Effects of Iclepertin on the QT Interval Following Oral Administration in Healthy Male and Female Subjects (a Double-blind, Randomised, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial, With Moxifloxacin as Positive Control)

This study aims to evaluate the effects of iclepertin in the range of therapeutic to supra-therapeutic exposures on the (QT/QTc): Electrocardiogram (ECG) time interval from the start of the QRS complex (ECG time interval) to the end of the T wave / QT interval corrected for heart rate, e.g. using the method of Fridericia or Bazett interval and other ECG parameters.

开始日期2024-01-25

申办/合作机构

Boehringer Ingelheim GmbH

NCT05731895

/ Completed临床1期

Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individualmatched Design Trial)

This study is open to people with and without liver problems. People can join the study if they are 18 to 79 years of age and have a body mass index (BMI) between 18.5 and 35 kg/m2.
Iclepertin (also called BI 425809) is a medicine that is being developed to treat diseases of the brain. The purpose of this study is to find out whether having liver problems influences how iclepertin is taken up in the body. All participants take iclepertin once as a tablet.
Participants are in the study for 2 to 3 weeks. During the first part of the study, they stay at the study site for 4 nights. Afterwards, there are 5 visits to the study site and 1 call. The site staff measures the amount of iclepertin in the blood. The doctors also regularly check participants' health and take note of any unwanted effects.

开始日期2023-03-08

申办/合作机构

Boehringer Ingelheim GmbH

NCT05723874

/ Completed临床1期

The Effect of Multiple Oral Doses of Bosentan on the Steady State Kinetics of BI 425809 After Oral Administration to Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Trial)

The main objective of this trial is to investigate the relative bioavailability of BI 425809 given alone (Reference) compared to a combined administration with the moderate CYP3A4 inducer bosentan (Test) following repeated oral administration.

开始日期2023-03-06

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 Iclepertin 相关的临床结果

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100 项与 Iclepertin 相关的转化医学

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100 项与 Iclepertin 相关的专利（医药）

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项与 Iclepertin 相关的文献（医药）

2025-10-01·Clinical Drug Investigation

The Effect of Multiple Oral Doses of a Glycine Transporter 1 Inhibitor, Iclepertin (BI 425809), on the Steady-state Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel: a Phase I Clinical Trial in Healthy Females

Article

作者: Madari, Shilpa ; Reuteman-Fowler, Corey ; Desch, Michael ; Balavarca, Yesilda ; Shatillo, Yury

BACKGROUND:

Iclepertin is a selective inhibitor of glycine transporter 1 recently investigated as a novel treatment for cognitive impairment associated with schizophrenia. Iclepertin is a potential mild inducer of liver cytochrome P450 3A4, which metabolises ethinylestradiol and levonorgestrel, which are used in combined oral contraceptives (OCs).

OBJECTIVES:

This trial investigated the potential drug interaction effect of steady-state iclepertin on the steady-state pharmacokinetics of combined OCs.

METHODS:

This phase I, non-randomised, open-label, two-period, fixed-sequence trial was conducted in healthy pre-menopausal female volunteers aged 18-35 years. In period 1, participants received a combined OC (ethinylestradiol 30 µg/levonorgestrel 150 µg once daily; reference treatment). In period 2, participants received a combined OC and iclepertin 10 mg once daily (test treatment). Primary pharmacokinetic endpoints of ethinylestradiol or levonorgestrel in plasma at steady state over a uniform dosing interval τ were area under the concentration-time curve (AUC_τ,ss) and maximum and minimum measured concentration (C_max,ss and C_min,ss); drug interaction potential was estimated by geometric mean ratios (test treatment/reference treatment) with two-sided 90% confidence intervals (CIs) using analysis of variance. Safety assessments included monitoring adverse events (AEs).

RESULTS:

In total, 19 participants entered the trial; 17 were treated (periods 1 and 2). Steady-state pharmacokinetics of ethinylestradiol and levonorgestrel were similar with and without iclepertin; geometric mean ratios for AUC_τ,ss, C_max,ss, and C_min,ss were slightly above 100%, and 90% CIs were within standard bioequivalence boundaries (80-125%). The number of on-treatment AEs was similar in period 1 (n = 13) and period 2 (n = 15); AEs were of mild-to-moderate severity.

CONCLUSION:

Iclepertin 10 mg had no meaningful effect on the pharmacokinetics of ethinylestradiol and levonorgestrel, suggesting that these drugs can be administered concomitantly.

TRIAL REGISTRATION:

ClinicalTrials.gov (NCT05613777; registered on 18 October 2023).

2025-09-01·EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS

Assessing the Effect of Food on the Pharmacokinetics of Iclepertin in Healthy Volunteers: A Phase I, Open-Label, Randomised, Cross-over Trial

Article

作者: Breithaupt-Groegler, Kerstin ; Madari, Shilpa ; English, Brett A ; Desch, Michael ; Jungnik, Arvid ; Hohl, Kathrin

BACKGROUND AND OBJECTIVES:

Iclepertin, a selective glycine transporter-1 inhibitor, was investigated as a potential treatment for cognitive impairment associated with schizophrenia. The objective of this trial was to determine the effect of food on the pharmacokinetics of iclepertin 10 mg.

METHODS:

This Phase I, open-label, 2-period cross-over trial randomised (1:1) healthy volunteers to 2 treatment sequences (fasted-fed or fed-fasted) to receive a single oral dose of iclepertin 10 mg once daily in either the fasted or fed state followed by cross-over to the other state. Primary endpoints included maximum measured concentration in plasma (C_max) and area under the concentration-time curve over the time interval from 0 to the last quantifiable data point (AUC_0-tz). The secondary endpoint was area under the concentration-time curve over the time interval from 0 extrapolated to infinity (AUC_0-inf). Relative bioavailability was estimated by calculating an adjusted geometric mean (gMean) fed/fasted ratio using analysis of variance. Safety was assessed.

RESULTS:

Of 16 participants enrolled [mean (SD) age: 37.1 (10.1) years], 15 were included in the analysis. The C_max, AUC_0-tz and AUC_0-inf of iclepertin were higher in the fed versus fasted state; adjusted gMean ratios (90% confidence intervals) were 118.33% (110.01, 127.28), 114.61% (110.13, 119.27) and 114.38% (110.11, 118.80), respectively. Iclepertin 10 mg was well tolerated.

CONCLUSION:

Iclepertin exposure was higher in fed versus fasted conditions, but the increase was minor, suggesting food has no meaningful effect on the pharmacokinetics of iclepertin 10 mg.

STUDY REGISTRATION:

ClinicalTrials.gov (NCT05347004; registered: 20 April 2022).

2025-08-01·CPT-Pharmacometrics & Systems Pharmacology

Evaluation of the Drug–Drug Interaction Potential of the GlyT1 Inhibitor Iclepertin (BI 425809): A Physiologically Based Pharmacokinetic (PBPK) Modeling Approach

Article

作者: Matsson, Elin M. ; Hanke, Nina ; Desch, Michael ; Nock, Valerie

ABSTRACT:

Despite predicting poor functional outcomes and being a significant patient burden, there are no approved pharmacotherapies to treat symptoms of cognitive impairment associated with schizophrenia (CIAS). Iclepertin (BI 425809) is a potent and selective inhibitor of glycine transporter‐1 (GlyT1) that was in Phase III development for the treatment of CIAS. Iclepertin is metabolized by the cytochrome P450 (CYP) 3A4 enzyme and also induces CYP3A4 at supratherapeutic concentrations, so drug–drug interactions (DDIs) with CYP3A4 perpetrators and substrates may be expected. A physiologically based pharmacokinetic (PBPK) model was built and qualified based on physiochemical, in vitro, and Phase I clinical data of iclepertin that included different administration routes, formulations, dose levels, single‐ and multiple‐dose administrations and food statuses. The iclepertin PBPK model was further qualified using clinical data of DDIs with a strong CYP3A4 inducer (rifampicin) and a strong CYP3A4 inhibitor (itraconazole). The qualified model was then applied to simulate DDIs of iclepertin 10 mg daily (the intended therapeutic dose) as a victim or perpetrator drug of CYP3A4. Based on the thorough qualification with clinical DDI data, the model was deemed qualified to predict new, untested clinical scenarios such as alternative drug doses, coadministration of different CYP3A4 substrates, coadministration of weak–moderate inducers and inhibitors of CYP3A4, and in the setting of polymedication in vivo. The model allows detailed analyses of DDI behaviors to inform appropriate prescribing of concomitant medications in patients treated with iclepertin.

项与 Iclepertin 相关的新闻（医药）

2025-10-07

·FierceBiotech

MapLight illuminates $262M IPO plans to fund Cobenfy competitor

Up to $120 million of its planned IPO funds will be used to finance the ongoing phase 2 study of Maplight Therapeutics\' muscarinic agonist ML-007C-MA for schizophrenia. \n MapLight Therapeutics is hoping to raise up to $262 million from its IPO, with the proceeds earmarked for its challenger to Bristol Myers Squibb’s schizophrenia med Cobenfy.The California-based biotech previously outlined plans for an anticipated Nasdaq listing, but only yesterday did the company attach some numbers to the plan. The idea is for MapLight to offer 14.7 million shares priced at $17 apiece, according to an Oct. 6 filing with the Securities and Exchange Commission (SEC).This should bring in net proceeds of $227.3 million—rising to $262.3 million if underwriters take up their full option of buying an additional 2.21 million shares at the same price.Up to $120 million of the funds will be used to finance the ongoing phase 2 study of MapLight’s M1/M4 muscarinic agonist ML-007C-MA for schizophrenia. The 300-person trial kicked off in July.Another batch of up to $70 million of the IPO proceeds has also been earmarked for a phase 2 study of ML-007C-MA in Alzheimer’s disease psychosis, which launched last month.Beyond that, up to $25 million is expected to fund an ongoing phase 2 study of MapLight’s 5-HT agonist ML-004 for autism spectrum disorder, with up to $40 million to be spent on preclinical studies of the GPR52 positive allosteric modulator ML-009 and the M4 antagonist ML-021.Though supported by Big Pharmas like Sanofi and Novo Nordisk parent company Novo Holdings, MapLight has readily burned through heaps of cash. The biotech’s deficit was $251.6 million as of June 30, per the latest SEC filing, with $60.5 million on hand. Should the IPO go through, MapLight would become just the second biotech to go public since February, following in the footsteps of LB Pharmaceuticals’ approximately $285 million listing earlier this month.While the IPO market has been largely stagnant for most of the year, it looks like schizophrenia biotechs are among the few willing to take the risk of going public. Besides MapLight, LB Pharmaceuticals also announced in September that it is hoping to raise up to $263 million from an IPO in order to finance its oral schizophrenia candidate.After decades of no new options, the schizophrenia space was shaken up last year with the approval of Bristol Myers Squibb’s Cobenfy. Since then, rival candidates from other companies have continued to struggle in the clinic, including Boehringer Ingelheim’s iclepertin, AbbVie’s emraclidine and Atai Life Sciences’ inidascamine.

IPO临床2期

2025-08-29

·DIA资讯

《精神分裂症治疗药物的全球管线和研发趋势分析》于2025 CNS创新论坛首发

精神分裂症(schizophrenia)是一种病因不明的疾病，通常在青少年期及成年早期高发，患者出现幻听、思维障碍、认知功能下降及行为异常等临床症状，影响患者生活的各个方面，已成为造成全球疾病负担的主要疾病之一。我国人口基数庞大，且精神分裂症常迁延复发，给患者、家庭及社会带来沉重的负担。抗精神病药是精神分裂症目前主要治疗手段，目前经治疗后能够符合临床和社会康复标准的精神分裂症患者仅达到13.5%。治疗精神分裂症的用药需求日趋增加，但临床研发困难重重。本文将结合精神分裂症领域未被满足的临床需求，重点介绍用于治疗精神分裂症的抗精神病药的发展历程、全球研发现状和新药管线，旨在为该类药物的进一步研发与临床应用提供参考。本文摘选部分内容分享，完整报告请扫描下方二维码获取：精神分裂症药物治疗的现状与问题要实现有临床价值的新药研发，并使患者切实获益，首先需要深入了解其未被满足的临床需求。精神分裂症未被满足的临床需求重点体现在精准诊断、疗效、安全性、依从性及成本效益等方面。精准诊断目前，诊断主要依靠症状学及病程观察。精神分裂症患者的临床症状多样，异质性明显；这提醒研究人员需要从整体上把握临床诊断。尽管近年来涉及精神分裂症生物标志物的研究数量较多，但目前仍缺乏可靠且有实质指导意义的生物标志物来辅助精准诊断。一些疾病研究通常从相对客观的治疗端入手，分析比较治疗效应差异的源头。然而，这些在诊断和治疗领域尚未取得突破性进展。精神分裂症研究路线大致如下：首先，开展小样本临床研究；然后，聚焦具有说服力的临床试验的积极结果数据，在独立的较大样本患者人群中进行重复验证；接着，分享和汇总相关数据，形成初步证据；随后，在独立的大样本人群中再次重复验证，建立相对可靠的单点证据；最后，进行新一轮研究以确认这一发现。然而，整体上推进精神分裂症的病理机制研究，仍需要将上述单点证据形成可关联的证据链。疗效及安全性研究显示，目前获批药物主要聚焦于多巴胺（dopamine，DA）和5-羟色胺（5-hydroxytryptamine，5-HT）通路，多为突触后多巴胺D2受体拮抗剂或部分激动剂，对于认知功能和阴性症状群疗效有限，且存在诸多不良反应。抗精神病药物的疗效有限、起效慢、对患者日常生活和认知功能不利影响的持续存在等，提示该领域存在较大未被满足的临床需求。依从性精神分裂症患者普遍存在依从性差的问题也是导致该疾病频繁复发、高度致残的重要原因。研究显示，74%的精神分裂症患者在治疗18个月内中断口服药物治疗，超过50%的精神分裂症患者住院结束后一个月内会中断治疗。停药患者疾病复发的风险比持续用药者增加约5倍。精神分裂症患者服药依从性差的可能影响诸多因素。成本效益精神分裂症作为一个病程漫长、复发性高及住院率高的疾病，依赖长期的药物维持治疗，所带来的医疗资源消耗及患者经济负担均是巨大的。例如，第1代传统抗精神病药本身费用虽然较低，但由于其对心血管系统和粒细胞的影响，会导致相关检验费用增加。相比之下，第2代非典型抗精神病药在改善症状的同时，较少产生锥体外系反应（extrapyramidal symptoms，EPS），再住院的费用有所降低。同理，虽然长效针剂作为新型药物价格较高，但其安全性和患者依从性已得到改善。抗精神病药(精神分裂症领域)的研发历程与困境研发历程抗精神病药的探索始于20世纪50年代，氯丙嗪（chlorpromazine）被引入精神科，并偶然被发现其具有改善精神分裂症症状的作用，从而开启了精神分裂症现代治疗的新纪元。第1代抗精神病药包括氯丙嗪、舒必利（sulpiride）、奋乃静（perphenazine）等。这类药物通过拮抗中枢神经系统内的多巴胺D2受体以改善症状。对于改善部分患者的阳性症状有效且安全，但在其他维度的精神症状群治疗不佳，也无法改善认知功能。其研发在20世纪80年代后逐步终止。20世纪90年代，抗精神病药进入相对蓬勃的发展阶段，第2代非典型抗精神病药陆续问世。相较于第1代药物，第2代的受体作用更广，从而在一定程度上改善阴性症状和认知障碍，同时降低EPS。常见的第2代抗精神病药物包括氯氮平（clozapine）、奥氮平（olanzapine）、利培酮（risperidone）等。阿立哌唑（aripiprazole）、布瑞哌唑（brexpiprazole）、卡利拉嗪（cariprazine）等因其独特的作用机制被认定为第3代抗精神病药物。第2代、第3代抗精神病药的不良反应有所减少，预防复发的效果略强于第1代，但部分药物更易引起代谢功能异常。目前，第2代、第3药物已发展成为主流药物。自2010年以来，抗精神病药的创新研发进入了瓶颈阶段。在这期间，全球只有6款新药上市（见图1），且大多除DA外新靶点的尝试并不顺利。面对新靶点研发的难题，许多药企选择另辟新径取得了一定的突破性进展。图1：全球新上市的抗精神病药（精神分裂症领域）临床研发困境全球精神分裂症的用药需求日趋增加，但抗精神病药的研发却面临重重困难。在精神疾病的临床试验中挑战众多，涵盖了研究设计、测量指标、研究实施以及患者识别和招募等方面。抗精神病药（精神分裂症领域）研发概览中国抗精神病药（精神分裂症领域）研发现状中国在精神分裂症领域的基础研究相对薄弱，中国医药企业在精神分裂症领域的研发投入比重也较低。近年来政府出台了多项政策鼓励药物创新，但由于我国创新药研发起步较晚，其自主创新能力和世界最先进水平相比还存在差距，目前仍以仿制药为主。中国精神分裂症创新药研发占多数的是快速跟进（fast follow）药物。图2：2020-2024年美国与中国抗精神病药（精神分裂症领域）临床试验数抗精神病药（精神分裂症领域）研发策略根据药物临床试验登记与信息公示平台收录的临床试验信息，近3年内全球共有63款抗精神病药处于活跃状态（见图3）。针对抗精神病药的研发思路主要包括:1）成熟产品剂型改良，对现有药物进行剂型改进，以提高药物的依从性和疗效；2）再创新复合制剂，研发更复杂的复合制剂，以期更好的临床获益；3）多巴胺作用靶点，探索更具选择性多巴胺受体的药物；4）创新靶点的探索，积极寻找新的作用机制，克服多巴胺能靶点作用导致的不良反应。图3：全球在研抗精神病药物（精神分裂症领域）概览成熟产品剂型改良近年来，许多药企致力于优化药物剂型。目前，有 12款抗精神病药在研发管线中属于此产品剂型改进类型，占总数的19%。值得一提的是，改进利培酮的产品占50%（见图4）。剂型的优化可以明显减少给药频率，提高用药便利性。图4：抗精神病药（精神分裂症领域）成熟产品改良概览再创新复合制剂目前大多数抗精神病药在达到疗效的同时可能会引发各种副作用。为了拓展精神分裂症药物治疗方式，研发人员致力于开发复方制剂，以提高药物的疗效并减少用药风险的发生。在这一趋势下，Alkermes公司的利巴维（Lybalvi）于2021年6月获得美国食品和药品监督管理局（Food and Drug Administration，FDA）批准上市，成为一例“老药新用”的成功案例。另一款新型在研药物KarXT（xanomeline/ trospium），正在FDA上市申请中，有潜力成为首个具双重机制非靶向DA/5-HT的新型药物（见图5）。图5：抗精神药物复合制剂概览多巴胺靶点近70年来，多巴胺受体一直是抗精神病药研发的基础。目前，多数已上市的抗精神病药作用于多巴胺通路。然而，直接阻断多巴胺受体的药物往往伴随难以克服的不良反应，尽管如此，创新产品中仍有14款以DA、5-HT受体为主要作用靶点的药物（见图6）。图6：全球在研多巴胺能靶点抗精神病药（精神分裂症领域）概览近年来，新一代具有新作用机制的抗精神病药的研发已逐渐超越了传统的突触后多巴胺D2受体拮抗剂，在精神分裂症的药物治疗领域展示出了一定的潜力。虽然目前精神分裂症领域大部分的管线药物仍处于早期探索阶段，但多数具备更多作用靶点和更精确的分子途径，其研发价值巨大。然而，因分子机制尚未完全阐明，研发仍面临失败率较高。然而，近期在多巴胺受体系统的基础研究方面取得了一些新的突破将为抗精神病药的开发提供新的思路。非多巴胺靶点目前针对多巴胺靶点的抗精神病药物面临诸多问题，因此，对新靶点的研发显得尤为迫切。对于非多巴胺靶点的探索相对积极，占整体研发管线数量的55%（见图7）。目前，抗精神病药研发管线中的新靶点包括6个磷酸二酯酶（phosphodiesterase，PDE）抑制剂，5个针对毒蕈碱型受体M1/M4的药物。此外，其他靶点的分布较为分散，包括钠/Kv3离子通道、痕量胺相关受体1（trace amine-associated receptor1，TAAR1）、D-氨基酸氧化酶（D-amino acid oxidase，DAAO）和甘氨酸转运蛋白1（glycine transporter1，GlyT1）等（见图8）药物因独特的作用机制而备受关注。此外，毒蕈碱受体激动剂是近年来抗精神类疾病药物研究的热门靶点。Emraclidine作为一款新型高选择性M4受体阳性变构调节剂，对M4具有高度特异性，被认为是潜在的同类最佳（best-in-class）抗精神病药物。图7：全球在研非多巴胺能新靶点抗精神病药（精神分裂症领域）临床试验数图8：全球在研非多巴胺能新靶点抗精神病药（精神分裂症领域）概览此外，抗精神病药研发管线中许多新作用机制药物已初步显示出对阳性、阴性和认知症状的疗效和安全性，认知障碍改善方面的药物包括BI-425809（GlyT1抑制剂）和luvadaxistat（DAAO抑制剂）等。 // 自20世纪50年代以来，抗精神病药首次进入临床，围绕如何降低药物不良反应，提高患者依从性以及降低复发住院率等问题一直在不断发展。遗憾的是，至今多数药物针对精神分裂症阴性症状，认知方面及残留阳性症状的治疗效果仍不尽如人意，临床需求未能得到充分满足，疾病负担依然巨大。因此，临床上迫切需要新型抗精神病药来拓展精神分裂症的治疗选择。目前抗精神病药物的研发思路主要分为对成熟产品改良、复合制剂再创新、多巴胺作用靶点以及创新靶点的探索。其中不少药物展现出了令人鼓舞的初步证据。除了不断加深对于精神分裂症生物学机制的理解外，也需有效控制安慰剂效应，采用准确率高且更加客观的评估方式应用于临床。此外，新的药物开发途径，有望为非多巴胺抗精神病药研发带来希望。以患者为中心的研发将成为未来研究的重点，综合考虑患者的特征、环境因素和诊疗反应，制定精准的个体化诊疗方案，将为精神分裂症患者带来更优的解决方案。创新研发的产品成功上市只是第一步，新药融入诊疗实践，成为临床最佳解决方案的一部分时，其临床价值才能充分彰显，未满足的临床需求也才能真正解决。声明原创内容的最终解释权以及版权归IQVIA艾昆纬中国所有。如需转载文章，请发送邮件至iqviagcmarketing@iqvia.com。

诊断试剂

2025-07-28

·FierceBiotech

Atai\'s schizophrenia drug fails to improve cognition in phase 2 study

Atai Life Sciences pivoted to inidascamine back in 2023 after the biotech’s ketamine-like drug floundered in the clinic. \n Atai Life Sciences’ schizophrenia drug has failed to improve cognition in a phase 2 study, leading the biotech to reaffirm that the therapy is no longer a priority.The drug in question, formerly called RL-007 and now known as inidascamine, is a modulator of the cholinergic, glutamatergic and GABA-B receptors. Recognify Life Sciences, which has been developing the drug, assessed the med in a midstage study of 242 patients in the U.S. and Europe with schizophrenia over six weeks.The trial failed to hit the primary endpoint of demonstrating improvement on a score of cognitive function when compared to placebo, according to atai. Searching for positives, the company pointed out that inidascamine had shown a “modest but consistent numerical improvement” on this score as well as “directionally positive effects” on a measure of real-world cognitive capacity.Inidascamine was well tolerated, with no sign of the side effects commonly seen with schizophrenia treatments such as sedation, weight gain or impacted movement.“Although we are disappointed that the study did not reach statistical significance on the primary efficacy endpoint, we are encouraged by the consistency of improvement signals across multiple cognitive and functional measures as well as replication on specific subsets of the cognitive measures; namely, symbol coding and verbal memory,” Recognify CEO Matt Pando, Ph.D., said in the July 25 post-market release.“These findings reinforce our commitment to addressing the significant unmet needs of cognitive impairment associated with numerous mental health and neurodegenerative conditions,” Pando added. “Inidascamine continues to exhibit a strong safety profile, and we look forward to analyzing the full data set to better understand the outcome and inform potential next steps for the program.” After decades of no new options, the schizophrenia space was shaken up last year with the approval of Bristol Myers Squibb’s Cobenfy. Since then, rival candidates from other companies have continued to struggle in the clinic, including Boehringer Ingelheim’s iclepertin and AbbVie’s emraclidine.There remain no FDA-approved treatments specifically for cognitive impairment associated with schizophrenia. Biogen, Roche and Pfizer have studied candidates in the setting but no longer have any active trials. Neurocrine Biosciences was investigating its DAAO inhibitor luvadaxistat in the indication, but those attempts were halted by a phase 2 fail last year.Atai pivoted to inidascamine back in 2023 after the biotech’s ketamine-like drug floundered in the clinic. The company had already incorporated the asset into its pipeline after securing a majority stake in Recognify in 2021.While Recognify said Friday that it will “continue to evaluate strategic options” for inidascamine, atai’s CEO Srinivas Rao, M.D., Ph.D., was clear that the drug has been deprioritized.“While we believe these results support the continued development of inidascamine by Recognify for CIAS as well as its potential application in other indications, as previously communicated, we intend to allocate Atai’s resources on our wholly owned pipeline of transformative psychedelic product candidates focused on affective disorders,” Rao said.

$Atai\'s schizophrenia drug fails to improve cognition in phase 2 study$

临床2期临床结果

100 项与 Iclepertin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
精神分裂症	临床3期	美国	Boehringer Ingelheim GmbH	2021-08-09
精神分裂症	临床3期	美国	Boehringer Ingelheim Pharma GmbH & Co., KG	2021-08-09
精神分裂症	临床3期	美国	Boehringer Ingelheim International GmbH	2021-08-09
精神分裂症	临床3期	中国	Boehringer Ingelheim GmbH	2021-08-09
精神分裂症	临床3期	阿根廷	Boehringer Ingelheim GmbH	2021-08-09
精神分裂症	临床3期	阿根廷	Boehringer Ingelheim International GmbH	2021-08-09
精神分裂症	临床3期	阿根廷	Boehringer Ingelheim Pharma GmbH & Co., KG	2021-08-09
精神分裂症	临床3期	奥地利	Boehringer Ingelheim GmbH	2021-08-09
精神分裂症	临床3期	奥地利	Boehringer Ingelheim International GmbH	2021-08-09
精神分裂症	临床3期	奥地利	Boehringer Ingelheim Pharma GmbH & Co., KG	2021-08-09

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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


Pubmed \| Eur J Drug Metab Pharmacokinet	临床1期	-	16	Iclepertin 10 mg (fed state + fasted state)	積願淵鬱憲糧範願簾膚(觸淵糧齋醖醖憲鹽範餘) = 鬱廠糧願範蓋鏇觸願顧憲艱膚顧衊醖衊積願積 (夢醖糧繭壓膚鏇廠遞壓 ) 更多	积极	2025-09-01
NCT04860830 (CONNEX-3, GlobeNewswire) 人工标引	临床3期	精神分裂症	-	Iclepertin	鹹製艱襯觸鹹廠製築獵(築積糧製繭艱鬱醖蓋鏇) = primary and key secondary endpoints were not met. 壓廠鹽餘憲壓築膚膚鏇 (觸構艱築餘鬱淵遞蓋衊 ) 未达到更多	不佳	2025-01-16
NCT03859973 (CTgov)	临床2期	精神分裂症	200	BI 425809 (BI 425809 10 mg + Computerized Cognitive Training)	餘膚鏇艱鹹窪鹹觸廠觸(鑰蓋齋壓製窪願膚繭膚) = 窪膚蓋網簾築艱壓襯壓簾積鏇觸艱淵鹹鏇鬱製 (繭簾顧鹹鬱餘淵網範糧, 壓夢積憲選製鏇鏇遞艱 ~ 遞製遞廠製願網廠壓醖) 更多	-	2023-11-18
				Placebo (Placebo + Computerized Cognitive Training)	餘膚鏇艱鹹窪鹹觸廠觸(鑰蓋齋壓製窪願膚繭膚) = 鑰願遞製鏇鏇艱鬱網鬱簾積鏇觸艱淵鹹鏇鬱製 (繭簾顧鹹鬱餘淵網範糧, 鏇窪壓願壓壓鬱獵餘襯 ~ 夢簾網鏇醖鑰壓醖築窪) 更多
NCT03783000 \| NCT03654170 (Pubmed)	临床1期	-	6	BI 425809	鑰糧鹹觸鹽憲築艱鬱遞(獵膚鹽構獵窪觸鑰簾鹽) = 膚齋窪遞憲鏇網築廠醖壓鹹鬱壓觸襯鹹鹽鏇壓 (糧膚廠鏇觸獵淵簾鏇壓 )	-	2021-12-22
NCT03988803 (CTgov)	临床1期	-	16	BI 425809 (BI 425809)	顧襯窪遞鬱鏇鹽憲齋鹹(遞糧鑰餘鏇獵衊鏇簾繭) = 淵壓積糧製製鑰窪廠醖憲顧齋淵鹽鑰夢壓選範 (憲窪窪鬱構廠餘選膚觸, 1.09) 更多	-	2021-03-17
				Memantine+BI 425809 (Memantine + BI 425809)	顧襯窪遞鬱鏇鹽憲齋鹹(遞糧鑰餘鏇獵衊鏇簾繭) = 鬱鏇衊築簾繭窪窪製壓憲顧齋淵鹽鑰夢壓選範 (憲窪窪鬱構廠餘選膚觸, 1.09) 更多
NCT02832037 (CTgov)	临床2期	精神分裂症	509	BI 425809 (BI 425809 2 mg Once a Day (q.d.))	遞壓製觸夢鑰淵憲鬱蓋(繭網遞願鏇糧鹽膚築衊) = 齋觸餘艱繭選蓋積觸夢襯廠鹽鹹鏇觸齋膚餘築 (範糧遞鏇繭鑰構廠淵壓, 0.6805) 更多	-	2021-02-24
				placebo+BI 425809 (BI 425809 5 mg q.d.)	遞壓製觸夢鑰淵憲鬱蓋(繭網遞願鏇糧鹽膚築衊) = 鑰積顧遞憲積壓鹽構窪襯廠鹽鹹鏇觸齋膚餘築 (範糧遞鏇繭鑰構廠淵壓, 0.6656) 更多
NCT03905096 (CTgov)	临床1期	-	32	BI 425809 (BI 425809 Alone Group (Part 1: Treatment A, Reference 1))	壓齋製壓網糧襯膚範鹹(鏇構遞鬱獵醖遞獵醖齋) = 顧網鹽齋淵獵鏇淵鬱醖襯膚鑰繭選膚夢鏇範製 (積鏇淵醖遞廠簾鹽觸鹽, 1.10) 更多	-	2021-02-17
				Don+BI 425809 (BI 425809 + Don Group (Part 1: Treatment B, Test 1))	壓齋製壓網糧襯膚範鹹(鏇構遞鬱獵醖遞獵醖齋) = 窪獵壓醖醖範顧願遞範襯膚鑰繭選膚夢鏇範製 (積鏇淵醖遞廠簾鹽觸鹽, 1.10) 更多
NCT02788513 (CTgov)	临床2期	阿尔茨海默症 \| 认知功能障碍	611	placebo+BI 425809 (2 mg BI 425809)	簾顧遞範衊醖觸鏇醖窪(廠鏇壓襯網鏇鏇鏇鹽蓋) = 顧淵艱壓膚艱衊積壓衊齋糧鏇鬱鏇廠鬱淵獵鑰 (襯糧夢廠遞製壓淵觸遞, 4.864) 更多	-	2020-11-06
				BI 425809 (5 mg BI 425809)	簾顧遞範衊醖觸鏇醖窪(廠鏇壓襯網鏇鏇鏇鹽蓋) = 選鬱衊製鏇蓋憲齋膚壓齋糧鏇鬱鏇廠鬱淵獵鑰 (襯糧夢廠遞製壓淵觸遞, 4.471) 更多
NCT02383888 (Pubmed \| Clin Ther) 人工标引	临床1期	-	49	BI 425809	觸襯糧繭夢簾廠鹽衊餘(獵鹽獵選蓋淵衊製築淵) = One drug-related AE of moderate somnolence was reported by a Japanese subject who received placebo. 膚鏇網獵積積製鹹鬱襯 (襯蓋觸範餘顧壓選夢構 )	积极	2019-05-01
				Placebo
NCT02337283 (Pubmed) 人工标引	临床1期	阿尔茨海默症 \| 精神分裂症	12	BI 425809	夢廠願壓簾糧積醖淵衊(齋夢夢蓋獵遞築願鹹艱) = 襯廠壓壓鏇構鏇鹽鏇膚蓋簾鹽遞醖夢顧鬱蓋蓋 (廠艱蓋簾鏇壓顧積選構 )	积极	2018-08-01
				BI 425809+BI 425809	-