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临床1期

- 67953964MDD1010

开始日期2024-07-05

申办/合作机构-

NCT06514742

/ Active, not 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）

2025-03-01·PCN reports : psychiatry and clinical neurosciences

Anhedonia: Current and future treatments

Review

作者: Serretti, Alessandro

Abstract:

Anhedonia is a transdiagnostic domain that leads to poor disorder outcome and low remission rates. This narrative review describes a broad range of interventions targeting anhedonia, including pharmacological, neuromodulatory, behavioral, and lifestyle‐based approaches. Drugs such as vortioxetine, agomelatine, bupropion, ketamine, and brexpiprazole show promising anti‐anhedonic effects, while traditional antidepressants, such as serotonin‐norepinephrine reuptake inhibitors (SNRIs) and, even more so, selective serotonin reuptake inhibitors (SSRIs), are less effective. Neuromodulation techniques, including repetitive transcranial magnetic stimulation, transcranial direct current stimulation, and transcutaneous auricular vagus nerve stimulation, proved effective at improving anhedonia, particularly when used in targeted areas. Psychotherapeutic interventions, including behavioral activation, mindfulness‐based strategies, and savoring techniques, also help re‐engage patients with pleasurable activities and enhance positive affect. Innovative treatments, such as aticaprant and psilocybin, showed promising results. Substantial evidence suggests that improving anhedonia leads to better psychosocial functioning, quality of life, and sustained remission. Although most data come from short‐term studies, several long‐term analyses suggest that maintaining hedonic improvements is feasible and beneficial. The reviewed evidence underscores the importance of routine assessment of anhedonia and the integration of symptom‐specific strategies. Tailoring interventions to address individual patterns of reward disruption may optimize outcomes for patients with anhedonia.

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.

项与 Aticaprant 相关的新闻（医药）

2025-03-14

·医药健闻

飞诺美中国研发中心落户天津；强生一周内放弃两款新药研发项目；复星医药控股子公司拟1.24亿美元出售资产 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态全球色谱创新企业飞诺美(Phenomenex)宣布，其中国研发中心正式落户天津。作为丹纳赫中国生命科学平台的一员，艾杰尔-飞诺美始终坚定推动丹纳赫“创升中国”的战略目标。中国研发中心的成立是飞诺美在华发展的重要里程碑，未来飞诺美中国将全面布局色谱产品的研发管线并加快国产化生产进程，更将深度融合中国供应链与天津生产基地的品控优势，打造“中国智造+中国速度”的创新新模式。中国平安已与日本盐野义制药(Shionogi)终止了合资协议，但平安的股权投资不受影响，仍为盐野义制药股东。平安盐野义有限公司发生股权变更，中国平安人寿保险股份有限公司退出股东行列，平安盐野义成为盐野义(香港)有限公司全资子公司。此前，平安盐野义的股东情况为：平安人寿持股49%，盐野义(香港)有限公司持股51%。 2025中国医学装备大会暨医学装备展览会启幕，美敦力展出近80款全球创新产品，覆盖心脏及血管健康、外科、骨科与神外、神经介入等领域。其中包括：美敦力全球首款将除颤电极导线植入胸骨下的血管外植入式心律转复除颤器Aurora、零金属人工心脏瓣膜Avalus、Symplicity Spyral RDN系统、第四代经导管主动脉瓣置换系统Evolut PRO+。美敦力还将举办PulseSelect一次性使用心脏脉冲场消融导管的中国上市会，并在中国首展Sonicision 7弯钳口无线超声刀。此外，脊柱手术机器人Mazor XC、擎航EngineNav骨科手术导航系统、NIM-Eclipse术中神经监测系统等本土智造产品也将亮相。印度亿万富豪迪利普·桑哈维（Dilip Shanghvi）控股的太阳制药宣布达成协议，以3.55亿美元收购总部位于美国的免疫疗法和肿瘤治疗公司Checkpoint Therapeutics。太阳制药将以每股4.10美元的现金对价收购这家总部位于马萨诸塞州公司的流通股。本次收购进一步丰富太阳制药在肿瘤皮肤病治疗领域的创新产品布局。该交易预计将于今年6月前完成。复星医药公告称，3月13日，公司控股子公司复星实业与Calcite Gem签订《股份转让协议》，复星实业拟以现金1.24亿美元的对价向Calcite Gem转让其所持有的标的公司（其主要资产系其通过其控股子公司NFH持有及运营的“和睦家”医院和诊所）940万股普通股，约占标的公司股份总数的6.6%。本次交易完成后，本集团将不再持有标的公司股权。如本次交易完成，预计将为本集团贡献税后收益人民币约6.5亿元（未经审计）。华润三九发布2024年度报告，公司去年全年实现营收276.17亿元，同比增长11.63%；归母净利润33.68亿元，同比增长18.05%。具体业务上，自我诊疗(CHC)业务板块为公司贡献营收124.82亿元，处方药实现营收40.06亿元，传统国药(昆药)实现营收52.13亿元。 Ascend Advanced Therapies宣布，任命John Chiminski和Karen Flynn担任董事会非执行董事。John将担任董事会主席，而EW Healthcare Partners已指派Karen作为其代表在公司董事会任职。他们的领导力和深厚的行业专业知识将在Ascend提升能力、实现增长的过程中发挥关键作用。产业动态强生在一周内放弃了两款新药研发项目。3月10日，Genmab宣布强生决定不再行使HexaBody-CD38（GEN3014）的全球开发和商业化选择权。GEN3014是新一代的CD38特异性IgG1单抗，结合了Genmab专有的HexaBody技术，旨在通过高效的CDC和其他Fc介导的效应功能诱导抗肿瘤活性。3月7日，强生停止了其在研药物aticaprant用于治疗重度抑郁症（MDD）的3期项目，原因是“疗效不足”。不过该公司指出，aticaprant安全性良好、耐受性佳，未来会探索其在其他未被满足医疗需求领域的开发机会。罗氏（Roche）宣布伊那利塞片在中国获批上市，联合哌柏西利和氟维司群，适用于内分泌治疗耐药（包括在辅助内分泌治疗期间或之后出现复发）、PIK3CA突变、激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的局部晚期或转移性乳腺癌成人患者。伊那利塞片（inavolisib，GDC-0077）是一款靶向PI3Kα突变体的选择性抑制剂。百奥泰的戈利木单抗注射液的上市申请已获受理，该药是国内首个申报上市的戈利木单抗生物类似药。戈利木单抗原研药为强生Simponi，系一种TNF-α单抗，目前该药已在我国获批类风湿性关节炎和强直性脊柱炎两项适应症。2024年，Simponi为强生带来了21.90亿美元收入。目前，国内仅百奥泰一家布局戈利木单抗生物类似药。 Pierre Fabre Laboratories与RedRidge Bio宣布达成独家研发合作与许可协议，旨在发现并开发针对多个靶点的双表位抗体（BPA）候选药物。RedRidge将负责对双方共同选定的未公开靶点进行BPA的工程设计、筛选与表征，而Pierre Fabre Laboratories将凭借其药物开发专长，推动两个联合开发项目进入临床开发阶段。此次合作将聚焦精准肿瘤学、皮肤病学及罕见疾病领域的治疗。沙特国家医疗集采公司（NUPCO）正式公布公立医院三年期外送检测服务集中采购项目中标结果。华大基因沙特合资公司Genalive中标9.5亿元订单。这是Genalive在沙特迄今最大的一笔外送检测服务订单。石药集团开发的SYH2051已获得美国FDA批准可以在美国开展临床研究。该产品为集团自主研发的化药1类新药，选择性靶向抑制ATM蛋白激酶及其下游信号蛋白CHK2和KAP1的磷酸化，延迟DNA双链断裂修复，导致持续的DNA双链断裂和ATM介导的细胞周期阻滞，从而抑制肿瘤细胞增殖。本次获批适应症为晚期实体瘤。联系美通社 +86-10-5953 9500 info@prnasia.com

并购免疫疗法

2025-03-13

·生物制品圈

强生：连续放弃两款新药研发项目

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 2025年以来，有多款重磅新药研发被终止。其中，强生在一周内放弃了两款新药研发项目。 3月10日，Genmab宣布强生决定不再行使HexaBody-CD38（GEN3014）的全球开发和商业化选择权。消息出来后，Genmab股价下跌7.8%。来源：企业官网 GEN3014 是新一代的 CD38 特异性 IgG1 单抗，结合了 Genmab 专有的 HexaBody 技术，旨在通过高效的 CDC 和其他 Fc 介导的效应功能诱导抗肿瘤活性。来源：企业官网 2019 年 6 月，Genmab 和强生就 GEN3014 达成全球许可和选择权协议。根据协议，Genmab需完成概念验证临床研究后，强生可选择支付1.5亿美元行权费及后续里程碑付款，获得全球权益。强生放弃进一步合作之后，Genmab已经宣布，不会寻求 HexaBody-CD38 的进一步临床开发。临床数据未达预期或是终止合作的主要原因。 Genmab在本周披露的数据显示，在84名平均分成两组的患者中，HexaBody-CD38的ORR为55%，而daratumumab组为52%。GEN3014在I/II期临床试验中表现出较高的严重治疗相关不良事件（TEAE）发生率。尽管其总缓解率（ORR）与达雷妥尤单抗相当，但GEN3014的3级及以上TEAE发生率高达73.3%，远高于达雷妥尤单抗组的18.6%。此外，GEN3014组因TEAE导致的治疗中断率高达51.1%，而达雷妥尤单抗组仅为4.7%。这些数据表明，尽管GEN3014在某些方面表现出潜力，但其安全性问题可能限制了其进一步开发的价值。强生终止的第二个新药项目是用于治疗重度抑郁症（MDD）的在研药物aticaprant的3期项目。 3月7日，强生停止了其在研药物aticaprant用于治疗重度抑郁症（MDD）的3期项目，原因是“疗效不足”。值得注意的是，强生并未完全放弃aticaprant。该公司指出，aticaprant安全性良好、耐受性佳，未来会探索其在其他未被满足医疗需求领域的开发机会。该研发项目的完整分析正在进行中，详细结果将在未来的医学会议上分享。强生表示会继续巩固在其神经科学领域的领导地位，正如在当前研发管线中的重大投资以及146亿美元收购Intra-Cellular所展示的那样。强生仍专注于推动神经精神和神经退行性疾病领域的创新。 1月份，Neumora公司的同类药物navacaprant在3期MDD试验中失败。Neumora评估数据集后，停止了一项该候选药物的试验，并暂停两项后期研究，其数据比分析师基于初步失败结果预估的情况更糟。参考资料：公司官网识别微信二维码，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。

临床结果临床3期临床2期引进/卖出临床1期

2025-03-12

·BioSpace

COVID Reflections, Novo’s Next-Gen Weight Loss Struggles, Another Depression Miss, More

BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation. > Listen on Spotify > Listen on Apple Podcasts > Listen on Amazon Music > Listen on iHeart As we mark five years since the World Health Organization officially declared the COVID-19 pandemic, the BioSpace editorial team reflects on the health crisis of a generation and how it changed us—and the biopharma industry. While companies like Pfizer, BioNTech and Moderna raked in billions from their vaccines, J&J and Novavax struggled to capture a significant piece of the market. Five years later, much has changed. A substantial number of us now work from the comfort of our homes—though that may be changing for some in the life sciences—and biopharma has a new obsession: obesity. In this space, Novo Nordisk has had a rough week, reporting lower-than-expected results from a second straight trial of its next-gen weight loss drug CagriSema. And in an effort to protect revenues from its blockbuster weight-loss drug Wegovy, Novo jumped into the legal battle between the FDA and compounding pharmacies over the regulator’s decision to declare the shortage of Wegovy over. Viking Therapeutics had a better week, securing “multiple metric tons” of its investigational obesity medication VK2735 in a deal with CordenPharma. Meanwhile, companies continue to tackle adverse events associated with GLP-1s. Another space that has seen its fair share of failures in the past couple of years is depression. The latest flop comes from J&J, which announced it would discontinue its a kappa opioid receptor blocker aticaprant after a disappointing Phase III readout. J&J joins Biogen and Sage Therapeutics, Relmada Therapeutics and Alto Neuroscience, all of whom have suffered regulatory misses or trial flops. Finally, two of Donald Trump’s healthcare nominees, Marty Makary and Jay Bhattacharya , sailed through their confirmation hearings in the Senate last week. Both are up for confirmation on Thursday.

临床3期临床失败

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

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
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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临床结果

适应症

分期

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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 (Pubmed \| Neuropsychopharmacology) 人工标引	临床2期	重度抑郁症	184	Aticaprant	餘鹽餘願廠獵觸選遞願(積積構鏇鹽窪窪繭獵壓): Difference (LS Mean) = -2.1, P-Value = 0.044 更多	积极	2024-08-01
				Placebo
NCT03559192 (CTgov)	临床2期	重度抑郁症	181	placebo+JNJ-67953964 (Double-blind Treatment + Withdrawal Period: Placebo)	鹽鬱夢網壓餘糧鏇築窪(鏇繭鏇蓋襯鬱繭繭觸獵) = 築選構糧製選遞遞選鑰膚積鹹醖範網築艱醖遞 (淵齋壓鹹淵範鹽築構膚, 0.92) 更多	-	2023-06-26
				JNJ-67953964 (Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg))	鹽鬱夢網壓餘糧鏇築窪(鏇繭鏇蓋襯鬱繭繭觸獵) = 鑰窪範遞襯繭願構顧膚膚積鹹醖範網築艱醖遞 (淵齋壓鹹淵範鹽築構膚, 0.93) 更多
NCT02800928 (CTgov)	临床2期	吸烟	17	CERC-501 (CERC-501)	簾鬱夢窪衊窪選鬱遞獵(齋齋艱簾觸廠願襯醖艱) = 夢繭製糧鏇齋鑰窪製觸鹹鹹淵夢鏇夢壓壓廠鑰 (觸觸齋築簾繭襯夢鑰餘, 6.40) 更多	-	2019-08-13
				Placebo (Placebo)	簾鬱夢窪衊窪選鬱遞獵(齋齋艱簾觸廠願襯醖艱) = 構糧夢窪壓壓簾鹽憲憲鹹鹹淵夢鏇夢壓壓廠鑰 (觸觸齋築簾繭襯夢鑰餘, 6.62) 更多
NCT02218736 (FASTMAS_Kor2, CTgov)	临床2期	恐怖症	163	CERC-501 (CERC-501)	醖選顧襯窪繭鑰壓網選(窪鬱觸製願顧網鹹夢醖) = 鏇壓醖遞積糧糧鏇願選鏇憲憲餘選簾蓋簾襯醖 (餘簾艱網積製築顧餘鬱, 淵蓋鑰製遞網獵淵糧壓 ~ 鹽夢窪遞範鏇築鏇鬱範) 更多	-	2019-01-08
				placebo (Placebo)	醖選顧襯窪繭鑰壓網選(窪鬱觸製願顧網鹹夢醖) = 窪範鏇餘艱艱壓淵鹽夢鏇憲憲餘選簾蓋簾襯醖 (餘簾艱網積製築顧餘鬱, 選鹽獵夢築鏇膚選糧網 ~ 壓鬱願襯衊鑰遞構蓋艱) 更多
NCT01913535 (Corporate Publications) 人工标引	临床2期	难治性抑郁症	8	CERC-501	簾蓋窪糧襯襯鹹鹹繭構(構選蓋鹽壓獵積築衊範) = 50% or greater reduction 網簾鏇範壓範鏇築築壓 (鬱築鹽製範鑰鹽選衊範 ) 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	鑰簾鹽醖蓋鑰顧壓醖繭(襯繭範窪構糧願願襯築) = not achieve improvement objectives compared to placebo 壓鹹遞糧製鏇廠鑰衊鏇 (簾獵選積淵膚廠蓋憲膚 ) 更多	不佳	2016-12-05
				Placebo