and Alzheimer's disease Age-specific cases of Parkinson's and Alzheimer's disease Gender-specific cases of Parkinson's and Alzheimer's disease Total diagnosed prevalent cases of Psychosis in Parkinson's and Alzheimer's disease Psychosis in Parkinson's and Alzheimer's Disease Treatment Market The current treatment of psychosis in Parkinson's and Alzheimer's disease includes both nonpharmacological and pharmacological treatments. The major goal of psychosis in Parkinson's and Alzheimer's disease treatment is to lessen the frequency and severity of psychotic symptoms while causing little worsening of motor symptoms. The use of conventional and atypical antipsychotics (e.g., aripiprazole, clozapine, quetiapine, and others) is the first-line treatment. However, atypical antipsychotics are frequently chosen in the initial therapy, which minimizes the likelihood of further worsening in patients. Aside from antipsychotics, 5-HT3 receptor antagonists, acetylcholinesterase inhibitors (donepezil, rivastigmine), and various antidepressants are utilized. While cognitive behavioral therapy (CBT), reasoning, and rehabilitation are used to reduce behavioral and psychological symptoms of dementia (BPSD), anxiety, psychosis, agitation, aggression, sleep difficulties, and other symptoms linked with psychosis in Parkinson's and Alzheimer's disease. The US FDA has approved ACADIA's NUPLAZID (pimavanserin), a receptor antagonist (5-HT2A, 5-HT2C), for the treatment of hallucination and delusion associated with psychosis in Parkinson's disease patients. It is the only approved therapy available in the US. Recent trials also suggest that the medicine is helpful in Alzheimer's disease patients with more severe psychosis. At the same time, more long-term studies are needed to define better the efficacy and long-term safety profile of pimavanserin for treating psychosis in Alzheimer's disease. Though the expensive cost of pimavanserin certainly restricts its use, the findings in Parkinson's disease psychosis patients and evidence from Alzheimer's disease trials are convincing. There are currently no approved medicines for Alzheimer's disease psychosis patients; the major treatment is antipsychotics. Off-label therapies that are routinely utilized include quetiapine, clozapine, risperidone, aripiprazole, citalopram, and escitalopram. Aripiprazole has been shown in clinical tests to be effective and safe. In contrast, citalopram has been shown to be useful in lowering agitation and the severity of hallucinations and delusions in Alzheimer's disease psychosis patients. To know more about psychosis in Parkinson's and Alzheimer's disease treatment guidelines, visit @ Psychosis in Parkinson's and Alzheimer's Disease Management Psychosis in Parkinson's and Alzheimer's Disease Pipeline Therapies and Key Companies Ulotaront (SEP-363856): Sunovion Pharmaceuticals KarXT (xanomeline-trospium): Karuna Therapeutics FANAPT (iloperidone): Vanda Pharmaceuticals Masupiridine (SUVN-502): Suven Life Sciences ENT-01: Enterin ITI-1284: Intra-Cellular Therapies MK-8189: Merck Sharp & Dohme Learn more about the FDA-approved drugs for psychosis in Parkinson's and Alzheimer's disease @ Drugs for Psychosis in Parkinson's and Alzheimer's Disease Treatment Psychosis in Parkinson's and Alzheimer's Disease Market Dynamics The psychosis in Parkinson's and Alzheimer's disease market dynamics are anticipated to change in the coming years due to increasing awareness and improved diagnosis. Increased awareness and a better understanding of disease pathogenesis have improved diagnosis and treatment. Moreover, the recent FDA approval of NUPLAZID, the first approved therapy for treating hallucinations and delusions associated with Parkinson's disease psychosis, suggests a positive shift in the psychosis in Parkinson's and Alzheimer's disease market. Furthermore, pharma companies have an opportunity to develop therapies with enhanced safety and tolerability profiles, effectively lowering symptoms and preventing the recurrence of psychosis in Parkinson's and Alzheimer's disease. In addition, the advancement of biomarkers for cognitive impairment enables exact diagnosis and individualized therapy. However, several factors are impeding the growth of psychosis in the Parkinson's and Alzheimer's disease market. Psychosis in Parkinson's disease and Alzheimer's disease is related to low quality of life, higher healthcare resource utilization, and a significant economic burden. NUPLAZID and the other atypical antipsychotics recommended for treatment include black box warnings and adverse effects. Moreover, a lack of a medication development pipeline, the ongoing use of antipsychotics despite the hazards, and a lack of specialized nonpharmacological interventions may cause a dip in the growth of psychosis in the Parkinson's and Alzheimer's disease market. Furthermore, there is a high attrition rate when drug development proceeds from first-in-human trials to pivotal registration studies due to a lack of efficacy. Hence all these factors may hamper the psychosis in Parkinson's and Alzheimer's disease market growth in the coming years. Scope of the Psychosis in Parkinson's and Alzheimer's Disease Market Report Therapeutic Assessment: Psychosis in Parkinson's and Alzheimer's Disease current marketed and emerging therapies Psychosis in Parkinson's and Alzheimer's Disease Market Dynamics: Attribute Analysis of Emerging Psychosis in Parkinson's and Alzheimer's Disease Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Psychosis in Parkinson's and Alzheimer's Disease Market Access and Reimbursement Discover more about psychosis in Parkinson's and Alzheimer's disease drugs in development @ Psychosis in Parkinson's and Alzheimer's Disease Clinical Trials Table of Contents Related Reports Parkinson's Disease Psychosis Pipeline Parkinson's Disease Psychosis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease psychosis companies, including Vanda Pharmaceuticals, Sumitomo Pharma, among others. Psychosis Market Psychosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psychosis companies, including Teva Pharmaceutical Industries Ltd., Amgen Inc., Pfizer Inc., Novartis International AG., Merck & Co. Inc., Sanofi S.A., among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease psychosis companies, including Vanda Pharmaceuticals, Sumitomo Pharma, among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies, including AZTherapies, Cerecin, Neurotrope, Lyndra, AC Immune, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

上市批准

100 项与 Masupirdine(Suven Life Sciences Ltd.) 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
躁动	临床3期	美国	Suven Life Sciences Ltd.	2022-11-01
躁动	临床3期	克罗地亚	Suven Life Sciences Ltd.	2022-11-01
躁动	临床3期	波兰	Suven Life Sciences Ltd.	2022-11-01
躁动	临床3期	塞尔维亚	Suven Life Sciences Ltd.	2022-11-01
阿尔茨海默病引起的痴呆症	临床3期	美国	Suven Life Sciences Ltd.	2022-11-01
阿尔茨海默病引起的痴呆症	临床3期	克罗地亚	Suven Life Sciences Ltd.	2022-11-01
阿尔茨海默病引起的痴呆症	临床3期	波兰	Suven Life Sciences Ltd.	2022-11-01
阿尔茨海默病引起的痴呆症	临床3期	塞尔维亚	Suven Life Sciences Ltd.	2022-11-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05397639 (CTAD2023)	临床3期	阿尔茨海默病引起的痴呆症	375	Masupirdine 50 mg	齋製網壓築範艱鏇艱網(壓鹽醖糧觸鏇製廠鑰範) = 鑰製獵鏇鹹衊觸艱遞蓋積顧鑰窪鑰鹹廠鏇窪膚 (窪憲築糧選壓膚齋網製 )	积极	2023-10-24
				Masupirdine 100 mg	齋積鹹簾壓廠簾獵餘願(製鏇鏇顧鑰餘壓餘願壓) = 鏇鏇網願窪繭選餘衊壓夢鏇夢餘夢鏇淵夢鏇糧 (齋衊窪艱餘構構餘餘製 )
NCT02580305 (CTgov)	临床2期	阿尔茨海默症	564	Placebo+Memantine+Donepezil	顧壓繭構醖遞遞鹽繭築(艱鏇鏇積糧範製鏇襯衊) = 積艱願顧襯齋遞繭餘餘觸鏇積憲獵鑰遞獵鹹願 (艱艱艱窪衊壓鹽窪鹹蓋, 0.5) 更多	-	2023-06-09
NCT02580305 (Pubmed \| Int J Geriatr Psychiatry)	临床2期	阿尔茨海默症	158	Masupirdine 100 mg	願餘製衊構鹹獵範衊顧(廠窪襯繭鬱選範簾壓衊): P-Value = 0.007	-	2022-10-01
				Placebo