Tobacco use is the leading cause of preventable death in the U.S., with 480,000 deaths per year and 7.7 million deaths globally. A major clinical symptom associated with abstinence from both licit and illicit drugs is insomnia, which is a clinically verified, major risk factor for relapse. Roughly half of the 40 million smokers in the U.S. attempt to quit annually, with very low rates of success. One major hurdle is poor sleep quality during abstinence. Compounding the problem is that some pharmaceuticals to help reduce smoking can increase insomnia. Poor sleep is recognized as a major impediment to maintaining abstinence from several drugs of abuse, including nicotine. Blockers of orexin have recently been proposed as a promising therapy for smoking cessation. Insomnia has been reported in up to 40% of smokers, and 80% report regular sleep disturbances, which can be amplified during abstinence. A new orexin blocker, daridorexant, was FDA approved within the past two years for the treatment of insomnia, and while it has been tested in healthy individuals with insomnia, it has not been tested in smokers, who suffer from insomnia, particularly during the withdrawal phase when trying to quit. Daridorexant has an improved profile of beneficial effects for those with insomnia, the most notable advantage being its shorter duration of action that promotes daytime alertness, which is problematic for both active smokers and smokers during withdrawal. Poor sleep leads to daytime sleepiness, which often leads to smoking to maintain alertness.

开始日期2026-02-10

申办/合作机构

Legacy Health

[+1]

NCT07136415

/ Not yet recruiting临床4期IIT

CELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal People

The goal of this clinical trial is to learn how three current insomnia therapies (trazodone, daridorexant, cognitive behavioral therapy for insomnia) compare with each other in peri- and post-menopausal women. It will also learn about the safety of the treatments. The main questions it aims to answer are:
Which commonly used insomnia therapies are most effective and safe for improving insomnia symptoms in peri- and post-menopausal people?
How well do the treatments work for people from different backgrounds, who are at different stages of menopause, and who have different conditions common during menopause (e.g., sleep apnea, mood disturbance, etc.)?
What medical problems do participants have when using these treatments?
Participants will:
Be asked to take trazodone every night, take daridorexant every night, or participate in an online behavioral program for insomnia, for a total of 12 months.
Participate in a total of one in-person visit and 6 virtual visits (phone calls) over the 12 months.
Wear (and keep) a Fitbit and fill out a daily sleep diary for at least 4 weeks over the 12 months.
Fill out online surveys 5 times over the 12 months.

开始日期2026-02-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+6]

100 项与盐酸达利雷生相关的临床结果

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100 项与盐酸达利雷生相关的转化医学

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100 项与盐酸达利雷生相关的专利（医药）

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136

项与盐酸达利雷生相关的文献（医药）

2026-06-01·SLEEP MEDICINE

Real-world findings of daridorexant in chronic insomnia: A pilot study on subjective and actigraphic sleep parameters

Article

作者: Turco, Francesco ; Hoxhaj, Domeniko ; Colitta, Alessandro ; Frumento, Paolo ; Faraguna, Ugo ; Maestri Tassoni, Michelangelo ; Pascazio, Alessia ; Fabbrini, Monica ; Bonanni, Enrica ; Siciliano, Gabriele ; Buracchi Torresi, Francesca ; Carnicelli, Marco

The real-world effectiveness of daridorexant is scarcely documented, with limited studies investigating factors that may modify its effectiveness and its possible influence on sleep misperception. This observational study aims at: (i) investigating the real-world effectiveness of daridorexant through a wide range of subjective sleep assessment methods and actigraphy, (ii) measuring changes in sleep misperception during daridorexant treatment; (iii) exploring daridorexant effect modifiers. Sleep data were collected at baseline (T0) and after 1 month (T1) and 3 months (T2) of treatment for 28 patients. Misperception indexes were determined by calculating the misalignment between subjective and objective measurements. Potential modifiers like age, sex, Body Mass Index (BMI), disease duration, and treatment regimen were explored. Reported and actigraphic total sleep time (TST) and sleep efficiency (SE) showed a statistically significant increase across the treatment period. Median TST misperception decreased from -1.96 h at T0 to -0.57 h at T2, and SE misperception improved from -19% to -7%. Self-reported sleep disturbances and daytime symptoms showed notable improvement, with an 8-point reduction in the Insomnia Severity Index and significant decreases in the Insomnia Daytime Symptoms and Impacts Questionnaire scores. Only one non-serious adverse event (sleep paralysis) was reported. Age, sex, BMI, and disease duration influenced treatment effectiveness. Overall, these findings provide preliminary real-world evidence of associations between daridorexant use and subjective and objective sleep parameters. The observed signals, particularly regarding sleep misperception, should be considered hypothesis-generating and require confirmation in larger, controlled studies.

2026-03-01·MATURITAS

Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial

Article

作者: Bassetti, Claudio ; Schaedel, Zoe ; Bakker, Talitha R ; Pain, Scott ; Briasoulis, Orestis ; Cassel, Petra ; Palmay, Christine ; Bertisch, Suzanne M ; Palacios, Santiago ; Trémollieres, Florence ; Stute, Petra ; Silvestri, Rosalia

OBJECTIVES:

To evaluate the efficacy and safety of daridorexant in women aged 47-55 years with insomnia disorder, an age group representative of the menopause transition.

STUDY DESIGN:

In this randomized, double-blind, placebo-controlled study (NCT03545191), conducted in 10 countries between May 2018 and May 2020, 930 patients with insomnia disorder were randomized using interactive response technology (1:1:1) to receive a single film-coated tablet of daridorexant 25 mg, 50 mg, or placebo every evening for 3 months. Subgroup analyses were performed among the 117 women aged 47-55 (25 mg n = 43; 50 mg n = 35; placebo n = 39).

MAIN OUTCOME MEASURES:

Efficacy endpoints included change from baseline to Month 3 of treatment in polysomnography-measured wake after sleep onset (WASO) and latency to persistent sleep (LPS), self-reported total sleep time (sTST), and insomnia-related daytime impairment, as recorded on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Safety endpoints included adverse events and score on a visual analog scale for morning sleepiness. Efficacy was analyzed in all randomized subjects, and safety in all who received at least one treatment dose.

RESULTS:

At Month 3, daridorexant 50 mg vs placebo decreased WASO and LPS by a least-squares mean (LSM) of 13.8 min (95 % CI -29.0, 1.4) and 14.7 min (-30.0, 0.6) respectively, increased sTST by an LSM of 21.8 min (-3.9, 47.4) and decreased (improved) IDSIQ total score by an LSM of 4.1 (-14.4, 6.3). No marked deviations from the effect in the overall population were observed. The incidence of somnolence/fatigue was low and comparable across groups. Morning sleepiness improved in all groups.

CONCLUSIONS:

These analyses suggest that daridorexant 50 mg provides benefit in sleep outcomes and daytime functioning in women aged 47-55 with insomnia disorder. Daridorexant 50 mg is well tolerated in this population, with no increased risk of next-morning sleepiness or somnolence.

CLINICALTRIALS:

GOV IDENTIFIER:

NCT03545191.

2026-02-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Sleep, wake, and signaling: Functional profiling of orexin agonists and antagonists using newly developed orexin β-arrestin 2 and miniGαq recruitment assays

Article

作者: Decker, Michael ; Mori, Silvia ; Deventer, Marie H ; Stove, Christophe P ; Angermann, Marcus

The excitatory neuropeptides orexin-A and -B interact with their target G protein-coupled receptors (GPCRs), the orexin 1 and orexin 2 (OX₁ and OX₂) receptors, which are widely expressed throughout the central nervous system. The orexin system plays a critical role in regulating several physiological processes such as sleep-wake cycles, feeding behaviour, and arousal, and is implicated in a variety of (neurological) disorders. In particular dysregulation of the orexin system is linked to sleep disorders such as narcolepsy (often associated with orexin deficiency) and insomnia (characterized by an overactivity of sleep-wake regulation). This has prompted a growing interest in orexin-targeting therapeutics. This study is the first to report the development of four OX₁ and OX₂ receptor luminescence bioassays based on functional complementation of a split-nanoluciferase enzyme, capable of monitoring β-arrestin 2 (βarr2) and Gα_q recruitment to activated OX₁ and OX₂ receptors. These assays were successfully applied to evaluate the pharmacological profiles of both agonists and antagonists, including the endogenous ligands orexin-A and -B, the clinically approved small molecule antagonists suvorexant and daridorexant, as well as EMPA (N-ethyl-2-[(6-methoxy-pyridin-3-yl)-(toluene-2-sulphonyl)-amino]-N-pyridin-3-ylmethyl-acetamide) and four other compounds described in literature to act at orexin receptors. The obtained receptor activation patterns and selectivity profiles were consistent with literature data, indicating the reliability and robustness of the assay systems. Overall, the newly developed assays expand the toolkit for orexin receptor research by allowing the characterization of both agonists and antagonists, thereby contributing to the functional characterization of potential new drug candidates for various pathological conditions.

339

项与盐酸达利雷生相关的新闻（医药）

2026-02-26

·今日头条

2026年2月26日医药板块新闻汇总

一、重磅合作与战略布局 1. 惠升生物×通化东宝：两款胰岛素商业化合作 - 四环医药旗下惠升生物与通化东宝(600867.SH)签署协议，将德谷门冬双胰岛素注射液(惠优加)、德谷胰岛素注射液(惠优达)两款重磅糖尿病药物商业化权益授予通化东宝 - 通化东宝将负责产品在中国大陆的推广、销售及市场开发，惠升生物保留产品生产权 2. 齐鲁制药：贝伐珠单抗英国获批上市 - 抗肿瘤药物贝伐珠单抗注射液(商品名:Ankevda)获英国MHRA批准，用于治疗结直肠癌、非小细胞肺癌等多种恶性肿瘤 - 标志着该产品成功进入欧洲高端市场，是齐鲁制药国际化战略的重要突破二、公司公告与重要动态 1. 百济神州：2025年全年收入53亿美元，同比增长40% - 第四季度全球总收入15亿美元，同比增长33%；全年总收入53亿美元，同比增长40% - 2026年全年总收入指引为62亿美元至64亿美元，预计持续增长 2. 多瑞医药：要约收购期满，股票明日复牌 - 王庆太预受要约股份1760.06万股，曹晓兵预受要约股份数量未披露 - 公司股票将于2026年2月27日(星期五)开市起复牌 3. 海南海药：控股股东延长解决同业竞争承诺期限 - 新兴际华集团及医药控股将自原承诺到期日(2026年3月13日)起延长2年解决同业竞争问题 - 新承诺期限至2028年3月13日 4. 赛诺医疗：披露2025年度业绩快报 - 2025年归母净利润4728.63万元，同比增长3057.05%，实现大幅扭亏为盈 - 今日股价上涨1.02%，报收22.88元，总市值95.63亿元 5. 中国医药：子公司获得药品注册证书 - 子公司收到国家药监局核准签发的药品注册证书，具体药品信息未详细披露三、新药研发与审批进展 1. 长春高新：儿童小阴茎新药引发关注，公司回应项目尚处早期 - 子公司金赛药业GenSci141软膏临床试验申请获国家药监局批准，是全球首款针对儿童小阴茎的药物 - 适应症包括高促性腺激素性性腺功能减退症、5α-还原酶2缺乏症等导致的儿童小阴茎 - 公司强调项目还处于早期阶段，近两年业绩承压，2025年净利预计下滑超90% 2. 仁和药业：互动平台确认生产销售磷酸奥司他韦胶囊 - 针对近期流感高发情况，公司明确表示有相关产品生产和销售四、行业数据与市场动态 1. 创新药ETF近20日"吸金"超8亿元 - 年内海外授权已突破530亿美元，机构指出今年创新药BD呈现三大转型 - 今日中证创新药产业指数下跌0.24%，长春高新上涨超6%，亿帆医药上涨超5% 2. 医药板块收盘分析 - 涨幅前五：百奥赛图(688796)涨8.15%、ST百灵(002424)涨4.96%、*ST万方(000638)涨4.92%、益诺思(688710)涨4.16%、健信超导(688805)涨3.65% - 跌幅前五：惠泰医疗(688617)跌2.98%、药明康德(603259)跌1.84%、东阿阿胶(000423)跌1.81%等 3. 险资2026年将继续加码医药生物行业 - 保险机构资产配置展望调查显示，多数机构计划小幅增配A股，看好医药生物与创新药等投资主题五、国际医药动态 1. Idorsia：2025年业绩强劲，QUVIVIQ销售额翻倍 - 瑞士制药公司Idorsia发布2025年业绩，核心产品QUVIVIQ(失眠治疗药物)销售额大幅增长

财报并购

2026-02-26

·制药网

抗失眠症药物领域再迎喜讯，该药企1类创新药获批临床

【制药网行业动态】近几年，越来越多的人出现睡眠困难，有数据统计显示，我国有1/4的人群睡眠不足6小时，近40%的人群存在夜间易醒的问题。入睡困难、睡眠不足等症状会影响人的认知表现，削弱免疫系统，导致增加患慢性疾病的概率。因此加强抗失眠药物研发举足轻重。　　据悉，近日康弘药业传来喜讯，公司自主研发的化药1类创新药KHN707片已获得国家药品监督管理局下发的药物临床试验批准通知书，同意该药品开展用于失眠症的临床试验。该临床试验的获批标志着KHN707片的研发进程进入了新的阶段。　　资料显示，KHN707片为选择性食欲素2(OX2R)受体拮抗剂，属于全新作用机制的失眠症治疗药物。根据公司公告，前期研究结果显示该药物在失眠模型中具有良好的治疗作用，且安全性较好，展现出潜在的临床应用前景。　　据悉，在抗失眠症新药领域，目前扬子江药业、恒瑞医药、豪森药业、信立泰等多家药企均有布局。如2025年9月，扬子江药业曾宣布，其自主研发的1类抗失眠创新药法赞雷生(Fazamorexant)Ⅲ期关键性临床研究成果发布。法赞雷生是一款双重食欲素受体拮抗剂(YZJ-1139片)，它能够同时抑制食欲素受体1型和2型，加快睡眠速度，延长深睡时间。本研究为一项多中心、随机、双盲、安慰剂对照Ⅲ期临床试验，共1034例成人失眠症患者服用试验药物。结果显示，法赞雷生作为食欲素双受体拮抗剂药，在成人失眠患者中表现出快速起效和良好的安全性。扬子江药业集团相关负责人表示，企业已向国家药品监督管理局(NMPA)药品审评中心(CDE)正式提交法赞雷生的新药上市申请(NDA)。　　除了在研新药外，当前国内已有不少于3款抗失眠创新药获批上市，其中2025年6月，先声药业与瑞士Idorsia公司合作开发的抗失眠创新药盐酸达利雷生片获批上市，用于治疗以入睡困难和/或睡眠维持困难为特征的成人失眠患者，且未被作为精神药品管制。资料显示，该产品是一款双重食欲素受体拮抗剂，通过阻断促进觉醒的食欲素神经肽(食欲素A和食欲素B)与其受体的结合，在不改变睡眠结构的前提下，帮助患者入睡和保持睡眠，嗜睡发生率低，有效提高次日日间功能。　　业内表示，与传统安眠药相比，食欲素受体拮抗剂从源头上规避了如成瘾性、长期服用后药效衰减等困扰，虽非完美，却是重要突破，因此是目前抗失眠症新药研发热门靶点之一。　　睡眠，作为人体不可或缺的生理需求，却成为了我国众多成年人的 “难题”。数据显示，我国18岁及以上人群中，睡眠困扰率高达48.5%。这一数据背后，反映出国民睡眠健康问题的严峻性，揭示出抗失眠药物领域巨大的市场需求。　　从国民睡眠困扰率居高不下，到国内药企纷纷布局创新研发，再到多款新药获批上市、进入临床试验，我国抗失眠药物领域正迎来快速发展的黄金期。睡眠健康关乎全民福祉，随着创新研发的持续深入，相信未来会有更多更安全、更有效的抗失眠药物问世，破解失眠困境。　　免责声明：在任何情况下，本文中的信息或表述的意见，均不构成对任何人的投资建议。

临床3期上市批准申请上市临床结果

2026-02-26

·BioSpace

Idorsia reports strong 2025 results with QUVIVIQ sales more than doubling – further sales growth ahead with multiple pipeline catalysts in 2026

Ad hoc announcement pursuant to Art. 53 LR Idorsia delivers on its upgraded 2025 guidance , with strong QUVIVIQ sales growth, disciplined investment, and a significantly improved bottom line. Focused investment in Idorsia’s pipeline of first-in-class medicines to drive future growth, with key readout for daridorexant in pediatric insomnia imminent and Lucerastat registration study advancing in Fabry’s disease. Allschwil, Switzerland – February 26, 2026 Idorsia Ltd (SIX: IDIA) announces strong financial and operational results for the full year 2025, setting a new base for further growth ahead and a catalyst rich 2026. Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented: “2025 marked a year of disciplined execution and renewed momentum for Idorsia. We delivered on our upgraded guidance, more than doubled QUVIVIQ sales, and significantly strengthened our financial position – demonstrating that focused investment and commercial excellence can go hand in hand. At the same time, we continued the next phase of growth: positioning TRYVIO/JERAYGO as the first treatment to target a new pathway in hypertension in decades and progressing our pipeline, including the upcoming readout of the pediatric insomnia study and the registrational program for lucerastat in Fabry disease. With multiple catalysts ahead, we enter 2026 with clarity, confidence, and a clear path toward sustainable growth.” QUVIVIQ ® (daridorexant) Global 2025 net sales grow to CHF 134 million, reflecting outstanding year-over-year momentum – with continued strong growth ahead. QUVIVIQ continues to reshape the insomnia treatment landscape, and we are investing to accelerate its trajectory toward blockbuster status. Growth will be driven by expanded global reach through partnerships targeting general practitioners, strategic commercial alliances, additional public reimbursement wins, potential U.S. descheduling, adoption of innovative digital and distribution models, and the initiation of a U.S. label-enhancing study focused on daytime functioning. New opportunity to transform the treatment paradigm in pediatric insomnia with results expected in Q2 2026 from the Phase 2 study for daridorexant – the only dual orexin receptor antagonist in development for this population with high unmet need. TRYVIO™ / JERAYGO™ (aprocitentan) TRYVIO is available in the US and used in the top 25 hypertension centers. Robust on-market experience among leading experts indicates “PRECISION-like” double-digit blood pressure reductions and confirms the tolerability pro diverse patient groups. Regulatory success in 2025 – JERAYGO is approved in EU, UK, Switzerland, and Canada. Partnering discussions to maximize the global value of TRYVIO/JERAYGO are progressing. Research & Development Alignment with the FDA on the registrational program for lucerastat, positioning Idorsia to advance the first oral therapy intended for all patients with Fabry disease. Advancing Idorsia’s immunology portfolio of first-in-class compounds – starting with Idorsia’s CCR6 antagonist proof-of-concept in psoriasis (proof-of-mechanism for other CCR6- and Th17-associated autoimmune diseases). Clinical validation for Idorsia's revolutionary drug-like synthetic glycan vaccine technology. Financial highlights for full year 2025 QUVIVIQ sales: CHF 134 million Contract revenue (one-off): CHF 72 million contract revenue Non-GAAP operating expenses: CHF 328 million Non-GAAP operating loss: CHF 100 million including one-off contract revenue of CHF 72 million (US GAAP operating loss: CHF 33 million including CHF 90 million one-off income from Viatris agreement) Strengthened balance sheet through successful debt restructuring and new financing. Financial Guidance for 2026 QUVIVIQ sales: CHF 200 million Non-GAAP operating expenses: approx. CHF 330 million Non-GAAP operating loss: CHF 120 million (US GAAP operating loss: approx. CHF 160 million) Positive commercial contribution and focused investment in value-driving pipeline assets results in continued improvement of underlying business performance. 2026 guidance reflects continued growth of QUVIVIQ (approximately 50% increase in Idorsia-led sales), investment in the lucerastat registration program, and development of the company’s immunology portfolio. TRYVIO/JERAYGO revenues and investments are not included, as these will be considered in any potential partnership agreement. All amounts exclude unforeseen events and any potential upsides from new direct-to-patient distribution models currently being implemented in several geographies and revenue related to additional business development activities. Financial results US GAAP results Full Year Fourth Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2025 2024 2025 2024 Net revenue 221 113 48 60 Operating expenses (268) (351) (106) (140) Operating income (loss) (33) (232) (56) (78) Net income (loss) (112) (264) (78) (84) Basic & diluted EPS (0.52) (1.45) (0.31) (0.45) Basic & diluted weighted average number of shares 214.7 182.4 248.3 188.3 Net revenue of CHF 221 million in 2025 resulted from product sales (CHF 134 million), product sales to partners (CHF 7 million), and contract revenues (CHF 79 million). This compares to net revenue of CHF 113 million in 2024 as a result of QUVIVIQ product sales (CHF 61 million), product sales to partners (CHF 47 million), and contract revenue (CHF 5 million). US GAAP operating expenses of CHF 268 million in 2025 and CHF 351 million in 2024 were impacted by a one-off gain of CHF 90 million (Viatris deal amendment) in 2025 and CHF 125 million (Viatris deal) in 2024, respectively. Excluding these one-off gains, US GAAP operating expenses for 2025 decreased by CHF 83 million, mainly driven by R&D expenses of CHF 102 million decreasing by CHF 42 million compared to 2024 (CHF 144 million), and SG&A expenses of CHF 221 million decreasing by CHF 52 million compared to 2024 (CHF 273 million). US GAAP net loss in 2025 amounted to CHF 112 million compared to CHF 264 million (net loss) in 2024. The reduced net loss in 2025 was primarily driven by revenue growth and lower operating expenses as a result of an operational restructuring initiated in Q4 2024. The US GAAP net loss resulted in a net loss per share of CHF 0.52 (basic and diluted) in 2025, compared to a net loss per share of CHF 1.45 (basic and diluted) in 2024. Non-GAAP* measures Full Year Fourth Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2025 2024 2025 2024 Net revenue 214 113 47 60 Operating expenses (328) (427) (96) (121) Operating income (loss) (100) (308) (47) (60) Net income (loss) (118) (330) (54) (73) Basic and diluted EPS (0.55) (1.81) (0.22) (0.39) Basic and diluted weighted average number of shares 214.7 182.4 248.3 188.3 * Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance. Non-GAAP net loss in 2025 amounted to CHF 118 million; the difference versus US GAAP net income was mainly driven by the one-off gain from the amendment of the Viatris deal (CHF 90 million), depreciation and amortization (CHF 17 million) , share-based compensation (CHF 6 m), impairment charges (CHF 3 m), restructuring charges (CHF 3 m), accretion and issuance cost amortization (CHF 16 m) and a debt extinguishment loss related to the debt restructuring (CHF 37 million). The non-GAAP net loss resulted in a net loss per share of CHF 0.55 (basic and diluted) in 2025, compared to a net loss per share of CHF 1.81 (basic and diluted) in 2024. Liquidity and indebtedness Liquidity on December 31, 2025, amounted to CHF 89 million. This amount does not include the remaining CHF 80 million available under the new money facility (term loan). (in CHF millions) Dec 31, 2025 Sep 30, 2025 Dec 31, 2024 Liquidity Cash and cash equivalents 89 64 106 Total liquidity* 89 64 106 Indebtedness Convertible loan 335 335 335 Convertible bonds 49 49 797 Debt notes** 753 753 - Term loan 18 13 - Other financial debt 187 186 189 Total indebtedness 1,342 1,336 1,321 *rounding differences may occur ** The debt notes issued by Idorsia Investments SARL in exchange for convertible bonds are senior secured with the shares in Idorsia Investments SARL. The A Notes only benefit from a limited and subordinated Swiss-law governed guarantee by Idorsia Ltd. Human Resources Idorsia reduced more than 200 positions worldwide in 2025, bringing the total number of permanent employees to 487 (2024: 689). Annual Report Idorsia's Annual Report 2025 – consisting of the Business Report, Governance Report, Compensation Report, Sustainability Report, and Financial Report, is available at . Note to Shareholders The Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2025, will be held on Wednesday, May 6, 2026. Registered shareholders with voting rights individually or jointly representing at least 0.5% of the share capital of the company, being entitled to add items to the agenda of the general meeting of shareholders, are invited to send in proposals, if any, to Idorsia Ltd, attention Corporate Secretary, Hegenheimermattweg 91, CH-4123 Allschwil, to arrive no later than March 22, 2026. Any proposal received after the deadline will be disregarded. In order to vote at the Annual General Meeting, shareholders must be registered in the company's shareholder register by April 27, 2026, 17:00 CEST, at the latest. Results Day Center Investor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: . Events First Quarter 2026 Financial Results reporting on April 28, 2026 Annual General Meeting of Shareholders on May 6, 2026 Half-Year 2026 Financial Results reporting on July 30, 2026 Notes to the editor About Idorsia The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact George Thampy Senior Vice President, Head of Investor Relations Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com – media.relations@idorsia.com – The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

疫苗临床2期上市批准财报

100 项与盐酸达利雷生相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11886 D11887	盐酸达利雷生	-	DB15031

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
入睡和睡眠障碍	美国	Idorsia Pharmaceuticals Ltd.	2022-01-07

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
睡眠	临床3期	美国	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	比利时	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	保加利亚	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	加拿大	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	捷克	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	芬兰	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	法国	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	德国	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	匈牙利	Idorsia Pharmaceuticals Ltd.	2018-05-29
睡眠	临床3期	韩国	Idorsia Pharmaceuticals Ltd.	2018-05-29

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临床结果

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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


Biospace 人工标引	临床3期	入睡和睡眠障碍	-	Daridorexant 50 mg	網窪構衊鏇淵範窪廠繭(築鑰構製簾製淵簾製願): P-Value = <0.0001 达到更多	积极	2026-01-19
				Placebo
NCT03545191 (Maturitas) 人工标引	临床2期	入睡和睡眠障碍	35	daridorexant 50 mg	繭鹹衊鑰廠遞夢蓋選積(淵襯築願艱觸簾糧觸顧) = 鏇窪繭襯顧鹹夢餘簾獵顧憲觸衊顧簾衊顧範餘 (願鹽膚夢鹹築蓋鹹鑰淵 ) 更多	积极	2026-01-07
				placebo	-
WSC2025	临床2期	入睡和睡眠障碍 \| 夜尿	60	Daridorexant 50 mg	網遞壓繭淵齋壓衊鑰獵(選範選鏇襯窪鹹餘築窪) = Daridorexant (vs. placebo) significantly improved IDSIQ total score (Weeks 1, 3) 願製獵鏇衊顧選顧壓簾 (餘齋獵遞衊鹹壓蓋膚鬱 ) 更多	积极	2025-09-05
				Placebo
NCT02839200 (WSC2025)	临床2期	入睡和睡眠障碍	231	Daridorexant 50mg	鏇醖鬱繭製壓鏇餘齋鑰(選鑰築淵獵鹹觸壓鏇壓) = 膚衊鹹淵膚壓糧範膚鏇獵鑰範獵憲鹹廠鹹觸選 (鹹廠廠衊糧顧襯鑰憲簾 ) 更多	积极	2025-09-05
				Zolpidem 10mg	鏇醖鬱繭製壓鏇餘齋鑰(選鑰築淵獵鹹觸壓鏇壓) = 夢壓衊構獵艱範艱壓齋獵鑰範獵憲鹹廠鹹觸選 (鹹廠廠衊糧顧襯鑰憲簾 ) 更多
NCT06630390 (CTgov)	临床2期	苏醒期谵妄 \| 术后认知功能障碍	11	Daridorexant 50 mg (Daridorexant)	鑰鑰鏇遞壓製膚鑰觸糧 = 選襯顧簾鹽願選鹽壓遞鏇齋膚遞繭鬱鬱襯淵製 (獵餘艱構齋築鏇簾鏇壓, 壓構夢鹹製廠繭簾壓觸 ~ 膚製顧選簾醖廠積築衊) 更多	-	2025-07-11
				Placebo (Placebo)	鑰鑰鏇遞壓製膚鑰觸糧 = 衊衊廠鬱廠醖製窪餘鑰鏇齋膚遞繭鬱鬱襯淵製 (獵餘艱構齋築鏇簾鏇壓, 餘艱遞衊願繭壓鹹衊壓 ~ 淵鑰壓遞蓋窪觸餘膚願) 更多
NCT03545191 (Pubmed \| Sleep Med)	临床3期	入睡和睡眠障碍	930	Daridorexant 50 mg	廠鹽繭簾夢範鑰顧齋壓(繭築遞齋築膚繭鏇窪鹽) = 襯壓鏇築餘繭餘膚糧窪積繭衊築襯醖遞襯築簾 (鑰衊鑰範衊餘繭餘蓋繭 )	积极	2025-07-01
				Daridorexant 25 mg	廠鹽繭簾夢範鑰顧齋壓(繭築遞齋築膚繭鏇窪鹽) = 糧製顧鹽蓋餘憲鹹醖窪積繭衊築襯醖遞襯築簾 (鑰衊鑰範衊餘繭餘蓋繭 )
NCT06010693 (NEWS) 人工标引	临床3期	入睡和睡眠障碍	206	达利雷生	壓窪鏇醖獵壓窪獵蓋鬱(衊廠餘構淵憲遞廠簾構) = 共纳入206例失眠障碍患者，于2024年6月达到首要疗效终点，即显著减少了治疗一个月末失眠患者的入睡后觉醒时间（WASO）。製鬱鹽廠顧襯糧範鬱窪 (憲築觸顧餘膚鏇鹹壓艱 ) 达到	积极	2025-06-23
NCT05597020 (CTgov)	临床4期	入睡和睡眠障碍 \| 夜尿	60	Placebo	築廠壓網網範遞網遞積(衊鬱願鏇願簾鏇夢築構) = 鹽醖選觸鬱鏇鏇艱襯鹽餘衊築廠衊積製蓋夢壓 (衊夢膚鹹衊醖遞選醖鹽, 鬱簾窪積觸廠獵壓憲餘 ~ 壓艱鹹鑰鏇醖艱鹹願艱) 更多	-	2025-04-18
NCT05702177 (Pubmed \| J Psychopharmacol)	临床1期	-	36	Daridorexant 25 mg	製簾繭鏇製範鏇餘製齋(顧鹽簾願網獵鹹獵鹹糧) = 構製糧衊廠淵鬱顧獵範齋構襯獵顧積襯夢鏇衊 (獵網積艱膚餘鹹艱觸觸 ) 更多	积极	2024-12-06
				Daridorexant 50 mg	製簾繭鏇製範鏇餘製齋(顧鹽簾願網獵鹹獵鹹糧) = 獵積夢網窪膚蓋廠鏇鹹齋構襯獵顧積襯夢鏇衊 (獵網積艱膚餘鹹艱觸觸 ) 更多
NCT05597020 (NEWS)	临床4期	入睡和睡眠障碍	60	达利雷生	願鏇簾餘膚齋鑰壓襯糧(願簾築鏇淵鬱衊襯壓選) = 醖壓憲網製艱繭願築構鏇淵窪網鹹廠構夢製觸 (觸顧網願鏇願壓遞鏇製 )	积极	2024-09-17
				安慰剂	願鏇簾餘膚齋鑰壓襯糧(願簾築鏇淵鬱衊襯壓選) = 襯願選餘積艱窪憲膚鹽鏇淵窪網鹹廠構夢製觸 (觸顧網願鏇願壓遞鏇製 )