A Phase 1, Multi-center, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Sulthiame (S-054502) in Participants With Varying Degrees of Renal Impairment and Matched Healthy Control Participants With Normal Renal Function

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of sulthiame in participants with mild and moderate renal impairment compared to those in healthy participants with normal renal function.

开始日期2026-09-29

申办/合作机构

Shionogi & Co., Ltd.

JPRN-jRCT2071250138

/ Recruiting临床1期

A phase 1 multiple-dose up-titration study to evaluate the pharmacokinetics, safety, and tolerability of sulthiame (SASS-002) in healthy Japanese and White adults

开始日期2026-03-01

申办/合作机构

Shionogi & Co., Ltd.

CTIS2023-510519-20-00

/ Completed临床2期IIT

SYNERGY OSA - EFFICACY, SAFETY and TOLERABILITY OF COMBINED THERAPY WITH A SOMNOMED ORAL APPLIANCE AND THE CARBONIC ANHYDRASE INHIBITOR SULTHIAME IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA. A Randomized, Double-Blind, Placebo Controlled, Proof-of-Concept Trial

开始日期2024-12-12

申办/合作机构-

100 项与舒噻美相关的临床结果

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100 项与舒噻美相关的转化医学

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100 项与舒噻美相关的专利（医药）

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382

项与舒噻美相关的文献（医药）

2026-08-01·Sleep and Breathing

Pharmacotherapy in obstructive sleep apnoea: a clinical guide

Review

作者: Shastry, Shashank ; Pinto, Lancelot Mark ; Kimoff, John R

PURPOSE:

Obstructive Sleep Apnoea (OSA) is a common, yet underdiagnosed disorder, with significant health implications. Continuous positive airway pressure (CPAP) remains the reference standard and first-line therapy. However, successful CPAP usage is influenced by factors such as access, cost, tolerance, patient education, early troubleshooting, and long-term adherence, all of which can be challenging and resource-demanding. Adding therapeutic options to the armamentarium is therefore welcome. There is a need for clinicians to be abreast of all the available therapeutic options for treatment of OSA.

METHODS:

We conducted an extensive literature review of the published studies that were conducted using non-CPAP pharmacotherapeutic modalities for OSA.

RESULTS:

This narrative review summarises the current landscape of OSA pharmacotherapy, focusing on mechanisms of action, clinical trial evidence, and endotype-based selection strategies. Emerging therapies such as the atomoxetine-oxybutynin combination and topiramate show promise in reducing severity of OSA, and improving sleep quality. GLP-1 receptor agonists like liraglutide and tirzepatide offer benefits beyond reducing the severity of OSA. Other agents such as sulthiame, solriamfetol, and pitolisant have also demonstrated efficacy. Wake-promoting agents like modafinil and armodafinil target the commonest symptom of OSA, sleepiness.

CONCLUSIONS:

This review provides a practical, endotype-aligned summary of pharmacologic options for the management of OSA.

2026-06-10·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

Pharmacological treatment of obstructive sleep apnea syndrome

Review

作者: Boldin, A V ; Filin, A A ; Tardov, M V ; Tardova, V M ; Bokova, I A ; Kotidis, I ; Bokova, O A

Obstructive sleep apnea syndrome (OSAS) is a potentially life-threatening condition that is increasingly prevalent in developed countries. OSAS treatment involves multiple components, including general lifestyle modifications and specific interventions such as intraoral fixation devices and continuous positive airway pressure (CPAP). Surgical treatments, including correction of nasopharyngeal and oropharyngeal structures, orthognathic operations, and bariatric surgery, are used under strict indications. Until recently, pharmacological management was limited to nasal decongestants for rhinitis exacerbation and modafinil for daytime sleepiness. However, low compliance with non-surgical therapies and limited efficacy of some surgical procedures highlight the need for effective drug treatments for OSAS. Despite decades of research, a highly effective pharmacological therapy was not available until the past 6—7 years, when new agents and their combinations were evaluated. Randomization by OSAS endotype is now recognized as crucial in clinical studies. This review summarizes recent advances in OSAS drug therapy, primarily based on randomized clinical trials, with a focus on agents such as semaglutide, tirzepatide, atomoxetine-oxybutynin, solriamfetol, sultiame, and acetazolamide, as well as established drugs. Further research with long-term follow-up and consideration of OSAS endotypes and drug side effects is needed. The importance of combining different therapeutic approaches for OSAS is emphasized.

2026-06-10·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

Obstructive sleep apnea and epilepsy comorbidity: possible complications and treatment options

Review

作者: Golovatyuk, A.O. ; Poluektov, M.G.

Epilepsy is one of the most prevalent neurological disorders, affecting approximately 50 million individuals globally. Sleep plays a crucial role in the progression of epilepsy, particularly concerning serious complications such as Sudden Unexpected Death in Epilepsy (SUDEP). The sleep patterns of individuals with epilepsy can be significantly disrupted by obstructive sleep apnea (OSA), which affects around 40% of adult epilepsy patients. The most effective treatment for OSA is continuous positive airway pressure (CPAP). Additionally, carbonic anhydrase inhibitors, commonly used to manage focal epileptic seizures, have shown beneficial effects on obstructive sleep apnea, rendering them a viable pharmacological alternative for treating OSA in epilepsy patients. This effect is most pronounced for sultiame.

项与舒噻美相关的新闻（医药）

2026-08-11

·MedLeaves

资本动态 | 美股医药企业IPO动态305期

美股医药企业IPO动态本文由MedLeaves团队原创，欢迎分享，转载需授权第305期作者叁柒观察、沉淀、贡献价值，共赴山海一周重点关注近2周美股5家医疗企业上市，均为美国的生物制药公司。 Apnimed, Inc. (APMD) 于2026年7月31日在NASDAQ上市，以每股16美元价格发行约1,200万股，募资1.92亿美元。Apnimed 是一家总部位于美国马萨诸塞州剑桥的临床阶段制药公司，成立于2017年。公司专注于睡眠相关呼吸疾病的口服药物治疗，核心领域为阻塞性睡眠呼吸暂停（OSA）。其技术平台围绕上气道神经肌肉调控机制，采用口服小分子固定剂量复方策略：核心候选药 AD109（Oxnimbi）由 aroxybutynin（M2/M3 抗毒蕈碱）与 atomoxetine（去甲肾上腺素再摄取抑制剂）组成，通过双重通路增强舌下神经兴奋性、提升睡眠期间上气道肌肉张力，从而维持气道通畅。管线方面，AD109 已完成两项 Phase 3 试验（SynAIRgy 与 LunAIRo），NDA 已获 FDA 受理，并获快速通道资格；AD504（atomoxetine + trazodone）处于早期开发阶段。公司此前与日本盐野义制药成立 SASS 合资公司共同开发 SASS-001（Phase 2a）及 SASS-002（Phase 2 完成），但已于 2026 年 3 月以 1 亿美元 upfront 将所持 SASS 股权出售给 Shionogi，AD109 与 AD504 仍为公司自有核心资产。 Attovia Therapeutics, Inc. (ATTO) 于2026年8月5日在NASDAQ上市，以每股17美元价格发行约1,700万股，募资2.89亿美元。Attovia Therapeutics 是一家总部位于美国加州圣卡洛斯的临床阶段生物制药公司，2023年成立。公司专注于免疫介导疾病领域，依托从 Alamar 独家授权引进的 ATTOBODY™ 平台——一种基于纳米抗体（VHH）的模块化蛋白设计平台，通过双位点结合（biparatopic）及专有连接子技术，可快速构建单特异性、双特异性及三特异性生物制剂，具备高亲和力、延长半衰期及优异组织渗透性。管线布局上，核心资产 ATTO-1310 为靶向 IL-31 的半衰期延长单抗，已完成 Phase 1 给药，针对慢性瘙痒及特应性皮炎；ATTO-2306（ATTO-3712）为靶向 IL-13 × IL-31 的双特异性抗体，即将进入 Phase 1，针对特应性皮炎等；ATTO-1091 为靶向炎症性肠病（IBD）的多特异性早期候选药物。 Braveheart Bio, Inc. (BRVE) 于2026年8月6日在NASDAQ上市，以每股18美元价格发行约2,100万股，募资3.8亿美元。Braveheart Bio 是一家总部位于美国加州旧金山的临床阶段生物制药公司，专注于肥厚型心肌病（HCM）等心血管疾病。公司核心资产 BHB-1893 是一种新一代口服选择性心脏肌球蛋白抑制剂（cardiac myosin inhibitor），2025年从江苏恒瑞医药获得大中华区以外的全球独家权益。该药物旨在改善现有疗法的起效速度、给药便利性及心脏安全性，已在全球完成300余例患者的 Phase 2 研究，数据显示可快速降低左心室流出道压差、NT-proBNP 及心肌肌钙蛋白 I，并改善患者运动耐量与生活质量。公司计划2026年下半年启动梗阻性HCM的全球 Phase 3 注册试验（LIONHEART-HCM），2027年上半年启动非梗阻性HCM Phase 3 试验（NOBLEHEART-HCM）。 Latigo Biotherapeutics, Inc. (LTGO) 于2026年8月7日在NASDAQ上市，以每股18美元价格发行约1,900万股，募资3.5亿美元。Latigo Biotherapeutics 是一家临床阶段生物制药公司，2020年由 Westlake Village BioPartners 孵化创立，致力于开发非阿片类疼痛药物。公司采用结构导向的小分子设计策略，核心聚焦外周电压门控钠通道 Nav1.8 的选择性口服抑制剂，旨在提供阿片样镇痛效果且无成瘾及呼吸抑制风险。核心管线 LTG-001 已在腹壁整形术后疼痛的随机对照试验（Phase IIb, 343例）中达到主要终点，显示出快速镇痛起效及阿片节约潜力，获FDA快速通道资格，有望作为关键注册试验支持上市；LTG-305 处于 Phase 1；LTG-321 为下一代 Nav1.8 抑制剂，已进入膝骨关节炎 Phase 2 概念验证；LTG-418 处于临床前阶段。 BlossomHill Therapeutics, Inc. (BLSM) 于2026年8月7日在NASDAQ上市，以每股16美元价格发行约937万股，募资3.5亿美元。BlossomHill Therapeutics 是一家总部位于美国加州圣地亚哥的临床阶段肿瘤学公司，2020年由 J. Jean Cui 博士创立，其曾主导发明三款FDA批准的靶向抗癌药（Xalkori、Lorbrena、Augtyro）。公司采用基于大环结构的化学设计策略，开发可形成更强靶点结合、具备脑穿透性的新一代小分子靶向药物。管线方面，BH-30643 为first-in-class非共价、大环、脑穿透性、突变选择性 OMNI-EGFR™ 抑制剂，正在开展针对 EGFR 突变 NSCLC（包括 C797S 耐药突变）的全球 Phase 1/2 SOLARA 试验；BH-30236 为大环 CLK 抑制剂，处于 Phase 1/1b，针对复发/难治急性髓系白血病及高危骨髓增生异常综合征（与 venetoclax 联用），获FDA孤儿药认定；BH-501284 为临床前泛 KRAS 抑制剂（Switch-II口袋，非共价），计划2027年Q1提交IND。 ...... （获取更多信息，请阅读下面原文）免责声明本订阅号（微信号：Medleaves）属于公益自媒体，发布的内容仅供对医疗行业感兴趣的读者学习。Medleaves对本订阅号所载资料的准确性、可靠性、时效性及完整性不作任何明示或暗示的保证。本订阅号发布的内容仅为Medleaves所有。未经Medleaves事先书面许可，任何机构和/或个人不得以任何形式转发、翻版、复制、发布或引用本订阅号发布的全部或部分内容，亦不得从未经Medleaves书面授权的任何机构、个人或其运营的媒体平台接收、翻版、复制或引用本订阅号发布的全部或部分内容。 MedLeaves 责编：寻真作者：叁柒审校：紫参

2026-03-25

·药番茄Pharmato

盐野义：1.5亿美元“买断”合资企业，布局睡眠呼吸暂停症(OSA) 百亿蓝海

3月24日，盐野义（Shionogi）宣布，将支付1亿美元的首付款，外加与管线 SASS-002 (Sultiame) 相关的 5000万美元里程碑付款及未来销售分成，全面收购其与美国生物技术公司 Apnimed 共同成立的合资企业Shionogi-Apnimed Sleep Science（简称SASS）中属于Apnimed的50%股权。这场总额超1.5亿美元的交易，折射出全球睡眠经济中一个即将爆发的百亿级蓝海市场：阻塞性睡眠呼吸暂停（OSA）的口服药物研发。阻塞性睡眠呼吸暂停，口服药的降维打击提到阻塞性睡眠呼吸暂停（OSA），许多人的第一反应是“打呼噜”。事实上，这是一种严重的慢性疾病。在全球范围内，约有超10亿成年人受到OSA困扰。由于睡眠期间保持上呼吸道开放的肌肉反复塌陷，患者会出现间歇性缺氧，长期极易引发心血管疾病、高血压甚至猝死。过去几十年里，CPAP（持续气道正压通气）呼吸机一直是OSA的“金标准”疗法。然而，带着面罩睡觉、机器的噪音以及携带不便，导致患者依从性极差（约一半的患者在一年内放弃使用）。这就为口服药物留下了巨大的未满足需求，而 Apnimed 的 AD109 正是这一领域的领跑者，需要指出的是，AD109 并不在此项交易中。 AD109：直击病灶的神经肌肉疗法作为潜在的First-in-class 药物，AD109创新性地将 aroxybutynin（一种新型抗毒蕈碱药）与 atomoxetine（一种选择性去甲肾上腺素再摄取抑制剂）结合。与市场上试图通过减重来缓解OSA的逻辑不同，AD109直接作用于导致上呼吸道塌陷的“神经肌肉根源”。去年，AD109在两项针对轻、中、重度OSA患者的Phase 3期临床试验（SynAIRgy和LunAIRo）中连续取得成功。Apnimed已经明确计划，将在2026年第二季度正式向美国FDA递交AD109的NDA。如果获批，这将是OSA治疗史上划时代的里程碑——患者只需在睡前吞服一粒药丸，就能畅享安睡。而此次盐野义收购的 SASS-002（舒替美）同样备受业界期待。作为一种碳酸酐酶抑制剂，其在早前的Phase 2期临床中已展现出改善OSA的显著潜力，未来有望与AD109形成错位竞争或优势互补。 GLP-1跨界入局值得注意的是，OSA赛道最近迎来了一位重磅“跨界超人”——GLP-1减肥神药。诸如礼来（Eli Lilly）的替尔泊肽（Zepbound）等药物，通过大幅减轻患者体重，显著降低了肥胖型OSA患者的疾病严重程度，于2024年12月获了FDA的OSA适应症批准。总结如果把视野放大，随着公众健康意识的觉醒以及诊断率的提升，根据市场调研机构预测，全球睡眠呼吸暂停设备及治疗市场规模将在2030年后突破百亿美元。目前OSA市场还处于孕育期，多种治疗方案探索中。致病机制多样性：并非所有OSA患者都是肥胖人群。对于因神经肌肉控制缺陷、颌面部解剖结构异常导致的OSA，GLP-1无能为力。依从性与经济性：减肥针剂价格昂贵且伴随胃肠道副作用，而专门针对气道肌肉机制的小分子口服药（如AD109）在便携性、依从性和成本上具有不可替代的优势。联合用药潜力：未来，针对重度OSA患者，“减重药打底 + 神经肌肉口服药日常维持”极可能成为一种全新的联合治疗范式。 --- 以上正文 --- 往期好文《新药价值评估模型 3.0》提示词 MASH 新药竞争格局-2026年3月口服GLP-1竞争格局 JPM值得关注的CNS领域进展：Kv7 钾离子通道诺和诺德：中国最高法院对司美格鲁肽化合物专利作出了积极的裁决报告：肿瘤浸润淋巴细胞（TIL）疗法综述 - 2025年12月 Treg：调节性T细胞（Treg）疗法演进过程、竞争格局（含附件）体内CAR-T：竞争格局全析，交易、管线、主流递送平台 TSLP竞争格局：SHR-1905启动特应性皮炎2期临床报告：FGF21的研究进展-2025年10月报告：T细胞衔接器（TCE）在自身免疫性疾病的研究进展 2026年的创新药，需要关注的重点声明：本文内容供业内同行交流学习，不代表药番茄表平台立场，不构成任何投资意见和建议。药番茄不对任何主体因使用本文内容而导致的任何损失承担责任。内容如有疏漏，欢迎沟通指出！

2026-03-24

·FierceBiotech

Shionogi pays Apnimed $100M for joint venture to awaken sleep disorder dream

Shionogi\'s deal with Apnimed includes a $100 million upfront fee and a $50 million milestone tied to SASS-002.\n Shionogi has struck a deal to take full control of its sleep disorder joint venture, agreeing to pay Apnimed $100 million upfront for its partner’s half of the business. Japan-based Shionogi set up the joint venture with Apnimed in 2023. Forming the Massachusetts-based company enabled Shionogi to pair its drug discovery capabilities with Apnimed’s obstructive sleep apnea (OSA) know-how. Last year, the joint venture, Shionogi-Apnimed Sleep Science (SASS), started a phase 2a trial of one candidate and added a second asset to its pipeline.Shionogi called the joint venture’s progress “steady” in a statement. Seeking to accelerate progress, the drugmaker agreed to buy Apnimed’s 50% stake in SASS. The deal includes the $100 million upfront fee and a $50 million milestone tied to SASS-002.SASS-001 is the most advanced candidate owned by SASS. The drug candidate combines sivopixant, a P2X3 receptor antagonist discovered by Shionogi, with a molecule that has an undisclosed mechanism of action. SASS is testing the combination in adults with sleep apnea with a central component in the phase 2a trial that began last year. Apnimed said one year ago to expect top-line data in the first half of 2026. The joint venture’s other named candidate is SASS-002, a formulation of the anti-seizure drug sulthiame. Apnimed acquired the rights to develop sulthiame in sleep apnea from Desitin Arzneimittel last year and cut Shionogi in on the deal to make the program part of SASS’ pipeline. Desitin completed a phase 2 trial of sulthiame in OSA in 2023. Adding the sulthiame program to SASS’ pipeline allowed Apnimed to keep its internal teams focused on AD109, a drug combination that targets a cause of upper airway collapse in people with OSA. Apnimed reported two phase 3 wins for AD109 last year and plans to seek FDA approval in the second quarter. In a statement, Apnimed CEO Larry Miller, M.D., said selling the SASS stake is “a strategic monetization” that will strengthen the biotech’s balance sheet. Apnimed disclosed a $35 million financing in December.

临床2期并购临床3期引进/卖出

100 项与舒噻美相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01787	舒噻美	N03AX03	DB08329

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
癫痫发作	日本	Kyowa Pharmaceutical Industry Co., Ltd.	2001-09-28

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
阻塞性睡眠呼吸暂停综合征	临床2期	瑞典	Desitin Arzneimittel GmbH	2018-02-21

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05236842 (Pubmed \| Lancet)	临床2期	阻塞性睡眠呼吸暂停综合征	298	Sultiame 100 mg	網範壓願獵襯艱膚淵鏇(蓋憲遞鹹繭顧觸衊膚窪) = 選壓範積積鏇壓蓋築選鑰獵廠窪簾鬱構鹹觸憲 (範鹹廠齋淵齋構蓋蓋製 )	积极	2025-10-01
				Sultiame 200 mg	網範壓願獵襯艱膚淵鏇(蓋憲遞鹹繭顧觸衊膚窪) = 廠簾繭齋鑰鬱醖顧選廠鑰獵廠窪簾鬱構鹹觸憲 (範鹹廠齋淵齋構蓋蓋製 )
Drugs 人工标引	N/A	阻塞性睡眠呼吸暂停综合征	298	Sulthiame 100 mg	夢憲遞餘選膚鹹鑰艱鏇(壓鬱醖築廠壓糧壓鏇鹹) = 淵選鑰醖製醖鑰醖築窪衊網窪繭襯積淵獵製衊 (廠醖鹽築觸餘積鬱醖選 )	积极	2024-09-13
				Sulthiame 200 mg	夢憲遞餘選膚鹹鑰艱鏇(壓鬱醖築廠壓糧壓鏇鹹) = 鹽願窪憲憲襯範窪憲膚衊網窪繭襯積淵獵製衊 (廠醖鹽築觸餘積鬱醖選 ) 更多
EUCTR2017-004767-13-SE (not available, WSC2022)	临床2期	睡眠呼吸暂停综合征	-	Sulthiame 200 mg	鹹簾糧餘遞膚壓醖遞艱(鹽繭衊膚壓廠鑰選鏇醖) = 製淵衊積艱網鏇選製積願顧願選醖蓋選願艱艱 (鑰觸廠鹽廠願鹽鑰襯遞 ) 更多	积极	2022-03-11
				Sulthiame 400 mg	鹹簾糧餘遞膚壓醖遞艱(鹽繭衊膚壓廠鑰選鏇醖) = 糧鑰鏇鹽築範醖鹽網獵願顧願選醖蓋選願艱艱 (鑰觸廠鹽廠願鹽鑰襯遞 ) 更多