A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

开始日期2024-07-25

申办/合作机构

Janssen Research & Development LLC

NCT05307692

/ Completed临床2期

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, and Clinical Efficacy of Seltorexant (JNJ-42847922) on Behavioral and Psychological Symptoms of Dementia in Patients With Probable Alzheimer's Disease

The purpose of this study is to investigate the effect of seltorexant versus placebo on the sum of Agitation and Aggression domain scores (A plus A) of the Neuropsychiatric Inventory-Clinician rating (NPI-C) in participants with probable Alzheimer's Disease (AD) with clinically significant agitation/aggression.

开始日期2022-05-19

申办/合作机构

Janssen Research & Development LLC

NCT05236868

/ Completed临床1期

An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-42847922 (Seltorexant) Administered as Oral Tablet and an Intravenous Microdose of 14C-seltorexant in Healthy Participants

The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.

开始日期2022-02-03

申办/合作机构

Janssen Research & Development LLC

100 项与 Seltorexant 相关的临床结果

登录后查看更多信息

100 项与 Seltorexant 相关的转化医学

登录后查看更多信息

100 项与 Seltorexant 相关的专利（医药）

登录后查看更多信息

项与 Seltorexant 相关的文献（医药）

2025-09-01·EUROPEAN ARCHIVES OF PSYCHIATRY AND CLINICAL NEUROSCIENCE

A new direction for adjunctive therapy of difficult-to-treat depression: examining the role of orexin receptor antagonists

Review

作者: Thase, Michael E

Abstract:

One of the several pressing unmet needs in the pharmacotherapy of MDD is development of drugs with novel mechanisms of action that can effectively treat depressed patients who do not respond to first- and second-line antidepressants. The value of identifying such a medication would be enhanced if it were also generally well-tolerated and addressed depressive symptoms that are less responsive to SSRIs or SNRIs, such as insomnia or anxiety. This narrative review summarizes the investigation of a novel class of medications originally developed to treat insomnia, the Orexin Receptor Antagonists (ORAs), as adjunctive treatments for depressed patients who have been able to tolerate but who do not obtain an adequate response to standard antidepressants. Although it is likely that the currently approved Dual Orexin Receptor Antagonists (DORAs)—suvorexant, lemborexant and daridorexant—are safe and useful options for concomitant therapy of insomnia in antidepressant-treated patients, these medications have not been approved for this indication. Moreover, DORAs have not been extensively studied as adjunctive therapies for MDD. By contrast, the investigational ORA seltorexant, which is a selective Orexin 2 receptor antagonist, has shown significant antidepressant effects in Phase 2 and Phase 3 trials. Although at least one more unequivocally positive pivotal study will be needed to garner FDA approval for clinical use in the United States, this drug shows promise as a novel and well-tolerated option for patients with difficult to treat depressive episodes.

2025-07-01·BRAIN RESEARCH

Activation of orexin receptor 2 plays anxiolytic effect in male mice

Article

作者: Chen, Lihua ; Li, Zicheng ; Wei, Siqi ; Yang, Hongwei ; Tian, Rui ; Zhu, Chenchen

Anxiety disorders are the most common psychiatric illnesses. Present drugs can provide temporary relief for anxiety, however, they also come with side effects and safety concerns such as dependence, suicide, overdose and so on. Therefore, it is critical to discover new anxiolytic targets. An ongoing area of interest in the field of psychiatric diseases is the orexin system. Emerging body of evidences show that orexin receptor 1 (OX1R) has promising potential as novel anxiolytic target. However, little attention has been paid to orexin receptor 2 (OX2R) in anxiety. In this study, by using behavioral test, stereotaxic surgery and microinjection, virus-mediated knockdown of OX2R and pharmacological method, we found that: (1) Intraperitoneal injection of OX2R antagonist Seltorexant induced increased baseline anxiety-like behaviors in male mice. (2) Intraperitoneal injection of OX2R agonist YNT-185 reduced baseline anxiety-like behaviors in male mice. (3) Intraperitoneal injection of YNT-185 alleviated morphine withdrawal-induced anxiety-like behaviors in male mice. (4) Microinjection of YNT-185 into the VTA played anxiolytic effect in male mice. (5) Virus-mediated OX2R knockdown in the VTA induced anxiety-like behaviors in male mice.

2025-06-01·MOLECULAR PSYCHIATRY

Treatment effect and safety of seltorexant as monotherapy for patients with major depressive disorder: a randomized, placebo-controlled clinical trial

Article

作者: Pandina, Gahan ; Etropolski, Mila ; Kezic, Iva ; Mesens, Sofie ; Drevets, Wayne C ; Savitz, Adam ; Van Der Ark, Peter ; Benes, Heike

Abstract:

The antidepressant efficacy and safety of seltorexant monotherapy in major depressive disorder (MDD) was investigated in a placebo-controlled, placebo lead-in, randomized, double-blind, phase 1b study. Participants were randomized to receive seltorexant (20 mg or 40 mg) or placebo. The treatment effect was assessed by changes in the Hamilton Rating Scale for Depression-17 item (HDRS17) from treatment-period baseline to week 5 in lead-in placebo non-responders (“enriched” intent-to-treat analysis set). As a secondary outcome, the effect of seltorexant on HDRS17 was assessed in patients with and without subjective insomnia. Seltorexant’s effects on polysomnography, serum cortisol, and cortisol waking response were also measured. In total, 128 participants were enrolled, including 86 in the enriched sample (lead-in placebo non-responders). The mean changes from baseline (SD) in HDRS17 score at week 5 differed significantly across arms: −7.0 (5.04) for seltorexant 20 mg, −5.5 (4.34) for seltorexant 40 mg, and −4.4 (3.67) for placebo (p = 0.0456), which was attributable to the difference between the 20 mg and placebo arms (p = 0.0049). Improvement in depression severity at week 5 for seltorexant 20 mg was greater in patients with higher baseline insomnia severity (nominal p = 0.0059). The treatment benefit in the 20 mg arm remained significant when HDRS scores were adjusted by removing the sleep items (nominal p = 0.0289). The mean HDRS17 change versus placebo was numerically larger in the 20 mg than the 40 mg arm, consistent with data from a previous study in which seltorexant was administered adjunctively to conventional antidepressants. In secondary analyses, the waking cortisol response decreased in the 20 mg arm but not the 40 mg or placebo arms, and while total sleep increased more in the 40 mg arm, this arm also showed reduced REM onset latency and increased stage N1 sleep, which were not evident in the 20 mg arm. These biomarker data suggest mechanistic hypotheses that may account for the apparent curvilinear dose-response relationship of seltorexant. Trial Registration: ClinicalTrials.gov, NCT03374475.

项与 Seltorexant 相关的新闻（医药）

2025-11-14

·医路我伴

失眠治疗新突破：沃诺雷生即将重磅上市，四大雷生类药物全方位对比与临床选择指南

引言：失眠困境与治疗革新随着现代社会生活节奏的加快和压力的累积，失眠已成为困扰国民健康的重要公共卫生问题。据统计，全球约有10%的成年人患有慢性失眠，而在中国，这一数字正以每年12%的速度增长。传统治疗药物如苯二氮䓬类和抗抑郁类镇静药虽能短期缓解症状，但长期使用易产生耐药性和依赖性，约38%的患者因副作用被迫中断治疗。这种治疗需求与安全隐患之间的矛盾，催生了对新型催眠药物的迫切期待。 2014年，全球首个食欲素受体拮抗剂苏沃雷生（Suvorexant）在美国上市，标志着失眠治疗进入"非中枢抑制"时代。其独特的作用机制通过阻断食欲素神经通路调节睡眠-觉醒周期，临床研究显示对耐药性失眠患者的有效率达72%，且次日残余效应发生率仅为传统药物的1/32。尽管该药物已在欧美广泛应用，但受限于专利保护，中国患者需等到2027年后才能通过仿制药获得这一治疗选择。治疗突破：2025年6月20日，先声药业的达利雷声（商品名：科唯可®）作为国内首个获批的雷生类药物正式上市，填补了中国食欲素受体拮抗剂领域的空白。这款新型DORA药物的出现，不仅为3亿中国失眠人群带来了安全有效的治疗新选择，更推动了临床治疗从"对症控制"向"机制调节"的范式转变。本报告将系统对比包括达利雷声在内的四大雷生类药物的药理特性、临床数据和适用人群，为医患双方提供基于循证医学的用药决策指南。通过解析药物分子结构差异与疗效-安全性曲线的关系，帮助临床医生精准匹配患者个体需求，最终实现失眠治疗的"量体裁衣"。沃诺雷生的临床价值与创新突破沃诺雷生（Vornorexant，研发代号ORN-0829、TS-142）作为新一代双重orexin受体拮抗剂（DORA），在失眠治疗领域展现出三大突破性优势，为临床提供了更精准、安全的治疗选择。其核心创新点体现在药代动力学优化、作用机制精准性及适用人群广泛性三个维度，且均得到临床研究数据的充分验证。药代动力学优势：超短效特性降低次日残留风险沃诺雷生具有快速吸收与消除的独特药代动力学特征，健康日本受试者研究显示其消除半衰期为1.32-3.25小时，达峰时间（Tmax）仅0.500-3.00小时。这一超短效特性（同类药物中半衰期最短）显著降低了传统催眠药物常见的次日嗜睡风险。睡眠相关药效学评估（包括卡罗林斯卡嗜睡量表、数字符号替换测试）显示，尽管给药后1-4小时嗜睡指标随剂量增加而升高，但次日早晨未检测到一致的剂量相关残留效应。在动物模型中，大鼠和犬的半衰期分别低至0.238小时和1.16小时，进一步验证了其快速清除的特性，支持"按需服用、精准调控睡眠"的治疗理念。作用机制精准性：双重orexin受体拮抗避免GABA系统干扰作为双重OX1/OX2受体拮抗剂，沃诺雷生通过精准阻断觉醒通路发挥作用，与传统苯二氮䓬类药物相比具有显著机制优势。其不作用于GABA受体系统，避免了对中枢神经系统的广泛抑制，从而降低认知功能损害和药物依赖风险。动物实验证实，在大鼠多导睡眠图研究中，口服1 mg/kg剂量即可产生强效促眠作用，并在1-10 mg/kg范围内呈现剂量依赖性的总睡眠百分比增加。这种机制特异性使得沃诺雷生在改善睡眠结构的同时，对正常生理觉醒功能影响较小，为睡眠-觉醒周期调控提供了新的药理学策略。适用人群广泛性：特殊群体的治疗突破沃诺雷生在老年人群中表现出良好的药代动力学一致性，健康日本受试者的I期研究显示，老年个体的暴露量与非老年个体基本相当，无需因年龄调整剂量。这一特性解决了传统催眠药物在老年患者中因代谢减慢导致的蓄积风险。此外，其对呼吸功能影响较小的特点（动物研究显示对睡眠呼吸暂停可能具有潜在治疗价值），为轻度呼吸功能不全的失眠患者提供了新选择。II期临床试验已证实其对失眠患者的睡眠促进作用，目前该药物已在日本进入III期临床试验阶段，有望成为覆盖广泛人群的一线失眠治疗药物。临床价值总结：沃诺雷生通过1.3-3.3小时的超短效半衰期、双重orexin受体精准拮抗机制，以及在老年和轻度呼吸功能不全人群中的适用性，构建了失眠治疗的"精准时间窗"概念，实现了疗效与安全性的优化平衡，代表了当前DORA类药物研发的最高水平。雷生类药物作用机制深度解析Orexin系统：睡眠-觉醒调节的核心枢纽 1998年发现的食欲素（orexin）系统是中枢神经系统调控觉醒状态的关键分子机制。该系统由下丘脑分泌的食欲素A/B神经肽及其OX1R、OX2R两种G蛋白偶联受体构成，通过投射至多个觉醒相关脑区（如蓝斑核、组胺能神经元）维持清醒状态的警觉性与注意力。生理状态下，食欲素神经元在清醒时高度活跃，通过激活OX1R/OX2R传递促觉醒信号；入睡时其活性显著降低，形成睡眠-觉醒周期的自然转换。这种动态调节机制的异常被认为是慢性失眠的重要病理基础。DORA类药物的作用原理：靶向阻断觉醒信号雷生类药物（DORAs）通过竞争性结合OX1R/OX2R受体，阻断食欲素的促觉醒作用，从而诱导生理性睡眠。与传统苯二氮䓬类药物增强GABA抑制性神经传递的机制不同，DORAs不直接改变中枢抑制性通路，而是通过调节内源性睡眠-觉醒节律发挥作用，理论上具有更低的依赖性风险。所有已上市雷生类药物均属于双重受体拮抗剂，但其受体结合特性存在显著差异：苏沃雷生：对OX2R的亲和力（Ki=0.35nM）略高于OX1R（Ki=0.55nM），且结合具有高度可逆性莱博雷生：呈现OX2R偏好性拮抗特征达利雷生：通过选择性抑制受体-配体结合，降低过度觉醒状态沃诺雷生：对OX1R（IC50=1.05nM）和OX2R（IC50=1.27nM）的抑制活性达到纳摩尔级且均衡性最佳机制创新点：沃诺雷生的均衡双受体拮抗特性（OX1R/IC50=1.05nM；OX2R/IC50=1.27nM）可能与其快速起效（Tmax≈1小时）和低残留效应相关。这种精确的分子设计既保证了对觉醒通路的有效阻断，又通过优化受体解离动力学减少了次日嗜睡风险。受体结合动力学与临床效应的关联 DORAs的受体结合参数与其临床药效学特征密切相关。沃诺雷生的IC50值比早期DORA类药物降低约30%，这种高亲和力特性使其能够在较低血药浓度下饱和受体结合位点。同时，其独特的受体-配体相互作用模式可能缩短了药物起效时间，而适度的受体解离速率则避免了长期占据导致的睡眠结构紊乱。这种"快速结合-适度解离"的动力学特征，为沃诺雷生在改善入睡困难和睡眠维持障碍方面的双重优势提供了分子基础。与传统催眠药物相比，雷生类药物通过靶向进化上高度保守的orexin系统，实现了对睡眠-觉醒周期的生理性调节。这种机制差异不仅带来了独特的临床获益，也为理解人类睡眠的神经生物学机制提供了重要实验依据。随着沃诺雷生等新一代DORAs的上市，基于受体结合特性的精准化失眠治疗已成为可能。四大雷生类药物全方位对比雷生类药物作为新型食欲素受体拮抗剂，其药代动力学特性、疗效与安全性存在显著差异。以下从获批状态、作用机制、剂量规格、半衰期及副作用等核心维度进行系统对比，为临床用药决策提供依据。药物名称苏沃雷生（Suvorexant）达利雷生（Daridorexant）莱博雷生（Lemborexant）沃诺雷生（Vornorexant）商品名 Belsomra® Quviviq Dayvigo - 获批时间 2014年（美国FDA） 2022年（美国/欧盟） 2019年12月（美国）研发阶段（III期）中国上市情况暂未上市 2025年6月（先声药业）已上市未获批药物类别双重食欲素受体拮抗剂（DORA）双重食欲素受体拮抗剂（DORA）双重食欲素受体拮抗剂（DORA）双重食欲素受体拮抗剂（DORA）剂量规格片剂：5mg、10mg、15mg、20mg 片剂：25mg、50mg 片剂：2.5mg 5mg、10mg 片剂：2.5mg、5mg、10mg 成人推荐剂量睡前10-20mg（最大20mg）睡前25mg（可增至50mg）睡前2.5-10mg 睡前2.5-10mg 半衰期 12小时 6-10小时（平均8小时） 17-19小时（有效半衰期） 1.5-3小时管制级别移除精麻管制药品非管制药品非管制药品非管制药品常见副作用嗜睡（7%）、头痛、口干、异常梦境嗜睡（5-6%）、口干、头痛嗜睡（7-10%）、疲劳、噩梦头痛（4%）、头晕（3%）、恶心（2%）关键维度差异解读1. 半衰期与残留效应：沃诺雷生优势显著半衰期是影响次日残留效应的核心因素。沃诺雷生（1.5-3小时）的超短半衰期使其在清晨血药浓度快速降至安全范围，显著降低日间嗜睡风险，尤其适合需要驾驶、操作机械或高精度工作的患者。相比之下，莱博雷生（17-19小时）和苏沃雷生（12小时）的半衰期较长，可能导致次日警觉性下降，老年患者需谨慎调整剂量。达利雷生（8小时）的半衰期居中，兼顾睡眠维持与残留效应控制，适用于多数成年患者长期使用。2. 副作用谱：达利雷生耐受性更佳在安全性方面，达利雷生的嗜睡发生率（5-6%）显著低于莱博雷生（7-10%）和苏沃雷生（7%），且口干等抗胆碱能副作用发生率最低。苏沃雷生需特别注意性别差异，女性上呼吸道感染发生率约为男性的2倍，且可能引发异常梦境和梦游等神经精神症状。莱博雷生的噩梦发生率相对突出，临床使用中需关注患者睡眠体验反馈。3. 特殊人群适配性：肝功能与年龄考量苏沃雷生禁用于重度肝功能不全患者，且其药代动力学受年龄、性别和体重影响显著——老年患者推荐剂量降至15mg/日，女性及肥胖患者血药浓度可能升高。达利雷生和莱博雷生在轻中度肝功能不全患者中无需调整剂量，但需警惕达利雷生在高剂量（100-150mg）下可能产生的药物依赖风险，其滥用潜力与唑吡坦相似。沃诺雷生适用于成人及老年失眠患者，包括轻度肝功能不全者，其特殊人群数据显示在轻中度肝功能损害患者中无需调整剂量。临床用药场景建议需驾驶/操作机械者：优先选择沃诺雷生（超短半衰期）。老年患者：推荐达利雷生（25mg起始）或莱博雷生（5mg起始），避免苏沃雷生的剂量相关副作用。长期使用者：达利雷生（非管制药品）较苏沃雷生（移除精麻药品）更便于处方管理。重度失眠合并肝功能不全：禁用苏沃雷生，可考虑低剂量达利雷生（25mg）。疗效特征与临床选择在睡眠改善指标上，苏沃雷生20mg和莱博雷生10mg在缩短入睡潜伏期（LPS）和减少夜间觉醒时间（WASO）方面表现突出，适合入睡困难与睡眠维持障碍并存的患者。达利雷生50mg在主观入睡时间（sTSO）改善上优于安慰剂，且日间功能影响较小。沃诺雷生的早期研究显示其在睡眠呼吸暂停合并失眠患者中具有潜力，但其疗效数据仍需进一步验证。综合而言，雷生类药物的选择需结合患者职业需求、肝肾功能状态及副作用耐受度，通过个体化剂量调整实现疗效最大化与风险最小化。临床选择指南与个体化用药策略针对雷生类药物的临床应用，需建立系统化的个体化选择框架。基于药物特性与患者因素，可采用“四步选择模型”指导临床决策：首先评估失眠类型（入睡困难/维持困难），其次考量合并症（如呼吸疾病、肝功能状态），再结合患者职业特性（如高危作业者需避免长半衰期药物），最终通过疗效与副作用监测动态调整方案。四步选择模型实践要点第一步：失眠类型分层入睡困难为主：优先选择达利雷生（半衰期短，对日间功能影响小），推荐睡前30分钟空腹服用。睡眠维持障碍：莱博雷生（半衰期较长）初始剂量5 mg，疗效不足可增至10 mg，但需预留7小时以上睡眠时间。第二步：合并症管理策略肝功能不全：中度肝功能损害患者：莱博雷生最大剂量5 mg，苏沃雷生（Belsomra®）调整为5 mg；重度肝功能不全：禁用苏沃雷生、莱博雷生及达利雷生。呼吸疾病：轻度阻塞性睡眠呼吸暂停（OSA）患者首选莱博雷生，其安全性已通过听觉觉醒阈值及驾驶能力评估验证。第三步：职业与特殊人群适配高危作业者：避免半衰期较长的莱博雷生，优先选择达利雷生（日间嗜睡发生率更低）；老年患者：苏沃雷生建议从5 mg起始剂量开始，在医生监控下调整。第四步：剂量调整与药物相互作用 CYP3A抑制剂联用：苏沃雷生与中度CYP3A抑制剂合用时剂量减半至5 mg，禁用强效抑制剂；中枢神经系统抑制剂联用：需降低苏沃雷生剂量以避免叠加镇静效应。典型临床场景应用示例合并轻度OSA的失眠患者：首选莱博雷生5 mg，临睡前服用，预留7小时睡眠窗口；若疗效不佳且耐受良好，可增至10 mg，但中度肝功能不全者需维持5 mg。高空作业人员：选择达利雷生，空腹服用以确保快速起效且无次日残留效应。指南推荐与安全性监测《中国失眠诊疗指南》强调，雷生类药物应作为二线治疗选择，使用前需排除发作性睡病（所有雷生类药物均禁用此类患者）。用药期间需监测肝功能指标及中枢抑制症状，尤其对于老年及合并用药患者，建议每2周评估一次疗效与耐受性。（注：具体剂量调整需结合患者个体反应及药物基因组检测结果，以上方案仅供参考。）安全性与耐受性评估雷生类药物的安全性风险可系统分为三类进行管理：常见副作用的对症处理、严重风险的早期预警及长期用药的安全性监测。常见副作用以嗜睡、头痛和口干为主，其中嗜睡在苏沃雷生、莱博雷生中的发生率均≥5%且显著高于安慰剂组，临床可通过起始低剂量（如莱博雷生5 mg）或调整服药时间（睡前30分钟）减轻日间残留效应。头痛症状通常程度轻微，可短期联用非甾体抗炎药缓解，而口干可通过增加水分摄入或使用人工唾液改善。严重风险预警需重点关注复杂睡眠行为，包括睡眠驾驶、梦游等罕见但高危事件。苏沃雷生和莱博雷生长期使用中均有此类报告，一旦发生需立即停药并评估精神状态。值得注意的是，苏沃雷生禁用于发作性睡病患者，因其可能加重猝倒症状。此外，所有雷生类药物均需警惕与中枢抑制剂（如苯二氮䓬类、阿片类）的联用风险，可能导致呼吸抑制或深度镇静。老年患者用药警示：沃诺雷生在健康老年受试者（≥65岁）中的I期研究显示，其药代动力学参数与非老年人群无显著差异，且肝肾代谢负担较低，提示在老年失眠患者中具有更好的耐受性。相比之下，莱博雷生10 mg剂量组在早晨认知测试中表现出注意力和记忆功能下降，而苏沃雷生可能引发次日残留嗜睡，需谨慎评估驾驶等危险活动。长期使用安全性方面，现有证据表明雷生类药物（如苏沃雷生、莱博雷生）无显著依赖性或成瘾性，停药后反跳性失眠发生率低于传统苯二氮䓬类1。但达利雷生作为管制物质，仍需严格控制处方剂量和疗程，尤其对有物质使用障碍史的患者。长期用药建议每3个月评估睡眠质量及不良反应，动态调整治疗方案。四种药物的安全谱对比显示，沃诺雷生在特殊人群中展现独特优势：其不经CYP450 3A4酶系统代谢，与其他药物相互作用风险较低，且在肝肾功能不全患者中无需调整剂量。而苏沃雷生、莱博雷生需警惕对认知功能的潜在影响，达利雷生则需监测肝功能指标（如ALT、AST）。临床选择时，应综合考量患者年龄、合并症及药物代谢特征，实现个体化安全用药。未来展望：雷生类药物的发展方向雷生类药物作为失眠治疗领域的重要突破，其未来发展将围绕精准化、联合化与数字化三大核心方向展开，通过技术创新与机制深化持续提升治疗效能。亚型选择性拮抗：提升安全性的关键路径现有雷生类药物多为OX1/OX2双靶点拮抗剂，而选择性OX2受体拮抗剂的开发成为降低中枢神经系统副作用的重要策略。处于III期临床阶段的Seltorexant（JNJ-922）展现出独特优势，其2-3小时的短半衰期设计可减少次日残留效应，目前正同步探索重度抑郁症、失眠及睡眠呼吸暂停的治疗潜力。机制研究表明，选择性阻断OX2受体能够精准调控睡眠-觉醒周期，同时避免OX1R相关的认知功能影响，为开发更安全的失眠药物提供了新思路。复方制剂与适应症拓展：拓宽治疗边界雷生类药物与其他机制药物的联合应用成为研发热点。以沃诺雷生（ORN-0829/TS-142）为例，该药除失眠适应症外，已进入睡眠呼吸暂停的I期临床研究阶段，其与褪黑素受体激动剂的复方制剂开发可能实现“快速入睡-维持睡眠”的双重目标。此外，达利雷生等药物在神经精神领域的跨界探索，暗示雷生类药物可能突破传统适应症框架，成为多系统疾病的辅助治疗选择。数字化管理：构建闭环治疗生态大正制药等企业已通过投资Biolinq等生物传感器公司，布局可穿戴设备与药物治疗的融合。皮肤贴附式电子传感器可实时监测心率变异性、皮肤电活动等睡眠相关生理指标，结合AI算法实现用药效果的动态评估。这种“药物+设备+数据”的模式不仅能优化个体化给药方案，还为失眠共病管理提供了全新范式，代表着雷生类药物向数字化健康管理领域延伸的重要方向。特殊人群研究突破点沃诺雷生等新一代雷生类药物已启动儿童、妊娠期女性等特殊人群的临床前评估，其短半衰期特性可能降低胎儿暴露风险。但需解决发育阶段药代动力学差异、长期安全性数据缺乏等关键问题，才能真正实现从“成人适用”到“全生命周期覆盖”的跨越。未来，随着亚型选择性药物的临床转化、复方制剂的协同设计以及数字化监测技术的成熟，雷生类药物有望在精准治疗的道路上实现新突破，为失眠患者提供更安全、更智能的治疗选择。 ~~END~~ 如果你觉得有收获，请点赞+分享+星标/关注=下次不迷路感谢关注！咨询渠道👇 微信:yidian3697 👉点击蓝字查看往期精彩推送：痛风治疗双雄对决：帝人非布司他 vs 富士多替诺雷，如何选择？科普常见50款日本处方药购买渠道和使用方法科普常见100款日本处方药购买渠道和使用方法说明失眠治疗新纪元：莱博雷生、达利雷生、苏沃雷生全方位对比指南揭秘日本男演员“生猛”的原因&日本伟哥家族全解析，建议收藏转发颠覆胰岛素注射！日本 "金丝雀" 复方药：双机制控糖 + 减重 3-5kg，2 型糖尿病患者新选择一周杀灭！日本武田幽门螺杆菌特效药全解析：三款精准分型，从青少年到难治性感染全覆盖文章用于交流学习，用药谨遵医嘱！免责声明：图文转自网络，不代表本平台立场，仅供读者交流学习，著作权属归原创者所有。如有侵权，请在后台留言联系我们进行删除，谢谢！

上市批准

2025-11-06

·Firstwordpharma

J&J's Caplyta wins FDA nod for depression add-on use

Johnson & Johnson has secured its first regulatory approval for Caplyta (lumateperone) since acquiring developer Intra-Cellular Therapies for $14.6 billion earlier this year, with the FDA clearing the drug as an adjunctive therapy for adults with major depressive disorder (MDD).The once-daily oral drug can now be used alongside standard antidepressants in patients who continue to experience lingering depressive symptoms despite antidepressant treatment — an estimated two-thirds of those treated for MDD.Caplyta, already approved for schizophrenia and bipolar depression, is thought to work through combined effects on serotonin and dopamine signaling, though its precise mechanism remains unclear. The drug binds strongly to serotonin 5-HT2A receptors and more moderately to dopamine D2 receptors. Unlike many antipsychotics, Caplyta does not require dose titration and has shown minimal effects on weight or metabolism, issues that often force patients to discontinue therapy.The new approval follows a review of two Phase III trials, Studies 501 and 502, in which Caplyta added to an antidepressant achieved statistically significant improvement on the Montgomery-Åsberg Depression Rating Scale (MADRS), versus an oral antidepressant plus placebo. Specifically, the drug reduced depression scores by 4.9 points and 4.5 points, respectively, over six weeks, with separation from placebo seen as early as the first week in one study and the second week in the other.Significant reductions in the key secondary endpoint of mean change in Clinical Global Impression Scale-Severity index (CGI-S) total scores from baseline were also demonstrated at six weeks in Study 501 (-0.7 points) and Study 502 (-0.5 points).What Caplyta "has been able to do in terms of efficacy, providing a path to remission for patients, being relatively easy to start on and stay on — we think this is foundational to really improving wellbeing for individuals who have this debilitating disorder," said Bill Martin, global therapeutic area head for neuroscience at J&J.The approval follows setbacks for some of the company's other depression candidates this year. In March, it discontinued the Phase III VENTURA programme of its kappa-opioid receptor antagonist aticaprant due to insufficient efficacy in MDD, and more recently, its orexin-2 receptor antagonist seltorexant missed the primary endpoint in a Phase III study of depressed patients with insomnia, though one key opinion leader thinks the drug still has "game-changer" potential (see – KOL Views Q&A: Phase III miss may boost blockbuster potential for J&J's seltorexant in MDD).

临床3期临床结果上市批准细胞疗法临床2期

2025-10-14

·Business Wire

Johnson & Johnson Reports Q3 2025 Results; Raises 2025 Sales Outlook

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2025. “Johnson & Johnson delivered another strong performance in the third quarter fueled by the depth and strength of our portfolio and significant progress across our pipeline,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “With a sharpened focus on the six priority areas of Oncology, Immunology, Neuroscience, Cardiovascular, Surgery and Vision, Johnson & Johnson is in a new era of accelerated growth and innovation, with pioneering treatments that will continue to transform lives.” Overall financial results Q3 ($ in Millions, except EPS) 2025 2024 % Change Reported Sales $23,993 $22,471 6.8% Net Earnings $5,152 $2,694 91.2% EPS (diluted) $2.12 $1.11 91.0% Q3 Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change Operational Sales1,2 5.4% Adjusted Operational Sales1,3 4.4% Adjusted Net Earnings1,4 $6,801 $5,876 15.7% Adjusted EPS (diluted)1,4 $2.80 $2.42 15.7% Free Cash Flow6,7 ~$14,200 $14,471 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 Third-quarter YTD 2025 is estimated as of October 14, 2025 Regional sales results Q3 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $13,708 $12,909 6.2% 6.2 - 4.4 International 10,285 9,562 7.6 4.4 3.2 4.4 Worldwide $23,993 $22,471 6.8% 5.4 1.4 4.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Segment sales results Q3 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $15,563 $14,580 6.8% 5.3 1.5 3.7 MedTech 8,430 7,891 6.8 5.6 1.2 5.7 Worldwide $23,993 $22,471 6.8% 5.4 1.4 4.4 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Third-Quarter 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 5.3%*, with net acquisitions and divestitures positively impacting growth by 1.6% due to CAPLYTA. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,070) basis points impact from STELARA in Immunology, as well as IMBRUVICA in Oncology. MedTech MedTech worldwide operational sales grew 5.6%*, with net acquisitions and divestitures negatively impacting growth by 0.1%. Growth was primarily driven by electrophysiology products, Abiomed and Shockwave in Cardiovascular, wound closure products in General Surgery, as well as Surgical Vision. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) October 2025 July 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 3.5% – 4.0% / 3.8% 3.2% – 3.7% / 3.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $93.0B – $93.4B / $93.2B 4.8% – 5.3% / 5.1% $92.7B – $93.1B / $92.9B 4.5% – 5.0% / 4.8% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $93.5B – $93.9B / $93.7B 5.4% – 5.9% / 5.7% $93.2B – $93.6B / $93.4B 5.1% – 5.6% / 5.4% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% $10.63 – $10.73 / $10.68 6.5% – 7.5% / 7.0% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% $10.80 – $10.90 / $10.85 8.2% – 9.2% / 8.7% 1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: Oct 2025 = $1.13 and July 2025 = $1.13 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine Other modeling considerations will be provided on the webcast. Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at Investor News, as well as Innovative Medicine Newsroom, MedTech News & Events, and www.factsabouttalc.com. Regulatory U.S. FDA approves TREMFYA (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor1 Press Release TREMFYA (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen Press Release Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG) Press Release Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis Press Release European Commission approves DARZALEX (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma Press Release European Commission approves IMBRUVICA (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant Press Release Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis Press Release Data Releases Johnson & Johnson to highlight breadth of its major depressive disorder portfolio at 2025 ECNP Congress1 Press Release Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill1 Press Release TREMFYA (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis1 Press Release Johnson & Johnson Unveils New Data Demonstrating Superior Clarity of Vision and Comfort of ACUVUE OASYS MAX 1-Day for ASTIGMATISM, and MULTIFOCAL for ASTIGMATISM Contact Lenses1 Press Release Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR Press Release TECVAYLI plus DARZALEX FASPRO treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma Press Release Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis Press Release Johnson & Johnson to showcase industry-leading neuropsychiatry innovations at the 2025 Psych Congress Annual Meeting Press Release Data published in The New England Journal of Medicine demonstrate RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) is re-setting survival expectations in first-line EGFR-mutated lung cancer Press Release RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer Press Release New real-world data elevating patient perspectives highlight the need for scientific advancement in maternal fetal immunology at ISUOG 2025 Press Release Johnson & Johnson Unveils Results from the VARIPURE Substudy of SECURE, a Real-World Study on VARIPULSE Platform, at 2025 European Society of Cardiology (ESC) Congress Press Release New Data from the DanGer Shock Randomized Control Trial, Published in The New England Journal of Medicine, Confirms the Long-Term Survival Benefit of the Impella CP Heart Pump Press Release Johnson & Johnson showcases latest advancements in Alzheimer's research at AAIC 2025 Press Release Product Launch U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated Press Release Johnson & Johnson Launches VIRTUGUIDE AI-Powered Patient-Matched Lapidus System in U.S. to Reduce Complexity in Bunion Surgery for Millions Press Release Other Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors Press Release 1 Subsequent to the quarter Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations. About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com. Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results. Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results. Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. THIRD QUARTER NINE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 9,402 8,871 6.0 % 6.0 - $ 26,655 24,993 6.7 % 6.7 - 6,161 5,709 7.9 4.3 3.6 17,983 17,639 1.9 1.3 0.6 15,563 14,580 6.8 5.3 1.5 44,638 42,632 4.7 4.5 0.2 4,306 4,038 6.6 6.6 - 12,902 12,105 6.6 6.6 - 4,124 3,853 7.0 4.5 2.5 12,089 11,564 4.5 3.9 0.6 8,430 7,891 6.8 5.6 1.2 24,991 23,669 5.6 5.3 0.3 13,708 12,909 6.2 6.2 - 39,557 37,098 6.6 6.6 - 10,285 9,562 7.6 4.4 3.2 30,072 29,203 3.0 2.3 0.7 $ 23,993 22,471 6.8 % 5.4 1.4 $ 69,629 66,301 5.0 % 4.7 0.3 THIRD QUARTER NINE MONTHS Percent Change Percent Change 2025 2024 Total Operations Currency 2025 2024 Total Operations Currency $ 13,708 12,909 6.2 % 6.2 - $ 39,557 37,098 6.6 % 6.6 - 5,440 4,914 10.7 4.4 6.3 15,937 15,291 4.2 1.5 2.7 1,231 1,173 4.9 7.3 (2.4 ) 3,604 3,579 0.7 7.6 (6.9 ) 3,614 3,475 4.0 3.4 0.6 10,531 10,333 1.9 1.8 0.1 10,285 9,562 7.6 4.4 3.2 30,072 29,203 3.0 2.3 0.7 $ 23,993 22,471 6.8 % 5.4 1.4 $ 69,629 66,301 5.0 % 4.7 0.3 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 23,993 100.0 $ 22,471 100.0 6.8 7,303 30.4 6,963 31.0 4.9 16,690 69.6 15,508 69.0 7.6 5,922 24.7 5,478 24.3 8.1 3,672 15.3 4,952 22.0 (25.8 ) 18 0.1 (99 ) (0.4 ) (478 ) (2.0 ) 1,798 8.0 63 0.3 41 0.2 7,493 31.2 3,338 14.9 124.5 2,341 9.7 644 2.9 263.5 $ 5,152 21.5 $ 2,694 12.0 91.2 $ 2.12 $ 1.11 91.0 2,428.6 2,427.9 31.2 % 19.3 % $ 8,436 35.2 $ 7,277 32.4 15.9 $ 6,801 28.3 $ 5,876 26.1 15.7 $ 2.80 $ 2.42 15.7 19.4 % 19.3 % 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 69,629 100.0 $ 66,301 100.0 5.0 22,288 32.0 20,343 30.7 9.6 47,341 68.0 45,958 69.3 3.0 16,923 24.3 16,416 24.8 3.1 10,413 15.0 11,934 18.0 (12.7 ) - - 194 0.3 (62 ) (0.1 ) (433 ) (0.7 ) (7,692 ) (11.1 ) 4,855 7.3 144 0.2 192 0.3 27,615 39.7 12,800 19.3 115.7 5,927 8.6 2,165 3.3 173.8 $ 21,688 31.1 $ 10,635 16.0 103.9 $ 8.94 $ 4.38 104.1 2,424.8 2,429.5 21.5 % 16.9 % $ 24,635 35.4 $ 23,558 35.5 4.6 $ 20,206 29.0 $ 19,296 29.1 4.7 $ 8.33 $ 7.94 4.9 18.0 % 18.1 % Third Quarter Nine Months Ended 2025 2024 2025 2024 $5,152 $2,694 $21,688 $10,635 15 2,388 (6,894 ) 5,466 1,048 1,171 3,435 3,355 - 4 - 77 168 47 302 207 - 38 - 157 97 328 475 928 (387 ) (37 ) (327 ) 374 - - - 194 2 - 29 - (168 ) (762 ) 826 (2,055 ) 874 5 672 (42 ) $6,801 $5,876 $20,206 $19,296 2,428.6 2,427.9 2,424.8 2,429.5 $2.80 $2.42 $8.33 $7.94 $2.72 $8.24 1 2 6.8% 6.8% 6.8% 6.0% 6.6% 6.2% 7.9% 7.0% 7.6% 1.5 1.2 1.4 - - - 3.6 2.5 3.2 5.3% 5.6% 5.4% 6.0% 6.6% 6.2% 4.3% 4.5% 4.4% (1.6) (1.1) (2.7) (1.9) 0.0 0.0 0.0 0.1 0.1 0.0 0.2 0.1 0.0 0.1 0.0 3.7% 5.7% 4.4% 3.3% 6.8% 4.4% 4.3% 4.6% 4.4% 4.7% 5.6% 5.0% 6.7% 6.6% 6.6% 1.9% 4.5% 3.0% 0.2 0.3 0.3 - - - 0.6 0.6 0.7 4.5% 5.3% 4.7% 6.7% 6.6% 6.6% 1.3% 3.9% 2.3% (1.9) (0.6) (2.9) (0.9) (0.8) (0.2) (1.1) (0.7) (1.8) (1.2) 0.0 0.0 0.0 0.3 0.1 0.0 0.4 0.1 0.1 0.2 0.1 3.4% 3.7% 3.5% 4.9% 4.1% 4.6% 1.4% 3.3% 2.2% REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 3,468 2,816 23.2 % 23.2 % - $ 9,866 7,835 25.9 % 25.9 % - 3,060 2,565 19.3 % 14.8 % 4.5 % 8,652 7,450 16.1 % 15.0 % 1.1 % 6,529 5,380 21.3 % 19.2 % 2.1 % 18,519 15,284 21.2 % 20.6 % 0.6 % 396 258 53.3 % 53.3 % - 1,072 565 89.6 % 89.6 % - 128 27 * * * 260 63 * * * 524 286 83.5 % 81.4 % 2.1 % 1,332 629 * * * 2,088 1,684 24.0 % 24.0 % - 5,934 4,789 23.9 % 23.9 % - 1,584 1,332 18.9 % 14.7 % 4.2 % 4,514 3,797 18.9 % 17.9 % 1.0 % 3,672 3,016 21.7 % 19.9 % 1.8 % 10,448 8,586 21.7 % 21.3 % 0.4 % 378 337 12.3 % 12.3 % - 1,048 940 11.5 % 11.5 % - 558 453 23.0 % 17.6 % 5.4 % 1,567 1,275 22.9 % 21.1 % 1.8 % 936 790 18.4 % 15.3 % 3.1 % 2,615 2,215 18.0 % 17.0 % 1.0 % 211 259 (18.3 )% (18.3 )% - 685 770 (11.0 )% (11.0 )% - 483 494 (2.3 )% (6.6 )% 4.3 % 1,453 1,537 (5.4 )% (6.4 )% 1.0 % 695 753 (7.8 )% (10.6 )% 2.8 % 2,139 2,307 (7.3 )% (7.9 )% 0.6 % 136 68 99.7 % 99.7 % - 388 156 * * - 61 21 * * * 130 49 * * * 198 89 * * * 518 205 * * * 85 64 34.2 % 34.2 % - 235 173 35.8 % 35.8 % - 37 12 * * * 79 29 * * * 122 75 60.8 % 59.1 % 1.7 % 314 202 55.3 % 54.9 % 0.4 % 115 105 9.3 % 9.3 % - 334 310 7.5 % 7.5 % - 62 30 * * * 160 93 73.0 % 72.6 % 0.4 % 177 135 31.3 % 29.9 % 1.4 % 494 403 22.6 % 22.5 % 0.1 % 5 5 (25.0 )% (25.0 )% - 18 25 (30.4 )% (30.4 )% - 108 144 (25.1 )% (26.8 )% 1.7 % 365 470 (22.3 )% (23.0 )% 0.7 % 113 150 (25.1 )% (26.8 )% 1.7 % 383 496 (22.8 )% (23.4 )% 0.6 % 56 36 54.6 % 54.6 % - 153 106 44.8 % 44.8 % - 39 50 (22.2 )% (25.6 )% 3.4 % 123 136 (9.7 )% (10.6 )% 0.9 % 94 86 9.7 % 7.7 % 2.0 % 276 242 14.0 % 13.6 % 0.4 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 2,676 3,068 (12.8 )% (12.8 )% - $ 7,377 8,499 (13.2 )% (13.2 )% - 1,493 1,552 (3.9 )% (6.3 )% 2.4 % 4,492 5,090 (11.8 )% (11.5 )% (0.3 )% 4,168 4,621 (9.8 )% (10.6 )% 0.8 % 11,868 13,590 (12.7 )% (12.6 )% (0.1 )% 326 281 16.2 % 16.2 % - 923 778 18.7 % 18.7 % - 19 27 (30.9 )% (30.9 )% - 63 89 (29.6 )% (29.6 )% - 132 112 17.7 % 16.7 % 1.0 % 413 380 8.6 % 10.4 % (1.8 )% 476 419 13.6 % 13.3 % 0.3 % 1,398 1,246 12.2 % 12.7 % (0.5 )% 309 299 3.6 % 3.6 % - 906 820 10.5 % 10.5 % - 377 218 73.0 % 69.8 % 3.2 % 1,130 787 43.5 % 44.6 % (1.1 )% 687 516 32.9 % 31.5 % 1.4 % 2,036 1,607 26.7 % 27.2 % (0.5 )% 1,022 1,770 (42.3 )% (42.3 )% - 3,081 5,021 (38.6 )% (38.6 )% - 549 906 (39.4 )% (41.4 )% 2.0 % 1,768 2,991 (40.9 )% (40.8 )% (0.1 )% 1,570 2,676 (41.3 )% (42.0 )% 0.7 % 4,848 8,012 (39.5 )% (39.5 )% 0.0 % 989 691 43.1 % 43.1 % - 2,384 1,789 33.3 % 33.3 % - 434 316 37.4 % 33.4 % 4.0 % 1,181 932 26.7 % 26.1 % 0.6 % 1,424 1,007 41.3 % 40.1 % 1.2 % 3,566 2,721 31.0 % 30.8 % 0.2 % 12 1 * * - 21 3 * * - 0 0 - - - 0 0 - - - 12 1 * * - 21 3 * * - 1,367 1,094 25.0 % 25.0 % - 3,712 3,250 14.2 % 14.2 % - 658 662 (0.7 )% (2.6 )% 1.9 % 2,011 2,090 (3.8 )% (3.7 )% (0.1 )% 2,024 1,755 15.3 % 14.6 % 0.7 % 5,722 5,340 7.2 % 7.2 % 0.0 % 240 - * * - 451 - * * - - - - - - - - - - - 240 - * * - 451 - * * - 14 26 (49.2 )% (49.2 )% - 76 101 (24.9 )% (24.9 )% - 127 117 9.0 % 8.5 % 0.5 % 376 382 (1.4 )% (0.4 )% (1.0 )% 140 142 (1.4 )% (1.8 )% 0.4 % 452 482 (6.3 )% (5.5 )% (0.8 )% 664 780 (14.9 )% (14.9 )% - 2,021 2,329 (13.2 )% (13.2 )% - 267 269 (0.9 )% (3.0 )% 2.1 % 804 830 (3.1 )% (3.0 )% (0.1 )% 929 1,049 (11.3 )% (11.9 )% 0.6 % 2,824 3,159 (10.6 )% (10.5 )% (0.1 )% 405 243 67.1 % 67.1 % - 1,047 660 58.7 % 58.7 % - 53 42 28.9 % 23.8 % 5.1 % 146 120 21.9 % 21.4 % 0.5 % 459 284 61.5 % 60.8 % 0.7 % 1,193 780 53.0 % 52.9 % 0.1 % 46 46 0.4 % 0.4 % - 119 161 (26.4 )% (26.4 )% - 210 235 (10.7 )% (12.3 )% 1.6 % 684 759 (9.8 )% (9.9 )% 0.1 % 256 281 (8.9 )% (10.2 )% 1.3 % 803 920 (12.7 )% (12.8 )% 0.1 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 815 815 (0.1 )% (0.1 )% - $ 2,358 2,324 1.5 % 1.5 % - 300 287 4.8 % 2.0 % 2.8 % 895 866 3.4 % 2.6 % 0.8 % 1,115 1,102 1.1 % 0.4 % 0.7 % 3,253 3,190 2.0 % 1.8 % 0.2 % 409 417 (1.6 )% (1.6 )% - 1,175 1,149 2.3 % 2.3 % - 168 166 1.1 % (1.8 )% 2.9 % 507 506 0.2 % (0.7 )% 0.9 % 578 583 (0.8 )% (1.7 )% 0.9 % 1,682 1,655 1.7 % 1.4 % 0.3 % 392 379 3.5 % 3.5 % - 1,139 1,120 1.7 % 1.7 % - 92 80 15.2 % 12.0 % 3.2 % 272 232 17.0 % 16.4 % 0.6 % 484 458 5.6 % 5.0 % 0.6 % 1,411 1,352 4.3 % 4.2 % 0.1 % 13 21 (36.5 )% (36.5 )% - 44 56 (21.5 )% (21.5 )% - 39 39 (1.0 )% (2.5 )% 1.5 % 116 127 (8.9 )% (9.1 )% 0.2 % 53 60 (13.1 )% (14.1 )% 1.0 % 160 183 (12.7 )% (12.9 )% 0.2 % 326 365 (10.5 )% (10.5 )% - 961 1,023 (6.0 )% (6.0 )% - 501 471 6.4 % 0.5 % 5.9 % 1,472 1,599 (7.9 )% (9.8 )% 1.9 % 829 836 (0.9 )% (4.3 )% 3.4 % 2,434 2,622 (7.2 )% (8.3 )% 1.1 % 7 8 (7.9 )% (7.9 )% - 21 24 (11.8 )% (11.8 )% - 378 323 16.9 % 9.9 % 7.0 % 1,082 926 16.8 % 13.6 % 3.2 % 385 330 16.4 % 9.5 % 6.9 % 1,103 950 16.1 % 13.0 % 3.1 % 315 355 (11.0 )% (11.0 )% - 932 990 (5.8 )% (5.8 )% - 81 94 (13.6 )% (18.5 )% 4.9 % 264 315 (16.1 )% (16.6 )% 0.5 % 397 449 (11.6 )% (12.6 )% 1.0 % 1,196 1,305 (8.3 )% (8.4 )% 0.1 % 4 3 57.3 % 57.3 % - 8 10 (11.0 )% (11.0 )% - 42 54 (21.2 )% (22.3 )% 1.1 % 126 358 (64.7 )% (64.6 )% (0.1 )% 47 56 (17.5 )% (18.5 )% 1.0 % 135 367 (63.3 )% (63.2 )% (0.1 )% 750 713 5.3 % 5.3 % - 2,381 2,061 15.5 % 15.5 % - 149 170 (13.1 )% (15.6 )% 2.5 % 461 543 (15.2 )% (14.7 )% (0.5 )% 899 884 1.7 % 1.2 % 0.5 % 2,842 2,605 9.1 % 9.2 % (0.1 )% 635 592 7.4 % 7.4 % - 1,946 1,697 14.7 % 14.7 % - - - - - - - - - - - 635 592 7.4 % 7.4 % - 1,946 1,697 14.7 % 14.7 % - 115 121 (5.2 )% (5.2 )% - 435 364 19.4 % 19.4 % - 149 170 (13.1 )% (15.6 )% 2.5 % 461 543 (15.2 )% (14.7 )% (0.5 )% 264 292 (9.8 )% (11.3 )% 1.5 % 896 908 (1.3 )% (1.0 )% (0.3 )% 9,402 8,871 6.0 % 6.0 % - 26,655 24,993 6.7 % 6.7 % - 6,161 5,709 7.9 % 4.3 % 3.6 % 17,983 17,639 1.9 % 1.3 % 0.6 % $ 15,563 14,580 6.8 % 5.3 % 1.5 % $ 44,638 42,632 4.7 % 4.5 % 0.2 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,306 1,148 13.8 % 13.8 % - $ 3,931 3,292 19.4 % 19.4 % - 908 819 10.8 % 8.4 % 2.4 % 2,698 2,353 14.6 % 13.8 % 0.8 % 2,213 1,966 12.6 % 11.6 % 1.0 % 6,629 5,645 17.4 % 17.1 % 0.3 % 720 660 9.1 % 9.1 % - 2,145 2,057 4.3 % 4.3 % - 698 619 12.6 % 10.4 % 2.2 % 2,064 1,889 9.2 % 8.6 % 0.6 % 1,418 1,279 10.8 % 9.7 % 1.1 % 4,209 3,946 6.7 % 6.4 % 0.3 % 336 293 14.5 % 14.5 % - 1,035 905 14.3 % 14.3 % - 86 68 26.8 % 20.2 % 6.6 % 256 207 23.9 % 20.7 % 3.2 % 423 362 16.8 % 15.6 % 1.2 % 1,291 1,112 16.1 % 15.5 % 0.6 % 220 163 34.4 % 34.4 % - 659 240 * * - 59 66 (11.2 )% (12.4 )% 1.2 % 169 66 * * * 278 229 21.2 % 20.9 % 0.3 % 828 306 * * * 30 30 0.0 % 0.0 % - 93 89 4.2 % 4.2 % - 65 66 (1.0 )% (2.5 )% 1.5 % 209 192 9.0 % 8.7 % 0.3 % 95 96 (0.7 )% (1.7 )% 1.0 % 302 281 7.5 % 7.2 % 0.3 % 1,396 1,359 2.7 % 2.7 % - 4,200 4,229 (0.7 )% (0.7 )% - 878 832 5.6 % 1.9 % 3.7 % 2,620 2,614 0.3 % (1.1 )% 1.4 % 2,274 2,191 3.8 % 2.4 % 1.4 % 6,820 6,843 (0.3 )% (0.8 )% 0.5 % 262 250 4.7 % 4.7 % - 796 785 1.3 % 1.3 % - 144 131 9.7 % 5.9 % 3.8 % 440 435 1.2 % 0.0 % 1.2 % 405 381 6.4 % 5.1 % 1.3 % 1,235 1,220 1.3 % 0.9 % 0.4 % 216 212 2.1 % 2.1 % - 673 684 (1.5 )% (1.5 )% - 160 140 14.3 % 10.9 % 3.4 % 482 463 4.0 % 3.0 % 1.0 % 377 352 7.0 % 5.6 % 1.4 % 1,155 1,147 0.7 % 0.3 % 0.4 % 512 497 3.0 % 3.0 % - 1,515 1,499 1.1 % 1.1 % - 281 265 6.4 % 2.5 % 3.9 % 818 786 4.1 % 2.7 % 1.4 % 793 761 4.2 % 2.9 % 1.3 % 2,333 2,285 2.1 % 1.6 % 0.5 % 406 400 1.3 % 1.3 % - 1,216 1,262 (3.7 )% (3.7 )% - 293 296 (1.1 )% (4.8 )% 3.7 % 881 930 (5.3 )% (6.8 )% 1.5 % 698 696 0.3 % (1.3 )% 1.6 % 2,096 2,191 (4.3 )% (5.0 )% 0.7 % REPORTED SALES vs. PRIOR PERIOD ($MM) REPORTED SALES vs. PRIOR PERIOD ($MM) THIRD QUARTER NINE MONTHS % Change % Change 2025 2024 Reported Operational (1) Currency 2025 2024 Reported Operational (1) Currency $ 1,031 983 4.9 % 4.9 % - $ 3,076 2,965 3.8 % 3.8 % - 1,511 1,451 4.1 % 2.2 % 1.9 % 4,417 4,373 1.0 % 0.9 % 0.1 % 2,542 2,434 4.4 % 3.3 % 1.1 % 7,493 7,338 2.1 % 2.1 % 0.0 % 477 448 6.2 % 6.2 % - 1,411 1,360 3.7 % 3.7 % - 688 661 4.2 % 2.1 % 2.1 % 1,991 1,977 0.7 % 0.5 % 0.2 % 1,165 1,109 5.0 % 3.8 % 1.2 % 3,402 3,337 1.9 % 1.8 % 0.1 % 555 535 3.8 % 3.8 % - 1,666 1,605 3.8 % 3.8 % - 823 791 4.0 % 2.2 % 1.8 % 2,426 2,397 1.2 % 1.3 % (0.1 )% 1,378 1,325 3.9 % 2.9 % 1.0 % 4,092 4,001 2.3 % 2.3 % 0.0 % 571 549 4.2 % 4.2 % - 1,694 1,619 4.7 % 4.7 % - 828 751 10.2 % 7.5 % 2.7 % 2,354 2,224 5.8 % 5.0 % 0.8 % 1,400 1,300 7.7 % 6.1 % 1.6 % 4,048 3,843 5.3 % 4.8 % 0.5 % 456 441 3.5 % 3.5 % - 1,337 1,288 3.8 % 3.8 % - 562 527 6.6 % 3.4 % 3.2 % 1,565 1,508 3.8 % 2.4 % 1.4 % 1,018 968 5.2 % 3.5 % 1.7 % 2,902 2,796 3.8 % 3.1 % 0.7 % 116 108 7.0 % 7.0 % - 358 331 8.0 % 8.0 % - 266 225 18.7 % 17.1 % 1.6 % 789 717 10.1 % 10.3 % (0.2 )% 383 333 14.9 % 13.8 % 1.1 % 1,147 1,048 9.4 % 9.6 % (0.2 )% 4,306 4,038 6.6 % 6.6 % - 12,902 12,105 6.6 % 6.6 % - 4,124 3,853 7.0 % 4.5 % 2.5 % 12,089 11,564 4.5 % 3.9 % 0.6 % $ 8,430 7,891 6.8 % 5.6 % 1.2 % $ 24,991 23,669 5.6 % 5.3 % 0.3 % GAAP to Non-GAAP Reconciliation $ in Millions Third Quarter Sept 28, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related Other Third Quarter Sept 28, 2025 Non-GAAP $ 3,672 (568 ) (11 ) 3,093 2,869 2,869 2,944 2,944 (368 ) 5 (48 ) 174 (1 ) (238 ) 6,446 568 (5 ) - 59 (174 ) - 1 6,895 $ 3,612 (480 ) (12 ) (1 ) 3,119 2,801 2,801 728 728 2 5 (156 ) (48 ) 213 (1 ) 15 1,287 480 (5 ) 168 49 (213 ) - 1 1,767 $ 19 19 252 252 - - (31 ) (25 ) 11 (45 ) (240 ) - 25 - (11 ) - - - (226 ) $ 7,303 (1,048 ) (12 ) (12 ) 6,231 5,922 5,922 3,672 3,672 (478 ) (15 ) (93 ) (85 ) 387 (2 ) (286 ) - - 18 18 63 (63 ) - 7,493 1,048 15 168 97 (387 ) - 2 8,436 2,341 193 3 34 16 (87 ) (874 ) 9 1,635 5,152 855 12 134 81 (300 ) 874 (7 ) 6,801 GAAP to Non-GAAP Reconciliation $ in Millions $ 3,549 (695 ) (2 ) 2,852 2,491 2,491 4,213 (2 ) 4,211 (155 ) (356 ) (19 ) (6 ) 41 (495 ) 4,482 695 356 19 6 (41 ) - 4 - 5,521 $ 3,381 (476 ) (6 ) (156 ) (16 ) 2,727 2,723 (3 ) 2,720 739 (36 ) (19 ) 684 (11 ) (19 ) (22 ) (85 ) (4 ) (141 ) 1,059 476 19 28 277 4 38 - - 1,901 $ 33 33 264 264 - - 1,906 (2,013 ) (45 ) (152 ) (2,203 ) - 2,013 - 45 - - - - (145 ) $ 6,963 (1,171 ) (6 ) (156 ) (16 ) (2 ) 5,612 5,478 (3 ) 5,475 4,952 (36 ) (19 ) (2 ) 4,895 1,798 (2,388 ) (136 ) 37 (689 ) - - (99 ) (99 ) 41 (41 ) - 3,338 1,171 2,388 47 328 (37 ) 38 4 - 7,277 644 169 527 9 59 (9 ) 6 1 (5 ) 1,401 2,694 1,002 1,861 38 269 (28 ) 32 3 5 5,876 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 11,670 (2,002 ) (24 ) 9,644 7,919 7,919 8,361 8,361 (520 ) 74 (275 ) 164 (14 ) (571 ) 17,208 2,002 (74 ) - 299 (164 ) - 14 19,285 $ 10,576 (1,433 ) (35 ) (52 ) 9,056 8,319 8,319 2,052 37 2,089 132 (78 ) (267 ) (155 ) 163 (15 ) (220 ) 3,912 1,433 78 302 170 (163 ) - 15 5,747 $ 42 42 685 685 - - (7,222 ) 6,898 (6 ) (330 ) 6,495 - (6,898 ) - 6 - - - (397 ) $ 22,288 (3,435 ) (35 ) (76 ) 18,742 16,923 16,923 10,413 37 10,450 (7,692 ) 6,894 (123 ) (436 ) 327 (29 ) (1,059 ) - - (62 ) (62 ) 144 (144 ) - 27,615 3,435 (6,894 ) 302 475 (327 ) - 29 24,635 5,927 603 (1,541 ) 58 118 (73 ) (672 ) 9 4,429 21,688 2,832 (5,353 ) 244 357 (254 ) 672 20 20,206 Johnson & Johnson and Subsidiaries GAAP to Non-GAAP Reconciliation $ in Millions $ 10,522 (2,087 ) (8 ) 8,427 7,594 7,594 9,831 (19 ) 9,812 (225 ) (399 ) (194 ) (100 ) (54 ) 26 (50 ) (996 ) 14,910 2,087 399 194 100 54 (26 ) - 77 - 17,795 $ 9,749 (1,268 ) (15 ) (206 ) (66 ) 8,194 7,976 (12 ) 7,964 2,103 (69 ) (79 ) 1,955 173 (15 ) (92 ) (472 ) (48 ) (454 ) 3,668 1,268 15 - 107 747 48 157 - - 6,010 $ 72 72 846 846 - - 4,860 (5,052 ) (127 ) (352 ) (671 ) (5,778 ) - 5,052 - - 127 352 - - - (247 ) $ 20,343 (3,355 ) (15 ) (206 ) (66 ) (8 ) 16,693 16,416 (12 ) 16,404 11,934 (69 ) (79 ) (19 ) 11,767 4,855 (5,466 ) (653 ) (374 ) (50 ) (1,688 ) 194 (194 ) - (433 ) (433 ) 192 (192 ) - 12,800 3,355 5,466 194 207 928 374 157 77 - 23,558 2,165 473 1,224 43 42 222 5 29 17 42 4,262 10,635 2,882 4,242 151 165 706 369 128 60 (42 ) 19,296

上市批准财报

100 项与 Seltorexant 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11269	Seltorexant	-	DB14961

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
重度抑郁症	临床3期	美国	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	阿根廷	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	比利时	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	保加利亚	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	加拿大	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	智利	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	捷克	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	丹麦	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	芬兰	Janssen Research & Development LLC	2020-09-15
重度抑郁症	临床3期	拉脱维亚	Janssen Research & Development LLC	2020-09-15

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04532749 (CTgov)	临床3期	入睡和睡眠障碍 \| 重度抑郁症	212	Seltorexant (Seltorexant)	簾齋觸艱蓋壓鹽窪襯顧(構製顧夢網餘壓淵窪構) = 醖艱艱觸構鬱鑰壓築艱餘製築觸窪膚廠積鏇夢 (網製顧網鏇醖衊選鬱構, 10.46) 更多	-	2025-06-04
				Placebo (Placebo)	簾齋觸艱蓋壓鹽窪襯顧(構製顧夢網餘壓淵窪構) = 憲積遞鬱襯願醖獵選範餘製築觸窪膚廠積鏇夢 (網製顧網鏇醖衊選鬱構, 9.51) 更多
NCT04533529 (ASCP2024) 人工标引	临床3期	重度抑郁症	588	Seltorexant	選鏇選壓顧願鹹膚壓廠(夢鹽網構網選鑰襯窪醖): Difference = -2.6 (95% CI, -4.53 ~ -0.74), P-Value = 0.007 更多	积极	2024-05-29
				Placebo
NCT03321526 (CTgov)	临床2期	重度抑郁症	107	seltorexant+serotonin-norepinephrine reuptake (Seltorexant)	繭蓋願鑰範餘窪鬱範鹹(範選衊醖廠鑰顧選築簾) = 遞衊範襯憲鹹製範鑰製獵廠築願醖衊艱蓋顧積 (構網壓簾願蓋積鹽鏇夢, 鬱鏇蓋襯蓋廠鏇窪簾糧 ~ 網夢構鹽夢蓋蓋襯鹹顧) 更多	-	2022-08-16
				Quetiapine XR (Quetiapine XR)	繭蓋願鑰範餘窪鬱範鹹(範選衊醖廠鑰顧選築簾) = 顧糧積願壓蓋鏇餘獵憲獵廠築願醖衊艱蓋顧積 (構網壓簾願蓋積鹽鏇夢, 膚壓夢鑰蓋夢願糧夢網 ~ 鬱築夢簾獵簾夢繭網窪) 更多
NCT03375203 (CTgov)	临床2期	入睡和睡眠障碍	365	Placebo	簾簾選糧觸鹹製遞醖遞(糧獵糧艱積製願簾製繭) = 襯衊繭憲獵鑰鹽構顧膚衊憲顧獵網夢遞選憲憲 (憲顧遞鏇廠鹹艱憲襯構, 78.547) 更多	-	2022-05-23
NCT03227224 (Pubmed \| Int J Neuropsychopharmacol)	临床2期	重度抑郁症	287	Seltorexant 20 mg	鑰遞鏇廠觸廠範遞衊積(構鹹積艱齋醖鏇淵簾顧): LSM difference = -4.5 (90% CI, -6.96 ~ -2.07)	积极	2021-07-29
				Placebo