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-

JPRN-jRCT2031210577 / Not yet recruiting临床3期IIT

A phase 3 study of S-812217 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2022-03-08

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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项与祖拉诺龙相关的文献（医药）

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 ; Chen, Shih-Yin Sharon ; Gerbasi, Margaret E ; Mak, Catherine ; Meltzer-Brody, Samantha

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.

2024-12-01·JOURNAL OF PSYCHOPHARMACOLOGY

Cognitive effects, pharmacokinetics, and safety of zuranolone administered alone or with alprazolam or ethanol in healthy adults in a phase 1 trial

Article

作者: Maruff, Paul ; Czysz, Andy ; Nandy, Indrani ; Walling, David P ; Moseley, Margaret K ; Jain, Rakesh ; Ona, Victor ; Dunbar, Joi ; Hassman, Howard A ; Levin, Seth

Background::

Zuranolone is an oral, once-daily, 14-day treatment course approved for adults with postpartum depression in the United States.

Aims::

To assess cognitive effects, pharmacokinetics, and safety of zuranolone, alone or with alprazolam/ethanol.

Methods::

This was a phase 1, two-part, two-period, randomized, double-blind, placebo-controlled crossover trial. Participants received zuranolone 50 mg or placebo once daily for 9 days, and additionally received alprazolam (1 mg, Part A), ethanol (males: 0.7 g/kg; females: 0.6 g/kg, Part B), or corresponding placebo on days 1, 5, and 9. Within each part, participants received all treatment combinations. Cognition was assessed using a computerized test battery; pharmacokinetics and safety were also evaluated.

Results::

All participants (Part A, N = 24; Part B, N = 25) received ⩾1 dose of zuranolone/placebo. Compared to placebo, zuranolone produced small-to-moderate cognitive decline (Cohen’s | d| = 0.126–0.76); effects were larger with alprazolam (Cohen’s | d| = 0.523–0.93) and ethanol (Cohen’s | d| = 0.345–0.88). Zuranolone coadministration with alprazolam (Cohen’s | d| = 0.6–1.227) or ethanol (Cohen’s | d| = 0.054–0.5) generally worsened cognitive decline when compared with zuranolone alone. Maximal pharmacodynamic effects occurred at approximately 5 h and were resolved by 12 h postbaseline. No pharmacokinetic interactions were observed. Incidence of adverse events was similar between groups; most events were mild or moderate in severity.

Conclusion::

A general small-to-moderate magnitude decline in cognition occurred with zuranolone alone. Coadministration with alprazolam/ethanol increased the magnitude, but not the duration, of effects compared with single-agent administration. Zuranolone prescribers and patients should be aware of the potential for increased central nervous system-depressant effects if coadministered with GABAergic active compounds such as alprazolam and ethanol.

300

项与祖拉诺龙相关的新闻（医药）

2024-11-25

·PRNewswire

Major Depressive Disorder Market to Register Immense Growth by 2034 Owing to a Robust Pipeline | DelveInsight

With the anticipated introduction of new treatments such as COMP360 (COMPASS Pathways), Zuranolone (SAGE Therapeutics/Biogen), LY03005 (Luye Pharma), REL-1017 (Relmada Therapeutics), Seltorexant (Minerva Neurosciences/Janssen Pharmaceutical), ABV-1504 (BioLite/ABVC BioPharma), and other and increasing disease awareness, it's reasonable to expect a significant transformation in the major depressive disorder market in the coming years. LAS VEGAS, Nov. 25, 2024 /PRNewswire/ -- Major depressive disorder (MDD), commonly referred to as depression, is a serious medical condition that affects a person's mood, behavior, thinking, and physical well-being. It is different from the temporary feelings of sadness that everyone experiences and should not be confused with the deep grief following the loss of a loved one. MDD is typically a recurrent and episodic condition, meaning that someone who has experienced depression and recovered is likely to face additional episodes, often within 2 to 3 years. As per DelveInsight analysis, the total diagnosed prevalent cases of MDD in the 7MM were found to be approximately 44 million cases in 2023, which is expected to increase during the forecast period (2024–2034). Among the severity-specific diagnosed prevalent cases of MDD, the highest prevalence was observed in moderate cases accounting for approximately 17 million cases in the 7MM in 2023 followed by severe cases and mild cases. Major depressive disorder can be addressed through several treatment approaches, including pharmacological interventions, psychotherapy, interventional methods, and lifestyle changes. Initial treatment often involves either medication, psychotherapy, or a combination of both, with combined therapy proving more effective than using either alone. For severe cases of major depression, electroconvulsive therapy is the most effective option. The current range of recommended pharmacological treatments for major depressive disorder primarily includes antidepressants such as monoamines, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and selective reuptake inhibitors, including medications like VRAYLAR, BRINTELLIX (now TRINTELLIX), SPRAVATO, REXULTI, and FETZIMA. In the upcoming major depressive disorder treatment market landscape, there are a plethora of companies investigating agents for use in major depressive disorder which includes Sage Therapeutics, Relmada Therapeutics, Johnson & Johnson Services, Inc., Biogen, COMPASS Pathways, Luye Pharma, and others. Many more pharma companies are conducting clinical trials for therapies for major depressive disorder. To know more about upcoming major depressive disorder therapies showing positive results, visit @ Drugs for Major Depressive Disorder Treatment DelveInsight estimates that the market size for major depressive disorder is expected to grow from USD 7.1 billion in 2023 with a significant CAGR by 2034. The disease awareness and the emergence of new products in the pipeline will add to the market growth in the future. In addition, persistently rising cases of MDD in the forecast period will contribute to the rise in the MDD treatment market. The current pipeline for major depressive disorder includes a range of drugs with diverse mechanisms of action (MoA). COMP360 (COMPASS Pathways) , Zuranolone (SAGE Therapeutics/Biogen) , LY03005 (Luye Pharma) , REL-1017 (Relmada Therapeutics) , seltorexant (Minerva Neurosciences/Janssen Pharmaceutical) , ABV-1504 (BioLite/ABVC BioPharma), and some others are the most promising drugs of this indication. Ongoing research and current trials have the potential to change the MDD market. Keen to know how the MDD market will evolve by 2034? Find out @ Major Depressive Disorder Market Report The potential for effective major depressive disorder treatment in the future is expected to grow with the addition of numerous drugs to the pipeline of new therapeutics. Currently, a variety of candidate drugs for the treatment of major depressive disorder are being tested in various clinical trials, with some showing positive results. Any drug approved with increased safety and efficacy is expected to cause significant changes in the overall major depressive disorder market. Now, let's examine the pipeline therapies under investigation for major depressive disorder COMP360: COMPASS Pathways Phase III COMPASS Pathways is investigating the use of its experimental psilocybin therapy, COMP360, for treating serious mental health conditions like major depressive disorder. COMP360 is a synthesized version of psilocybin, the active compound found in certain "magic mushrooms," and is administered alongside psychological support. Psilocybin has shown promise in therapeutic applications, and COMP360 has been granted Breakthrough Therapy status by the US FDA as well as an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Currently, COMPASS Pathways is running a Phase II trial for MDD, with a Phase III trial underway in partnership with Massachusetts General Hospital to further explore its potential in meeting mental health treatment needs. The company is anticipated to release top-line data from two key trials, COMP005 and COMP006, by the fourth quarter of 2024 and mid-2025, respectively, for the treatment of TRD. Zuranolone: SAGE Therapeutics/Biogen Phase III Zuranolone, being developed by SAGE Therapeutics and Biogen, is a next-generation oral, highly potent, and selective positive allosteric modulator, designed for specific targeting of synaptic and extrasynaptic GABAA receptors. The binding sites for neuroactive steroids (NASs) are different from those for GABA, benzodiazepines, and barbiturates. The GABA system, which is the primary inhibitory signaling pathway in the brain and central nervous system (CNS), plays a key role in regulating CNS function. SAGE-217 is currently in phase III clinical development for major depressive disorder and is being evaluated through the LANDSCAPE and NEST clinical trial programs, which include multiple studies involving thousands of participants, with varying dosing regimens, clinical endpoints, and treatment approaches. In February 2023, the US FDA accepted the New Drug Application (NDA) for zuranolone in the treatment of MDD. However, in August 2023, the FDA issued a Complete Response Letter (CRL) regarding the NDA for zuranolone for treating adults with MDD. Sage and Biogen are now assessing the feedback and determining their next steps. LY03005: Luye Pharma LY03005, developed by Luye Pharma, is one of the company's key products in the CNS therapeutic space. It is their exclusive extended-release tablet formulation of ansofaxine hydrochloride, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) designed for treating major depressive disorder. LY03005 aims to offer improved efficacy and fewer side effects compared to conventional antidepressants like SSRIs and SNRIs. Ansofaxine, a prodrug of desvenlafaxine, strongly inhibits dopamine reuptake in addition to serotonin and norepinephrine, demonstrating superior efficacy in clinical trials. In March 2020, the US FDA accepted the NDA submission for LY03005, which is currently in Phase III pivotal clinical trials for MDD treatment. Seltorexant: Minerva Neurosciences/Janssen Pharmaceutical Phase III Seltorexant, developed by Minerva Neurosciences and Janssen Pharmaceutical, is a selective orexin-2 receptor antagonist intended as an adjunctive treatment for major depressive disorder and for managing insomnia. It is the most advanced ORX2-specific molecule in clinical development, acting as an antagonist by binding to its receptor. Seltorexant is being studied for two main uses: insomnia without psychiatric disorders and MDD in patients who do not respond adequately to SSRIs or SNRIs. In May 2024, Johnson & Johnson reported positive topline results from the pivotal Phase III MDD3001 trial, which assessed its efficacy and safety as an add-on therapy to antidepressants in adults and elderly MDD patients. Discover which therapies are expected to grab major MDD market share @ New Treatments for Major Depressive Disorder REL-1017: Relmada Therapeutics Phase III REL-1017, being developed by Relmada Therapeutics, is a novel chemical entity (NCE) and an NMDA receptor (NMDAR) channel blocker that specifically targets overactive channels while preserving normal glutamatergic neurotransmission. The U.S. FDA has granted it Fast Track Designation as an immunotherapy for treating major depressive disorder. In a Phase II trial, REL-1017 exhibited rapid, strong, and lasting antidepressant effects, with statistically significant improvements over placebo in depression measures. The study also indicated a favorable safety, tolerability, and pharmacokinetic profile for the drug. Currently, it is in late-stage development for MDD, being tested in Phase III trials for both adjunctive and monotherapy. In June 2024, Relmada published clinical data from the Reliance I Study. The company is actively enrolling patients in ongoing trials for REL-1017, including Reliance II (Study 302), with top-line results expected in the latter half of 2024, and Relight (Study 304), which is anticipated to provide results about six months after the completion of Study 302. ABV-1504: ABVC BioPharma Phase II ABV-1504, developed by ABVC BioPharma, features PDC-1421 as its active ingredient and is classified as a botanical investigational new drug. Through its subsidiary BioLite, ABVC has completed a Phase II trial of ABV-1504, a botanical Norepinephrine Transporter (NET) inhibitor. This trial, conducted at Stanford University, showed that the PDC-1421 capsule was safe and well-tolerated among six enrolled adult patients. Both low and high doses of PDC-1421 successfully achieved the study's primary endpoints, showing a necessary 40% improvement in ADHD-RS-IV test scores. In April 2023, PDC-1421 was awarded a US patent (US 11,554,154 B2) for the treatment of Major Depressive Disorder (MDD). The drug has also completed a Phase II trial in MDD patients, and the company intends to hold an End of Phase II (EOP II) meeting with the FDA in the near future. Itruvone (PH10): VistaGen Therapeutics Phase II Itruvone (PH10), being developed by VistaGen Therapeutics, is an investigational first-in-class synthetic neurosteroid that is odorless and fast-acting, showing promise for various neuropsychiatric conditions related to depression and suicidal thoughts. VistaGen is focusing on PH10 as a potential quick-acting, non-sedating, and non-addictive treatment for MDD that patients can conveniently self-administer at home. When self-administered, a microgram-level dose of PH10 sprayed into the nose interacts with nasal chemosensory receptors, activating brain neural circuits to produce rapid antidepressant effects without the side effects, systemic exposure, or safety issues associated with FDA-approved treatments for MDD, such as oral antidepressants and esketamine. After successfully completing Phase IIa trials for MDD, VistaGen is now gearing up for the planned Phase IIb clinical development of PH10 for this condition. Moreover, in December 2022, PH10 received fast-track designation from the US FDA. LPCN 1154: Lipocine Phase II LPCN 1154, developed by Lipocine, is an oral formulation of brexanolone designed for rapid relief of postpartum depression. Its active ingredient is a naturally occurring positive allosteric modulator of the GABAa receptor. This medication is intended to provide an "at-home" treatment option, making it more accessible than the current standard care, which involves invasive procedures and hospitalization. In September 2022, the FDA approved Lipocine's proposal to demonstrate the efficacy of LPCN 1154 through a single pivotal pharmacokinetic bridge to the approved IV infusion of brexanolone via a 505(b)(2) NDA submission. In June 2024, Lipocine announced positive topline results from a pivotal pharmacokinetic study, confirming that LPCN 1154 is bioequivalent to IV brexanolone for PPD treatment. Lipocine aims to submit the NDA by the end of the fourth quarter of 2024. Discover more about drugs for major depressive disorder in development @ Major Depressive Disorder Clinical Trials DelveInsight's latest published market report titled as Major Depressive Disorder Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the major depressive disorder country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The major depressive disorder market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of MDD Gender-specific Diagnosed Prevalent Cases of MDD Severity-specific Diagnosed Prevalent Cases of MDD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM major depressive disorder market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this major depressive disorder market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the major depressive disorder market. Also, stay abreast of the mitigating factors to improve your market position in the major depressive disorder therapeutic space. Related Reports Major Depressive Disorder Pipeline Major Depressive Disorder Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key major depressive disorder companies, including GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, among others. Treatment-Resistant Depression Market Treatment-Resistant Depression Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TRD companies, including Navitor Pharmaceuticals, Supernus Pharmaceuti, Novartis, Relmada Therapeutics, Beckley Psytech, COMPASS Pathways, Axsome Therapeutics, Celon Pharma, among others. Treatment-Resistant Depression Pipeline Treatment-Resistant Depression Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key treatment-resistant depression companies, including Axsome Therapeutics, COMPASS Pathways, Merck Sharp & Dohme Corp., Navitor Pharmaceuticals, Inc., Taisho Pharmaceutical Co., Ltd., GH Research Limited, Novartis Pharmaceuticals, Reckitt Benckiser LLC, Relmada Therapeutics, Inc., SAGE Therapeutics, Navitor Pharmaceuticals, Sumitomo Dainippon Pharma, Alkermes, AbbVie, Janssen Pharmaceuticals, Celon Pharma, ACADIA Pharmaceuticals, Pherin Pharmaceuticals, ATAI Life Sciences, among others. Postpartum Depression Market Postpartum Depression Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postpartum depression companies, including Sage Therapeutics, Epharmix, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床3期临床结果快速通道突破性疗法

2024-11-25

·药时代

临床试验三连败，Sage再停管线

欢迎参加2024肝病新药联盟年会暨减重新药论坛！是抄底良机，还是巨石天坑？传奇对冲基金Baker Brothers表示，十分理解Biogen。今年第三季度，Baker Brothers清仓了Sage Therapeutics。据悉，Baker Brothers刚在今年第一季度建仓。 Baker Brothers是百济神州的“二股东”，其持股比例仅次于大股东安进。今年6月，还入股了康方的合作伙伴Summit。仅隔一个季度，Baker Brothers就“风紧扯呼”，意味着其投资判断出现了失误，“你以为是谷底，实际却在半山腰。” 无独有偶，四年前的Biogen以31.25亿美元的价格（包括股权投资：104.14 美元/股，溢价40%），引进Sage两款CNS候选产品时，也曾想着“抄底”一波。如今，Sage股价“很美”，报5.17美元/股。 0-3完败 2024年11月20日，Sage第三次宣布了Dalzanemdor（SAGE-718，以下简称718）的临床失败，在用于治疗亨廷顿病（HD）的II期试验中，未达主要终点，今年4月，Sage公布718的首次失败，在用于治疗帕金森病相关认知障碍的II期试验中，未达主要终点，该适应症被放弃开发；今年10月，Sage公布718的第二次失败，在用于治疗阿尔茨海默病（AD）的II期试验中，同样未达主要终点，AD适应症也被放弃。与所有在研适应症交手后，718 0-3完败，Sage最终宣布终止该药物开发。 718是一款NMDA受体（N-甲基-D-天冬氨酸）正向变构调节剂。NMDA受体是中枢神经系统发育的重要组成部分，其作用是控制突触可塑性，介导学习和记忆功能。如果NMDA受体被过度激活，会导致Ca2+过量流入神经元，引起细胞死亡，这种现象被称为兴奋毒性，而兴奋毒性又与神经退行性病变（中风、帕金森、老年痴呆等）有关。反之，当NMDA受体被阻断时，会改变突触间的信号传递，导致幻听、认知障碍、精神分裂等。那么理论上，只要合理控制NMDA受体的活性，便可治疗由此（NMDA受体过度激活/阻断）引发的一系列疾病。据不完全统计，全球针对该靶点在研药物超过200种，其中关于NMDA受体负向异构调节剂的相关研究较为成功，氯胺酮、Auvelity（右美沙芬+安非他酮）被广泛用于抑郁症治疗。至于NMDA受体正向异构调节剂，718就是全球首创（FIC），他的失败将影响着市场对所有NMDA受体正向异构调节剂在研药物的看法。穷途末路？随着主要资产718的研发终止，Sage剩余管线相对较少，且价值不高。针对社交互动障碍开发的 SAGE-319 目前处于 I 期，而另外两个项目（689/421）正处于临床前开发阶段。至于SAGE-324，就是文章开头Biogen斥资30多亿引进的产品之一。该药物于今年7月，在用于治疗原发性震颤（ET）的二期研究中未达主要终点；今年9月，324被Biogen退货，该药物的后续开发仍在评估（如有）。目前，唯一能支撑起Sage运转下去的，就只剩下两款商业化产品Brexanolone与zuranolone，两者均是治疗产后抑郁症（PPD）的产品，zuranolone算是Brexanolone的迭代产品。如今，Brexanolone销售额不断下滑，2024年Q3单季度，仅卖出80万美元，同比下降70%。且Sage官网介绍，该药将于2024年12月31日起终止在美销售。至于zuranolone虽然2024年Q3单季度，卖出1100万美元，比Brexanolone强，但需要与Biogen一起分钱，Biogen拥有该药物美国以外市场（除日本、中国台湾以及韩国）的开发及商业化权益。（这就是30多亿美元引进的第二款产品）。截止2024年9月30日，Sage 拥有 5.69 亿美元的现金、现金等价物和有价证券，加上近期两轮重大裁员，以及终止718节省下的成本，现金流仍算健康。穷途末路倒不至于，只是，未来Sage的路将怎么走，将不得而知。封面图来源：pixabay 把握时代机遇，攻克肝病顽疾！— 2024肝病新药联盟年会暨减重新药论坛（第一轮通知）往期推荐定了！特朗普公布FDA局长人选 11亿美元！诺华重磅加码「细胞与基因疗法」进军非洲市场！没有专利也可以~ | 药时代BD项目版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩!

临床2期临床结果

2024-11-25

·生物制药小编

Q3被百济二股东清仓的Biotech

2024Q3高瓴旗下专注于美股持仓的HHLR大规模减少了持仓企业，持仓呈现出集中化的特点，而同为百济股东之一的Baker Brother本季度的变动反而没有那么显著。在新建仓几家Biotech的同时，也清仓了几家Biotech。Baker Brother的清仓是较为合理的，在本季度这些企业或多或少都出现了一些问题。 Sage Therapeutics Sage公司在本季度迎来了危急时刻，今年的早些时候该公司的核心管线——NDMA受体调节剂dalzanemdor在阿尔兹海默症和帕金森症中先后失败，因此这直接导致公司在上个月出现了一波裁员潮。更悲剧的是最近该公司宣布，Dalzanemdor也未能改善成年亨廷顿舞蹈症患者的认知功能。这意味着这家公司目前只能寄托于和渤健合作的Zurzuvae销售额不会太难看。 Baker Brother在今年第一季度建仓了Sage，现在清仓也说明可能失算了。 Aligos Therapeutics 数据很好但是股价下跌是Aligos Therapeutics的最直接反映，这家以非酒精性脂肪肝药物为卖点的公司在本季度公布了核心管线THR-β激动剂ALG-055009临床数据。作为首款MASH药物Rezdiffra的挑战者，ALG-055009需要证明自己有独到优势。 Baker Brother建仓该公司于Q1，也算是一种看好。然而，尽管数据史无前例地好，但是投资人觉得临床中存在问题，ALG-055009的临床中并没有严格筛选掉以前服用过GLP-1药物的受试者。同时，安慰剂组的数据疑似太好了，按理来说应该出现患者肝脏脂肪下降的情况，但ALG-055009的临床中竟然反常地增加了。这些不合理之处让这家公司走势破朔迷离。 Athira Pharma Athira Pharma在本季度迎来了核心管线fosgonimaton的重大失利，fosgonimaton是一种用于治疗中枢神经系统疾病的HGF/MET系统的皮下小分子阳性调节剂。然而，该药物在针对阿尔茨海默病的II/III期LIFT-AD试验中未能达到主要和关键的次要终点，导致公司股价大幅下跌。 Adaptimmune Therapeutics “Biotech憋了多年，终于迎来了产品上市，可没有人看好未来前景，股价一路走低，前景暗淡，债台高筑”这样的事件就发生在Adaptimmune身上。作为推动首款TCR-T疗法Afami-cel上市的企业，有太多里程碑可以颁发给Adaptimmune，但是商业化前景上，没人看好Afami-cel会是个重磅炸弹。适应症软组织肉瘤本身就是一类肿瘤中的罕见疾病，考虑到高昂的价格，在产品上市的里程碑后，这家公司的股价反而一路走低。本季度内一直徘徊于1美元左右。 Achilles Therapeutics 相比于上述几家公司，Achilles Therapeutics的情况就没有那么好了，现在这家英国公司已经走到了破产边缘，已经着手探寻“价值最大化”战略。9月份时，在没有看到临床数据希望的情况下，这家公司决定放弃最后一款TILs管线的两个临床，这使得该公司目前已经没有任何在研管线。总结总的来说，Baker Brother本季度变动不大，从总体来看前十大持仓总体价值提高，这可能和Baker Brother主要注重生物制药有关，而HHLR的不少持股变动可能反映了对美国大选中概股影响的合理反馈。

细胞疗法

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

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
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,

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适应症	最高研发状态	国家/地区	公司	日期
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.	-
运动失调	临床前	美国	SAGE Therapeutics, Inc.	2017-04-12

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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


NCT04442490 (CTgov)	临床3期	重度抑郁症	543	Placebo (Placebo)	鏇構鑰鹹鬱鏇壓鑰觸蓋(窪鏇醖糧蓋繭憲鹹積衊) = 製構獵糧鏇壓壓鏇繭選觸窪齋鏇簾夢襯鑰憲鹹 (餘鬱築選鹹膚積齋餘膚, 糧窪鏇襯憲衊願築構願 ~ 鹹壓網糧衊築夢鹹鏇願) 更多	-	2023-12-05
				SAGE-217 (SAGE-217 50 mg)	鏇構鑰鹹鬱鏇壓鑰觸蓋(窪鏇醖糧蓋繭憲鹹積衊) = 願繭築範鬱膚鬱製繭壓觸窪齋鏇簾夢襯鑰憲鹹 (餘鬱築選鹹膚積齋餘膚, 膚網廠壓醖窪顧醖窪夢 ~ 構艱構蓋顧遞夢顧鹽醖) 更多
NCT04476030 (CTgov)	临床3期	重度抑郁症	440	Escitalopram+Matching Placebo+Sertraline+Desvenlafaxine+Duloxetine+Citalopram (Placebo + Assigned ADT)	構糧願艱壓構夢餘遞艱(衊餘衊憲築糧壓窪艱廠) = 窪製鬱鑰網製糧鏇淵壓構齋簾繭鹹積鬱鑰淵廠 (糧窪淵壓鹽壓製範艱觸, 衊積膚鬱鹽餘願齋窪醖 ~ 餘鏇襯衊繭繭構鹹憲網) 更多	-	2023-11-07
				Escitalopram+Sertraline+Desvenlafaxine+Duloxetine+SAGE-217+Citalopram (SAGE-217 + Assigned ADT)	構糧願艱壓構夢餘遞艱(衊餘衊憲築糧壓窪艱廠) = 鑰艱艱範齋鏇觸繭壓選構齋簾繭鹹積鬱鑰淵廠 (糧窪淵壓鹽壓製範艱觸, 艱築鏇窪壓鬱糧願蓋鏇 ~ 鑰鹽觸顧膚蓋鑰獵鏇願) 更多
NCT04442503 (Pubmed \| Am J Psychiatry)	临床3期	产后抑郁症	196	Zuranolone 50 mg/day	積齋窪獵窪網觸願範蓋(獵範鬱壓獵襯齋醖餘築) = 製憲範鹽鹽鹹構醖艱築廠鹽糧蓋網顧積衊壓餘 (淵構壓鬱淵顧廠築糧鏇 )	积极	2023-09-01
				Placebo	積齋窪獵窪網觸願範蓋(獵範鬱壓獵襯齋醖餘築) = 簾獵襯襯鏇積繭製觸觸廠鹽糧蓋網顧積衊壓餘 (淵構壓鬱淵顧廠築糧鏇 )
NCT04442503 \| NCT02978326 (FDA) 人工标引	临床3期	产后抑郁症	345	ZURZUVAE 50 mg (Study 1)	(繭簾簾繭夢窪鹹淵鏇窪) = 顧繭遞製範鏇遞選選廠範範鹽鹽廠廠繭築艱淵 (選壓繭鬱獵艱願鏇願繭, 0.82)	积极	2023-08-04
				Placebo (Study 1)	(繭簾簾繭夢窪鹹淵鏇窪) = 餘鏇願選膚餘糧鹹鑰蓋範範鹽鹽廠廠繭築艱淵 (選壓繭鬱獵艱願鏇願繭, 0.82)
NCT04442503 (CTgov)	临床3期	产后抑郁症	200	Placebo (Placebo)	選憲憲艱顧蓋衊蓋鹽窪(繭願衊網鑰獵鏇壓鹹膚) = 壓積艱繭鑰鹹願構膚糧鬱鑰簾鏇膚鑰衊齋鏇鏇 (範繭餘簾積繭製獵鬱觸, 鹹觸夢蓋壓鹹鑰餘範蓋 ~ 廠齋選網壓鏇廠壓艱壓) 更多	-	2023-06-22
				SAGE-217 (SAGE-217 50 mg)	選憲憲艱顧蓋衊蓋鹽窪(繭願衊網鑰獵鏇壓鹹膚) = 顧選鹹顧夢淵遞選範壓鬱鑰簾鏇膚鑰衊齋鏇鏇 (範繭餘簾積繭製獵鬱觸, 鏇鹽壓遞廠顧糧願鹽窪 ~ 廠範醖襯鑰簾艱襯鹽網) 更多
NCT03771664 (CTgov)	临床3期	入睡和睡眠障碍 \| 重度抑郁症	87	Placebo (Placebo)	醖繭膚壓製廠艱積衊顧(觸膚蓋糧糧構構壓衊夢) = 鬱糧築選顧窪鹽鬱鹹壓糧膚遞遞廠醖膚繭製築 (蓋憲窪憲遞蓋衊鏇蓋蓋, 範餘築醖衊憲範鬱選憲 ~ 壓壓觸觸襯齋遞網齋餘) 更多	-	2022-10-20
				SAGE-217 (SAGE-217)	醖繭膚壓製廠艱積衊顧(觸膚蓋糧糧構構壓衊夢) = 壓繭淵鏇衊選獵製齋積糧膚遞遞廠醖膚繭製築 (蓋憲窪憲遞蓋衊鏇蓋蓋, 憲構廠簾簾蓋窪顧齋網 ~ 壓醖膚廠鏇繭繭糧獵鏇) 更多
NCT04007367 (CTgov)	临床3期	重度抑郁症	53	Placebo (Double-Blind Phase: Placebo)	網窪製廠鏇艱鬱齋鹽遞(鏇網遞觸遞廠獵窪積蓋) = 艱艱鑰範製鏇襯窪鹽憲觸鬱鹹顧獵蓋蓋簾簾艱 (襯繭選艱鏇廠製網觸獵, 鏇範範餘憲齋鬱夢蓋顧 ~ 淵齋範選製廠壓網襯鏇) 更多	-	2022-10-03
				SAGE-217 (Double-Blind Phase: SAGE-217)	餘鏇獵衊鹽艱鹽製廠衊(築夢鏇網廠廠衊築艱鏇) = 觸廠餘窪壓襯膚膚衊鑰網襯簾網壓壓糧鏇淵醖 (簾網願選蓋簾齋襯鬱壓, 鏇簾餘願願鹹獵網夢膚 ~ 顧製選衊壓遞簾製壓構) 更多
NCT03864614 (SHORELINE, Corporate Publications) 人工标引	临床3期	重度抑郁症	924	Zuranolone (30mg cohort)	遞選廠餘繭糧蓋鬱製鑰(衊構壓網艱遞醖願鏇醖) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 壓憲齋糧遞構鏇積餘築 (獵獵鏇鹹鏇鏇艱網齋獵 )	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)	製廠鹹憲醖膚艱膚窪鏇(鹹製憲淵廠衊觸夢簾遞) = 壓鹹鬱壓淵遞繭鹽遞範糧鹹艱衊壓淵鏇製鑰築 (製淵膚襯鹽遞顧醖範鏇, 艱襯淵壓壓製簾範願蓋 ~ 遞遞繭襯壓鑰鹹蓋積廠) 更多	-	2021-12-16
				Placebo (Part B: Placebo)	網鹹構鬱繭鏇鑰鑰膚選(憲餘廠觸鹽獵簾鬱鹽襯) = 顧淵壓膚襯鹽壓範艱廠範淵鏇蓋鏇衊膚憲繭餘 (網顧網選鏇醖夢鬱觸獵, 顧鏇蓋築蓋醖顧築選積 ~ 顧簾遞鹹積鏇襯憲構餘) 更多
NCT02978326 (Pubmed \| JAMA Psychiatry) 人工标引	临床3期	产后抑郁症	153	Zuranolone	襯壓廠醖鹹構膚廠願壓(鑰鹹獵蓋夢鹹廠艱衊窪) = 構範構築網繭鹹顧糧艱簾範壓觸齋積鏇衊顧鹹 (範選鏇願衊觸鬱構繭鹹 ) 更多	积极	2021-09-01
				Placebo	襯壓廠醖鹹構膚廠願壓(鑰鹹獵蓋夢鹹廠艱衊窪) = 獵鏇鹽醖築遞鏇鹹觸廠簾範壓觸齋積鏇衊顧鹹 (範選鏇願衊觸鬱構繭鹹 ) 更多