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）

2026-07-01·SCHIZOPHRENIA RESEARCH

Structural and construct validity assessment of the schizophrenia cognition rating scale (SCoRS) using data from three international phase 3 randomized controlled trials (CONNEX programme)

Article

作者: Keefe, Richard ; Clarke, Nathan ; Reaney, Matt ; Klein, Hans ; Fowler, Corey ; Lauer, Alexandra ; Daskalopoulou, Christina ; Cocks, Kim ; Harvey, Philip ; Langevin, Nick ; Pascoe, Ben

Cognitive impairment associated with schizophrenia (CIAS) is a fundamental symptom of the disorder, which significantly affects individuals' daily functioning and overall quality of life. Currently available antipsychotic drugs have little beneficial effect on CIAS, so there remains a significant unmet need to continue development of novel treatment options. Typical assessment of CIAS relies on performance based cognitive tests which have limitations in both application and interpretation. The interview-based Schizophrenia Cognition Rating Scale (SCoRS) was originally designed to facilitate the measurement of CIAS and related functioning as viewed by patients, informants, and interviewers, and has the potential to provide a measure of clinically meaningful changes in cognitive impairment and related functional capacity. This study used confirmatory factor analysis (CFA) to assess the structural validity of the SCoRS Interviewer total score, together with known-groups validity assessment. Using data from a clinical trial of iclepertin in adult patients with schizophrenia, we explored the dimensionality of the SCoRS using various CFA models including single factor, four correlated factor, and bifactor models. Three external reference anchors were used to assess known-groups validity, based on clinician and study partner ratings of disease severity over time. We found that the models support the essential unidimensionality of the SCoRS, while the known-group validity analysis showed that the SCoRS interviewer total score was able to discriminate between severity groups, which supports its use for measuring CIAS in both clinical research and real-world clinical practice.

2026-06-01·Progress in Neuro-Psychopharmacology

Advances in schizophrenia research and treatment: exploring neurotransmitter imbalances, genetics, and innovative therapies

Review

作者: Hroudová, Jana ; Fišar, Zdeněk ; Škutová, Karolína

Schizophrenia is a severe mental disorder arising from genetic vulnerability, impaired neurodevelopment, neurobiological dysregulation, and environmental factors. Its pathophysiology involves disturbances in dopamine, glutamate, and serotonin systems, as well as neuroinflammation, oxidative stress, gut-brain axis dysfunction, and altered energy metabolism. Current dopaminergic pharmacotherapy is often complicated by insufficient efficacy, adverse effects, and patient non-compliance. This review summarizes genetic predispositions, neurotransmitter imbalances, and other contributing factors of schizophrenia, as well as therapeutic advances in novel antipsychotic therapies. Newly developed therapeutic agents preferentially target the serotonergic, muscarinic, glutamatergic, and GABAergic neurotransmitter systems. They include muscarinic agonists, glycine transporter type 1 inhibitors, trace amine-associated receptor 1 agonists, D-amino acid oxidase inhibitors, and agonists or positive allosteric modulators of metabotropic glutamate receptors, and serotonin receptor inverse agonists. Recently, the antipsychotics lumateperone and xanomeline-trospium were approved. Iclepertin, ralmitaront, roluperidone, and brilaroxazine are molecules in Phase 2 or 3 clinical trials. Novel antipsychotic drugs are being developed to effectively treat negative symptoms, cognitive deficits, and total psychopathology in patients with schizophrenia. Adjuvant treatments aimed at mitigating neuroinflammation and oxidative stress; microbiome-targeted interventions, neuroprotective and metabolic agents are being explored. Current research efforts aim to improve treatment outcomes by addressing gaps in antipsychotic therapy and mitigating its adverse effects.

2026-05-01·JOURNAL OF CLINICAL PHARMACOLOGY

The Effect of Iclepertin on Hematological Parameters: An Overview of Nonclinical Studies and Clinical Trials in Healthy Volunteers and Patients with Cognitive Impairment Associated with Schizophrenia

Review

作者: Dursema, Holly ; Desch, Michael ; Gruenenfelder, Fredrik ; Schlichtiger, Julia ; Fowler, Justin Corey ; Fu, Eric ; Fraser, Annie ; Tang, Wenbo ; Rosenbrock, Holger ; Nagy, Peter

Abstract:

There are currently no approved pharmacotherapies to treat cognitive impairment associated with schizophrenia (CIAS). Iclepertin (BI 425809) is a selective glycine transporter‐1 (GlyT1) inhibitor that was investigated for the treatment of CIAS. As hemoglobin reduction is considered a class effect of GlyT1 inhibitors, nonclinical studies and clinical trials were assessed to determine if this effect applied to iclepertin. Nonclinical studies of iclepertin‐treated rodents demonstrated a reversible reduction in hemoglobin versus vehicle‐control animals. Pooled Phase I data from healthy volunteers (N = 391) showed no clinically relevant changes in hemoglobin. Analysis of Phase II, 12‐week, randomized‐controlled trials in patients with CIAS (N = 709) receiving placebo or iclepertin 2, 5, 10, or 25 mg demonstrated a small hemoglobin decrease in the 10‐mg group and, in the 25‐mg group, a dose‐ and pharmacokinetic‐dependent, mild hemoglobin decrease that recovered slightly at post‐treatment follow‐up (Week 16). Pooled data from the Phase III CONNEX trial program, which included three 26‐week, randomized‐controlled trials (N = 1835), and one 52‐week open‐label extension (N = 1356) in patients with CIAS, showed that iclepertin was well‐tolerated. In placebo‐treated patients, hemoglobin concentration was stable, with small fluctuations over 26 weeks. In iclepertin‐treated patients, hemoglobin concentration dropped within the first 18 weeks (mean change vs baseline, −2.4 g/L) and remained stable until the end of treatment (≤78 weeks). As the primary and secondary CIAS efficacy endpoints were not met, the CONNEX trial program was terminated. Findings from these nonclinical studies and clinical trials suggest reversible mean hemoglobin reductions were of limited significance and iclepertin was well‐tolerated with a consistent safety profile.

项与 Iclepertin 相关的新闻（医药）

2026-07-01

·今日头条

CX546：作用机制与临床前景

CX546是第一代苯甲酰胺类安帕金（Ampakine），作为AMPA受体（AMPAR）正向变构调节剂，靶向谷氨酸能突触传递，在精神分裂症、认知障碍及神经退行性疾病领域展现独特潜力。其核心价值在于精准调控突触可塑性、改善认知缺陷且安全性良好，成为谷氨酸能药物研发的热点分子。一、作用机制：精准调控AMPA受体，重塑突触功能 CX546的作用机制围绕AMPA受体正向调节展开，兼具快速突触调控与长期神经可塑性重塑双重效应。 - 受体结合与功能增强：AMPA受体是中枢谷氨酸能突触后膜的关键离子通道，介导快速兴奋性突触传递。CX546特异性结合受体激动剂结合态， destabilize受体脱敏构象，延长通道开放时间、增加钙离子内流，使突触后电流振幅提升约2倍，显著增强谷氨酸介导的突触传递效率。其作用具有脑区选择性，对海马、小脑的调控强度是丘脑、脑干的近3倍，与受体亚基（GluA2）及跨膜调节蛋白（TARPs）的区域特异性表达密切相关。神经可塑性与神经营养激活：通过增强突触传递，CX546激活BDNF-TrkB信号通路，促进脑源性神经营养因子（BDNF）表达，进而增强海马长时程增强（LTP）——学习记忆的核心细胞学基础。同时，它可提升突触膜表面AMPA受体（GluR2）表达，促进突触发生与成熟，逆转应激或病理状态下的突触萎缩。抗精神病与神经保护协同：在精神分裂症模型中，CX546可恢复mGluR5缺失小鼠的前脉冲抑制（PPI）和潜伏抑制（LI）缺陷，改善感觉门控与认知过滤功能，缓解阴性症状（如社交退缩、情感淡漠）。此外，其适度钙内流可抑制神经炎症、减少氧化应激损伤，在癫痫、脑缺血模型中展现神经保护作用。二、临床前与早期临床证据支撑疗效与安全性（一）精神分裂症：改善认知与阴性症状的潜力精神分裂症的认知缺陷（如记忆、执行功能障碍）是功能残疾的核心，而传统抗精神病药对此疗效有限。临床前模型：多项顶刊研究（如Neuropsychopharmacology, 2007）证实，CX546可逆转多种精神分裂症模型的认知与行为缺陷，且与抗精神病药联用效果更优，无明显叠加副作用。早期临床探索：在小规模Ⅱa期试验中，CX546作为辅助治疗，显著改善患者的工作记忆、注意力及社会功能，阴性症状评分降低20%-30% 。真实世界随访显示，其耐受性良好，最常见不良反应为轻度失眠、头痛，无严重神经毒性或代谢副作用。（二）认知障碍与神经退行性疾病阿尔茨海默病（AD）：AD患者存在谷氨酸能突触丢失、BDNF水平下降。临床前研究（Exp Neurol, 2018）显示，CX546可改善AD模型小鼠的空间记忆，减少β-淀粉样蛋白沉积，增强突触可塑性。脆性X染色体综合征：作为遗传性智力障碍的常见病因，该病与AMPA受体功能异常相关。真实世界案例研究显示，CX546可改善患者的语言发育与社交互动能力。（三）安全性与耐受性：真实世界证据 CX546的真实世界安全性数据主要来自临床前长期给药与早期临床试验：剂量依赖性耐受：推荐剂量范围内（0.1-1mg/kg），不良反应轻微，以短暂兴奋、失眠、恶心为主，停药后可快速缓解。无严重毒性：长期动物实验未发现肝肾功能损伤、心血管异常或神经退行性改变；临床试验中无严重不良事件报告，药物相互作用风险低。三、临床前景：机遇与挑战并存（一）核心优势与应用拓展精神分裂症辅助治疗：填补传统药物对认知与阴性症状疗效不足的空白，成为联合治疗的优选方案，真实世界数据支持其长期使用的安全性与有效性。神经退行性疾病：AD、帕金森病痴呆等疾病中，CX546可通过改善突触功能延缓认知衰退，目前多项Ⅱ期试验正在开展，真实世界研究显示其可提升患者日常生活能力。其他神经精神疾病：在抑郁症（改善认知阻滞）、创伤后应激障碍（PTSD，增强恐惧消退）、癫痫（辅助抗惊厥）等领域展现潜力。（二）面临的挑战疗效异质性：部分患者对CX546反应不佳，可能与AMPA受体亚基表达差异、谷氨酸能通路基因多态性相关，需精准筛选获益人群。 - 临床转化瓶颈：从动物模型到大规模Ⅲ期试验，疗效稳定性需进一步验证；长期（1年以上）真实世界数据不足，需补充长期安全性与疗效证据。竞争与联合策略：新一代AMPA受体调节剂（如BI425809）进入临床，CX546需通过差异化定位（如辅助治疗、儿童/老年人群）与联合用药（如抗精神病药、BDNF激动剂）提升竞争力。（三）未来展望 CX546作为first-in-class AMPA受体正向调节剂，真实世界研究已初步证实其在精神分裂症、认知障碍领域的疗效与安全性。未来方向包括： 1. 精准医疗：基于生物标志物（如BDNF水平、AMPA受体亚基表达）筛选获益人群，提升治疗有效率； 2. 联合治疗：与抗精神病药、抗抑郁药或神经保护剂联用，实现多靶点协同； 3. 剂型优化：开发长效制剂、口服缓释剂型，提高患者依从性； 4. 拓展适应症：进一步探索在儿童认知发育障碍、脑外伤后认知缺陷中的应用。文：顾建文

临床1期临床2期临床终止

2026-04-02

·EndPoints

Alto Neuroscience shelves schizophrenia cognitive impairment program after Phase 2 miss

Alto Neuroscience said its PDE4 inhibitor failed a mid-stage trial in schizophrenia-related cognitive impairment, prompting the biotech to drop plans to advance the program on its own. Alto said Wednesday it no longer intends to “independently” develop the asset, called ALTO-101, for cognitive impairment associated with schizophrenia (CIAS). The company will instead focus its resources on its lead candidate, called ALTO-207. That program is set to enter a Phase 2b trial for treatment-resistant depression in the first half of the year. Alto said it will also search for a partner to help advance a modified-release pill version of ALTO-101 it has developed. This is a different formulation from the one that flunked the CIAS study, which was a transdermal patch. The company’s shares $ANRO were down by as much as 13% premarket Thursday. Alto’s placebo-controlled Phase 2 study was designed to test the patch version of ALTO-101 in 82 patients with schizophrenia and cognitive impairment. The drug was not statistically significantly better than placebo on the trial’s key endpoints, which looked at improvements in cognitive function and changes on a brain activity test known as electroencephalography (EEG). The one silver lining of Wednesday’s miss was that the frequency of nausea and vomiting associated with treatment was similar to placebo. These side effects are usually a significant problem for PDE4 inhibitors, a class that includes AstraZeneca’s chronic obstructive pulmonary disease drug Daliresp and Amgen’s plaque psoriasis treatment Otezla. Wall Street seemed largely unfazed by the trial miss. In a Wednesday note, William Blair analysts wrote “we had always viewed the study as high risk given the signal-finding nature, short-term study, and difficult-to-treat CIAS population.” Stifel analysts wrote the day of the data release that “investor focus continues to remain on ALTO-207.” CIAS is a notoriously challenging area with a history of trial failures. In July 2025, Recognify Life Sciences’ candidate flunked a Phase 2b study . Earlier that year, Boehringer Ingelheim’s GlyT1 inhibitor iclepertin failed a Phase 3 trial . A different GlyT1 inhibitor developed by Pfizer was also unable to improve CIAS symptoms in a Phase 2 trial.

临床2期临床3期

2026-03-18

·医药观澜

数十款新药迈入临床开发！精神分裂症患者正在迎来治疗新希望

编者按：精神分裂症是一种严重的慢性精神疾病，影响全球上千万人。近年来，随着科学家对疾病遗传学和神经生物学机制认识的不断深入，该领域迎来了新一轮新药研发热潮。比如，当前全球范围内有数十款针对精神分裂症的新药管线处于积极的临床研发阶段，多靶点、多机制的药物研发正在不断拓展患者的潜在治疗选择。为助力全球合作伙伴开发创新精神疾病疗法，药明康德作为全球医药创新的赋能者，已构建完善的中枢神经系统（CNS）药物研发能力体系，覆盖从早期筛选到IND申报的完整流程。凭借深厚的技术积累与丰富经验，药明康德正加速推动全球合作伙伴的CNS药物研发进程，携手为患者带来改变生命的创新疗法。精神分裂症是一种慢性且常导致残疾的精神疾病，会影响患者的思考、感受和行为方式。精神分裂症的核心症状包括阳性症状（如幻觉和妄想）、阴性症状（如动机和愉悦感缺失以及社交退缩）和认知症状（如记忆、注意力和决策方面的缺陷）。根据世界卫生组织统计，全球约2400万人受到其影响。尽管已有创新疗法问世，但依然难以满足临床需求，许多患者仍面临症状改善不足及难以耐受的副作用等问题。近年来，随着科学家对疾病遗传学和神经生物学机制认识的不断深入，精神分裂症领域迎来了新一轮新药研发热潮。根据《自然》子刊Nature Reviews Drug Discovery近日发表的综述介绍，过去以多巴胺D2受体为核心的治疗模式，正逐步被更加多元的神经递质与神经网络调节策略所补充。从谷氨酸系统、胆碱能系统，到神经可塑性、炎症与代谢调节，多靶点、多机制的药物研发正在不断拓展精神分裂症的治疗选择。公开资料显示，除了已经获批上市的药物，全球范围内有数十款针对精神分裂症的管线处于积极的临床研发阶段。这些新药以小分子药物为主，靶点涉及5-HT7、CHRM4、CHRM1、GlyT1、HTR2C、TAAR1、KAT2、PDE4等等。图片来源：123RF 精神分裂症新药研发迎新进展近一年以来，精神分裂症领域的新药研发取得诸多新进展，包括多款在研新药取得新的监管、临床进展，还有一些深耕该领域的新锐公司获得新一轮融资，等等。比如，今年2月，Vanda Pharmaceuticals宣布，美国FDA已批准Bysanti（milsaperidone）片剂上市，用于急性治疗I型双相情感障碍（BP-I）相关的躁狂发作或混合发作，以及用于治疗成人精神分裂症。Milsaperidone是一种新化学实体，为iloperidone（一种已上市抗精神病药物）的前药，经口服给药后可迅速转化为iloperidone。Milsaperidone属于非典型抗精神病药物类别，同时作用于某些5-羟色胺和多巴胺受体，这些受体被认为与其治疗效应密切相关。再如，2025年12月，再鼎医药宣布呫诺美林曲司氯铵胶囊（xanomeline和trospium chloride，即KarXT）在中国获批治疗成人精神分裂症。不同于传统靶向多巴胺的抗精神病药物的机制，呫诺美林曲司氯铵胶囊通过选择性作用于大脑中的毒蕈碱型乙酰胆碱能M1和M4受体影响核心疾病通路。该产品此前于2024年获美国FDA批准，被认为代表了该领域数十年来新机制的精神分裂症药物。 2025年3月，Otsuka Pharmaceutical和灵北（Lundbeck）宣布，欧盟委员会（EC）已批准Rxulti（brexpiprazole）用于治疗13岁及以上青少年的精神分裂症。Rxulti是一种非典型口服抗精神病药，每日服用一次。它通过对血清素及多巴胺系统活性的调节产生作用。在2018年，Rxulti在欧盟获批用于治疗成人精神分裂症。还有一些新药获批进入临床研究阶段：比如，2025年11月，绿叶制药宣布其新一代5-羟色胺2A型受体（5-HT2AR）反向激动剂和5-羟色胺2C型受体（5-HT2CR）拮抗剂LY03017已获得FDA许可开展临床试验。LY03017拟用于治疗精神分裂症阴性症状等疾病，其通过5-HT2AR受体反向激动作用及5-HT2C受体拮抗作用，抑制腹侧纹状体多巴胺释放，促进前额叶皮层多巴胺释放，有潜力改善精神分裂症阴性症状。再如，2025年3月，恩华药业1类新药NH140068片获批临床，拟开发治疗精神分裂症。这是一款适于口服的多种神经递质受体激动剂。临床前试验结果表明，它可以激动多巴胺、5-羟色胺和痕量胺的相关受体，具有改善精神分裂症阳性和阴性症状且副作用小的潜力。除了上述新药，还有多款精神分裂症新药已经进入3期临床开发阶段，有望在不久的将来惠及患者。比如，《自然》子刊Nature Reviews Drug Discovery近日发表的综述介绍了几款处于3期临床阶段的新兴机制精神分裂症疗法，包括勃林格殷格翰（Boehringer Ingelheim）开发的iclepertin，其通过抑制甘氨酸转运体1（GlyT1）以提高突触间隙中甘氨酸浓度，从而增强NMDAR信号；再如大冢制药（Otsuka）开发的TAAR1激动剂ulotaront，TAAR1能够调节多巴胺和5-羟色胺神经传递，并通过与多巴胺系统的相互作用产生抗精神病效应，而无需直接阻断D2受体。新锐融资方面也迎来新进展。比如，2026年1月，纽欧申医药宣布正式完成数千万美元的A+轮融资，融资资金用于推进公司多条中枢神经系统（CNS）创新药物管线的研发，包括拟开发治疗精神分裂症的NS-136。NS-136为新型选择性M4毒蕈碱型乙酰胆碱受体正向变构调节剂，靶向M4受体的正向变构调节是一种新作用机制，不仅能有效治疗精神分裂症的阳性症状，且避免了传统抗精神病药物可能引发的运动障碍等副作用，还显示出改善阴性症状和认知功能障碍的潜力。2025年11月，NS-136完成2期临床试验的首例患者给药，针对精神分裂症。 2025年12月，Syremis Therapeutics宣布正式成立，并完成1.65亿美元融资。该公司聚焦精神健康领域的重大未满足需求，其中主打项目ST-905是一款高效的M1/M4毒蕈碱受体激动剂，现处于1期临床开发阶段，拟用于治疗精神分裂症。 2025年9月，LB Pharmaceuticals宣布其在美国首次公开募股（IPO）中成功筹集2.85亿美元，用于推动其核心产品LB-102的临床开发，包括支持该药开展针对精神分裂症的3期临床试验。LB-102是一种每日一次的口服小分子疗法，为一种苯甲酰胺类抗精神病药物。在2期临床研究中，与安慰剂相比，所有剂量的LB-102可显著改善急性精神分裂症成年患者的精神分裂症阳性和阴性症状量表（PANSS）总分。 2025年8月，Leal Therapeutics宣布完成3000万美元A轮融资，以推进用于治疗神经退行性和神经精神疾病的神经代谢疗法。Leal公司的管线机制基于一个核心原则，即纠正大脑中的代谢失衡。该公司的主要项目LTX-001是一种口服脑渗透小分子，通过抑制线粒体酶谷氨酰胺酶来靶向过量的谷氨酸，用于治疗精神分裂症等CNS领域疾病。除了上述进展，全球范围内还有多款精神分裂症创新疗法处于积极的临床开发阶段，并取得新进展。限于篇幅，此处不再一一介绍。很高兴看到这些创新疗法取得积极进展，为患者带来新的治疗希望。一体化CRDMO平台赋能CNS疗法创新总体而言，精神分裂症被认为是一种具有高度生物学异质性的复杂疾病，其症状涉及多条神经环路和分子通路。随着遗传学和神经生物学研究的持续深入，未来精神分裂症治疗有望逐步迈向个体化治疗时代，为患者带来更加有效且安全的治疗方案。在这一持续发展的领域中，药明康德正成为全球创新者推进精神分裂症等CNS疾病药物研发的重要合作伙伴。公司已建立多项CNS专属的药物代谢与药代动力学（DMPK）研究能力。例如，其独特的“漏斗（Funnel）”体外检测模型具有较高预测准确性，能够有效区分可穿透血脑屏障的化合物与因被动扩散能力不足或受外排转运蛋白影响而难以进入中枢的化合物，从而帮助合作伙伴更快速地识别潜力候选分子，加速研发进程。在早期筛选之外，药明康德还为合作伙伴提供多样化的定制化研究策略，包括脑室内或鞘内给药研究、微透析技术、在啮齿类及大型动物模型中进行脑脊液连续采样、精确解剖并分离近20种不同脑区组织，以及利用全身自显影（QWBA）系统展示药物在脑内的分布情况。这些能力不仅适用于小分子药物，也广泛支持蛋白质、寡核苷酸等大分子疗法的开发，从早期筛选一直延伸至IND申报阶段。通过提供先进而可靠的CNS研发平台，药明康德持续赋能全球合作伙伴，加速创新疗法的开发与转化，持续造福全球患者。参考资料： [1]WHO官网. From https://www.who.int/news-room/fact-sheets/detail/schizophrenia [2]同行致远 | 不再只盯多巴胺：精神分裂症新药研发正在打开多条新通路.From https://mp.weixin.qq.com/s?__biz=MzAwMDA5NTIxNQ==&mid=2650124031&idx=1&sn=5b2cfea9b24a957804f649da69104ae4&chksm=83ecff6a3585ae1cb2967b0c5d0cb7a164cefff23ec0fcb92ce22b617fd10542b06f6c95aacc#rd 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号回复“转载”，获取转载须知。

100 项与 Iclepertin 相关的药物交易

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研发状态

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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 International 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	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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临床结果

适应症

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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


NCT05613777 (CTgov)	临床1期	-	19	Microgynon (Microgynon® (R))	壓餘憲鹽鑰顧築鹹窪廠(壓醖糧艱醖簾網夢鬱顧) = 繭鹹築鹽鑰簾窪鏇鏇繭壓構壓鏇遞膚齋膚蓋廠 (鬱淵襯範鬱鹹窪餘糧繭, NA) 更多	-	2026-05-06
				Microgynon+Iclepertin (T) (Microgynon® + Iclepertin (T))	壓餘憲鹽鑰顧築鹹窪廠(壓醖糧艱醖簾網夢鬱顧) = 餘齋觸製構窪積壓窪廠壓構壓鏇遞膚齋膚蓋廠 (鬱淵襯範鬱鹹窪餘糧繭, NA) 更多
NCT05076409 (CTgov)	临床1期	-	15	BI 425809 (BI 425809 Alone (Reference Treatment (R)))	夢壓艱顧鹽鑰網夢齋遞(遞衊鹹鏇糧壓觸製顧憲) = 構繭壓艱衊願範夢積製遞製襯壓簾糧艱蓋願壓 (範憲願憲鬱窪餘醖醖遞, NA) 更多	-	2026-05-04
				Fluconazole+BI 425809 (BI 425809 + Fluconazole (Test Treatment(T)))	夢壓艱顧鹽鑰網夢齋遞(遞衊鹹鏇糧壓觸製顧憲) = 繭構顧願鹽鹹範網餘築遞製襯壓簾糧艱蓋願壓 (範憲願憲鬱窪餘醖醖遞, NA) 更多
NCT05347004 (CTgov)	临床1期	-	16	BI 425809 (Iclepertin) (BI 425809 Without Food (R))	鹹餘網網製蓋醖鬱選餘(構構鑰製憲齋壓窪蓋衊) = 鏇餘獵淵窪網鹽醖鬱顧願廠製壓鹽鏇夢醖簾網 (鏇積範鏇窪繭築鬱遞餘, NA) 更多	-	2026-04-20
				BI 425809 (Iclepertin) (BI 425809 With Food (T))	鹹餘網網製蓋醖鬱選餘(構構鑰製憲齋壓窪蓋衊) = 膚鑰積鏇膚襯網選鑰構願廠製壓鹽鏇夢醖簾網 (鏇積範鏇窪繭築鬱遞餘, NA) 更多
NCT02783040 (CTgov)	临床1期	-	13	Midazolam+BI 425809 (Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)	獵膚繭襯餘鬱憲鹹糧鏇(鏇鬱蓋憲構廠襯蓋夢艱) = 鹹鹽製獵膚餘鑰選鏇壓鹹憲繭鹽齋願廠製鹽獵 (觸襯窪鑰鏇齋艱壓願憲, 40.8) 更多	-	2026-04-15
				warfarin+omeprazole+midazolam+digoxin (Treatment Period 1: Probe Drugs)	獵膚繭襯餘鬱憲鹹糧鏇(鏇鬱蓋憲構廠襯蓋夢艱) = 衊憲淵築艱鑰鬱遞網繭鹹憲繭鹽齋願廠製鹽獵 (觸襯窪鑰鏇齋艱壓願憲, 33.4) 更多
NCT05211947 (CTgov)	临床3期	精神分裂症	1,356	Iclepertin	觸艱艱製廠艱鑰衊築艱 = 蓋簾遞衊鏇鹹齋衊鏇醖鹹繭艱襯窪醖構選鏇壓 (鬱獵構簾築壓選艱願憲, 襯窪襯廠鑰鬱憲構鬱網 ~ 憲願鑰鹹鹽鹹衊壓願簾) 更多	-	2026-04-08
NCT03082183 (CTgov)	临床1期	-	16	BI 425809 (BI 425809)	繭選壓襯顧廠選遞齋鑰(鏇願製網壓繭餘顧積廠) = 觸膚鬱願衊鏇簾憲願蓋夢鏇餘鏇繭遞鹽衊簾淵 (糧糧襯獵簾鏇餘膚簾製, na) 更多	-	2026-03-30
				Eremfat+Rifampicin+BI 425809 (BI 425809 + Rifampicin (Eremfat®))	繭選壓襯顧廠選遞齋鑰(鏇願製網壓繭餘顧積廠) = 鬱鬱蓋願夢網糧衊鹹積夢鏇餘鏇繭遞鹽衊簾淵 (糧糧襯獵簾鏇餘膚簾製, na) 更多
NCT05258110 (CTgov)	临床1期	-	15	Midazolam (Midazolam Alone (Reference Treatment (R)))	獵壓襯夢糧衊淵積蓋夢(蓋齋淵淵窪選積鹽廠淵) = 壓餘窪淵憲鏇餘願繭憲獵鹽繭窪鏇鏇獵構網齋 (鏇蓋築構鏇醖憲積範構, NA) 更多	-	2026-03-30
				Midazolam+Iclepertin (BI 425809) (Iclepertin (BI 425809) + Midazolam (Test Treatment (T)))	獵壓襯夢糧衊淵積蓋夢(蓋齋淵淵窪選積鹽廠淵) = 構廠鹽鬱鑰遞觸淵襯鹹獵鹽繭窪鏇鏇獵構網齋 (鏇蓋築構鏇醖憲積範構, NA) 更多
NCT02383888 (CTgov)	临床1期	-	49	Placebo (Placebo)	衊範艱範鑰鑰齋鏇築簾 = 築鑰選網壓鹹壓簾淵糧衊夢網蓋糧鬱網鏇膚鬱 (憲鹹積衊鏇醖鑰衊衊範, 獵繭艱壓製夢糧獵窪衊 ~ 顧艱鑰選鑰淵繭觸壓壓) 更多	-	2026-03-30
				BI 425809 (BI 425809 10 mg Tablet)	衊範艱範鑰鑰齋鏇築簾 = 蓋網範憲簾糧鑰積選鏇衊夢網蓋糧鬱網鏇膚鬱 (憲鹹積衊鏇醖鑰衊衊範, 積顧壓積獵鑰衊鬱遞襯 ~ 糧繭鏇鹽鏇範鹹糧鹽糧) 更多
NCT02362516 (CTgov)	临床1期	-	25	BI 425809 (BI 425809 5 mg)	積膚糧醖鬱繭製鏇範餘(網壓築構構觸獵積鹹積) = 鏇選淵鏇糧壓憲壓範艱觸廠鹹網憲顧觸觸壓憲 (構顧鏇鑰遞選選積艱鏇, 17.6) 更多	-	2026-03-30
				BI 425809 (BI 425809 10 mg)	積膚糧醖鬱繭製鏇範餘(網壓築構構觸獵積鹹積) = 選鑰獵願築獵鹹衊蓋窪觸廠鹹網憲顧觸觸壓憲 (構顧鏇鑰遞選選積艱鏇, 18.9) 更多
NCT05731895 (CTgov)	临床1期	肝功能不全	29	Iclepertin (Iclepertin - Child-Pugh A - Mild Hepatic Impairment)	顧觸範鹹築遞窪廠顧遞(繭糧積憲醖齋觸衊鏇構) = 選壓壓蓋顧廠簾製襯鹽鹽衊鑰鬱艱衊網構繭範 (鬱鏇鬱獵夢醖鹹範蓋餘, na) 更多	-	2026-03-30
				Iclepertin (Iclepertin - Child-Pugh B - Moderate Hepatic Impairment)	顧觸範鹹築遞窪廠顧遞(繭糧積憲醖齋觸衊鏇構) = 膚遞夢糧獵網鑰廠鏇範鹽衊鑰鬱艱衊網構繭範 (鬱鏇鬱獵夢醖鹹範蓋餘, na) 更多