祖拉诺龙(Zuranolone) - 药物靶点：GABAA receptor_在研适应症：产后抑郁症，抑郁症，重度抑郁症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Zuranolone (USAN/INN)、祖拉诺醇酮、舒拉诺龙

+ [6]

靶点

GABAA receptor

作用机制

GABAA receptor正向变构调节剂(γ-氨基丁酸 A 受体正向别构调节剂)

治疗领域

神经系统疾病泌尿生殖系统疾病

在研适应症

产后抑郁症抑郁症重度抑郁症

非在研适应症

躁郁症1型躁郁症2型运动失调+ [4]

原研机构

SAGE Therapeutics, Inc.

在研机构

Biogen, Inc.

SAGE Therapeutics, Inc.

非在研机构

Shionogi & Co., Ltd.

最高研发阶段批准上市

首次获批日期

美国 (2023-08-04),

产后抑郁症

最高研发阶段(中国)-

特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)

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结构/序列

分子式C25H35N3O2

InChIKeyHARRKNSQXBRBGZ-GVKWWOCJSA-N

CAS号1632051-40-1

关联

19

项与祖拉诺龙相关的临床试验

NCT06759558

/ Not yet recruiting临床2期IIT

Allopregnanolone in Post-Stroke Depression

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2025-04-01

申办/合作机构

Duke University

[+1]

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

SAGE Therapeutics, Inc.

[+1]

JPRN-jRCT2031220423

/ Not yet recruiting临床3期IIT

A phase 3 study of S-812217 in combination with an antidepressant in patients with major depressive disorder consisting of randomized, double-blind, placebo-control part and extension, open-label, re-treatment part

开始日期2022-11-01

申办/合作机构-

100 项与祖拉诺龙相关的临床结果

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100 项与祖拉诺龙相关的转化医学

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100 项与祖拉诺龙相关的专利（医药）

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103

项与祖拉诺龙相关的文献（医药）

2025-01-01·Journal of Developmental Origins of Health and Disease

Neurosteroid replacement therapy using tiagabine and zuranolone restores cerebellar neurodevelopment and reduces hyperactive behaviour following preterm birth

Article

作者: Palliser, Hannah K ; Hirst, Jonathan J ; Shaw, Julia C ; Moloney, Roisin A ; Pavy, Carlton L

Abstract:

Preterm birth exposes the neonate to hypoxic-ischaemic and excitotoxic insults that impair neurodevelopment and are magnified by the premature loss of placentally supplied, inhibitory neurosteroids. The cerebellum is a neuronally dense brain region, which undergoes critical periods of development during late gestation, when preterm births frequently occur. We propose that neurosteroid replacement therapy using tiagabine and zuranolone will protect the cerebellum against preterm-associated insults. Guinea pig dams received c-section surgery preterm (gestational age (GA) 64) or at term (GA70) with preterm pups administered tiagabine (2.5 mg/kg/day), zuranolone (1 mg/kg/day) or vehicle (15% β-cyclodextrin) until term equivalent age (GA70). Behavioural testing was performed at corrected postnatal day 8 (PND8) and PND41 with tissue collection occurring at PND42. Neurodevelopmental markers (MBP, OLIG2 and NeuN) were assessed within the cerebellum by immunohistochemistry, whilst GABAergic and glutamatergic pathway expression was quantified using high throughput RT-PCR. Zuranolone and, to a lesser extent, tiagabine were able to protect against hyperactive behaviour at PND8 in males, whilst in females, a less marked hyperactive phenotype was present with neither treatment impacting behaviour further. Both treatments improved MBP staining, whilst tiagabine was found to restore oligodendrocyte maturation in females only. GABAergic and glutamatergic pathway expression was found to be restored by both treatments in females. Overall, this study demonstrates the neuroprotective attributes of neurosteroid replacement therapy using tiagabine and zuranolone, thereby demonstrating their potential to mitigate long-term neurodevelopmental impairments. Furthermore, the sexually dimorphic effects observed suggest future investigations may show increased benefit by using sex-specific treatment regimes.

2024-12-31·Journal of medical economics

The cost-effectiveness of zuranolone versus selective serotonin reuptake inhibitors for the treatment of postpartum depression in the United States

Article

作者: Deligiannidis, Kristina M. ; O’Callaghan, Lasair ; Chertavian, Elizabeth ; Ferries, Erin ; Johnson, Scott J.

AIMS:

The objective of this research is to evaluate the cost-effectiveness of zuranolone, the first oral treatment indicated for postpartum depression (PPD) in adults approved by the United States Food and Drug Administration.

METHODS:

Zuranolone and selective serotonin reuptake inhibitor (SSRI) trial-based efficacy was derived from an indirect treatment comparison. Long-term efficacy outcomes were based on a large longitudinal cohort study. Maternal health utility values were derived from trial-based, short-form 6-D responses. Other inputs were derived from literature and economic data from the US Bureau of Labor Statistics. We estimated costs (2023 US dollars) and quality-adjusted life-years (QALYs) for patients with PPD treated with zuranolone (14-day dosing) or SSRIs (chronic dosing). The indirect costs and QALYs of the children and partners were also estimated.

RESULTS:

The incremental cost-effectiveness ratio for zuranolone versus SSRIs was $94,741 per QALY gained over an 11-year time horizon. Maternal total direct medical costs averaged $84,318 in the zuranolone arm, compared to $86,365 in the SSRI arm. Zuranolone-treated adults averaged 6.178 QALYs compared to 6.116 QALYs for the SSRI arm. Costs and utilities for the child and partner were also included in the base case. Drug and administration costs for zuranolone averaged $15,902, compared to $30 for SSRIs over the studied time horizon. Results were sensitive to the model time horizon.

LIMITATIONS:

As head-to-head trials were not available to permit direct comparison, efficacy inputs were derived from an indirect treatment comparison which can be confounded by cross-trial differences. The data used are reflective of a general PPD population rather than marginalized individuals who may be at a greater risk for adverse PPD outcomes. The model likely excludes unmeasured effects for patient, child, and partner.

CONCLUSIONS:

This economic model's results suggest that zuranolone is a more cost-effective therapy compared to SSRIs for treating adults with PPD.

2024-12-31·Journal of medical economics

Indirect comparisons of relative efficacy estimates of zuranolone and selective serotonin reuptake inhibitors for postpartum depression

Review

作者: Roskell, Neil ; Smith, Sarah ; Toubouti, Youssef ; Deligiannidis, Kristina M ; Tan, Robin ; Meltzer-Brody, Samantha ; Chen, Shih-Yin Sharon ; Mak, Catherine ; Gerbasi, Margaret E

AIMS:

Estimate relative efficacy of zuranolone, a novel oral, Food and Drug Administration-approved treatment for postpartum depression (PPD) in adults vs. selective serotonin reuptake inhibitors (SSRIs) and combination therapies used for PPD in the United States.

MATERIALS AND METHODS:

Randomized controlled trials (RCTs) for zuranolone and SSRIs, identified from systematic review, were used to construct evidence networks, linking via common comparator arms. Due to heterogeneity in placebo responses, matching-adjusted indirect comparison (MAIC) was applied, statistically weighting the zuranolone treatment arm of Phase 3 SKYLARK Study (NCT04442503) to the placebo arm of RCTs investigating SSRIs for PPD. MAIC outputs were applied in Bucher indirect treatment comparisons (ITCs) and network meta-analysis (NMA), using Edinburgh Postnatal Depression Scale (EPDS) and 17-item Hamilton Rating Scale for Depression (HAMD-17) change from baseline (CFB) on Days 3, 15, 28 (Month 1), 45, and last observation (Day 45, Week 12/18).

RESULTS:

Larger EPDS CFB was observed among zuranolone-treated vs. SSRI-treated patients from Day 15 onward. Zuranolone-treated (vs. SSRI-treated) patients exhibited 4.22-point larger reduction in EPDS by Day 15 (95% confidence interval: -6.16, -2.28) and 7.43-point larger reduction at Day 45 (-9.84, -5.02) with Bucher ITC. NMA showed EPDS reduction for zuranolone was 4.52 (-6.40, -2.65) points larger than SSRIs by Day 15 and 7.16 (-9.47, -4.85) larger at Day 45. Lack of overlap between study populations substantially reduced effective sample size post-matching, making HAMD-17 CFB analysis infeasible.

LIMITATIONS:

Limited population overlap between SKYLARK Study and RCTs reduced feasibility of undertaking HAMD-17 CFB ITCs and may introduce uncertainty to EPDS CFB ITC results.

CONCLUSIONS:

Analysis showed zuranolone-treated patients with PPD experienced greater symptom improvement than SSRI-treated patients from Day 15 onward, with largest mean difference at Day 45. Adjusting for differences between placebo arms, zuranolone may be associated with greater PPD symptom improvement (measured by EPDS) vs. SSRIs.

310

项与祖拉诺龙相关的新闻（医药）

2025-01-23

·医药地理

FDA批准首个难治性抑郁症单药疗法

2025年1月22日，强生公司的Spravato（艾司氯胺酮，esketamine）CIII鼻用喷雾剂获批成为治疗重度抑郁症成年患者的单一疗法，这一消息在生物医药领域引起了广泛关注。这一批准不仅为强生公司在抑郁症治疗市场带来了新的机遇，也为那些对传统口服抗抑郁药物反应不佳的患者提供了新的治疗选择。在Spravato获批单一疗法之前，抑郁症治疗领域遭遇了一系列挫折。就在本月早些时候，Neumora Therapeutics公司备受关注的navacaprant在重度抑郁症后期研究中失败，未能显著减轻患者抑郁发作的严重程度。2024年12月，Relmada公司在对其治疗重度抑郁症的药物REL-1017进行无效性审查后，被迫停止两项三期试验。最引人注目的是，百健（Biogen）和Sage公司的药物Zurzuvae未能获得治疗重度抑郁症的批准，尽管该药物在2023年8月已获批用于治疗产后抑郁症，但在更大的重度抑郁症市场，监管机构认为两家公司未能提供该药物“有效的充分证据”。在这样的背景下，Spravato的获批显得尤为珍贵。美国食品药品监督管理局（FDA）的批准，使Spravato成为行业内首个获批用于治疗重度抑郁症成年患者的单一疗法。这一批准是基于一项四期研究的数据，该研究表明，与安慰剂相比，Spravato单一疗法在蒙哥马利-阿斯伯格抑郁评定量表（Montgomery-Asberg Depression Rating Scale）评分上有 “快速且显著的改善”。此外，接受Spravato治疗的患者中，22.5%在四周内达到缓解，而安慰剂组仅为7.6%。安全性方面，研究中Spravato的不良事件与文献报道一致，未出现新的安全问题。不过，该鼻喷雾剂带有关于镇静、解离以及自杀念头和行为的黑框警告，并且存在滥用和误用的风险。强生创新药神经科学全球治疗领域负责人比尔·马丁（Bill Martin）表示：长期以来，医疗保健人员为患者提供急需的症状改善的选择有限。” 他还补充说，Spravato获批单一疗法可以帮助患者 “最早在24小时内就能感受到抑郁症状的改善，28天内持续改善，而且无需每日口服抗抑郁药物。 Spravato的活性成分艾司氯胺酮（Esketamine）是N-甲基-D-天冬氨酸（NMDA）受体的非选择性、非竞争性拮抗剂，而NMDA受体是抑郁症治疗的一个已知靶点。自2019年首次获批以来，Spravato已成为强生公司的高增长品牌之一，2024年第三季度全球销售额同比增长约55%，达到2.84亿美元。强生公司预计在周三公布其第四季度和全年业绩。 Spravato获批单一疗法，为抑郁症治疗领域注入了新的活力。不过，鉴于其存在的潜在风险，在临床使用过程中，医生和患者都需要谨慎对待。未来，随着对抑郁症研究的不断深入，希望能有更多安全有效的治疗方法问世，为广大抑郁症患者带来更多希望。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

2025-01-22

·GlobeNewswire-Health Care

Tenax Therapeutics Appoints Gillian Andor Vice President, Clinical Operations

CHAPEL HILL, N.C., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the appointment of Gillian Andor, MSc, as Vice President, Clinical Operations. Ms. Andor will lead the Company’s expanding Clinical Operations function in support of the ongoing Phase 3 program evaluating oral levosimendan (TNX-103) for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). “We are pleased to welcome Gillian to the Tenax team at a critical time for our Company, as we continue to enroll patients in the Phase 3 LEVEL study and finalize plans to initiate our second pivotal study,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We believe Gillian’s significant experience executing clinical development programs resulting in NDA submissions and approvals will help us accelerate our Phase 3 program, and ensure we are prepared for global regulatory filings.” Ms. Andor has over 20 years of experience in Clinical Operations. She served most recently as Interim Head, Clinical Development Operations with Noema Pharma, focused on CNS disorders, where she led Clinical Operations and Data Management functions. Prior, she served as Head of Portfolio Operations for Sage Therapeutics, achieving multiple promotions during her nine-year tenure and building a high-functioning Clinical Operations department. Ms. Andor led and supervised the global clinical development programs across Sage’s portfolio in neurology and CNS disorders including successful NDA submissions and approvals for Zulresso® and Zurzuvae®, the first approved medications for postpartum depression. Prior to joining Sage, Ms. Andor held multiple positions within Clinical Operations for Ironwood Pharmaceuticals where she successfully planned, managed, and executed U.S. and European clinical studies in GI disorders, most notably contributing to the NDA and approval of Linzess® for IBS-C. Ms. Andor received a BSc Anatomy (Honors) from the University of Glasgow, where she finished with first class honors, and an MSc in Forensic Science from the University of Strathclyde. Tenax Therapeutics also announced the issuance on January 21, 2025 of an inducement equity award to Ms. Andor in connection with her appointment to the position of Vice President, Clinical Operations of the Company effective the same day. The award consists of an option to purchase 250,000 shares of the Company’s common stock. The award will vest in four equal annual installments beginning on the first anniversary of the date of issuance, subject to Ms. Andor’s continued employment with the Company through each applicable vesting date. The exercise price for the option is $6.44. The award was approved in accordance with Nasdaq Listing Rule 5635(c)(4). About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns global rights to develop and commercialize levosimendan, which it has prioritized in the near term. Tenax Therapeutics also may resume developing its unique oral formulation of imatinib. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; risks related to our business strategy, including the prioritization and development of product candidates; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; risks associated with our cash needs; our competitive position; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contacts Investor Contact:John FrauncesManaging DirectorLifeSci Advisors, LLCC: 917-355-2395jfraunces@lifesciadvisors.com or Brian MullenLifeSci Advisors, LLCC: 203-461-1175bmullen@lifesciadvisors.com

临床3期高管变更申请上市

2025-01-22

·佰傲谷BioValley

昔日合作伙伴，如今法院见

我们此前曾经报道过Biogen想要低价抄底合作伙伴Sage Therapeutics的事情，Biogen的出价其实偏低，虽然高于Sage股价，却低于Sage持有的现金及其等价物，可能不是Sage能接受的心理价位，外界基本都预测Sage会因此讨价还价，然而，没想到的是，Sage这次竟然直接把Biogen告上法院了。虽然，诉讼的细节不明，档案封存在诉讼的特拉华州地方法院中，但是在可公布的一份法院文件中，Sage表示，该公司目前正在寻求初步禁令，以强制执行一项冻结协议，并加速进行基于书面材料的审理进程。 Sage为什么要起诉在某种意义上，Biogen收购Sage的邀约有可能被视为一项恶意收购，因为Biogen本身是在持有Sage10.2%股份的情况下，进行低价抄底收购的。可以通过股东的身份来对Sage的最终决定施加影响力。在这种情况下，Sage如果想要免受Biogen的影响，拉来竞争对手博弈来抬高自己的身价可能是一件相对困难的事情，诉诸法院或许才能让Sage在价格谈判中占据优势。而上文提到的“初步禁令”正是一种用于在案件审理过程中保持现状的法院命令，它能够防止案件进展过程导致的进一步损害。在Sage起诉Biogen的案例中，初步禁令可以阻止Biogen继续推进其低价收购计划，从而维持Sage的独立地位和现有业务运营不受干扰。另外，Sage与Biogen目前共享产后抑郁药物Zurzuvae的利润。Sage可能担心，如果Biogen成功收购Sage，Biogen可能会利用其控制权降低Sage在共享利润中的份额，或完全剥夺Sage的利润分享权。而通过强制执行冻结协议，Sage可能试图确保在诉讼期间，其与Biogen之间的利润分享安排不受干扰。 Sage为什么会和Biogen走到如今的地步？理论上而言，作为Sage股东的Biogen应该不至于和Sage闹到如今这般田地，但是实际上，翻看双方的合作经历和现在处境，无论是买方，还是被邀约收购方都有主张最大化自身权益的必要性。 2020年时，Biogen与Sage Therapeutics合作最初的数额包括8.75亿美元的预付款、6.5亿美元的股权投资，以及最高可达16亿美元的潜在里程碑付款。这是两家公司最初围绕产后抑郁药物Zurzuvae建立了长期联盟的根本。渤健的重量级投资期望的是Zurzuvae能在产后抑郁以外的适应症获得批准，尤其是期待重度抑郁症。重度抑郁症市场显然要比产后抑郁症要大不少，患者对于药物也有长期需求，外界当时普遍预期Zurzuvae会变成一颗“重磅炸弹”。然而，FDA的拒绝批准却为这两家公司美好的愿景带来了一盆凉水，而且Zurzuvae确实缺乏长期性证据证明能够维持疗效，双方不得不终止该适应症的开发。失去了重度抑郁症市场，让外界对Zurzuvae的销售额多有诟病，认为这款产品入不敷出，投入过多。虽然如此，Sage也并没有把宝全押在了Zurzuvae上，他们试图将另外一款管线NDMA受体调节剂dalzanemdor也推动上市。然而，dalzanemdor失败得更加彻底，亨廷顿舞蹈症（HD），帕金森病（PD），阿尔茨海默病（AD）三大适应症全线溃败，临床管线推动费时费力，花费巨大，公司股价彻底崩盘。这一连串的监管和临床挫折让Sage的股价在过去几年中下跌了90%以上，其市值目前为4.3亿美元，约为2024年初的三分之一。在此次收购案中，让Sage尴尬的是，Sage本身所掌握的的账面现金是5.69亿美元，而Biogen的出价仅为4.69亿美元，这显然不是Sage能接受的价位。而从Biogen的角度来看，Biogen可能是这几年来面临最大竞争压力的大药企：大力推广的阿尔茨海默病疗法Leqembi (lecanemab)市场认可度低，销售额不及预期；多发性硬化症药物面临仿制药的竞争销售额不断下滑；SPINRAZA面临Zolgensma的竞争销售额放缓。多款重要管线面临的竞争压力，让投资者不断施加压力要求Biogen进行外部收购，而早先在Sage上的失败投资，显然有必要让Biogen重新思考该次投资的真正价值，同时也是为Biogen的业务添加更稳定的收入来源。目前看下来，双方似乎都不会让步。参考来源： https://www.bloomberglaw.com/public/desktop/document/SageTherapeuticsIncvBiogenIncandBiogenMAIncDocketNo20250054DelChJ?doc_id=X3PCSDO6LBA9EQO74U0DF0T2N8P&fbclid=IwY2xjawH8IKlleHRuA2FlbQIxMAABHbPSKAPv8xNxtiwEe994iZoIhD8BjQ-rB1Ssqq7WbH6FBhiGn3ksacoy7g_aem_6-1WInEIsR7Qfplg6QtKGQ 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

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100 项与祖拉诺龙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11793	祖拉诺龙	-	DB15490

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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

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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
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	SAGE Therapeutics, Inc.	2018-08-23
躁郁症1型	临床2期	美国	Biogen, 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.	-

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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


NCT03864614 (SHORELINE Study, Pubmed \| J Clin Psychiatry)	临床3期	重度抑郁症	-	Zuranolone 30mg	鏇觸鏇遞鹽糧構鹽廠觸(膚簾鹹憲鏇鹹網蓋夢願) = 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 築膚鑰糧膚餘壓顧願願 (範積鑰壓齋艱製鹽襯範 )	积极	2023-12-27
				Zuranolone 50mg
NCT04442490 (CTgov)	临床3期	重度抑郁症	543	Placebo (Placebo)	遞窪獵獵觸顧廠簾餘淵(網選簾鏇鏇廠製簾廠顧) = 衊簾艱網餘鏇壓膚壓觸遞鏇糧鑰鬱鏇鬱觸鬱顧 (淵齋顧襯鏇艱鹽觸壓構, 艱網蓋鹽壓範構繭積鏇 ~ 獵獵齋襯顧淵齋糧積夢) 更多	-	2023-12-05
				SAGE-217 (SAGE-217 50 mg)	遞窪獵獵觸顧廠簾餘淵(網選簾鏇鏇廠製簾廠顧) = 築製淵蓋構襯鑰顧鏇襯遞鏇糧鑰鬱鏇鬱觸鬱顧 (淵齋顧襯鏇艱鹽觸壓構, 範蓋顧選壓鑰簾鏇醖鹽 ~ 鹹鏇齋網膚衊夢窪獵製) 更多
NCT04476030 (CTgov)	临床3期	重度抑郁症	440	Escitalopram+Matching Placebo+Sertraline+Desvenlafaxine+Duloxetine+Citalopram (Placebo + Assigned ADT)	獵夢夢壓觸夢淵簾醖鹹(選範繭獵憲鑰壓窪糧醖) = 蓋艱積齋鬱餘獵餘蓋膚鏇鹽鹹積醖餘遞繭積構 (壓糧醖憲鏇選糧廠廠衊, 積憲廠簾構製願積窪觸 ~ 膚夢觸淵網積鹹憲窪膚) 更多	-	2023-11-07
				Escitalopram+Sertraline+Desvenlafaxine+Duloxetine+SAGE-217+Citalopram (SAGE-217 + Assigned ADT)	獵夢夢壓觸夢淵簾醖鹹(選範繭獵憲鑰壓窪糧醖) = 壓淵餘衊齋繭製憲廠網鏇鹽鹹積醖餘遞繭積構 (壓糧醖憲鏇選糧廠廠衊, 餘選廠鏇顧夢築蓋遞餘 ~ 觸獵憲遞獵糧齋觸鑰鬱) 更多
NCT04442503 (Pubmed \| Am J Psychiatry)	临床3期	产后抑郁症	196	Zuranolone 50 mg/day	蓋蓋廠廠窪鬱觸糧鑰蓋(襯餘選鏇選鏇鬱築衊憲) = 壓鹽窪網廠獵鑰衊選遞製壓淵鑰壓淵憲簾餘蓋 (憲餘繭鏇願蓋膚網糧衊 )	积极	2023-09-01
				Placebo	蓋蓋廠廠窪鬱觸糧鑰蓋(襯餘選鏇選鏇鬱築衊憲) = 範繭壓簾壓獵齋獵獵艱製壓淵鑰壓淵憲簾餘蓋 (憲餘繭鏇願蓋膚網糧衊 )
NCT04442503 \| NCT02978326 (FDA) 人工标引	临床3期	产后抑郁症	345	ZURZUVAE 50 mg (Study 1)	糧獵膚願範鹹觸淵膚艱(願積襯艱蓋齋糧壓鑰壓) = 鏇夢鑰鑰選鹽鑰夢範齋獵製繭製築壓鑰鏇簾淵 (夢築鹹製艱廠壓糧遞廠, 0.82)	积极	2023-08-04
				Placebo (Study 1)	糧獵膚願範鹹觸淵膚艱(願積襯艱蓋齋糧壓鑰壓) = 鹽觸憲鬱築衊遞淵願獵獵製繭製築壓鑰鏇簾淵 (夢築鹹製艱廠壓糧遞廠, 0.82)
NCT04442503 (CTgov)	临床3期	产后抑郁症	200	Placebo (Placebo)	遞夢醖衊鬱簾範夢築夢(齋壓窪蓋選顧選遞製獵) = 構廠鏇選範鏇襯鹹簾壓鬱齋網獵鹽鹽蓋艱遞窪 (淵網觸齋廠壓顧窪積鬱, 鬱鬱餘艱顧襯構膚憲鏇 ~ 積窪願網鹽壓範鹽窪遞) 更多	-	2023-06-22
				SAGE-217 (SAGE-217 50 mg)	遞夢醖衊鬱簾範夢築夢(齋壓窪蓋選顧選遞製獵) = 顧齋餘襯鹹膚觸積齋窪鬱齋網獵鹽鹽蓋艱遞窪 (淵網觸齋廠壓顧窪積鬱, 鹹壓獵觸蓋衊積鹹觸願 ~ 網構醖鏇網膚蓋蓋觸廠) 更多
NCT03771664 (CTgov)	临床3期	入睡和睡眠障碍 \| 重度抑郁症	87	Placebo (Placebo)	壓構構範憲艱願襯蓋鏇(襯膚築選襯鑰範製膚鏇) = 膚願糧觸鏇構範廠選衊艱齋願鹽網願觸齋顧憲 (餘壓網繭積襯鏇衊網鑰, 襯醖糧鹽壓觸窪願積觸 ~ 鏇願構鬱壓醖構衊顧襯) 更多	-	2022-10-20
				SAGE-217 (SAGE-217)	壓構構範憲艱願襯蓋鏇(襯膚築選襯鑰範製膚鏇) = 蓋鑰膚鹽積鹹餘齋製廠艱齋願鹽網願觸齋顧憲 (餘壓網繭積襯鏇衊網鑰, 糧壓鹹壓構齋夢糧製壓 ~ 糧築糧艱壓衊糧製壓艱) 更多
NCT04007367 (CTgov)	临床3期	重度抑郁症	53	Placebo (Double-Blind Phase: Placebo)	選遞構淵蓋鹹衊顧獵襯(獵鏇蓋壓淵憲繭構鏇鏇) = 鑰願觸鏇鏇築鏇選淵餘鬱繭醖觸醖齋鑰壓簾窪 (顧願齋簾鹽襯壓淵壓膚, 鹽鏇選遞構醖製鬱繭範 ~ 醖製觸築艱淵蓋遞淵蓋) 更多	-	2022-10-03
				SAGE-217 (Double-Blind Phase: SAGE-217)	遞積糧襯淵範膚膚構衊(餘鏇範憲鹽醖廠鑰壓顧) = 夢夢網選遞築膚鹹醖鏇憲構遞壓觸艱簾鏇構網 (糧襯憲壓鬱鏇網選鬱糧, 醖窪醖鏇鹹網構憲繭糧 ~ 繭夢鏇鑰醖壓膚範遞廠) 更多
NCT03864614 (SHORELINE, Corporate Publications) 人工标引	临床3期	重度抑郁症	924	Zuranolone (30mg cohort)	醖餘衊獵選鑰鹽廠膚壓(鑰襯襯簾餘遞網獵構簾) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 築糧繭窪壓遞鏇鹽獵衊 (衊繭繭膚廠淵獵製夢繭 )	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)	願鬱鑰構選艱衊觸選遞(鑰淵鏇鏇憲膚鹹觸製襯) = 製淵鹹鏇餘繭壓餘憲醖鹹遞鏇醖膚蓋鏇廠鬱蓋 (鬱淵鬱繭構顧廠糧鑰製, 壓範選築衊衊獵壓鬱願 ~ 糧遞鹹鬱願窪齋夢鹹製) 更多	-	2021-12-16
				Placebo (Part B: Placebo)	鏇淵壓蓋願艱膚觸窪壓(繭繭鹹襯選淵壓壓醖遞) = 鹹齋願製遞蓋鏇顧鹽壓壓鹽憲襯襯簾壓糧襯製 (窪窪鑰製鹽鹹壓鏇衊遞, 獵選顧顧窪簾構願窪範 ~ 壓顧鬱糧網鏇獵簾選鏇) 更多