A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia, Followed by Open-Label Treatment

Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.

开始日期2021-12-07

申办/合作机构

Neurocrine Biosciences, Inc.

NCT04234672

/ Completed临床1期

A Phase 1 Study to Assess Absolute Bioavailability of TAK-831 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Subjects

The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) [14C]TAK-831 in Period 2.

开始日期2020-02-17

申办/合作机构

Neurocrine Biosciences, Inc.

[+1]

NCT03706469

/ Completed临床1期

A Phase 1, Open-Label, Randomized, Single Dose, 5-Period, 5-Treatment Study to Evaluate the Relative Bioavailability and Effect of Food on TAK-831 Tablet Formulations in Healthy Subjects

The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.

开始日期2018-10-18

申办/合作机构

Neurocrine Biosciences, Inc.

[+1]

100 项与 Luvadaxistat 相关的临床结果

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100 项与 Luvadaxistat 相关的转化医学

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100 项与 Luvadaxistat 相关的专利（医药）

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项与 Luvadaxistat 相关的文献（医药）

2025-01-01·BIOLOGICAL PSYCHIATRY

Finding the Right Dose: NMDA Receptor–Modulating Treatments for Cognitive and Plasticity Deficits in Schizophrenia and the Role of Pharmacodynamic Target Engagement

Review

作者: Sehatpour, Pejman ; Kantrowitz, Joshua T. ; Kantrowitz, Joshua T

Cognitive impairment associated with schizophrenia (CIAS) and related deficits in learning (plasticity) are among the leading causes of disability in schizophrenia. Despite this, there are no Food and Drug Administration-approved treatments for CIAS, and the development of treatments has been limited by numerous phase 2/3 failures of compounds that showed initial promise in small-scale studies. NMDA-type glutamate receptors (NMDARs) have been proposed to play an important role in schizophrenia; moreover, the NMDAR has a well-characterized role in cognition, learning, and neuroplasticity. We review previously published clinical trials in CIAS that focused on NMDAR modulator treatments, focusing on published and recent developments of the use of novel NMDAR-modulating treatments for CIAS both alone and combined with plasticity/learning paradigms to enhance learning. We use this discussion of previous studies to highlight the importance of incorporating pharmacodynamic target engagement biomarkers early in treatment development, which can help predict which compounds will succeed or fail in phase 3. A range of direct and indirect NMDAR modulators are covered, including D-serine, D-cycloserine, memantine, and glycine and first-generation glycine transport inhibitors (e.g., sarcosine and bitopertin), as well as recent positive studies of iclepertin, a novel glycine transport inhibitor, and luvadaxistat, a D-amino acid oxidase inhibitor that increases brain D-serine levels, and indirect noninvasive brain stimulation NMDAR-modulating treatments. Several examples of successful use of pharmacodynamic target engagement biomarkers for dose/drug discovery are emphasized, including the mismatch negativity, auditory steady state, and time-frequency event-related potential approaches.

2024-12-28·INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY

Therapeutic potential of D-amino acid oxidase inhibitors for cognitive impairment associated with schizophrenia: learnings from luvadaxistat

Review

作者: Khin, Ni A ; Singh, Jaskaran B ; Terry-Lorenzo, Ryan T ; Fan, Reuben H

Abstract:

Hypofunction of the N-methyl-D-aspartate receptor (NMDAR) has been proposed to underlie the pathophysiology of schizophrenia, suggesting that promoting NMDAR activity may alleviate the negative or cognitive symptoms associated with schizophrenia. To circumvent excitotoxicity that may accompany direct agonism of the glutamate binding site on the NMDAR, therapeutic trials have focused on targeting the glycine binding site on the NMDAR. Direct administration of either glycine or D-serine, both of which are endogenous coagonists at the NMDAR glycine site, has yielded mixed outcomes across an array of clinical trials investigating different doses or patient populations. Furthermore, directly administering D-serine and glycine is challenging, and thus attention has turned to alternative, indirect methods that increase endogenous D-serine and glycine levels in the brain, such as D-amino acid oxidase (DAAO) inhibitors and glycine transporter 1 inhibitors, respectively. In this review, we provide an overview of the evidence supporting the potential of NMDAR modulators in general, and DAAO inhibitors in particular, as potential adjunctive treatments for schizophrenia. We also discuss the preclinical and clinical data related to luvadaxistat, an investigational highly selective and potent DAAO inhibitor that was under development for the treatment of the cognitive impairment associated with schizophrenia.

2024-08-01·SCHIZOPHRENIA RESEARCH

INTERACT: a randomized phase 2 study of the DAAO inhibitor luvadaxistat in adults with schizophrenia

Article

作者: Ratti, Emiliangelo ; Hanson, Elizabeth ; Evans, Rebecca ; Ge, Tingting ; Singh, Jaskaran B ; Galderisi, Silvana ; Asgharnejad, Mahnaz ; DeMartinis, Nicholas ; Dunayevich, Eduardo ; Dong, Cheng ; Murthy, Venkatesha

Deficits in N-methyl-d-aspartate receptor (NMDAR) signaling are implicated in the pathogenesis of schizophrenia. Luvadaxistat (TAK-831/NBI-1065844) is an investigational d-amino acid oxidase (DAAO) inhibitor that increases d-serine levels at NMDAR coagonist sites. INTERACT is a phase 2 randomized, placebo-controlled study that evaluated the efficacy and safety of three doses of luvadaxistat, covering a range of DAAO occupancy and d-serine levels, in patients with schizophrenia with persistent negative symptoms. The study included a 14-day, single-blinded placebo run-in period and a 12-week, double-blinded treatment period. The primary efficacy endpoint was the 12-week change from baseline in Positive and Negative Syndrome Scale-Negative Symptom Factor Score (PANSS NSFS). Secondary efficacy endpoints included the 12-week changes from baseline in Brief Assessment of Cognition in Schizophrenia (BACS) score and Schizophrenia Cognition Rating Scale (SCoRS) score. Safety endpoints included adverse event assessments. The full analysis set included all randomized patients (N = 256 [placebo, n = 87; luvadaxistat 50 mg, n = 58; 125 mg, n = 56; 500 mg, n = 55]); 228 patients completed the study. No significant improvements in PANSS NSFS were observed at any dose versus placebo at week 12. Improvements were observed with luvadaxistat 50 mg versus placebo in cognitive endpoints: BACS composite score (nominal one-sided p = 0.031) and SCoRS interviewer total score (nominal one-sided p = 0.011). Luvadaxistat did not significantly improve negative symptoms of schizophrenia. However, luvadaxistat 50 mg met the prespecified secondary endpoints for cognitive performance (BACS) and function (SCoRS), warranting further investigation in patients with cognitive impairment associated with schizophrenia. Luvadaxistat was well-tolerated in INTERACT, with no new safety signals observed. ClinicalTrials.gov: NCT03382639.

项与 Luvadaxistat 相关的新闻（医药）

2025-05-22

·深蓝观

当阿斯利康向神经类药物说“再见”

李昀 | 撰文高翼 | 编辑近日，阿斯利康宣布退出CNS（中枢神经系统）类药物的开发，引发业界热议。4月29日，公司在投资者电话会议上宣布了这一消息。同时发布的2025年一季度财报显示，公司已经终止了多项相关管线，包括与礼来合作开发治疗阿尔茨海默症的MEDI1814、处于2期临床的偏头痛单抗MEDI0618、治疗糖尿病神经痛的双抗MEDI7352，至此公司神经科学在研管线全部清零。对这一结果，业内其实早已有预料。CNS的开发从来都泥泞不堪，去年许多MNC也都折戟：比如强生连续终止了3个相关临床项目，艾伯维则在去年 11 月宣布其收购 Cerevel 的核心药物、一款用于治疗精神病症状急性加重的精神分裂症新药的两项临床试验失败。然而，像阿斯利康这样公开表示不再碰CNS的情况比较罕见。一名投资人分析称：公司之所以会做这种声明，大概率表示转型并不是由于项目失败，而是战略收缩和优化配置。也是在引导市场从更加积极的角度进行解读。从二级市场表现来看，公司的业务调整得到了投资者的认可：消息宣布当日，公司股价不跌反涨：涨 2.55%，报 71.71 美元。不过，其中一部分原因在于财务情况：阿斯利康当天发布的2025Q1财报给出了一个交代：2025 年 Q1 总营收 135.88 亿美元，同比增长 10%。净利润增长更明显，同比增长33.99%。“他们的新产品在美国市场推广得不错，”上述投资人提到，“尤其是R&I业务，这几年都在加大投入。”而R&I也确实贡献了Q1季报中最亮眼新药：哮喘药特泽利尤单抗增长明显，报告期内收入 2.17 亿美元，增长 85%。阿斯利康的相关高层也表示：放弃神经科学领域将使公司能够专注于核心治疗重点，资助“高价值项目”。并提到了“核心治疗”的几大领域：体重管理、血脂异常、呼吸系统疾病和免疫学适应症。公司的目标是到 2030 年实现年收入 800 亿美元以及推出 20 种新药。上述投资人分析称，这两个目标几乎不太可能同时实现。“从目前的增长速度来看，破800亿美元依然需要一到两款新的重磅炸弹。但是20款新药不是一个小数字，加上市场推广费用，非常牵拽资源。”因此，砍掉CNS业务，其实算是砍掉了一些阻碍前行的重量，让阿斯利康在奔向短期目标的道路上跑得更快。一名关注过CNS投资的业内人士也提到：尽管从未满足的临床需求来说，CNS潜力巨大，但五年内诞生重磅炸弹的概率相对其他领域更小。“能不能成功看的还是新的机制和技术手段，比如基因治疗。但同样的技术，在其它应用领域起步更早、基础更深，收获期应该会更早到来。“-01-业绩支撑点对于阿斯利康而言，其实已经从去年几年的战略调整上吃到了甜头。2024 年，阿斯利康全年营收同比增长 21% ，达到 540.73 亿美元，在全球制药企业营收 TOP10 排名中跃升至第 5 位，这是阿斯利康近几年来的最好成绩。复盘来看，公司其实从一些调整中收获颇丰。继续加大肿瘤领域的投资力度，其对ADC领域的投资，即使在掷金如土的新药领域也算得上激进：和第一三共的三笔交易总值超150亿美元，并且为该领域专门打造高级管理团队。同时，公司也在其他领域精简资源：比如2020年，公司将心血管及糖尿病代谢业务合并重组，心血管与糖尿病两大治疗领域正式合并为心血管糖尿病代谢业务部。这种调整在2024财年取得了不错的效果：ADC Enhertu不负众望成为新王牌，销售增长速度最快，全年销售额增长 58%，达到19.82亿美元。肿瘤业务依然是阿斯利康表现最强劲的板块，实现营收223.53亿美元，同比增长24%，占总营收的41%。其余三大业务板块：疫苗与免疫、罕见病和心血管、肾脏及代谢疾病 2024 年分别实现营收14.62亿美元、87.68亿美元、125.17亿美元；分别同比增长 8%、16%、20%。上述投资人称，阿斯利康能有如今的表现，和公司CEO帕斯卡离不开关系。“尽管这个人争议比较大。但是有一点是公认的：他是MNC高管中比较难得的战略家，扭转了之前公司的颓势，主要靠的就是做减法+大并购。”这种战略的实行，必须依赖成本控制和业务之间的重组与平衡。从目前公司的布局和市场趋势来看，阿斯利康已经为自己的研发日程表排得满满当当：体重管理代谢类药物、ADC 、放射性药物、下一代 IO 双特异性抗体、细胞治疗和 T 细胞接合剂、基因治疗和基因编辑等方面，阿斯利康都处在研究的白热化阶段。如果其中一两个能够进展顺利，未来几年公司并不缺增长驱动力。显然，在阿斯利康的战略规划中，CNS 业务难以在资源分配上与这些具有高增长潜力的核心业务竞争，成为一张弃牌的结果也就不难理解了。-02-CNS的命运2024年，精神分裂症药市场迎来了35年以来的首款新药：KarXT。这是一种选择性毒蕈碱 M1/M4 受体激动剂，为该病症的治疗打开了新的思路。然而，独木难支。一款新药的成功上市解决不了该领域的底层问题。上述相关领域投资人认为，该药的临床成功有运气成分。“整个大环境都还处于试错阶段，偶尔一次试对了并不能代表什么。但总归是个开始。”CNS的底层问题在于研发缺乏机制基础。精神疾病常常缺乏生物标志物，诊断依赖症状描述，异质性很强，被形容为“在黑屋子里找黑猫”。同时，大部分的化合物无法有效穿透进入脑组织。这就导致，很多在动物实验有效的新药进入临床后往往失效。由于可应用的产品有限，加上其疗效一直饱受争议，因此新药即使上市，显性或隐性的限制也会比较多。比如治疗阿尔茨海默症的Lecanemab、Aduhelm虽获批，因高昂价格受限于医保政策，商业化进展缓慢。卫材公司设定的目标是在 2024 财年前让 10000 名患者接受Lecanemab治疗，但截至次年1月，美国只有 2000 名患者接受了这种淀粉样蛋白抗体治疗。由于学界对该药疗效并具有普遍信任，根据Spherix Global Insights的一项调查：少于一半的美国神经科医生会向患者推荐Lecanemab。因此，过去数间，辉瑞、安进、默沙东等家药企相继缩减CNS 投入，就连一直专注该领域的渤健也在拓展其他领域。这种集体性的战略调整，凸显出CNS在药物研发方面的艰难处境。2024年也是CNS“事故”频发的一年。除了上文提到的强生和艾伯维以外，被终止的比较重要的临床管线还包括：Neurocrine的精神分裂症药物 luvadaxistat ，Neumora的靶向毒蕈碱受体 M4 的高度选择性正变构调节剂NMRA - 266 ，Sage 的新药Dalzanemdor阿尔茨海默症和帕金森病相关认知障碍这两项适应症的临床研究。而终止原因，要么是被FDA叫停，要么则是临床研究未达到主要终点。“虽然退出CNS对阿斯利康这家公司没有太大影响，甚至好处大于坏处。但对专注于这个领域的biotech来说，算得上是一个噩耗，因为又少了一家可以买单的MNC。”上述相关领域的投资人说。在他看来，对于这些biotech来说，未来并不一定是死局。还有一些留存业务的MNC，如BMS、罗氏、诺华等，可能会因为阿斯利康的退出加大研发投入、加快推进相关管线进程，争取在新的竞争格局中占据有利地位。但从投资角度来看，MNC依然是投资风向标：尽管业内依然存在对CNS抱有好感和期待的MNC，但是整体的退出趋势对高风险做出了提示。尤其是在现在的寒冬环境下，未来对该领域的投资会变得更加谨慎。“未来的投资主流看的可能还是公司有没有前沿的技术平台。比如基于人工智能的研发技术，平台对靶点的精准筛选和设计能力。这是一个对创新度要求、复合研究能力要求非常高的领域，投资策略也会更激进。”投资人说到。-03-MNC的顾虑在过去几年里，MNC普遍体验到一种危机四伏感：专利悬崖的阴影始终盘旋，但同时研发难度曲线不断攀升，成本高涨，每个新药上市的平均成本已超过25亿美元；而医保支付压力加大，尤其是在欧美国家，药价谈判趋严。整体而言，MNC的困境可以被总结成“研发风险上升”和“增长速度放缓”的双面夹击，也就是成本端和收入端的失衡。在这种情况下，大部分MNC都选择收缩战线、聚焦核心。MNC有几条道路可以走，视其实力和已有管线矩阵而定：可以选择“高风险/高利润”路线，比如诺华，虽然外围业务都砍得一个不剩了，但依然保留了一些高风险业务线，在CGT、AI驱动靶点发现等方面持续大投入；当然，企业也可以选择“低风险/中高利润”路线，比如赛诺菲就是稳健地将K药开发一条路走到底。对RNA、细胞治疗等领域投资较少，未来虽然可能错过风口，但靠着已有的围绕K药展开的研发管线，也不会过得太差。但显然，从上述的分析来看：CNS目前还处于“高风险/低利润”的区间里，因此很多MNC都会选择将其进行冷处理。此外，监管环境的日益严格也促使 MNC 更加谨慎地对待研发项目。在 CNS 等复杂领域，新药获批难度加大，使得 MNC 在权衡风险与收益时更加保守。而在自身具有优势的核心领域，MNC 凭借已有的技术积累和临床经验，更容易满足监管要求，提高新药获批的成功率。总的来说，最近几年MNC的研发选择已经不如过去急速上升期那样具有多元化的趋向。随着市场的扩容，“多元化”的角色被越来越多地交给biotech和风投基金。那些如CNS一般被MNC“放弃”的领域，还需要后者的继续哺育，才能最终回到巨头们的餐桌上。 ......欢迎添加作者交流：李昀：liyun940820

财报基因疗法并购临床2期

2025-04-11

·生物制品圈

下一个赛道来自“精分”？强生、BMS、再鼎、绿叶竞逐

精神病领域有望迎来下一个重磅药物。4月9日晚，强生宣布已完成对Intra - cellular的收购，通过此次收购，强生不仅将卢美哌隆（lumateperone）纳入囊中，还包括具有同类最优潜力的临床阶段管线，进一步丰富了其在精神健康领域的布局。据悉，此前强生豪掷146亿美元收购中枢神经系统（CNS）治疗药物的企业Intra - cellular。这一金额超过了强生自己在2024年创下的全球医药企业收购金额记录。强生天价收购Intra-cellular，主要目标就是拿下具有两大类精神疾病适应症的卢美哌隆，其销售业绩表现强劲，从2020年的2281万美元增长至2023年的4.64亿美元，2024年预计达到6.85亿美元。本次，强生对Intra-Cellular的收购，只是CNS领域蓬勃发展的一个缩影。精神类药物市场正成为全球药企新的竞争焦点，也带起了该赛道的风口，达成的收购金额呈现上涨趋势，其中Karuna是以140亿美元被BMS收购，艾伯维以87亿美元收购Cerevel 。MNC对CNS的兴趣还在延续，2025年1月渤健宣布将总估值为4.42亿美元“抄底”Sage。不过，高价押注CNS赛道能否真正带来预期的市场回报？CNS“难啃的骨头”相较于传统优势领域（如肿瘤、免疫）竞争白热化，CNS领域仍有大量未被满足的临床需求。然而CNS的药物研发领域一直被认为是医药行业的“硬骨头”，从机制不明，到动物模型难验证、临床开发难，每一项都是CNS药物开发的拦路虎。2024年11月，艾伯维宣布其收购 Cerevel的核心药物——用于治疗精神病症状急性加重的精神分裂症新药Emraclidine的两项EMPOWER临床试验失败。同年，Neumora精神分裂症治疗药物NMRA-266因临床前数据显示该药物引发了兔子的抽搐被FDA叫停试验。NMRA-266 是 M4 毒蕈碱受体的高选择性正变构调节剂；2024年9月，Neurocrine的精神分裂症药物luvadaxistat二次临床II期失败，最终决定停止开发luvadaxistat（NBI-1065844）。而在此之前，罗氏和丹麦灵北制药都曾宣布终止相关管线。接连的试验失败凸显了CNS药物研发的高风险特性，也表明这一领域的药物以及更广泛的新神经科学项目背后机制的复杂性远超预期。收购公告中，强生强调了自身在神经科学领域近70年的经验，拥有多款商业化的神经类药物，其中抗抑郁鼻腔喷雾剂Spravato在2024年销售额突破10亿美元，研管线中还有两款III期临床产品seltorexant和aticaprant。2024年Q3更新的研发管线中，强生终止了3个CNS临床研究项目，分别是seltorexant治疗阿尔茨海默病的2期临床研究、P2X7拮抗剂治疗双相障碍的2期临床研究以及JNJ-0376治疗帕金森病的I期临床研究。可见即使手握可观盈利产品的强生，也面临CNS的研发困境。2024年，强生神经科学业务营收71.15亿美元，在创新制药业务中占比仅12.5%，远低于肿瘤业务的36.48%和免疫业务的31.30%。收购Intra-Cellular不仅能助力强生在神经领域的发展，还囊括一款50亿美元的重磅炸弹。卢美哌隆2019年首次获得FDA批准，治疗精神分裂症，2021年12月又获批了双相情感障碍适应症。在这两大适应症的支撑下，卢美哌隆已经展现出了不菲的商业化潜力。2023年，其销售额已经达到4.62亿美元，同比增长86%；2024年继续增长，前三季度销售额达到4.82亿美元，预计全年最高可达6.85亿美元。值得一提的是，卢美哌隆还将继续快速增长。就在2024年底，Intra-Cellular向FDA提交了卢美哌隆的第3项新适应症上市申请，用于重度抑郁症（MDD）的辅助治疗。MDD的潜在患者人数要远多于精分和双相。根据强生披露的数据，全球超过10亿人——即每8人中就有1人患有神经精神或神经退行性疾病。而在美国，大约240万成年人患有精神分裂症，610万成年人患有双相情感障碍，2100万成年人患有MDD。因此，强生对Caplyta寄予厚望，预计其销售峰值将达到50亿美元。研发难且热情不减根据Frost & Sullivan的预测，全球神经科学药物市场规模将从2022年的1600亿美元增长到2028年的2200亿美元。尽管开发CNS药物具有较大的难度和风险，但由于市场进入壁垒高，且空间潜力巨大，仍吸引着许多药企抢滩布局。技术进步也是推动CNS领域发展的重要因素，2024年9月，BMS宣布Karuna的核心产品KarXT获美国FDA批准上市，它是数十年来首个获批的全新机制的精神分裂症治疗药物。此次批准使BMS在神经科学和精神病学领域获得了重要的立足点。值得一提的是，再鼎医药拥有KarXT大中华区市场的权益，据再鼎医药披露的信息，中国约有80万精神分裂症患者。有望于2024年到2025年上半年获得研究的关键数据，并在中国内地提交KarXT用于精神分裂症的新药上市申请。据悉，除了治疗精神分裂症以外，KarXT目前正在进行注册临床试验，评估治疗阿尔茨海默病精神病的效果，预计2026年获得数据。此外，BMS认为KarXT在其他适应症方面也具有潜力，包括I型双相情感障碍和阿尔茨海默病躁动症。有分析师估计，BMS的KarXT已进入FDA的精神分裂症治疗程序，其销售额可能高达60亿美元。在KarXT身后，全球已进入临床Ⅲ期或注册申请阶段的抗精神分裂症药物已有9款，包括三菱制药的roluperidone、丹麦灵北制药与恩华药业的Lu AF35700、SyneuRx的苯甲酸钠、Newron的依文酰胺、勃林格殷格翰的iclepertin等。此外，国内药企绿叶制药自研的瑞可妥（Rykindo）是一种利培酮微球产品，分别于2021年、2023年在中国、美国获批上市，用于治疗精神分裂症和双相情感障碍，是首个由中国药企自主研发并在美获批的中枢神经系统新药。在CNS领域，绿叶制药还有数款已上市产品或在研管线，彰显出极为强劲的竞争力。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期临床3期

2025-01-27

·PRNewswire

Neurocrine Biosciences Announces Amendment to Strategic Collaboration with Takeda to Develop and Commercialize Osavampator (formerly NBI-1065845/TAK-653)

- Neurocrine Obtains Exclusive Worldwide Development and Commercialization Rights Excluding Japan and Converts to Royalty-Bearing License for Osavampator - Takeda Reacquires Rights to Osavampator in Japan SAN DIEGO, Jan. 27, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it has amended its agreement with Takeda to develop and commercialize osavampator (NBI-1065845/TAK-653). Under the amended agreement, Neurocrine will obtain exclusive rights for all indications to develop and commercialize osavampator, a potential first-in-class AMPA positive allosteric modulator in development for patients with inadequate response to treatment of major depressive disorder (MDD) in all territories worldwide except Japan, where Takeda will reacquire exclusive rights. Under the terms of the updated agreement, each company is responsible for development costs in their respective region, and both companies are eligible to receive royalty payments. "This streamlined collaboration structure allows Neurocrine to focus on bringing this important medicine to patients as quickly as possible," said Kyle Gano, Ph.D., Chief Executive Officer at Neurocrine Biosciences. "With the recent successful completion of our End-of-Phase 2 meeting with FDA for osavampator, we look forward to beginning the Phase 3 program in the first half of this year." "With its long-standing expertise developing therapies for serious psychiatric disorders, Neurocrine is the ideal partner to develop osavampator," said Sarah Sheikh, M.Sc., B.M., B.Ch, MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda. "As it continues to progress through clinical development, osavampator has the potential to add a meaningful new treatment option for patients with MDD." About the Collaboration with Takeda In 2020, Neurocrine Biosciences and Takeda entered into a strategic collaboration to develop and commercialize compounds in depression and schizophrenia, including an exclusive license to both osavampator and NBI-1070770, which are being studied for the treatment of major depressive disorder, as well as a preclinical GPR139 antagonist development program. About Osavampator Osavampator is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in development for patients with MDD who have not benefited from treatment with at least one antidepressant in their current episode of depression. In April 2024, Neurocrine announced positive topline data for its Phase 2 SAVITRI™ study in adult subjects with MDD. Neurocrine plans to initiate a Phase 3 program in the first half of this year. About Major Depressive Disorder Major depressive disorder (MDD) is a serious disorder characterized by a persistently depressed mood, loss of interest, poor concentration, and decreased energy, among other symptoms. According to the World Health Organization, MDD is one of the leading causes of disability, is a serious condition that presents an increased risk of suicide and self-harm, and is associated with increased all-cause mortality rates. More than 21 million people in the U.S. live with MDD and it is estimated that roughly a third of those do not respond to available antidepressants. About Neurocrine Biosciences Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter) and Facebook. (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. SAVITRI is a trademark of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from transactions with Takeda Pharmaceutical Company Limited; statements regarding the clinical results from, and our future development plans with respect to, osavampator, as well as the therapeutic potential and clinical benefits or safety profile of osavampator. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; risks that the benefits of the agreements with Takeda may never be realized; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. SOURCE Neurocrine Biosciences, Inc. 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期引进/卖出临床结果临床3期

100 项与 Luvadaxistat 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16067

研发状态

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
认知功能障碍	临床2期	美国	Neurocrine Biosciences, Inc.	2021-12-07
认知功能障碍	临床2期	保加利亚	Neurocrine Biosciences, Inc.	2021-12-07
认知功能障碍	临床2期	捷克	Neurocrine Biosciences, Inc.	2021-12-07
认知功能障碍	临床2期	塞尔维亚	Neurocrine Biosciences, Inc.	2021-12-07
认知功能障碍	临床2期	西班牙	Neurocrine Biosciences, Inc.	2021-12-07
精神分裂症	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2018-01-04
精神分裂症	临床2期	美国	Neurocrine Biosciences, Inc.	2018-01-04
精神分裂症	临床2期	保加利亚	Takeda Pharmaceutical Co., Ltd.	2018-01-04
精神分裂症	临床2期	保加利亚	Neurocrine Biosciences, Inc.	2018-01-04
精神分裂症	临床2期	捷克	Takeda Pharmaceutical Co., Ltd.	2018-01-04

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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


NCT03382639 (CTgov)	临床2期	精神分裂症	256	Placebo (Placebo)	遞鑰範膚餘醖夢鹹鏇願(壓鬱艱淵選築選憲鬱鏇) = 範淵淵積餘鏇鏇壓艱繭鑰膚衊夢憲壓鑰膚鏇網 (選鬱鏇觸鏇鹽製襯簾網, 0.44) 更多	-	2024-02-28
				Luvadaxistat (Luvadaxistat 125 mg)	遞鑰範膚餘醖夢鹹鏇願(壓鬱艱淵選築選憲鬱鏇) = 範鹽選構壓餘廠構鏇廠鑰膚衊夢憲壓鑰膚鏇網 (選鬱鏇觸鏇鹽製襯簾網, 0.51) 更多
NCT03687684 (CTgov)	临床1期	-	40	placebo+TAK-831 (Japanese Cohort 1: Placebo)	膚構醖觸鏇憲糧憲憲構 = 遞餘窪願築醖鬱糧淵願窪製鹽醖鑰壓淵範餘鹹 (壓艱網構壓膚鏇選艱鏇, 鹹簾鹹選鹹顧糧積遞淵 ~ 齋壓選製齋衊壓鬱淵廠) 更多	-	2020-06-29
				TAK-831 (Japanese Cohort 1: TAK-831 100 mg)	膚構醖觸鏇憲糧憲憲構 = 艱夢製鏇衊願鬱鹹構願窪製鹽醖鑰壓淵範餘鹹 (壓艱網構壓膚鏇選艱鏇, 簾構選窪艱淵壓顧觸艱 ~ 構選遞壓築範齋艱齋窪) 更多
NCT03214588 (CTgov)	临床2期	Friedreich共济失调	67	TAK-831 Placebo (Placebo)	壓憲鬱鹽築襯蓋廠壓鏇(衊窪襯鬱顧遞觸觸鬱簾) = 製壓觸憲艱鹽夢鑰獵繭醖顧夢選遞齋醖簾鏇醖 (網積艱製觸築鹹蓋網顧, 0.000448) 更多	-	2019-12-19
				TAK-831 (TAK-831 75 mg)	壓憲鬱鹽築襯蓋廠壓鏇(衊窪襯鬱顧遞觸觸鬱簾) = 憲醖選獵鑰醖積鹹廠襯醖顧夢選遞齋醖簾鏇醖 (網積艱製觸築鹹蓋網顧, 0.000622) 更多
NCT03224325 (CTgov)	临床1期	-	50	Placebo (Placebo (Pooled))	選鹽簾鏇遞餘鬱糧醖製 = 鹹製遞廠網網鹽鑰鏇膚鏇膚製壓鏇糧夢鬱淵鹽 (顧鑰簾淵範夢醖鏇膚蓋, 範鏇築窪廠齋淵糧觸糧 ~ 鑰淵鹹鹽醖憲膚築憲餘) 更多	-	2019-11-19
				TAK-831 (TAK-831 100 mg)	選鹽簾鏇遞餘鬱糧醖製 = 憲鑰觸齋鹹醖遞築襯鏇鏇膚製壓鏇糧夢鬱淵鹽 (顧鑰簾淵範夢醖鏇膚蓋, 醖蓋糧範艱構夢糧衊遞 ~ 膚醖鹽鹹鬱簾廠齋醖夢) 更多