This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

开始日期2024-11-21

申办/合作机构

Idorsia Pharmaceuticals Ltd.

[+1]

NCT06630390

/ Completed临床2期IIT

Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery

The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events.
Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.

开始日期2024-11-11

申办/合作机构

University of Rochester

NCT06311864

/ Enrolling by invitationN/A

Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada

The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia.

开始日期2024-06-20

申办/合作机构

Peripharm, Inc.

[+1]

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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126

项与盐酸达利雷生相关的文献（医药）

2025-07-01·SLEEP MEDICINE

Effect of daridorexant on nighttime wakefulness and next-morning sleepiness: assessing the transition from night to day in insomnia disorder

Article

作者: Luyet, Pierre-Philippe ; Dauvilliers, Yves ; Olivieri, Antonio ; Braunstein, Guy ; Zammit, Gary

OBJECTIVE/BACKGROUND:

Reducing wakefulness throughout the night without next-day residual effects are essential characteristics for drugs for chronic insomnia disorder. In Phase 3 trials, daridorexant significantly reduced polysomnography-determined wake after sleep onset (WASO) versus placebo, and rates of daytime somnolence were similar to placebo. This analysis examines the effect of daridorexant on WASO in each 2-h quarter (Q) of the night (8-h recording), and on next-morning sleepiness, daytime alertness and ability to function (assessed daily using visual analog scales [VAS]), and the correlation between these night and day assessments.

PATIENTS/METHODS:

Data from 930 patients with insomnia disorder randomized to daridorexant 50 mg (n = 310), 25 mg (n = 310) or placebo (n = 310) for 3 months were analyzed.

RESULTS:

At Month 1, daridorexant 25 mg and 50 mg significantly decreased WASO versus placebo in Q2 (least-square mean difference [LSMD] 25 mg: -4.7 min p < 0.0001; 50 mg: -7.1 min p < 0.0001), Q3 (LSMD 25 mg: -3.3 min p = 0.0086; 50 mg: -7.2 min p < 0.0001) and Q4 (LSMD 25 mg: -4.3 min p = 0.0055; 50 mg -8.5 min p < 0.0001). Results were similar at Month 3. VAS scores for next-morning sleepiness, daytime alertness and ability to function improved from Day 1 in all groups and continued to improve over time, with treatment numerically ranked as daridorexant 50 mg > 25 mg > placebo. No significant correlations were found between WASO (overall and at any quarter) and the three VAS scores.

CONCLUSION:

Daridorexant reduces wakefulness throughout the entire night while independently decreasing morning sleepiness and improving daytime functioning and alertness.

2025-06-03·Expert Opinion On Drug Safety

Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS)

Article

作者: Rosenblat, Joshua D ; Mansur, Rodrigo B ; Kwan, Angela T H ; Ho, Roger ; McIntyre, Roger S ; Rhee, Taeho Greg ; Teopiz, Kayla M ; Cao, Bing ; Le, Gia Han ; Wong, Sabrina

BACKGROUND:

Package inserts for the FDA-approved dual orexin receptor antagonists (DORAs) suvorexant, lemborexant and daridorexant state that suicide risk should be monitored. It remains unknown whether suicidality is attributed to DORAs. We aim to evaluate suicidality associated with DORAs reported to the FDA Adverse Event Reporting System (FAERS).

METHODS:

The reporting odds ratio (ROR) was determined with trazodone as the control. Significant disproportionate reporting was determined when 95% confidence intervals (CIs) did not encompass 1.0. We used information components (ICs) to calculate the lower limit of the 95% CI (IC₀₂₅). IC was significantly increased when the IC₀₂₅ ≥0.

RESULTS:

Suvorexant (0.025 ROR), lemborexant (0.019 ROR) and daridorexant (0.002 ROR) were significantly associated with lower odds of reported completed suicides compared to trazodone (p < 0.05). There was no significantly increased RORs for the DORAs regarding suicidal ideation, depression suicidal, suicidal behavior and suicide attempts. Nonsignificant associations between all parameters of suicidality were observed for each DORA using IC₀₂₅.

CONCLUSION:

We did not find a significant association between any parameter of suicidality captured in the FAERS for each DORA. All persons treated for insomnia pharmacologically/non-pharmacologically should be evaluated for emergence/worsening of any suicidality aspect.

2025-05-01·ALCOHOL

Effects of daridorexant on rest/wake activity patterns and drinking in adult rats exposed to chronic ethanol vapor in adolescence

Article

作者: Amodeo, L R ; Ehlers, C L ; Benedict, J ; Wills, D N

Disturbance in sleep and activity rhythms are significant health risks associated with alcohol use during adolescence. Many investigators support the theory of a reciprocal relationship between disrupted circadian rhythms, sleep patterns, and alcohol usage. However, in human studies it is difficult to disentangle other factors (i.e. lifestyle, psychiatric, genetic) when determining what is causal in the relationship between substance use and sleep/activity disruptions. To this end, we used an animal model of adolescent alcohol exposure whereby male and female Wistar rats are exposed to 5 weeks of intermittent alcohol vapor during adolescence (P22-P57). Five days after ethanol vapor rats were allowed to select to drink alcohol or water in a two-bottle choice procedure for a period of 5 h, 4 days a week for 6 weeks. Activity data was collected using a "Fitbit-like" device during vapor exposure, during acute withdrawal, and after 3 weeks of protracted withdrawal. Significant changes in rest/wake activity and circadian measures were seen during 24-h withdrawal and after 3 weeks of withdrawal. Four weeks following withdrawal, the effects of the dual orexin antagonist, Daridorexant, (DAX 30 mg, 100 mg, or vehicle control), on alcohol drinking and rest and activity rhythms were assessed over a 24 h period. Both daridorexant doses led to changes in circadian measures and rest/wake activity patterns. These results showed that daridorexant reduced activity, but it did not improve rest quality as measured by the mean inactive episode duration and inactive fragmentation ratio. Additionally, we did not find a significant difference in drinking behavior in animals treated with the orexin antagonist. Thus, it appears that data from this animal model do not support the use of this drug to improve adolescent alcohol-induced sleep disturbance and/or to decrease alcohol drinking.

172

项与盐酸达利雷生相关的新闻（医药）

2025-05-30

·药智网

失眠 “熬” 出百亿级市场

近日，卫材原研的双食欲素受体拮抗剂莱博雷生（Lemborexant）获国家药监局批准上市，标志着中国失眠治疗领域正式进入“双食欲素拮抗剂时代”。全球销售额超26亿元与传统镇静催眠药物不同，莱博雷生通过竞争性结合食欲素1型受体（OX1R）和2型受体（OX2R），精准抑制食欲素介导的觉醒驱动，从而诱导自然睡眠。并且，与传统GABA-A促眠药对快速眼动睡眠（REM）的抑制作用不同，莱博雷生可同时实现非快速眼动睡眠（NREM）和REM时长的延长，通过优化睡眠结构使其更趋近于生理性睡眠状态。临床试验表明，莱博雷生对患者记忆与认知功能影响轻微，服用后对日间活动（尤其是驾驶等需要精神集中的行为）无显著干扰。研究显示，该药无身体依赖性，使用者长期（12个月）用药后停药，既无戒断症状，也不会出现失眠反弹现象，自上市以来尚未发现成瘾性报告。目前，莱博雷生已在全球20多个国家及地区上市，在日本该药被纳入《日本失眠障碍治疗专家共识》，成为睡眠起始与维持困难的双一线推荐药物，在中国莱博雷生此前已通过“港澳药械通”政策，于大湾区部分医院先行使用。卫材财报显示，莱博雷生在2024财年全球销售额实现538亿日元（折合人民币约26.9亿元），成为卫材产品收入中除阿尔茨海默病药物Lenvima外的第二大支柱。随着其在国内上市，依托国内庞大的失眠患者市场，莱博雷生有望迎来新的商业化增长高峰。注：本文仅作信息交流之目的，文中观点不代表药智网立场，也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。市场潜力巨大中国睡眠研究会2025年3月发布的《2025年中国睡眠健康调查报告》显示，我国18岁及以上人群睡眠困扰率达48.5%，其中女性睡眠困扰率为51.1%，高于男性的45.9%。随着年龄增长，睡眠困扰率呈现递增趋势，65岁及以上人群睡眠困扰率最高，达73.7%。弗若斯特沙利文数据显示，在国内，2016年至2020年失眠症成人患病人数从2.5亿增至2.7亿，预计2024年达3.0亿、2030年增至3.3亿。同期失眠症药物市场规模从98.4亿元增至117.0亿元，预计2025年、2030年分别达151.2亿元、211.9亿元。德邦证券指出，2022年我国失眠化药市场规模42亿元，同比增长18.9%，其中苯二氮卓类药物销售额14.8亿元（占比最高），市场增长潜力显著。图片来源：开源证券当前国内临床用于失眠治疗的药物主要涵盖两类：一类是以地西泮、艾司唑仑、氯硝西泮为代表的苯二氮卓类镇静催眠药，另一类是唑吡坦、扎来普隆、右佐匹克隆等非苯二氮卓类镇静催眠药。这些药品在国内上市均已超过20年，市场上仿制药品种丰富。其中，苯二氮卓类药物因普遍存在耐药性、依赖性和成瘾性等不良反应，临床应用正逐步被非苯二氮卓类药物替代。受制于国内将失眠治疗药物纳入国家二类精神药品的严格管制政策，新药研发与上市进程长期滞后。自2007年右佐匹克隆获批以来，国内失眠新药市场经历了长达16年的空白期，直至2023年12月，京新药业的创新药地达西尼胶囊获批上市，用于失眠障碍患者的短期治疗，才终结了这一局面。地达西尼胶囊是新型苯二氮䓬受体激动剂，通过与GABAa受体α1亚型结合，温和激活受体并抑制中枢神经系统以诱导睡眠。与传统完全激活剂不同，其作用机制避免了过度激活受体导致的深度抑制副作用，具有快速入睡、维持整夜睡眠、不影响睡眠结构、不易成瘾及老年群体耐受性良好等优势，填补了镇静催眠领域的医疗需求空白。该药由罗氏启动研发，后授权Evotec公司全球开发。2010年京新药业与Evotec达成合作，2023年12月地达西尼在国内获批上市。地达西尼在治疗成人原发性失眠症上表现良好。对于成人患者，相比于安慰剂，1.5 mg和2.5 mg的地达西尼分别延长总睡眠时长33.1和45分钟，减少入睡后的觉醒16.7和25.7分钟，减少觉醒次数1.2和2.6次，两种剂量均显著改善了患者的睡眠质量。此外，地达西尼治疗老年原发性失眠症也表现良好，且能显著降低老年患者日间生理性睡眠倾向。根据《中国成人失眠诊断与治疗指南》（2023版），当下国内失眠首选药物包括双食欲素受体拮抗剂、非苯二氮䓬类药物和新型苯二氮䓬受体激动剂。注：本文仅作信息交流之目的，文中观点不代表药智网立场，也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。新品有望陆续获批苯二氮卓类药物作为市场主流安眠药，虽能快速诱导睡眠，但长期使用易引发药物依赖性，且常伴随次日头晕、乏力等残留效应。尤为值得注意的是，依赖者突然停药可能出现戒断综合征，表现为失眠反跳性加重、肢体麻木，甚至出现精神症状如妄想，这极大限制了其临床长期应用。食欲素是下丘脑分泌的关键神经肽，主要通过激活中枢觉醒通路维持清醒状态，同时参与摄食、代谢及血压调节等生理过程。针对这一靶点开发的食欲素受体拮抗剂，可分为三类：OX1R拮抗剂（主要用于焦虑和成瘾治疗）、选择性OX2R拮抗剂及双重OX1/2R拮抗剂（DORAs）。其中，DORAs通过阻断食欲素A/B与受体的结合，精准抑制失眠患者过度活跃的觉醒信号，从而实现“按需助眠”的作用机制，避免了传统镇静药物对中枢神经系统的广泛抑制。《中国成人失眠诊断与治疗指南（2023版）》明确指出，尽管部分非苯二氮卓类药物（如唑吡坦、右佐匹克隆）有长期应用证据，但考虑到潜在成瘾风险，仍建议短期使用（一般不超过4周），长期用药需定期评估。而DORAs作为新一代失眠治疗药物，具有“无明确药物依赖性证据、可长期应用、停药后无显著反跳性失眠”的独特优势。苏沃雷生（Suvorexant）由默沙东研发，于2014年获FDA批准用于治疗入睡困难及睡眠维持障碍，是全球首个食欲素受体拮抗剂。苏沃雷生的销售额在2021年为3.18亿美元，但自2020年起呈现下滑趋势，2022年降至2.58亿美元。在国内，默沙东已布局相关专利，其中药物专利预计2027年到期，制剂专利则延续至2033年。继苏沃雷生之后，卫材研发的莱博雷生（Lemborexant）于2019年12月获FDA批准，用于成人入睡困难或睡眠维持困难型失眠，目前已在日本、加拿大、澳大利亚等国家上市。在国内，莱博雷生目前尚未纳入二类精神药品管理范畴。瑞士IDORSIA公司研发的达利雷生（Daridorexant）于2022年1月获FDA批准，同年11月，先声药业与IDORSIA达成独家许可协议，获得该药物在中国的临床开发及商业化权利。2024 年 7 月，先声药业宣布，达利雷生在中国的上市申请获得药监局受理，也就是说这款食欲素受体拮抗剂已在中国进入上市审评倒计时。依托先声药业在神经领域的市场经验（如先必新注射液的销售基础），该药物未来有望在国内失眠治疗市场占据一席之地。三款食欲素拮抗剂有效性对比图片来源：德邦证券在失眠创新药的研发管线中，食欲素受体是当前的主流靶点，部分药物已进入关键临床阶段：扬子江药业法赞雷生（fazamorexant/YZJ-1139）：作为双重食欲素受体高效拮抗剂，通过抑制觉醒通路改善睡眠，可显著加快入睡速度并延长睡眠时间。目前在治疗失眠的临床3期，2期数据显示，该药能剂量依赖性地将睡眠效率提升至健康水平，且与安慰剂相比无明显中枢神经系统副作用，次日残留效应极低，展现出良好的安全性和有效性。武田制药TAK-360：口服OX2R激动剂，聚焦2型发作性睡病和特发性嗜睡症治疗，通过调节食欲素通路改善异常觉醒状态，与失眠治疗形成差异化布局。翰森制药HS10506：新型高亲和力选择性OX2R拮抗剂，处于1/2期临床阶段。健康受试者研究显示，单次口服最高60mg剂量时，安全性和耐受性良好，药代动力学特征理想，并能产生预期的嗜睡效应。东阳光药业HEC83518：2020年1月获NMPA临床试验许可，用于失眠治疗，目前处于临床1期。结语随着现代社会节奏加快与压力持续增加，睡眠健康问题日益凸显，全球失眠症确诊人数呈逐年上升趋势。中国失眠症药物市场虽起步较晚、初期规模有限，但凭借较高的行业集中度，众多创新药企正加速布局仿制药与创新药的研发及上市进程。在药物研发方向上，食欲素受体拮抗剂已展现出成为“下一个重磅品种”的潜力。这类药物通过精准调控觉醒-睡眠平衡通路发挥作用，与传统失眠治疗药物（如苯二氮卓类、非苯二氮卓类）相比，具有显著差异化优势。参考资料：1、各公司官网、官媒2、开源证券3、德邦证券声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

上市批准财报临床研究

2025-05-28

·汇聚南药

被围剿的日本新药！

昨日，卫材宣布卫材原研的双食欲素受体拮抗剂——莱博雷生（中文商品名：达卫可®）正式获批上市，用于治疗成人失眠，特别是入睡困难和/或睡眠维持困难。2019年12月20日，莱博雷生率先在美国上市，后续在全球20多个国家及地区获得药品批准和上市。值得注意的是，2021年6月，莱博雷生就已在中国香港上市，得益于“港澳药械通”政策，2023年1月广州就已开出首张该品处方。莱博雷生已完成了部分患者教育，对国内医生患者来说并不算陌生。四代助眠药失眠已经成了现代人的一大困扰。据《2024中国居民睡眠健康白皮书》显示：2024年，64%的居民正在面临睡眠质量欠佳的困扰，59%的人存在失眠症状，完全无睡眠障碍的人群仅占19%。目前助眠药物已发展出四代，研发向着疗效更佳，副作用更小的方向前进着。第一代药物（巴比妥类）：以苯巴比妥为代表，成瘾性强、疗效局限；第二代药物（苯二氮卓类）：地西泮、艾司唑仑等，安全性显著提升，但长期用药仍伴随反跳性失眠、记忆损伤等风险，临床需严格监测；第三代药物（非苯二氮卓类）：唑吡坦、佐匹克隆等，可显著减少次日宿醉效应，是目前失眠治疗金标准；第四代药物（双重食欲素受体拮抗剂类）：苏沃雷生、达利雷生等，精准调控睡眠-觉醒周期，昼夜节律紊乱患者新希望。卫材的莱博雷生同样属于第四代助眠药物，也是目前国内唯一一款上市的第四代助眠药物。而除此之外，这个产品最大的产品优势其实在于：无成瘾性，不会出现戒断症状。无成瘾性助眠药市场？国内有睡眠障碍问题的人群占比非常高，但是助眠药物的市场并没有很大，据不完全统计统计，国内前三代助眠药物合计销售额还停留在10亿左右。市场不佳最主要原因还是成瘾性问题，前三代药物，包括第四代的苏沃雷生，均存在身体依赖性问题，停药会产生戒断反应，因此这些助眠药在国内均被纳入第二类精神药品目录，受强监管。而莱博雷生则暂未发现成瘾性，据卫材公布的临床数据显示，患者服用莱博雷生后，其记忆和认知功能影响小，患者醒来后对开展工作及其他日间活动，尤其是驾驶影响小，大部分患者长期（12个月）使用后停药，不会出现戒断症状，也不会出现失眠反弹，上市后至今没有发现具有成瘾性。莱博雷生凭借暂未发现成瘾性的卖点，已成为日本失眠治疗的一线推荐药物。日本市场数据显示，其市场份额在上市三年内反超传统药物，患者依从性高达78%。因其成瘾性低，目前美国和日本对莱博雷生的监管等级都不高。国内对于莱博雷生的监管尚不明确，但应当会参照美日政策进行考量。那么若莱博雷生未被列入精神药物管控目录，该品种的未来将不可限量。被围剿的日本新药日本研发的药物，总是更受国内仿制药企业关注，中日两国种族差异小，仿制药大部分只需要进行一个桥接试验即可，需要进行大临床的可能性非常小。由此可以发现，但凡日本有新药在国内上市，就必定有国内企业争相仿制。2024年6月，大冢制药的布瑞哌唑片在国内获批上市，不到一年，国内仿制申请就已达三十多家。2024年7月，协和麒麟的依伏卡塞片在国内获批上市，两个月后，就有三家企业提交了上市申请。2025年4月，日本兴和制药的佩玛贝特片在国内获批上市，一个月后，提交仿制申请企业已达5家。莱博雷生片，也免不了被国内仿制企业瞄准，莱博雷生化合物专利预计2031年06月12日到期，组合物专利预计2035年10月21日到期。离产品专利到期还有五六年，国内已有企业登记了BE试验。外资原研企业在国内上市所花费了大量的时间和金钱，上市后窗口期仅有短短几年，目前莱博雷生片的专利保护期还有五六年，尚有竞争余地。助眠类药物市场广阔，但品种的患者教育还是较为困难的，国内竞争环境特殊，也有在国外大杀四方的药物进国内后水土不服的情况，就看卫材如何布局了。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~免责声明“汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：药通社往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

上市批准

2025-05-28

·GlobeNewswire-Health Care

Shareholders vote in favor of all proposals by the Board at Idorsia’s Annual General Meeting 2025

Allschwil, Switzerland – May 28, 2025At today’s Annual General Meeting (AGM) of Idorsia Ltd (SIX: IDIA) held in Basel, Switzerland, shareholders voted convincingly in favor of all proposals by the Board of Directors. The meeting was attended by 166 shareholders, representing a total of 97’748’740 shares, or 43.28% of the total outstanding shares. Led by the Chairman of the Board, Jean-Paul Clozel the company presented a business update. Jean-Paul Clozel, MD, Chairman of the Board of Directors, commented:“On behalf of the Board, I would like to thank the shareholders for their support and loyalty. I strongly believe that with their backing, with our products and pipeline, and with our people working to ramp-up the sales of QUVIVIQ and activate the pipeline, Idorsia can become one of the most successful biotech companies in Europe.” The shareholders approved the Annual Report 2024, the Consolidated Financial Statements 2024, and the Statutory Financial Statements 2024. Shareholders also endorsed the Compensation Report 2024 and the Sustainability Report 2024 by way of consultative vote. The shareholders approved the appropriation of available earnings and that the net loss for the year 2024 be carried forward. The shareholders granted discharge to all members of the Board of Directors and of the Executive Committee for the financial year 2024. The shareholders approved the amendments to the Articles of Association regarding share capital. The shareholders re-elected all Board members who stood for re-election for a term of office until the conclusion of the AGM 2026. In addition, the shareholders elected Jean-Paul Clozel as Chairman of the Board, and the members of the Nominating, Governance and Compensation Committee: Srishti Gupta, Mathieu Simon, and Bart Filius. Following the AGM, the Board of Directors of Idorsia comprises a total of 5 members: Jean-Paul Clozel (Chairman), Mathieu Simon, Srishti Gupta, Sandy Mahatme, and Bart Filius. Shareholders approved the aggregate maximum amount of compensation for the Board of Directors for the term of office until the AGM 2026 and aggregate maximum amount of compensation for the Idorsia Executive Committee (IEC) for the financial year 2026. BachmannPartner AG, who was represented by Mr Alain Bachmann, was re-elected as Independent Proxy for a term of office until the conclusion of the AGM 2026. Deloitte AG, Basel, was re-elected as the company's statutory auditors for the financial year 2025 (for a term of office until the conclusion of the AGM 2026). Notes to the editor About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. 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 contactInvestor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.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 "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 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

高管变更

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,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
睡眠	申请上市	中国	江苏先声药业有限公司	2024-07-16
睡眠	申请上市	中国	Farmea	2024-07-16
睡眠	申请上市	中国	Idorsia Pharmaceuticals Deutschland GmbH	2024-07-16
创伤后应激障碍	临床2期	美国	Idorsia Pharmaceuticals Ltd.	2023-11-02
阻塞性睡眠呼吸暂停综合征	临床1期	德国	Idorsia Pharmaceuticals Ltd.	2019-03-14
慢性阻塞性肺疾病	临床1期	德国	Idorsia Pharmaceuticals Ltd.	2018-11-15

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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


NCT05597020 (CTgov)	临床4期	入睡和睡眠障碍 \| 夜尿	60	Placebo	選願齋顧繭窪衊齋夢糧(淵築構選襯襯齋衊鏇醖) = 簾衊簾衊鏇獵遞繭艱繭鏇糧壓齋製齋鬱積選鬱 (簾壓鑰醖遞膚夢醖願鏇, 窪醖積壓襯顧簾選醖壓 ~ 醖衊鏇選製鹹鬱憲繭顧) 更多	-	2025-04-18
NCT05702177 (Pubmed \| J Psychopharmacol)	临床1期	-	36	Daridorexant 25 mg	醖築鬱構網積遞齋糧夢(遞糧淵鹹廠製鬱艱齋鑰) = 選餘網壓願餘壓構鑰淵廠廠襯觸壓遞壓鏇鏇鹽 (觸顧簾觸獵鹽鹹鬱醖繭 ) 更多	积极	2024-12-06
				Daridorexant 50 mg	醖築鬱構網積遞齋糧夢(遞糧淵鹹廠製鬱艱齋鑰) = 網鏇壓鏇積鹽鹽衊觸艱廠廠襯觸壓遞壓鏇鏇鹽 (觸顧簾觸獵鹽鹹鬱醖繭 ) 更多
EAN2024	N/A	入睡和睡眠障碍	23	Daridorexant	廠鑰顧餘廠夢鏇願築齋(夢鹽蓋製網蓋築鏇鏇範) = Questionnaire scores indicated a clinically meaningful reduction: IDSIQ- cognitive domain by 10 網願簾獵餘顧糧壓簾餘 (網糧鏇餘餘廠夢鹽蓋選 ) 更多	积极	2024-06-28
NCT05480488 (Pubmed) 人工标引	临床1期	-	18	midazolamant 50 mwarfarin	網鬱壓憲衊糧獵鑰廠艱(糧範糧壓範鏇齋艱窪壓) = 蓋獵鏇選製製遞夢襯餘憲鬱壓鏇願糧膚顧窪簾 (鏇鏇鹹選鏇醖繭襯鏇觸 ) 更多	积极	2024-03-13
				daridorexantmgmidazolamwarfarin	網鬱壓憲衊糧獵鑰廠艱(糧範糧壓範鏇齋艱窪壓) = 鹹齋窪壓淵鏇齋淵夢積憲鬱壓鏇願糧膚顧窪簾 (鏇鏇鹹選鏇醖繭襯鏇觸 ) 更多
NCT03545191 (Phase 3 trial, WSC2023)	临床3期	入睡和睡眠障碍 \| 阻塞性睡眠呼吸暂停综合征	930	Daridorexant 50 mg	廠構襯憲糧鬱製鏇鏇積(餘範簾糧壓鬱鬱淵窪艱) = Two participants discontinued study treatment due to AEs (both in placebo) 築鏇選鹹願鹹範築鹹壓 (廠鑰壓鬱艱齋醖願遞窪 ) 更多	积极	2023-10-22
				Placebo
NCT03575104 \| NCT03545191 (Phase 3 studies, WSC2023)	临床3期	入睡和睡眠障碍	-	Daridorexant 50 mg	鏇艱齋膚鑰鹹鹹鹹鏇構(簾襯齋鹹選襯餘獵膚醖) = 鏇夢築鹹簾繭鹹憲醖網鬱膚衊淵夢醖襯艱選醖 (顧鏇蓋網廠選願簾遞壓 ) 更多	积极	2023-10-22
NCT03679884 (Pubmed) 人工标引	临床3期	入睡和睡眠障碍	804	Daridorexant	網襯繭夢願廠鑰鹽獵顧(築鹽選範壓鹹觸觸鏇襯) = Overall incidence of treatment-emergent adverse events was similar across groups (35-40%). 膚憲積鏇遞膚醖膚構鹽 (廠網構襯窪窪簾襯鑰遞 ) 更多	积极	2022-12-09
				Placebo
NCT03545191 (Pubmed)	临床3期	入睡和睡眠障碍	930	Daridorexant 50 mg	鹹製夢憲襯醖築廠蓋壓(遞選鑰夢醖夢窪憲衊齋) = no cases of cataplexy 範觸鏇憲憲簾鏇憲觸憲 (鬱壓鹽鏇廠遞網觸壓選 ) 更多	-	2022-09-13
				Daridorexant 25 mg
NCT03545191 (Phase 3 trial \| NCT03679884 \| ###DELETE \| phase-3, CTgov)	临床3期	入睡和睡眠障碍	930	Daridorexant 25 mg (Daridorexant 25 mg)	鏇蓋網鬱觸鬱鬱鏇顧鬱(網構憲夢網願鹹繭齋糧) = 網獵鏇蓋衊襯淵鑰淵膚淵鬱糧淵憲蓋願衊餘鹽 (鏇衊簾鑰齋鬱網淵齋齋, 範網鏇糧憲窪顧構窪顧 ~ 憲鏇範膚壓糧觸餘淵積) 更多	-	2022-03-25
				Daridorexant 50 mg (Daridorexant 50 mg)	鏇蓋網鬱觸鬱鬱鏇顧鬱(網構憲夢網願鹹繭齋糧) = 衊範艱廠獵網糧淵衊淵淵鬱糧淵憲蓋願衊餘鹽 (鏇衊簾鑰齋鬱網淵齋齋, 廠醖築鏇鬱鏇鬱憲鑰齋 ~ 壓鹽製觸餘醖願窪壓範) 更多
NCT03575104 (CTgov)	临床3期	入睡和睡眠障碍 \| 睡眠	924	Daridorexant (Daridorexant 10 mg)	齋膚構觸蓋壓積襯選網(窪蓋觸鏇醖襯觸網餘壓) = 鏇鏇鬱鹹憲製鏇醖餘壓鹹繭蓋鏇網膚廠願壓獵 (衊簾鏇蓋窪獵窪壓窪遞, 膚顧壓鑰衊鏇壓襯鑰膚 ~ 製齋鹽鏇壓艱餘選選齋) 更多	-	2022-03-25
				Daridorexant (Daridorexant 25 mg)	齋膚構觸蓋壓積襯選網(窪蓋觸鏇醖襯觸網餘壓) = 製獵願顧窪蓋衊製觸衊鹹繭蓋鏇網膚廠願壓獵 (衊簾鏇蓋窪獵窪壓窪遞, 遞選網範獵選觸願觸顧 ~ 鬱糧襯蓋獵顧網顧遞範) 更多