The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are:
* Is zuranolone safe to take by participants who have moderate to severe post-stroke depression?
* Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression?
* Does zuranolone treat moderate to severe post-stroke depression?
The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days.
Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.

开始日期2025-09-01

申办/合作机构

Duke University

[+1]

NCT07047820

/ RecruitingN/A

Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting

In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities.
This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from CVS Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy.
The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms.
The main question researchers want to answer in this study is:
- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15?
Researchers will also learn more about:
* Changes in participants' EPDS scores from before treatment to Day 45, which is 30 days after treatment ends.
* How many participants breastfeed their babies while taking zuranolone
* How many participants do not start new medicine after finishing their zuranolone treatment
* How many participants take new medicines after finishing zuranolone
* How many participants already tried other medicines for their depression symptoms before joining this study
* How many participants take other medicines in general while taking zuranolone
This study will be done as follows:
People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study.
Those who agree to take part will answer written questions about their symptoms using the EPDS tool. They will also answer other survey questions about their background, environment, and general health information. Participants must take their first dose of zuranolone within 7 days of joining the study.
Participants will then be asked to answer questions using the EPDS tools, 15 days and 45 days after taking the first dose of zuranolone.

开始日期2025-06-30

申办/合作机构

Biogen, Inc.

NCT05655507

/ Completed临床1期

A Phase 1, Study to Evaluate the Pharmacokinetics and Safety of Zuranolone in Adolescents (12 to 17 Years of Age) With Major Depressive Disorder

The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.

开始日期2023-04-19

申办/合作机构

Biogen, Inc.

100 项与祖拉诺龙相关的临床结果

登录后查看更多信息

100 项与祖拉诺龙相关的转化医学

登录后查看更多信息

100 项与祖拉诺龙相关的专利（医药）

登录后查看更多信息

137

项与祖拉诺龙相关的文献（医药）

2026-01-01·JOURNAL OF AFFECTIVE DISORDERS

Modeling the efficacy of a novel antidepressant zuranolone for major depressive disorder

Article

作者: Qian, Yudie ; Liu, Jianmin ; Lin, Weiwei ; Chen, Rui ; Hong, Limian

This research aimed to quantify the treatment potential of zuranolone-a novel positive allosteric GABA_A receptor modulator-in adults with major depressive disorder (MDD). Publicly available databases were systematically searched to identify randomized, placebo-controlled trials. We used changes in rating scale scores from baseline to perform a model-based meta-analysis, characterizing the progression of drug efficacy and placebo response over time and comparing zuranolone's efficacy and safety profiles with those of established antidepressants (escitalopram and amitriptyline). Pharmacokinetic modeling and meta-analysis frameworks were applied to assess efficacy and placebo response characteristics. A total of 37 trials (N = 8735 individuals) were incorporated in the final analysis. Zuranolone exhibited a rapid onset of action (k = 0.75 day^-1), 10-fold and 27.8-fold faster than amitriptyline (k = 0.075 day^-1) and escitalopram (k = 0.027 day^-1), respectively. Amitriptyline exhibited the highest pure efficacy, continuously increasing over time. The 95 % confidence intervals (CIs) of zuranolone and escitalopram overlapped, suggesting similar efficacy. Zuranolone achieved significant symptom improvement within two weeks of treatment (-6.64 %, 95 % CI: -9.77 % to -3.39 %) and sustained efficacy through four weeks post-treatment. The dropout rate was lower with zuranolone (2.4 %, 95 % CI: 1.5 to 3.3 %) than with escitalopram (4.5 %, 95 % CI: 3.0 to 5.9 %). Primary adverse events related to zuranolone included somnolence, headache, dizziness, and sedation, with no severe safety signals observed. Zuranolone demonstrates a safety profile comparable to escitalopram as well as rapid-onset antidepressant action, sustained clinical efficacy, and favorable tolerability, highlighting its potential as a promising therapeutic option for MDD.

2025-10-01·Archives of Womens Mental Health

#Zuranolone: How TikTokers Perceive the First Available Oral Medication for Postpartum Depression

Article

作者: Idoko, Joseph ; Chavez, Martin R ; Jacobsohn, Tamar ; Rekawek, Patricia ; Kinzler, Wendy L ; Drohan, Lilly

2025-09-01·PSYCHOPHARMACOLOGY

Comment on the study “the efficacy and safety of zuranolone for treatment of depression: a systematic review and meta-analysis”

Letter

作者: Umer, Mohammad ; Naveed, Aiman ; Zaheer, Zaofasha

389

项与祖拉诺龙相关的新闻（医药）

2025-09-17

·investors.biogen.com

Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe

Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11 The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPD The EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared to placebo CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum depression (PPD) in adults following childbirth. ZURZUVAE is a once-daily, oral, 14-day treatment which represents a novel therapeutic approach, offering the first and only treatment indicated for PPD in the E.U. “This approval is a major milestone in addressing a critical unmet need in maternal health for women in Europe, where postpartum depression is underdiagnosed and undertreated,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “ZURZUVAE is a 14-day treatment course which can improve the symptoms of PPD as early as day 3. This is a significant step forward from the current standards of care and our team is committed to engaging with the medical community and local authorities as we work to secure access for eligible European patients.” PPD is one of the most common medical conditions associated with pregnancy.3-5 Symptoms of PPD may include depressed mood, anxiety, affected ability to bond with the newborn, functional impairment of daily activities, feelings of guilt and worthlessness, doubts about motherhood, and thoughts of self- or infant harm.3 Left untreated, PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidities and repercussions on child development.1, 12, 13 In Europe, up to 20% of women with a recent pregnancy experience symptoms of PPD.6-11 Because clinical guidelines for screening and management of depression during and after pregnancy vary across European countries, many cases may go undiagnosed and untreated.5 Death by suicide during the perinatal period is a leading cause of maternal mortality in Europe.1-2 The EC’s approval of ZURZUVAE is based on the SKYLARK study that evaluated ZURZUVAE which met its primary end point, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17), a common measure of depression severity, at day 15 as compared to placebo. All key secondary endpoints were also met, with significant reduction in depressive symptoms being seen as early as day 3 and sustained through day 45 compared to placebo. ZURZUVAE was generally well-tolerated. The most frequently reported side effects ≥ 5% and greater than placebo in patients treated with ZURZUVAE 50 mg were somnolence, dizziness, and sedation. For detailed product information, please see the Summary of Product Characteristics on the European Medicines Agency website at www.ema.europa.eu. The U.S. Food and Drug Administration (FDA) approved ZURZUVAE in August 2023 and the Drug Enforcement Agency (DEA) scheduled it as a Class IV controlled substance in October 2023. In August 2025, ZURZUVAE received regulatory approval in the U.K. by the Medicines and Healthcare products Regulatory Agency (MHRA). About ZURZUVAE® (zuranolone)ZURZUVAE® is a once-daily, oral, 14-day medicine for treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the central nervous system and contributes to regulating brain function. ZURZUVAE was discovered by Sage Therapeutics, Inc., and in 2020 Biogen and Sage Therapeutics entered into a collaboration to jointly develop and commercialize ZURZUVAE in the U.S. As part of the agreement, Biogen received exclusive rights to develop and commercialize ZURZUVAE outside of the U.S., excluding Japan, Taiwan and South Korea. In July 2025, Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) completed its acquisition of Sage Therapeutics and is now the collaboration partner with whom Biogen is working in the U.S. About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including, among others, relating to: the potential benefits, efficacy and safety of zuranolone (marketed as ZURZUVAE); our commitment to work to secure access for eligible patients in order to improve outcomes for, and address unmet needs of, patients with postpartum depression; the anticipated benefits, risks and potential of our collaboration arrangements; the potential of our commercial business and pipeline programs, including ZURZUVAE; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References:

上市批准并购引进/卖出临床研究临床结果

2025-09-04

·生物制品圈

抗抑郁赛道，前赴后继

▲多重福利来袭，点击即可预约 2022年8月，60多年来全球首个采用新机制的抗抑郁口服药Auvelity （氢溴酸右美沙芬和盐酸安非他酮复方缓释片）在美国获批上市，打破了抗抑郁老药市场格局。 2023年8月，首个也是唯一一个用于成人产后抑郁症（PPD）口服治疗药物Zurzuvae（Zuranolone）在美国获批上市，拓宽了抑郁症治疗患者人群。 2025年1月，强生宣布以总交易额约为146亿美元收购Intra-Cellular Therapies，该公司核心产品为5-羟色胺2A（5-HT2A）受体拮抗剂和多巴胺受体D2调节剂Caplyta（卢美哌隆，Lumateperone），Caplyta已获FDA批准用于治疗成人精神分裂症，以及与双相I型或II型障碍相关的抑郁发作。 2025年8月，艾伯维以高达12亿美元的价格收购Gilgamesh Pharmaceuticals旗下的抗抑郁药物bretisilocin，该药物目前处于临床2期。这些新机制药物获批和重磅交易显示了制药行业对抑郁症治疗领域的重视和投入，也反映了市场对新型、更有效抑郁症药物的迫切需求。 01 抑郁症流行病学抑郁症是一种常见的精神障碍，主要表现为情绪低落、兴趣减退、思维迟缓和身体不适等症状。它不仅影响患者的生活质量，还可能对工作、学习和社交功能产生负面影响。根据2021年全球疾病负担研究，全球抑郁症发病数为3.5744亿例，患病数为3.3241亿例，伤残调整生命年（DALYs）为5633万。抑郁症在全球范围内都是一个重大的公共卫生挑战，其发病率、患病率和DALYs的年龄标准化率虽有下降趋势，但绝对病例数和年龄标准化率仍在增加[1]。重度抑郁症是美国最常见的精神障碍之一。对于某些人来说，重度抑郁症会导致严重的损伤，干扰或限制一个人进行主要生活活动的能力。 2021年，美国估计有2100万成人至少经历过一次重度抑郁发作，占所有美国成人的8.3%。其中，女性的发病率为10.3%，高于男性的6.2%，18-25岁年龄段的发病率为18.6%，是所有年龄段中最高的，在有多种（两个或以上）种族身份的人群中，重度抑郁发作的发病率最高，为13.9%（图1）[2]。图1. 2021年美国18岁或以上成年人过去一年重度抑郁发作的患病率据估计，美国有500万12至17岁的青少年至少有一次重度抑郁发作。这一数字占美国12至17岁人口的20.1%。与男性（11.5%）相比，青春期女性（29.2%）的重度抑郁发作患病率更高。重度抑郁发作的患病率在两个或两个以上种族的青少年中最高（27.2%）。图2. 2021 年美国青少年重度抑郁发作的过去一年患病率根据中国精神卫生调查（CMHS）的数据，中国抑郁症的终生患病率为6.8%，12个月患病率为3.6%。这意味着超过9500万中国人一生中曾患过抑郁症。女性抑郁症的终生患病率为8.0%，显著高于男性的5.7%[3]。 02 抑郁症发病机制到目前为止，抑郁症的发病机制吸引了世界各地越来越多的研究人员进行探索，但确切的发病机制仍不清楚。受体假说已被用于从多个角度阐明抑郁症的发病机制[1]。除了众所周知的受体，如NMDA受体、AMPA受体、糖皮质激素受体、5-HT受体、GABA受体和DA受体外，“非经典”受体，如代谢型谷氨酸受体、阿片受体和胰岛素受体，对抑郁症的发病机制也很重要（图1）。此外，大量研究表明，抑郁症的发生和发展与遗传基础密切相关，遗传基础占抑郁症风险的近 40-50%，导致抑郁症成为一种高度遗传的疾病，并受到更广泛的关注。由于抑郁症（MDD）的发病机制复杂，准确的诊断方法和药物治疗策略相对有限。为了解释抑郁症的发病机制，提出了几种假说，包括：（i）下丘脑-垂体-肾上腺（HPA）轴功能障碍假说，（ii）单胺假说，（iii）炎症假说，（iv）遗传和表观遗传异常假说，（v）大脑结构和功能重塑假说，以及（vi）社会心理假说（图3）[4]。图3. 抑郁症发病机制 HPA轴功能障碍假说认为，抑郁症的发生与HPA轴的过度激活和负反馈机制受损密切相关。这种功能障碍导致GC水平异常升高，进而影响神经递质和神经营养因子的活性，最终导致抑郁症的发生。单胺假说是解释抑郁症发病机制的经典理论之一,单胺假说认为，抑郁症的发生与大脑中单胺类神经递质的缺乏有关，主要包括5-羟色胺（5-HT，血清素）去甲肾上腺素（NE）、多巴胺（DA）等神经递质。许多抗抑郁药物的作用机制都是通过增加大脑中单胺类神经递质的水平来发挥作用。例如，选择性5-羟色胺再摄取抑制剂（SSRIs）通过抑制5-HT的再摄取，增加突触间隙中5-HT的浓度，从而改善抑郁症状。三环类抗抑郁药（TCAs）则同时抑制5-HT和NE的再摄取。这些药物的疗效支持了单胺假说。然而，没有任何一种假说能够单独充分解释抑郁症（MDD）的病理基础，而这些假说所提出的许多机制相互之间存在交互作用。近年来，在识别抑郁症的新药物疗法、诊断标准以及非药物预防措施方面取得了巨大进展，并启动了相关的临床试验。具体而言，越来越多的证据表明，星形胶质细胞功能障碍在抑郁症中起着重要作用。在实验动物中，通过药物消融内侧前额叶皮质（mPFC）中的星形胶质细胞会导致抑郁样症状，而且对抑郁症患者的尸检研究显示，其前额叶皮质（PFC）、海马和杏仁核中胶质细胞的密度降低。 03 获批的抑郁症药物全球已有多款药物上市，不过目前世界各地抗抑郁症治疗相关指南中推荐的药物治疗方案一致性差，美国常用的12种抗抑郁药包括了选择性5-羟色胺再摄取抑制剂（SSRIs）、5-羟色胺和去甲肾上腺素再摄取抑制剂（SNRIs）以及非典型抗抑郁药。这些药物分别是：舍曲林（左洛复）、艾司西酞普兰（来士普）、曲唑酮、氟西汀（百忧解）、安非他酮（安非他酮）、度洛西汀（欣百达）、喹硫平（思瑞康）、西酞普兰（喜普妙）、文拉法辛（怡诺思）、阿立哌唑（安律凡）、帕罗西汀（帕罗西汀）和米氮平（瑞美隆）。这些药物常被用于治疗重度抑郁症及相关疾病，因为它们疗效显著且副作用各有不同，使临床医生能够根据患者个体需求调整治疗方案[5]。全球常用的抗抑郁症药物有灵北的艾司西酞普兰、辉瑞的舍曲林、艾伯维的氟伏沙明、GSK的帕罗西汀、礼来的度洛西汀和惠氏的文拉法辛等。近几年，也有一些新颖机制的抗抑郁药物获批上市。 2019年3月，艾司氯胺酮鼻喷雾剂首次获得美国FDA批准，用于治疗难治性抑郁症（TRD），需与口服抗抑郁药联合使用。艾司氯胺酮（Esketamine）是氯胺酮的右旋异构体，具有更高的效价，通过阻断NMDA受体，增加谷氨酸的释放，激活AMPA受体，促进神经营养因子（如BDNF）的产生，从而增强突触可塑性和神经再生（图4）[6]。图4. 艾司氯胺酮作用机制艾司氯胺酮的SUSTAIN-3试验结果显示：在诱导治疗期间，蒙哥马利-阿斯伯格抑郁量表（MADRS）总分有所下降，且这种下降在优化/维持治疗期间得以维持（各阶段基线至阶段终点的平均[标准差]变化：诱导期：-12.8[9.73]；优化/维持期：+0.2[9.93]）。在诱导治疗终点时，有35.6%的参与者达到缓解；在第112周和优化/维持治疗终点时，分别有48.5%和49.6%的参与者达到缓解（图5）[7]。图5. 艾司氯胺酮的SUSTAIN-3试验结果 2023年4月20日，中国国家药品监督管理局正式批准了强生公司生产的盐酸艾司氯胺酮鼻喷雾剂（商品名：速开朗）在中国上市。这是中国首个获批的具有全新作用机制和给药方式的抗抑郁药物，主要用于与口服抗抑郁药联合使用，能够快速缓解伴有急性自杀意念或行为的成人抑郁症患者的抑郁症状。 2025年1月21日，强生宣布FDA批准了SPRAVATO®（Esketamine）CIII 鼻喷雾剂的补充新药申请（sNDA），使这种创新疗法成为第一个也是唯一一个针对对至少两种口服抗抑郁药反应不足的重度抑郁症（MDD）成年人的单一疗法。 2022年8月，美国生物医药公司Axsome Therapeutics的抗抑郁口服药Auvelity获得美国FDA批准，用于治疗成年人抑郁症（MDD），成为60多年来全球首个采用新机制的抗抑郁口服药，在拥挤的抗抑郁老药市场中开辟了一个新市场。 Auvelity是一种固定剂量的复方缓释片，主要成分包括氢溴酸右美沙芬（45mg）和盐酸安非他酮（105mg），右美沙芬作为NMDA受体拮抗剂和σ-1受体激动剂，调节谷氨酸能神经传递，具有抗惊厥和神经保护作用，还能阻断血清素和多巴胺的再摄取；安非他酮抑制CYP2D6酶，延长右美沙芬的半衰期，从而增强其效果（图6）。图6. Auvelity作用机制临床试验数据显示，Auvelity治疗成人MDD患者起效迅速，治疗1周即可显著改善抑郁症状。治疗2周后，临床治愈率较安慰剂有显著提高，且持续至治疗结束。安全性结果显示Auvelity耐受性良好（图7）。图7. Auvelity的疗效 2023年8月4日，渤健和Sage Therapeutics公司共同开发的神经活性类固醇γ-氨基丁酸A型（GABAA）受体阳性别构调节剂Zurzuvae（Zuranolone）获FDA批准，成为首个也是唯一一个用于成人产后抑郁症（PPD）口服治疗药物。2025年7月24日，欧洲药品管理局（EMA）的人用药品委员会（CHMP）也推荐授予Zurzuvae上市许可。 Zurzuvae的一项临床试验（NCT04442503）研究发现，每天服用 Zurzuvae 50 mg，持续2周的女性在第15天的抑郁症状显着减轻。与安慰剂评分相比，Zurzuvae 50mg的17项汉密尔顿抑郁量表（HAMD-17）降低了-15.6（HAMD-17），安慰剂评分降低了-11.6，差异为-4.0，抑郁症状从第 3天开始改善，一直持续到第42天（图8）[8]。图8. Zurzuvae的疗效 04 在研的新机制抗抑郁药物除此之外，还有很多在研的新机制抗抑郁药物，如Osavampator、Seltorexant、GH-001、NBI-1070770和JJH201501等（图9）。图9. 部分获批和在研的抗抑郁症药物代表性药物 1.Osavampator Osavampator（NBI-1065845或者TAK-653）最初是由武田制药研发的一种AMPA受体正变构调节剂（PAM）。2020年，Neurocrine Biosciences获得了osavampator及其他六个神经精神疾病项目的独家授权，支付了1.2亿美元的首付款。根据最初的协议，武田制药有资格获得高达4.95亿美元的开发里程碑付款、高达14亿美元的商业里程碑付款，以及最高达到两位数比例的净销售额分成。2025年1月27日，武田重新谈判了这笔交易，重新获得osavampator在日本的独家权益（图10）[9]。图10. Osavampator的结构临床前研究显示：Osavampator在大鼠强迫游泳行为模型（RSBM）中，经过6天的给药后，产生了显著的抗抑郁样效应。然而，与氯胺酮不同的是，TAK-653并未在大鼠中诱导出过度运动行为，而这种行为是与人类精神分裂样副作用相关的行为指标。因此，TAK-653可能是一种具有改善安全性潜力的药物，可用于治疗包括难治性抑郁症（TRD）在内的重度抑郁症（图11）[10]。图11. Osavampator临床前研究结果 2024年4月，Neurocrine公布了osavampator在成年MDD受试者中的2期SAVITRI™研究的积极顶线数据：接受osavampator治疗的患者在第28天（主要终点）和第56天（次要终点）的蒙哥马利-阿斯伯格抑郁评分量表（MADRS）总分上均显示出统计学上显著的改善（图12）。图12. Osavampator的临床结果今年1月28日，Neurocrine宣布启动一项3期注册研究，以评估 osavampator的疗效、安全性和耐受性，用于重度抑郁症（MDD）抗抑郁药的辅助治疗[11]。 2.Seltorexant Seltorexant 是强生公司旗下杨森制药开发的一种选择性食欲素-2受体（OX2R）拮抗剂，旨在治疗伴有失眠症状的重度抑郁症（MDD）和阿尔茨海默病等神经科学领域疾病。目前强生已终止seltorexant治疗阿尔茨海默病的临床研究，但是seltorexant在治疗伴有失眠症状的重度抑郁症显示积极效果，仍在进行中。 2024年，Mesens等人在《Molecular Psychiatry》杂志上报道了Seltorexant的一项临床1b期试验（NCT03374475）结果：共有128名参与者入组，包括86名富集样本（安慰剂导入期无反应者）（图13）[12]。在第5周时，汉密尔顿抑郁量表17项（HDRS17）评分从基线的平均变化（标准差）在各组之间存在显著差异：Seltorexant 20mg组为-7.0（5.04），Seltorexant 40mg组为-5.5（4.34），安慰剂组为-4.4（3.67）（p=0.0456），这一差异归因于20mg组与安慰剂组之间的差异（p=0.0049）。在基线失眠症状较严重的患者中，Seltorexant 20mg在第5周时对抑郁严重程度的改善更为显著（名义p=0.0059）。当通过去除睡眠项目来调整HDRS评分时，20mg组的治疗益处仍然显著（名义p=0.0289）。与安慰剂组相比，20mg组的HDRS17评分变化在数值上大于40mg组，这与之前的研究数据一致，在之前的研究中，Seltorexant是作为传统抗抑郁药物的辅助药物给药的。在次要分析中，20mg组的皮质醇觉醒反应有所下降，而40mg组或安慰剂组则没有这种变化；尽管40mg组的总睡眠时间增加更多，但该组也显示出快速眼动睡眠潜伏期缩短和N1期睡眠增加，而在20mg组中则没有这种现象。这些生物标志物数据提出了可能解释Seltorexant表观曲线剂量反应关系的机制假设。图13. Seltorexant的临床1b期试验结果 2024年5月，强生宣布seltorexant在一项针对伴有失眠症状的重度抑郁症患者的III期临床试验（MDD3001）中达到了所有主要和次要终点。该研究显示，seltorexant在改善抑郁症状和减少睡眠障碍方面具有统计学意义和临床意义（图14）[13]。图14. Seltorexant的临床3期试验结果 3.GH001 GH001是由GH Research PLC开发的一种用于治疗难治性抑郁症（TRD）的药物。其主要成分是美布福汀（mefenamic acid，5-MeO-DMT），通过专有的吸入方式给药。GH001的开发旨在通过激活5-羟色胺2A受体（5-HT2A）来产生抗抑郁效果（图15）。图15. GH001临床试验进展 2025年2月，GH Research宣布GH001的一项用于难治性抑郁症（TRD）患者的随机、双盲、安慰剂对照2b期临床试验（GH001-TRD-201）达到了主要终点：GH001在第8天使蒙哥马利-阿斯伯格抑郁量表（MADRS）总分从基线显著降低15.2分，而安慰剂组增加了0.3分（差异为-15.5分，p<0.0001）。试验中的所有次要终点均达到，结果与主要终点一致。与安慰剂相比，GH001治疗在第8天使临床医生总体印象严重程度量表（CGI-S）和汉密尔顿焦虑量表（HAM-A）的评分以及生活质量问卷（Q-LES-Q-SF）的评分均显著改善，具有临床意义和统计学意义[14]。 2025年7月，GH Research宣布向FDA提交了对之前宣布的 GH001 研究性新药申请（IND）临床搁置的完整答复。他们现在已经收到了 FDA 的回复，只剩下一个保留问题。FDA要求他们提供与之前公布的大鼠呼吸道组织学结果相关的额外数据或进一步的理由。他们坚信，基于科学证据，呼吸道组织学结果是大鼠特异性的。没有与狗毒理学相关的其他请求。没有与设备相关的问题。与 FDA 就 IND 完全缓解的接触正在进行中。他们正在积极努力解决剩余的问题。 GH Research计划在2026年启动GH001的全球关键性计划，目前正在进行准备工作，包括成立指导委员会以及选择临床研究组织和研究地点。 4.Bretisilocin Bretisilocin是由生物技术公司Gilgamesh Pharmaceuticals研发的一款5-HT2A受体激动剂和5-HT释放剂，通过作用于5-HT2A受体来发挥疗效，2025年8月，艾伯维公司以12亿美元收购了该药物（图16）。图16. Gilgamesh Pharmaceuticals的研发管线与传统迷幻药物（如LSD和psilocybin）相比，Bretisilocin具有更短的半衰期，仅需约两小时即可完成治疗，且不引发幻觉。 2025年5月27日，Gilgamesh宣布了Bretisilocin的一项针对重度抑郁症患者 2a 期结果：接受两次药物治疗的患者中，94%在一个月后症状得到了显著缓解。在另一项2a期研究中，与低剂量对照组相比，蒙哥马利-奥斯伯格抑郁量表（MADRS）总分改善具有统计学显著性。第14天时，单剂量（10mg）治疗组MADRS总分较基线改变-21.6分，而低剂量（1mg）对照组改变-12.1分（p=0.003）（图17）。图17. Bretisilocin的临床试验结果 5.JJH201501 JJH201501是由吉贝尔利用其氘代药物研发技术平台研发的伏硫西汀衍生物，是一种新型的多受体作用机制的抗抑郁药，通过将伏硫西汀中甲基氢替换成氘来增强药物的稳定性，减缓代谢速度，从而达到增加药效、减少药物不良反应的目的（图18）。图18. JJH201501的研发进展 JJH201501目前已完成了I期、IIa期和IIb期临床研究。2024年5月11日，由吉贝尔药业主办的“JJH201501片Ⅲ期临床研究全国研究者启动会”在北京成功举办。目前，抗抑郁新药JJH201501正在有序开展Ⅲ期临床试验，按目前的计划，预计2025年完成Ⅲ期临床研究并提交上市申请。 6.LY03021 绿叶制药集团是一家致力于创新药物的研发、生产和销售的国际化制药公司。绿叶制药在抗抑郁症药物研发方面取得了显著进展，其核心产品若欣林®（盐酸托鲁地文拉法辛缓释片）是中国首个自主研发并拥有自主知识产权的抗抑郁1类创新药，于2022年12月获批上市（图19）。若欣林通过其独特的三重再摄取抑制作用（SNDRI），全面改善抑郁症状，尤其对快感缺失、阻滞和认知障碍等改善突出，克服了现有药物的缺陷，且不引起失眠和嗜睡，不影响性功能、体重和脂代谢。 2025年8月18日，绿叶制药集团宣布若欣林用于治疗广泛性焦虑障碍的Ⅲ期临床试验已完成患者入组，预计2025年底提交上市申请。该试验为多中心、随机、双盲、安慰剂对照研究，以评估若欣林治疗广泛性焦虑障碍的安全。 LY03021是绿叶制药自主研发的1类创新药，通过靶向NET、DAT和GABAAR三个靶点发挥作用。该产品通过作用于突触内GABAA受体亚型α1β2γ2和突触外GABAA受体亚型α4β3δ，增强GABA对GABAA受体激活，调节脑内谷氨酸-GABA能平衡，抑制下丘脑-垂体-肾上腺（HPA）轴过度激活，快速发挥抗抑郁作用。非临床研究显示，LY03021给药后24小时即显著改善模型动物的抑郁症状，且连续用药至21天疗效稳定，具有快速起效和疗效持久的优势。 2025年8月3日，LY03021在中国开展的I期临床研究已完成首例受试者入组。图19. 绿叶制药CNS管线小结抑郁症是一种常见的心理健康障碍，对患者的身心健康和社会功能等多方面造成严重危害，传统抗抑郁症药物在治疗抑郁症方面具有重要作用，但存在起效缓慢、副作用多、治疗反应差异大等缺点。这些缺点可能影响患者的治疗依从性和康复进程，因此仍需新颖机制的抗抑郁症药物。随着抑郁症发病机制研究的深入，越来越多新颖机制的抗抑郁药物被开发，有望给患者更多的选择。主要参考文献 1.Jian Rong et.al, Global, regional and national burden of depressive disorders and attributable risk factors, from 1990 to 2021: results from the 2021 Global Burden of Disease study, The British Journal of Psychiatry, First View, pp. 1 – 10 2.https://www.nimh.nih.gov/health/statistics/major-depression 3.Prof Yueqin Huang, Prof Yu Wang, Prof Hong Wang, et al. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. Feb 2019. 4.Lulu Cui et.al, Major depressive disorder: hypothesis, mechanism, prevention and treatment, Signal Transduction and Targeted Therapy (2024) 9:30 5.MedicineNet：What Are the Top 5 Antidepressants? 6.Piotr Kawczak, Igor Feszak et.al, Ketamine, Esketamine, and Arketamine: Their Mechanisms of Action and Applications in the Treatment of Depression and Alleviation of Depressive Symptoms 7.Naim Zaki, MD et.al, Safety and efficacy with esketamine in treatment resistant depression: long-term extension study, International Journal of Neuropsychopharmacology, 2025, pyaf027 8.https://www.drugs.com/zurzuvae.html 9.Atsushi Suzuki et.al, Strictly regulated agonistdependent activation of AMPAR is the key characteristic of TAK653 for robust synaptic responses and cognitive improvement, Scientific Reports (2021) 11:14532 10.Hiroe Hara et.al, TAK-653, an AMPA receptor potentiator with minimal agonistic activity, produces an antidepressant-like effect with a favorable safety profile in rats, Pharmacology Biochemistry and Behavior Volume 211, December 2021, 173289 11.Neurocrine Biosciences Announces Initiation of Phase 3 Registrational Program for Osavampator as an Adjunctive Therapy for the Treatment of Major Depressive Disorder in Adults 12.Sofie Mesens et.al, Treatment effect and safety of seltorexant as monotherapy for patients with major depressive disorder: a randomized, placebo-controlled clinical trial, Molecular Psychiatry (2025) 30:2427–2435 13.Seltorexant, adjunctive to antidepressants, in adults with MDD with insomnia symptoms: results of a double-blind, randomized, placebo-controlled study 14.GH Research Announces Primary Endpoint Met in Phase 2b Trial with GH001 in TRD Demonstrating -15.5 Point Placebo-adjusted MADRS Reduction 15.Gilgamesh Pharmaceuticals Announces Positive Topline Phase 2a Results for GM-2505 in Major Depressive Disorder (MDD) 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

并购临床2期上市批准

2025-08-20

·渤健生物

2025年度“医药界诺贝尔奖-盖伦奖”提名揭晓，渤健四款产品入围！

2025年8月11日，美国盖伦基金会（The Galien Foundation）公布2025年度盖伦奖（Prix Galien USA Awards）候选名单。渤健旗下四款创新产品，Qalsody™（凯盛迪™）、Leqembi®（乐意保®）、Skyclarys®及Zurzuvae®入围。盖伦奖被誉为“医药界的诺贝尔奖”，是医药和生物医疗行业的最高荣誉，旨在表彰为改善人类健康做出的杰出科学创新1。盖伦奖的候选药品均为在近5年内获得美国食品药品监督管理局（FDA）批准上市的，并且展现出对改善人类健康产生重大影响的产品。 Qalsody（中文名：凯盛迪™）是全球首款获批上市，用于治疗携带超氧化物歧化酶1（SOD1）基因突变的肌萎缩侧索硬化（ALS）成人患者的疾病修正治疗药物2,3。该产品已于2025年6月在中国商业上市4。 ALS是一种进行性神经退行性疾病，患者大脑和脊髓的上下运动神经元受累，导致肌肉无力、萎缩，最终因吞咽困难、呼吸无力而死亡，患者确诊后的平均寿命为3-5年。ALS的发病原因尚未完全明确，目前已知有多个致病基因被证实与ALS的发病有关。其中，SOD1是首个被发现的ALS致病基因，也是中国ALS人群中最常见的致病基因。SOD1-ALS患者的平均发病年龄约为50岁，患者多为脊髓起病，主要特点为下肢起病，典型表现为上下神经元同时受损5。由于疾病进程不可逆，因此“早发现、早诊断、早治疗”对于延缓疾病进展，维持生活质量至关重要。 Leqembi（中文名：乐意保®）是由渤健和卫材共同开发的，20年来首款被FDA完全批准用于治疗阿尔茨海默病（AD）的疾病修正治疗药物6。该产品已于2024年在中国商业上市7。FDA曾授予其加速审评资格及突破性疗法认定。阿尔茨海默病（AD）是老年人中最常见的神经退行性疾病8，已经成为日益严重的健康危机。全球现存5,000万痴呆患者，其中60-70%是AD源性的痴呆患者9。目前，我国阿尔茨海默病的早期就诊率为28.6%，轻度认知障碍就诊率仅为2.8%。大多数患者确诊时已经是疾病的中晚期，错失了获得早期诊疗的机会。早发现、早诊断、早治疗是最迫切也是最可行的第一步10。 Zurzuvae是FDA批准的，首个用于治疗产后抑郁症（PPD）成人患者的口服疗法11。在此之前，FDA批准的PPD治疗方式仅为静脉注射12。 PPD是一种常见的在女性分娩后出现的精神疾病，其症状可能包括情绪低落、兴趣和愉悦感丧失、睡眠和食欲问题、注意力难以集中、精神运动迟缓或激进、持续的疲劳感、强烈的内疚感以及自我价值感缺失。在极端情况下，患有PDD的产妇甚至可能产生导致自杀的念头或行为13。 *该药品尚未在中国大陆获批上市。 Skyclarys是首款获得FDA批准的，用于治疗16岁以上弗里德赖希共济失调症（Friedreich’sAtaxia，FA）患者的药物14。Skyclarys在2017年6月获得孤儿药认定，并在2021年11月被FDA授予快速通道资格。 FA是一种遗传性的、并会寿命缩短的神经肌肉疾病。大多数患者在青少年时期确诊。患者会出现下肢反射消失，构音障碍，视觉和听觉障碍等症状，并可能在确诊后的10到20年内失去行走能力，平均预期寿命为37岁15。 *该药品尚未在中国大陆获批上市。 Reference： 1. 盖伦奖百度百科：https://baike.baidu.com/item/%E7%9B%96%E4%BC%A6%E5%A5%96/20276181?fr=ge_ala 2. Ionis announced FDA advisory committee voted unanimously for a potential accelerated approval of tofersen for SOD1-ALS. Retrieved April 25, 2023, from https://ir.ionispharma.com/news-releases/news-release-details/ionis-accounces-fda-advisory-committee-voted-unanimously 3. 托夫生注射液说明书（NMPA批准版本：2024-09-26）[EB/OL]. https://www.biogen.cn/content/dam/corporate/apac/china/zh-cn/disease-areas/als/%E6%89%98%E5%A4%AB%E7%94%9F%E6%B3%A8%E5%B0%84%E6%B6%B2%E8%AF%B4%E6%98%8E%E4%B9%A6_202409.pdf 4. 新华网：《渐冻症精准治疗药物凯盛迪在中国商业上市开启渐冻症“对因治疗”新纪元》https://app.xinhuanet.com/news/article.html?articleId=f1ca049e083c14c989648171694c4099×tamp=1205 5. 王诗婵，商慧芳. 肌萎缩侧索硬化基因型和表型研究进展. Chin J Nerv Ment Dis. 2023:49(5):296-304 6. 湖南日报：《20年来首款获得FDA完全批准的阿尔茨海默病新药上市》https://baijiahao.baidu.com/s?id=1770724150205951078&wfr=spider&for=pc 7. 新浪财经：《中国紧随美国和日本之后，成为第三个"乐意保"上市国家》https://cj.sina.com.cn/articles/view/7243395680/1afbd726002001fzu2 8. https://www.niehs.nih.gov/research/supported/health/neurodegenerative 9. 丁香园：《历时五年余，华山医院郁金泰教授牵头制定阿尔茨海默病循证预防国际指南》 https://neuro.dxy.cn/article/718681 10. 中国新闻网：《专家呼吁：多方聚力共促阿尔茨海默病早诊早治》http://m.chinanews.com/wap/detail/zw/jk/2025/03-31/10392193.shtml 11. FDA Approves First Oral Treatment for Postpartum Depression. Retrieved August 4, 2023 from https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression 12. 中国医药创新促进会：《重磅！口服抗产后抑郁疗法获FDA批准上市》 https://www.phirda.com/artilce_32390.html?module=trackingCodeGenerator 13. 王雅倩，马占强. 产后抑郁症的病理机制与治疗药物. Pharmacy Information 药物资讯, 2025, 14(2), 97-105 14. Reata Pharmaceuticals Announces FDA Approval of SKYCLARYS™ (Omavaloxolone), the First and Only Drug Indicated for Patients with Friedreich’s Ataxia. Retrieved February 28, 2023, from https://www.businesswire.com/news/home/20230228006450/en/Reata-Pharmaceuticals-Announces-FDA-Approval-of-SKYCLARYS%E2%84%A2-Omavaloxolone-the-First-and-Only-Drug-Indicated-for-Patients-with-Friedreich%E2%80%99s-Ataxia 15. Corben LA, et al., Clinical Management Guidelines Writing Group. Clinical management guidelines for Friedreich ataxia: best practice in rare diseases. Orphanet J Rare Dis. 2022;17(1):415. Biogen-270863-CHN-08/2025

突破性疗法上市批准加速审批

100 项与祖拉诺龙相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11793	祖拉诺龙	-	DB15490

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
产后抑郁症	美国	SAGE Therapeutics, Inc.	2023-08-04
产后抑郁症	美国	Biogen, Inc.	2023-08-04

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
抑郁症	申请上市	加拿大	Biogen, Inc.	2024-12-01
重度抑郁症	申请上市	美国	SAGE Therapeutics, Inc.	-
入睡和睡眠障碍	临床3期	美国	Biogen, Inc.	2019-02-04
躁郁症1型	临床2期	美国	Biogen, Inc.	2018-08-23
躁郁症1型	临床2期	美国	SAGE Therapeutics, Inc.	2018-08-23
躁郁症2型	临床2期	美国	Biogen, Inc.	2018-08-23
躁郁症2型	临床2期	美国	SAGE Therapeutics, Inc.	2018-08-23
特发性震颤	临床2期	美国	Biogen, Inc.	2017-03-24
帕金森病	临床2期	美国	Biogen, Inc.	2016-11-30
癫痫发作	临床1期	美国	SAGE Therapeutics, Inc.	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03864614 (SHORELINE Study, Pubmed \| J Clin Psychiatry)	临床3期	重度抑郁症	-	Zuranolone 30mg	繭鬱獵艱積襯醖簾膚夢(製構膚蓋鏇範淵築艱積) = Of patients who experienced TEAEs, most reported mild or moderately severe events, and responders to zuranolone experienced improvements in depressive symptoms with initial and repeat treatment courses 鹹願膚獵選淵蓋醖蓋艱 (艱鏇顧憲構蓋鑰繭憲廠 )	积极	2023-12-27
				Zuranolone 50mg
NCT04442490 (CTgov)	临床3期	重度抑郁症	543	Placebo (Placebo)	窪範淵餘繭繭鬱遞鑰艱(窪糧鹽鑰遞醖製繭鏇鑰) = 襯繭齋鑰繭製築鬱餘簾選願築繭憲襯積網鏇顧 (襯憲願獵壓觸簾衊齋夢, 0.50) 更多	-	2023-12-05
				SAGE-217 (SAGE-217 50 mg)	窪範淵餘繭繭鬱遞鑰艱(窪糧鹽鑰遞醖製繭鏇鑰) = 願鏇膚艱淵網齋襯獵簾選願築繭憲襯積網鏇顧 (襯憲願獵壓觸簾衊齋夢, 0.51) 更多
NCT04476030 (CTgov)	临床3期	重度抑郁症	440	Escitalopram+Matching Placebo+Desvenlafaxine+sertraline+Duloxetine+Citalopram (Placebo + Assigned ADT)	構艱窪鏇顧簾餘製製夢(鹹醖選艱鹽願憲艱艱鹹) = 範築繭衊廠廠淵範壓網觸蓋網築鹹選簾鹽窪願 (糧窪鹽網膚鏇網糧齋範, 0.38) 更多	-	2023-11-07
				Escitalopram+Desvenlafaxine+sertraline+Duloxetine+SAGE-217+Citalopram (SAGE-217 + Assigned ADT)	構艱窪鏇顧簾餘製製夢(鹹醖選艱鹽願憲艱艱鹹) = 製鹽鹽鑰蓋鹹鏇齋構顧觸蓋網築鹹選簾鹽窪願 (糧窪鹽網膚鏇網糧齋範, 0.39) 更多
NCT04442503 (Pubmed \| Am J Psychiatry)	临床3期	产后抑郁症	196	Zuranolone 50 mg/day	齋鬱壓鑰壓襯醖廠衊構(齋願鏇襯築積齋築窪蓋) = 範鹽鏇蓋鑰襯窪範淵鹽淵積淵鹽糧製壓遞製製 (簾蓋糧醖構網壓構夢築 )	积极	2023-09-01
				Placebo	齋鬱壓鑰壓襯醖廠衊構(齋願鏇襯築積齋築窪蓋) = 顧範網選鏇築繭憲廠鏇淵積淵鹽糧製壓遞製製 (簾蓋糧醖構網壓構夢築 )
NCT04442503 \| NCT02978326 (FDA) 人工标引	临床3期	产后抑郁症	345	ZURZUVAE 50 mg (Study 1)	淵鑰範艱艱鏇製廠淵膚(餘繭淵願壓衊製觸鹽醖) = 網蓋構窪鬱憲廠築窪淵壓鹽廠願網願艱艱構願 (積壓餘鏇鏇鬱衊築壓窪, 0.82)	积极	2023-08-04
				Placebo (Study 1)	淵鑰範艱艱鏇製廠淵膚(餘繭淵願壓衊製觸鹽醖) = 窪鑰選網繭窪願築觸觸壓鹽廠願網願艱艱構願 (積壓餘鏇鏇鬱衊築壓窪, 0.82)
NCT04442503 (CTgov)	临床3期	产后抑郁症	200	Placebo (Placebo)	鹹鬱築製夢鏇構構齋簾(築獵簾夢鹹窪網範獵鹹) = 鹹衊壓鹹淵壓繭糧構淵衊鹽築網廠餘鹽壓壓鏇 (衊蓋鬱蓋鏇構齋網簾積, 2.34) 更多	-	2023-06-22
				SAGE-217 (SAGE-217 50 mg)	鹹鬱築製夢鏇構構齋簾(築獵簾夢鹹窪網範獵鹹) = 憲餘醖衊艱顧夢顧鹽製衊鹽築網廠餘鹽壓壓鏇 (衊蓋鬱蓋鏇構齋網簾積, 2.49) 更多
NCT03771664 (CTgov)	临床3期	入睡和睡眠障碍 \| 重度抑郁症	87	Placebo (Placebo)	構鬱餘範顧糧鹹簾鑰膚(襯鹹鹹夢蓋齋壓蓋淵廠) = 構鏇餘觸選築襯鹹遞顧夢鑰構製顧蓋壓構鏇範 (鏇鏇鏇淵簾鹹夢餘鏇鹽, 14.9367) 更多	-	2022-10-20
				SAGE-217 (SAGE-217)	構鬱餘範顧糧鹹簾鑰膚(襯鹹鹹夢蓋齋壓蓋淵廠) = 憲蓋遞膚觸願鑰衊淵衊夢鑰構製顧蓋壓構鏇範 (鏇鏇鏇淵簾鹹夢餘鏇鹽, 9.8100) 更多
NCT04007367 (CTgov)	临床3期	重度抑郁症	53	Placebo (Double-Blind Phase: Placebo)	窪願鏇襯積齋簾襯觸獵(鑰網選選繭淵鏇選鏇襯) = 鬱壓壓築積廠夢蓋廠憲構鹽範製築醖鹹築憲選 (鑰淵積衊廠選蓋壓夢糧, 顧醖糧繭觸製範顧襯鬱 ~ 鬱廠齋齋廠餘選願窪觸) 更多	-	2022-10-03
				SAGE-217 (Double-Blind Phase: SAGE-217)	壓窪淵艱簾艱襯觸網淵 = 構齋艱蓋鬱鬱鏇遞鹽積簾鏇觸憲鏇繭鹹鏇艱壓 (顧齋遞糧齋廠餘夢醖窪, 襯製網鹹顧範齋蓋鹽簾 ~ 簾製衊獵顧構憲夢衊壓) 更多
NCT03864614 (SHORELINE, Corporate Publications) 人工标引	临床3期	重度抑郁症	924	Zuranolone (30mg cohort)	醖窪鹽築積願願鹹構範(淵餘製餘鹹餘憲糧餘鬱) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 鏇範餘積範襯顧艱鹹淵 (鹹襯齋積艱願廠夢夢夢 )	积极	2022-09-19
				Zuranolone (50 cohort)
NCT02978326 (CTgov)	临床3期	产后抑郁症	276	SAGE-217 15/20 mg Oral Solution (Part A: SAGE-217 15/20 mg Oral Solution)	鹹窪淵遞夢鏇構鹽範遞 = 鑰餘衊鑰鏇網襯夢觸窪獵夢鑰膚衊觸鬱鏇夢醖 (窪襯選鹹製齋膚鬱襯艱, 憲蓋壓願窪齋淵網網衊 ~ 簾網齋夢衊艱願選繭襯) 更多	-	2021-12-16
				Placebo (Part B: Placebo)	鏇窪壓憲繭築選獵鏇糧(構醖艱網窪選網廠淵網) = 選艱網鬱觸築淵網積鹹獵糧網選蓋齋範願鏇簾 (鏇積遞膚鑰憲蓋遞鬱築, 1.07) 更多