A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia

The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor [SSRI] or serotonin-norepinephrine reuptake inhibitor [SNRI]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.

开始日期2024-09-19

申办/合作机构

Janssen Research & Development LLC

CTIS2023-510472-31-00 / Not yet recruiting

- 67953964MDD1010

开始日期2024-07-05

申办/合作机构-

NCT06514742 / Recruiting临床3期

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and an Open Label Long-term Extension Treatment With Aticaprant

The purpose of this study is to evaluate how well aticaprant works as compared with placebo when given along with an antidepressant therapy in improving the depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have not responded well to current antidepressant therapy with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).

开始日期2024-06-26

申办/合作机构

Janssen Research & Development LLC

100 项与 Aticaprant 相关的临床结果

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100 项与 Aticaprant 相关的转化医学

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100 项与 Aticaprant 相关的专利（医药）

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项与 Aticaprant 相关的文献（医药）

2024-10-01·JOURNAL OF AFFECTIVE DISORDERS

Preclinical and clinical efficacy of kappa opioid receptor antagonists for depression: A systematic review

Review

作者: Kwan, Angela T H ; Rosenblat, Joshua D ; Meshkat, Shakila ; Choi, Hayun ; Vasudeva, Shreya ; Cao, Bing ; Ho, Roger ; McIntyre, Roger S ; Teopiz, Kayla M ; Le, Gia Han ; Rhee, Taeho Greg ; Wong, Sabrina ; Phan, Lee

BACKGROUND:

Approximately 30 % of persons with Major Depressive Disorder (MDD) inadequately respond to conventional antidepressants. Kappa opioid receptor (KOR) antagonists, aticaprant and navacaprant, are in development as treatments for MDD. Herein, we aim to comprehensively evaluate the safety, efficacy and pharmacology of aticaprant and navacaprant for MDD.

METHODS:

We performed a systematic review of primary research investigating aticaprant and navacaprant on PubMed, OVID, and Scopus databases from inception to April 2024. Studies that reported on the pharmacological profile and/or safety and efficacy of aticaprant and navacaprant were included.

RESULTS:

Navacaprant monotherapy and aticaprant adjunctive therapy are in development for MDD. Navacaprant exhibits 300-fold selectivity for the KOR compared to the mu-opioid receptor, while aticaprant exhibits 30-fold selectivity. At clinically-relevant doses, navacaprant and aticaprant occupy 87-95 % and 73-94 % of KORs, respectively. Clinical trials of the foregoing agents (navacaprant as monotherapy and actiprant as adjunctive therapy) reported significant improvement in depressive symptoms and may clinically benefit measures of anhedonia. Both agents appear well-tolerated, with most adverse events mild and no known safety concerns.

LIMITATIONS:

Aticaprant and navacaprant treatment for MDD are in early stages of clinical trials and results from Phase 3 pivotal trials are not yet available.

CONCLUSIONS:

Kappa opioid receptor antagonists may serve as mechanistically-novel treatments for MDD and persons who inadequately respond to index conventional antidepressants. Anhedonia is debilitating and insufficiently treated with conventional antidepressants. Future research vistas should establish the efficacy and safety of KORAs in phase 3 studies in both acute and maintenance paradigms.

2024-08-01·Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology

Efficacy and safety of aticaprant, a kappa receptor antagonist, adjunctive to oral SSRI/SNRI antidepressant in major depressive disorder: results of a phase 2 randomized, double-blind, placebo-controlled study

Article

作者: Canuso, Carla M ; Fava, Maurizio ; Popova, Vanina ; Drevets, Wayne C ; Pemberton, Darrel J ; Kezic, Iva ; Mareels, Guy ; Melkote, Rama ; Van Der Ark, Peter ; Schmidt, Mark E

Abstract:

This was a double-blind, randomized, phase 2 study of adults (18–64 years) with DSM−5 diagnosis of major depressive disorder (MDD), with moderate-to-severe episode severity (Montgomery–Åsberg Depression Rating Scale [MADRS] ≥25) despite an adequate course with ongoing antidepressant for ≥6 weeks to ≤12 months. Following a double-blind placebo lead-in period (up to 3 weeks), participants were randomized to receive once daily aticaprant 10 mg or continue placebo, added to their ongoing treatment, for 6 weeks. Of 184 participants enrolled, 169 were included in safety analyses (aticaprant n = 85, placebo n = 84) and 166 in full intent-to-treat (fITT) efficacy analyses; 121 placebo lead-in non-responders (<30% reduction in MADRS total score) in fITT were included in enriched ITT (eITT) analyses. Improvement (least squares mean difference [upper limit 1-sided 80% CI] versus placebo) in MADRS total score at week 6 for aticaprant was significant versus placebo (eITT: −2.1 [−1.09], 1-sided p = 0.044; effect size (ES) 0.23; fITT −3.1 [2.21], 1-sided p = 0.002; ES 0.36). The between-group difference was larger among participants with Snaith–Hamilton Pleasure Scale (SHAPS) score greater/equal to versus less than baseline median SHAPS. The most common treatment-emergent adverse events reported for aticaprant (versus placebo) were headache (11.8% versus 7.1%), diarrhea (8.2% versus 2.4%), nasopharyngitis (5.9% versus 2.4%), and pruritus (5.9% versus 0%). One participant (1.2%) in each arm discontinued treatment due to an adverse event. In this study of participants with MDD and inadequate response to SSRI/SNRI, adjunctive treatment with aticaprant significantly reduced depressive symptoms versus placebo, without resulting in significant safety signals, supporting further investigation in larger trials.

2024-07-02·EXPERT OPINION ON EMERGING DRUGS

Aticaprant: (a κ-opioid receptor antagonist) for major depressive disorder

Review

作者: Young, Allan H. ; Jelen, Luke ; Hampsey, Elliot

INTRODUCTION:

Major depression is a common, disabling mental health condition associated with the highest disease burden for any neuropsychiatric disorder worldwide, according to the WHO. Due to the imperfect efficacy and tolerability profiles of existing treatments, investigational compounds in novel treatment classes are needed. Opioid-receptor antagonists are a potential new class of treatments currently under investigation.

AREAS COVERED:

Major depressive disorder is first overviewed. Existing treatments, both their mechanisms of action and their place within the antidepressant space, are discussed herein. Then, the profile of Aticaprant and the wider context of kappa-opioid antagonism for depression are discussed in focus.

EXPERT OPINION:

Early evidence indicates that Aticaprant may possess desirable pharmacodynamic and pharmacokinetic properties. A lack of convincing efficacy data at the time of writing precludes any definitive statement on its potential as an antidepressant.

项与 Aticaprant 相关的新闻（医药）

2024-10-15

·Endpoints

J&J trims pipeline, including two mid-stage neuroscience studies

Johnson & Johnson cut a handful of trials across its portfolio in the third quarter, including a Phase 2 study of a touted neuroscience treatment. Missing in the company’s updated pipeline list is a trial testing seltorexant in patients with probable Alzheimer’s disease who have clinically significant agitation or aggression. Earlier this year, the trial record in a US database was updated from “still recruiting patients” to “completed.” Additional cuts to the neuroscience pipeline include a Phase 2 bipolar treatment targeting the P2X7 receptor, and a Phase 1 treatment for Parkinson’s disease, JNJ-0376. An early-stage psoriasis candidate was also culled. In the oncology unit, J&J ended a Phase 3 study of Imbruvica as a treatment for relapsed or refractory patients with mantle cell lymphoma in combination with venetoclax. “We regularly prioritize programs in our portfolio to ensure sustainable delivery of transformative medicines to patients with unmet needs,” a spokesperson said. Seltorexant had a positive readout earlier this year as an adjunctive treatment for patients with both major depressive disorder and insomnia. The company has included the asset among its future blockbusters , estimating between $1 billion to $5 billion in potential revenue. Driving those projections is the anticipated launch in patients with depression, as opposed to treating Alzheimer’s agitation or aggression. Elsewhere, J&J no longer included fellow adjunctive MDD treatment aticaprant on the list of assets with expected 2024 readouts, though a spokesperson clarified that Phase 3 data are expected “to be available in house” by the end of the year. Editor’s note: This story was updated with a response from a Johnson & Johnson spokesperson on the timeline for Phase 3 data of aticaprant.

临床2期临床3期

2024-09-16

·FiercePharma

Bridging research and clinical care in a new era of psychiatry

None By Dr. L. Alison McInnes and Jimmy QianWe’re finally moving towards a causality-based nosology for psychiatry: specific symptoms with defined biological underpinnings can now be targeted by new therapies. But how do we bridge clinical development with real-world care? How do we ensure trial endpoints are synchronized with real-world measures, payer requirements, and clinical society guidelines? Below, we dig into the widening gap between research and clinical care. No consensus on how to measure transdiagnostic symptomsExcitingly, researchers have been able to characterize underlying neural circuitry for certain symptoms. The NIMH Fast-Fail Trials initiative, which stipulated that a drug candidate should alter a biomarker in an objectively measurable fashion, accelerated this movement. For anhedonia, investigators identified ventral striatum abnormalities during reward anticipation that normalized in response to kappa opioid receptor (KOR) antagonists. Despite this advancement, there has yet to be consensus on how to measure anhedonia in the clinic. Many clinicians do not practice measurement-based care, and even amongst those who do, measurement of anhedonia is typically confined to the first question of the PHQ-9. Moreover, anhedonia is a transdiagnostic symptom that should be measured across multiple diagnoses, not just depression.Progress has also been made in elucidating the neurocircuitry of cognition in depression. Leanne Williams’ group has identified biotypes with distinct fMRI signatures and associated cognitive abnormalities that may predict differential response to treatment. Meanwhile, Alto Neuroscience is developing cognitive profiling tools to subtype patients for enriched response to its pipeline agents. However, there is no consensus approach to measure cognition in the real-world. Furthermore, tools for characterizing cognitive deficits in depression do not necessarily capture the deficits observed in other disorders. Today, real-world clinicians often miss subtle but disabling cognitive symptoms for lack of appropriate measurement tools.Researchers have made additional advancements in precision measurement spanning EEG, fMRI, digital phenotyping, proteomics, and more. Yet as research progresses, the gap to real-world care widens. New mechanisms of action require more from cliniciansNovel mechanisms of action are also being developed, often enabling precise targeting of pharmacotherapies to specific symptoms. Continuing the anhedonia example, the phase 3 KOR antagonists aticaprant and navacaprant leverage the fact that elevated levels of dynorphin, which activates KORs, are associated with stress, anhedonia, and dysregulation of reward processing.Seltorexant, a selective orexin-2 receptor antagonist, is being studied specifically for depression with insomnia symptoms. Xanomeline-trospium, a dual M1/M4 muscarinic agonist, has shown promise in treating positive, negative, and cognitive symptoms of schizophrenia, with scientists speculating that dual agonism confers broad activity while M1 agonism may be more involved in cognitive improvements.Additional novel mechanisms are being studied or have been recently approved, spanning NMDA and AMPA receptor modulators, dual orexin receptor antagonists, 5HT2a receptor antagonists, GABAA receptor modulators, digital therapeutics, and more. New treatment options coupled with the complexity of treatment pathways and symptom clusters mean clinicians will need to know how to prioritize different mechanisms, measure success, and monitor side effects.Most patients have constellations of symptoms, so how are clinicians to make decisions about which to treat first with these targeted therapies? A hospitalist has objective physiological measures to help prioritize interventions to stabilize an inpatient; similarly, psychiatrists need novel objective measures to select the best treatment pathway for individual patients. Diagnosing and measuring previously untreatable conditions is a challengeIt is wonderful to see therapies for hitherto untreatable indications. Tardive dyskinesia is an example of a historically-neglected condition as there were no effective therapeutics. Why should clinicians and patients spend time measuring symptoms if there is no solution? Though valbenazine and deutetrabenazine have recently been approved for tardive dyskinesia, it is under-diagnosed in the real-world. The symptom measures used in trials are not typically used – or even known – by real-world clinicians. Similar dynamics exist for negative symptoms of schizophrenia, cognitive impairment, and other conditions. Our solution: a Learning Health SystemWe appreciate an analogy by one of the leaders of precision psychiatry, “You wouldn't want to launch electric vehicles without building an EV charging network first.” With breakthroughs in drug development comes an increased need for connectivity across biopharma, regulators, clinicians, payers, and clinical societies.At Osmind, our Learning Health System approach lowers barriers between research and patient care. By building consensus around the same precision measurements, we align evidence goalposts and generate cohorts of well-characterized patients for research. We deploy these measures directly at the point of care through our technology and EHR. Our collaboration with the American Psychiatric Association is an example of this approach.“As we advance in understanding the biological underpinnings of mental illness, an important challenge – and opportunity – will be to ensure that these insights translate into improvements in patient care,” says Husseini Manji, MD, a Strategic Advisor at Osmind. “We must work collaboratively across sectors to create a seamless integration of precision diagnostics and targeted therapeutics into everyday practice and real-world outcomes.”

临床3期临床2期

2024-09-12

·药精通Bio

全球在研小分子抗抑郁症新药盘点

Apimostinel CAS : 1421866-48-9 机理：NMDA受体部分激动剂状态：II期（IV）和I期（口服）临床试验开发者：Allergan 也称为NRX-1074，是一种最初由Naurex开发的用于治疗抑郁症的药物-但目前正在由Naurex和Allergan（收购Naurex）共同研究。该药物对NMDA受体具有选择性的部分激动剂的功能，特别是在甘氨酸结合位点的变构位点。虽然Apimostinel表现出GLYX-13（另一种正在由Naurex开发的药物）相似的作用机制，但它与GLYX-13的不同之处在于其重量更显着。一项比较分析表明，按重量计，Apimostinel的效力是GLYX-13的数千倍。之前我已经讨论了使用NRX-1074来治疗抑郁症的潜在好处，并提到它起效快，没有拟精神病作用并且似乎耐受良好。初步证据表明，服用Apimostinel后，抑郁症状可能在24小时内消失。此外，Apimostinel的情绪增强作用似乎是剂量依赖性的，因此更高剂量的抗抑郁作用更为明显。值得一提的是，在早期试验中，单剂量的Apimostinel提供的缓解抑郁症状的症状要比SSRIs持续数周的缓解率更高。 BTRX-246040 CAS : 1307245-86-8 机理: NOC 受体拮抗剂状态: Phase II 开发者: BlackThorn Therapeutics 该药物最初由礼来公司进行研究，但现在似乎与黑刺李疗法联系在一起，并有了一个新的化学名称。2016年发表的一项概念验证研究报告称，LY-2940094(40毫克)是安全的，耐受性好，对治疗人类抑郁症有效——持续时间超过8周。它作为一种抗抑郁药物的初步疗效通过格里-汉密尔顿抑郁评分量表(GRID-Hamilton Depression Rating scale)从基线到8周的17个总分的显著变化得到证明。此外，研究还发现LY-2940094在治疗的第一周内改变了对情绪刺激的处理——在情绪测试系列中，对积极面部表情相对于消极面部表情的认知增强就是证据。LY-2940094的初步调查数据是第一批显示NOP受体拮抗剂治疗抑郁症的潜力的数据。关于BTRX-246040是否将继续用于治疗重度抑郁症，还是将其作为治疗其他神经系统疾病的治疗手段而接受调查，还存在一些争议。然而，与大多数抗抑郁药物相比，BTRX-246040表现出独特的作用机制。拮抗NOC受体似乎能增加大脑几个区域的单胺浓度，增强神经发生，并调节下丘脑-垂体-肾上腺轴的激活。 CERC-301 CAS : 808732-98-1 机理: NMDA 受体 (NR2B-selective) 拮抗剂状态: Phase II 开发者: Cerecor 2013年，FDA授予CERC-301“快速通道指定”，作为抑郁症和自杀意念的潜在辅助治疗药物。药效学研究表明，CERC-301对NMDA受体NR2B亚基具有高选择性拮抗作用。它对NMDA受体NR2B亚基的选择性亲和性被认为可以最大限度地降低与其他非选择性NMDA受体拮抗剂共同发生的拟精神分裂效应(如药物诱导的精神病)的可能性。 CERC-301的显影剂Cerecor表明，CERC-301具有快速的抗抑郁活性，从而在给药几分钟或几小时内就能缓解抑郁症状，而不是几天或几周。来自CERC-301试验的初步数据表明，该药物耐受性良好且安全。许多人认为，CERC-301是正在开发的治疗抑郁症的NMDA拮抗剂中最有前途的。 CERC-501 CAS : 1174130-61-0 机理: KOR 拮抗剂状态: Phase III 开发者: Janssen CERC-501是美国礼来公司首次研发的药物，名为LY-2456302。然而，在2015年2月，礼来公司将LY-2456302卖给了Cerecor公司，后者将其更名为CERC-501。2016年，CERC-501作为一种抗抑郁II期临床试验难治性抑郁症患者达到效果。截至2017年8月，Cerecor将CERC-501出售给了Janssen Pharmaceuticals，后者正在继续开发其作为抑郁症的辅助疗法和药物滥用障碍的干预疗法。药效学评估显示，CERC-501是一种选择性的、短效的KOR (kappa阿片受体)拮抗剂。研究表明，激活kappa类阿片受体(KORs)会引发烦躁、幻觉和精神幻像效应——同时也会强化神经化学系统，与奖赏缺乏综合症、慢性压力和重度抑郁症有关。用CERC-501拮抗kappa阿片受体(KOR)可能通过抵消已有的kappa阿片受体激活而促进抗抑郁效果。CERC-501与其他抗抑郁药(如SSRIs)联合使用可产生协同情绪增强作用(或比单独使用任何一种药物效果更好)。有报道称，在三期临床试验中，CERC-501的副作用不严重。 Liafensine (DB104) CAS:1198790-53-2 机理: SNDRI 状态: Phase II 开发者: Denovo Biopharma Liafensine (DB104)，原名BMS-820836，是一种SNDRI(5 -羟色胺-去甲肾上腺素-多巴胺再摄取抑制剂)或三层再摄取抑制剂，最初由AMRI开发，授权给百时美施贵宝治疗重度抑郁症。通过二期临床试验，该药物表现出与依西酞普兰(即依地普仑)和度洛西汀(即欣百达)相似的疗效。但百时美施贵宝终止其开发，主要原因是其疗效并不明显优于依地普乐和欣百达。它的疗效相对于副作用和滥用潜力可能是Liafensine 被百时美施贵宝停止开发的原因。2017年，Denovo Biopharma获得了Liafensine的许可权，三重再摄取抑制剂的二期临床试验仍在继续。 JNJ-39393406 CAS : 953428-73-4 机理: Alpha-7 nAChR 调制器状态: Phase II 开发者: Janssen JNJ-39393406用于治疗重度抑郁症和戒烟。与目前市场上大多数抗抑郁药相比，JNJ-39393406的独特之处在于，它仅作为-7烟碱乙酰胆碱受体的选择性正变构调制器(PAM)。药效学研究表明，该药物不会与-4-beta-2或-3-beta-4尼古丁乙酰胆碱受体或- 5-HT3受体相互作用。更重要的是，药物似乎并没有与62种受体和酶相互作用。截至2018年2月，JNJ-39393406正在进行治疗重度抑郁症和尼古丁戒断的II期临床试验。JNJ-39393406以前被研究作为阿尔茨海默病和精神分裂症的干预措施，但是，经评估后被放弃了。 Ansofaxine (LY03005) CAS : 916918-84-8 机理: SNDRI 状态: Phase I 开发者: 绿叶制药盐酸Ansofaxine(LY03005)是绿叶制药集团开发的用于治疗中重度抑郁症的三重摄取抑制剂(5 -羟色胺-去甲肾上腺素-多巴胺)。对Ansofaxine的药效学评价表明，它具有SNDRI的作用，是去文拉法辛的前药。然而，与去文拉法辛(即Pristiq)相比，Ansofaxine在同时调节血清素和去甲肾上腺素的同时，具有显著的多巴胺能效应。到目前为止，Ansofaxine已经在两个人体试验中进行了评估，分别有72名和48名参与者。从现有的I期试验数据来看，Ansofaxine在40毫克至160毫克的剂量下似乎具有良好的耐受性和安全性。绿叶制药集团认为，与目前市面上的抗抑郁药相比，这种新药的副作用更少，起效更快。 MIN-117 CAS : 310392-93-9 机理: SDRI 状态: Phase II 开发者: Minerva Neurosciences MIN-117是一种血清素-多巴胺调制器，由Minerva神经科学公司开发用于治疗重度抑郁症。其作用机制针对受体和转运体的结合，包括:α- 1a受体;α-1B受体;5-HT2A受体;SERT(羟色胺转运体);和DAT(多巴胺转运体)。具体来说，MIN-117被证明是一种5-HT1A和5-HT2A拮抗剂;血清素和多巴胺再摄取抑制剂;α- 1a和α- 1b肾上腺素能受体调节剂。 Minerva神经科学提示MIN-117旨在解决重性抑郁症伴有共病焦虑或焦虑症状的患者的未控制症状。开发人员推测MIN-117将比目前市场上的大多数抗抑郁药物反应更快、更安全、耐受性更好。目前MIN-117作为干预抑郁症的临床试验正处于II期。 Seltorexant (MIN-202) CAS : 1293281-49-8 机理: Orexin-2 拮抗剂状态: Phase II (complete) 开发者: Minerva Neurosciences & Janssen Seltorexant，又称MIN-202 (Minerva)和JNJ-42847922或JNJ-922 (Janssen)，是一种正在研究中的小分子、选择性orexin受体拮抗剂，由Minerva神经科学和Janssen开发。临床试验正在评估Seltorexant对重度抑郁症和失眠的治疗效果。据开发人员介绍，Seltorexant可以阻断大脑中促进觉醒的神经元的激活，特别是通过与orexin 2 (Orx-2)受体结合。 NSI-189 CAS : 1270138-40-3 机理: 神经发生诱导物状态: Phase III (?) 开发者: Neuralstem Inc. NSI-189是由Neuralstem公司开发的一种实验性药物，用于治疗重度抑郁症、认知障碍和神经退行性疾病。NSI-189是通过超过10000个化合物筛选，以确定哪些在体外(细胞)诱导最大程度的神经发生。NSI-189在体外和啮齿类动物中都表现出了疗效，随后将在患有重度抑郁症的人身上进行测试。在II期临床试验中，NSI-189通过降低220名重性抑郁症患者的MADRS评分而未能达到其主要终点。NSI-189仍将继续接受神经系统和中枢神经系统疾病的治疗评估，包括:神经病、缺血性中风和认知障碍。 Rapastinel (GLYX-13) CAS : 117928-94-6 机理: NMDA 受体调制器状态: Phase III 开发者: Allergan Rapastinel(原名GLYX-13)是Allergan公司开发的一种药物(在收购Allergan之前由Naurex公司进行测试)，作为治疗耐药性抑郁症(或对2种或2种以上一线干预无效的抑郁症)的辅助干预手段。这种药物在口服时是不活跃的，而在静脉注射时是特别设计的。它在NMDA受体复合物的甘氨酸亚基的变构位点起选择性、适度的局部激动剂(混合拮抗剂/激动剂)的作用。初步证据表明Rapastinel作用快速，并产生长期的抗抑郁反应。此外，Rapastinel似乎是通过抑制和增强NMDA受体介导的信号转导而增强认知功能的。无论动物年龄多大，给动物服用Rapastinel能增强记忆和学习能力，还能促进神经保护作用。 Rapastinel被归类为一种glyxin化合物，来源于修改单克隆抗体的结构，调节NMDA受体，称为“B6B21”。基于初步的试验数据，Rapastinel是治疗难治性抑郁症最有希望的治疗手段之一。 SAGE-217 CAS : 1632051-40-1 机理: GABAA受体调制器状态: Phase III 开发者: Sage Therapeutics Sage -217是由Sage Therapeutics公司研发的一种研究性化学药物，用于治疗重度抑郁症和产后抑郁症，以及帕金森病、失眠和癫痫的原发性震颤。据Sage Therapeutics公司介绍，Sage -217是一种合成的孕烷神经类固醇，它是GABAA受体的一种正变构调制器。SAGE-217的目标是改进并继承Brexanolone ——另一种圣人治疗抑郁症的药物，目前已进入临床试验阶段。在用于治疗女性产后抑郁症(PPD)患者的3期试验ROBIN中，达到了试验的主要和次要终点。重症抑郁三期失败。 Travivo (Gepirone ER) CAS:83928-66-9;83928-76-1 机理: 5-HT1A 选择性部分激动剂状态: 等待 FDA 批准开发者: Fabre-Kramer Pharmaceuticals Travivo (Gepirone ER)是一种抗抑郁药物，最初因疗效问题被FDA多次拒绝。它第一次被否决是在2004年，然后在2007年再次被否决。FDA在2015年审查了Gepirone的数据，推翻了他们最初对该药物的排斥——给予了有利的评价。2016年3月FDA对Travivo (Gepirone ER)治疗重度抑郁症的疗效进行了有利的规定。参考原文：30+ New Antidepressants (2018): Drugs In Clinical Trials TIS2024第四届自免疾病细胞疗法与干细胞疗法论坛重磅来袭，点击图片查看重磅嘉宾，合作详询：王晨 180 1628 8769 （扫码立即报名获取TIS2024免费票）

临床2期快速通道临床1期并购

100 项与 Aticaprant 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11831	Aticaprant	-	DB12341

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适应症	最高研发状态	国家/地区	公司	日期
快感缺乏	临床3期	美国	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	阿根廷	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	澳大利亚	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	比利时	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	巴西	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	保加利亚	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	捷克	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	匈牙利	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	意大利	Janssen Research & Development LLC	2022-06-22
快感缺乏	临床3期	波兰	Janssen Research & Development LLC	2022-06-22

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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


NCT03559192 (CTgov)	临床2期	重度抑郁症	181	placebo+JNJ-67953964 (Double-blind Treatment + Withdrawal Period: Placebo)	繭鹽鹹築膚顧範淵壓繭(醖觸艱範廠窪簾鬱衊糧) = 淵夢繭遞顧積獵遞鏇構醖繭繭顧鏇壓糧糧醖築 (製衊艱築築鹽鹽網餘夢, 壓鏇簾廠廠鬱鏇築窪鑰 ~ 膚顧艱鑰淵鏇膚網糧獵) 更多	-	2023-06-26
				JNJ-67953964 (Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg))	繭鹽鹹築膚顧範淵壓繭(醖觸艱範廠窪簾鬱衊糧) = 鹹鑰構範鏇構夢鏇淵鑰醖繭繭顧鏇壓糧糧醖築 (製衊艱築築鹽鹽網餘夢, 醖糧憲窪鹽製遞憲膚糧 ~ 鑰鹽簾遞艱蓋壓範顧膚) 更多
NCT02800928 (CTgov)	临床2期	吸烟	17	CERC-501 (CERC-501)	鑰鑰獵鹽醖構廠壓淵夢(網築鏇願壓積膚齋憲夢) = 壓齋鹽網獵積製鹹蓋願窪艱構夢衊繭遞憲積衊 (醖廠製蓋鑰鏇範鹹鏇顧, 製壓壓鑰願網獵膚選鹹 ~ 鹽廠襯憲構餘獵襯構夢) 更多	-	2019-08-13
				Placebo (Placebo)	鑰鑰獵鹽醖構廠壓淵夢(網築鏇願壓積膚齋憲夢) = 淵範衊遞繭醖衊壓範衊窪艱構夢衊繭遞憲積衊 (醖廠製蓋鑰鏇範鹹鏇顧, 餘艱餘選選壓淵鑰蓋網 ~ 夢積膚憲廠糧鏇範鬱觸) 更多
NCT02218736 (FASTMAS_Kor2, CTgov)	临床2期	恐怖症	163	CERC-501 (CERC-501)	齋糧襯壓製鹽廠衊壓淵(淵襯醖餘鬱醖廠網選網) = 製鹹廠醖遞願鹹鹹廠廠網範糧製襯簾選網齋襯 (積衊艱範鏇範憲淵衊艱, 蓋餘構範襯蓋窪壓鹹鏇 ~ 鬱憲淵衊網鏇醖蓋憲鏇) 更多	-	2019-01-08
				placebo (Placebo)	齋糧襯壓製鹽廠衊壓淵(淵襯醖餘鬱醖廠網選網) = 膚淵衊醖膚鏇構網蓋繭網範糧製襯簾選網齋襯 (積衊艱範鏇範憲淵衊艱, 夢襯觸遞艱淵選膚衊淵 ~ 淵網網簾糧積鏇醖積醖) 更多
NCT01913535 (Corporate Publications) 人工标引	临床2期	难治性抑郁症	8	CERC-501	範廠網網觸簾廠淵製餘(蓋廠鏇簾襯製繭鏇鹽獵) = 50% or greater reduction 衊廠醖膚構艱齋衊艱製 (觸衊築鏇獵窪糧壓觸遞 ) 更多	积极	2017-05-01
				Placebo
NCT02641028 (PipelineReview) 人工标引	临床2期	尼古丁依赖辅助	71	Aticaprant	糧襯衊憲醖觸積獵選選(顧壓醖鹹鬱壓鑰鏇鹽糧) = not achieve improvement objectives compared to placebo 願憲蓋廠鑰築構範遞餘 (糧觸膚顧鏇積鏇願襯繭 ) 更多	不佳	2016-12-05
				Placebo