The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are:
* Does Lemborexant help participants improve sleep and reduce insomnia symptoms?
* How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)?
Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder.
Participants will:
* Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg)
* Complete clinical assessments and in-person study visits
* Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs)
* Use a wearable device which will be used to collect and monitor physiological data

开始日期2025-02-01

申办/合作机构

Unity Health Toronto

[+3]

NCT06779149

/ Not yet recruitingN/AIIT

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

The primary aims of this study is to contrast the effectiveness of CBT-I and pharmacotherapy (lemborexant) compared to placebo on sleep and mental health outcomes in people with insomnia disorder and anxiety/depressive symptoms. In addition, the study will evaluate whether insomnia phenotypes (i.e., +/- 6hrs of sleep) at baseline moderate the effectiveness of the intervention on both sleep and mental health outcomes.

开始日期2025-02-01

申办/合作机构

Université Laval

[+2]

NCT06823752

/ Not yet recruiting临床2期IIT

A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults with Insomnia Disorder: a Randomised Placebo-controlled Cross-over Study.

The goal of this clinical trial is to explore the potential neuroprotective benefits of a dual orexin receptor antagonist (DORA) in adults with insomnia. The main questions it aims to answer are:
* Does the DORA reduce blood-based phosphorylated TAU181, in adults with insomnia, when compared to placebo
* Does the DORA reduce other blood-based biomarkers of neurodegeneration, including phosphorylated TAU217, amyloid beta 40:42 ratio, Neurofilament Light Chain (NFL) and Glial Fibrillary Acidic Protein (GFAP), when compared to placebo.
Participants will:
* Take 10mg Lemborexant nightly for two weeks
* Take a matching placebo nightly for two weeks
* Visit the research institute for a screening visit and for an overnight visit at the conclusion of each study drug treatment (3 visits in total).

开始日期2025-02-01

申办/合作机构

Woolcock Institute of Medical Research

100 项与莱博雷生相关的临床结果

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100 项与莱博雷生相关的转化医学

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100 项与莱博雷生相关的专利（医药）

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274

项与莱博雷生相关的文献（医药）

2025-04-01·JOURNAL OF SLEEP RESEARCH

Respiratory safety of lemborexant in adult and elderly subjects with moderate‐to‐severe chronic obstructive pulmonary disease

Article

作者: Hall, Nancy ; Lorch, Daniel ; Cheng, Jocelyn Y. ; Moline, Margaret

Summary:

Because some hypnotics worsen respiratory conditions, it was important to determine the respiratory safety of lemborexant, a competitive dual orexin‐receptor antagonist approved to treat adults with insomnia, in subjects with moderate‐to‐severe chronic obstructive pulmonary disease. E2006‐A001‐113 (Study 113; NCT04647383) was a multicentre, multiple‐dose, randomised, double‐blind, placebo‐controlled, two‐period crossover study in adult subjects with moderate or severe chronic obstructive pulmonary disease (per spirometry‐based Global Initiative for Chronic Obstructive Lung Disease [GOLD] criteria). Subjects (N = 30) were randomised to two treatment sequences comprising 8‐night treatment periods (washout ≥ 14 days) with lemborexant 10 mg or placebo. Peripheral oxygen saturation (SpO2; primary endpoint), apnea–hypopnea index, objective sleep parameters and sleep architecture measures were assessed after single (Day 1) and multiple (Day 8) doses. There was no significant difference in least‐squares mean SpO2 after a single dose of lemborexant (91.1%) versus placebo (91.5%). Although a statistically significant difference in SpO2 was observed after multiple doses (least‐squares mean: lemborexant, 91.3%; placebo, 90.8%) favouring lemborexant, this was not considered clinically meaningful. Apnea–hypopnea index was not significantly different between treatments after single or multiple doses. Total sleep time and total rapid eye movement sleep were significantly greater on Days 1 and 8 with lemborexant versus placebo. Treatment‐emergent adverse events were reported in five (16.7%) subjects when taking lemborexant and four (13.3%) subjects when taking placebo; treatment‐emergent adverse events were mostly mild. Lemborexant was well tolerated and did not adversely impact SpO2 or apnea–hypopnea index after single and multiple doses relative to placebo in subjects with moderate‐to‐severe chronic obstructive pulmonary disease.

2025-03-01·Neuropsychopharmacology reports

Efficacy and safety of lemborexant in subjects with insomnia disorder receiving medications for depression or anxiety symptoms

Article

作者: Nierenberg, Andrew A. ; Culpepper, Larry ; Blier, Pierre ; Takaesu, Yoshikazu ; Kubota, Naoki ; Malhotra, Manoj ; Moline, Margaret ; Pinner, Kate ; Yardley, Jane ; Krystal, Andrew

Abstract:

Aim:

Individuals with insomnia frequently have comorbid depression or anxiety. This study sought to provide a preliminary indication of the effects of lemborexant (LEM) in subjects treated for mild depression/anxiety symptoms.

Methods:

E2006‐G000‐303 (NCT02952820; EudraCT 2015‐001463‐39; SUNRISE‐2) was a 12‐month, phase 3, randomized, placebo‐controlled, double‐blind study where subjects with insomnia disorder were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10) for 6 months. During the second 6 months (not reported), placebo‐treated subjects were re‐randomized to LEM5 or LEM10. In this post hoc analysis, changes from baseline (CFB) in subject‐reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Fatigue Severity Scale, and Insomnia Severity Index were evaluated in subjects treated with medications for symptoms of depression/anxiety (subpopulation).

Results:

Of 949 randomized subjects, 61 treated with medications for symptoms of depression/anxiety were included. In the subpopulation, CFB comparing LEM with placebo were generally smaller than the overall population due to a larger placebo response in the subpopulation. However, the magnitudes of CFB within the active treatment groups for sSOL, sWASO, sTST, and sSE were similar between the subpopulation and the overall population. No new safety signals were observed in the subpopulation.

Conclusion:

LEM treatment benefited subjects with insomnia treated with medications for depression/anxiety symptoms, with no new safety signals. A greater placebo response in the subpopulation than in the overall population decreased the drug versus placebo effect size for LEM, as has been reported for other insomnia medications.

2025-03-01·Drug and alcohol dependence reports

Phase 1b/2a safety study of lemborexant as an adjunctive treatment for insomnia to buprenorphine-naloxone for opioid use disorder: A randomized controlled trial

Article

作者: Ramey, Tatiana ; La Rosa, Christina ; Sabo, Roy T ; Moeller, F Gerard ; Bjork, James M ; Arias, Albert J ; Keyser-Marcus, Lori ; Simmons, Kameron ; Martin, Caitlin E ; Pignatello, Tiffany

Background:

Evidence supports the common incidence of sleep disturbance in opioid use disorder (OUD) as a potential marker of disrupted orexin system functioning. This study evaluated the initial safety and tolerability of a challenge dose of lemborexant, a dual orexin antagonist, as an adjunct to buprenorphine/naloxone.

Methods:

Patients (18-65 years old) with OUD receiving sublingual buprenorphine/naloxone, with a Pittsburgh Sleep Quality Index total score of 6 or higher, were recruited from outpatient clinics. After randomization, while being monitored on an inpatient research unit over two 10-hour daytime periods, participants received a placebo or lemborexant (5 mg on day one and 10 mg on day two) along with buprenorphine/naloxone. Primary outcomes included safety and tolerability: adverse events, physiologic measures, sedation level assessments. Generalized linear mixed model analysis assessed the effect of study drug and time on outcomes.

Results:

N=18 (14=male, 4=female) were randomized to lemborexant (n=12) or placebo (n=6). No unanticipated problems occurred; five adverse events occurred in the lemborexant group and two in the placebo group with no serious adverse events. None of the physiologic measures showed a significant interaction of time and placebo vs. lemborexant (5 or 10 mg): Pulse oximetry (F=0.6; p=0.84), End-tidal CO2 (F=0.5; p=0.91), Heart rate (F=0.6; p=0.82), Systolic blood pressure (F=0.7; p=0.73), Diastolic blood pressure (F=2.0; p=0.06). At 9 hours after study drug administration, all participants returned to baseline sedation levels and were discharged.

Conclusions:

Findings support the initial safety and tolerability of lemborexant as an adjunctive treatment for insomnia in humans receiving buprenorphine for OUD. Future longitudinal work is warranted with larger samples.

项与莱博雷生相关的新闻（医药）

2025-02-08

·求实药社

暴增超 2000%！卫材「仑卡奈单抗」前三季度收入 1.94 亿美元

来源：Insight数据库 2 月 7 日，卫材发布了 2024 财年 Q3 业绩报告。前三季度（2024.4.1--2024.12.31），卫材总营收为 6012 亿日元，约合 39.38 亿美元（汇率按 1 日元=0.00655 美元计算，下同），同比增长约9%。其中，制药业务收入为 5691 亿日元（约合 37.28 亿美元），同比增长约8%。研发费用投入 1253 亿日元（约合 8.21 亿美元），同比增长 0.6%。截图来自：卫材财报（下同）业绩增长的驱动力主要来自三款产品，即：抗肿瘤药 Lenvima（仑伐替尼）、新型失眠药物 Dayvigo (莱博雷生) 、阿尔茨海默病药物 LEQEMBI（仑卡奈单抗）。这三款产品的总收入达到了 3181 亿日元，约合 20.84 亿美元，同比增长约24%。仑伐替尼是一种口服多激酶抑制剂，可双重抑制 VEGFR 和 FGFR，是卫材肿瘤领域的支柱产品。该药已获批治疗 5 种癌症类型的 6 个适应症，主要为子宫内膜癌和肾细胞癌。 2024 年前三季度，仑伐替尼收入 2481 亿日元（约合 16.25 亿美元），同比增长 11.1%。增长的主要驱动力还是美国市场，收入达到 1755 亿日元，同比增长约15%。新型失眠药物 Dayvigo 收入 405 亿日元（约合 2.65 亿美元），同比增长近30%。仑卡奈单抗收入保持稳健增长。前三季度，仑卡奈单抗的全球收入已达到 296 亿日元（约合 1.94 亿美元），同比增长 2014%。在中国，仑卡奈单抗于 2024 年 6 月底才上市，创造了 28 亿日元（约合0.18 亿美元）的收入。卫材预计该药的 2024 财年收入有望实现 425 亿日元的预期目标。仑卡奈单抗目前已经在 10 个国家和地区获批上市，并在 17 个国家和地区接受监管审评。此外，卫材还推出了仑卡奈单抗的皮下注射剂型，并已向美国 FDA 递交上市申请，PDUFA 日期为 2025 年 8 月 31 日。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。联系我们 ABC 2025 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！

财报上市批准

2025-02-07

·医药观澜

2025年有望在中国获批上市的9款神经系统疾病新药

▎药明康德内容团队报道中枢神经系统（CNS）和精神系统疾病往往疾病机制复杂、新药研发难度大，患者存在未被满足的临床需求。本文将盘点9款有望在2025年获NMPA批准上市的CNS领域新药*，它们覆盖的适应症包括精神分裂症、阿尔茨海默病、嗜睡、失眠症等等。（*本文统计范围为于2023年1月~2025年1月期间向CDE递交上市申请的新药；新药仅统计注册分类为1类、3.1类、5.1类的新药；仅盘点有望首次获批的新药，不含新适应症）图片来源：123RF 百时美施贵宝、再鼎医药：呫诺美林曲司氯铵作用机制：M1/M4型毒蕈碱乙酰胆碱受体激动剂和毒蕈碱受体拮抗剂的组合适应症：精神分裂症 2025年1月，百时美施贵宝和再鼎医药共同申报的5.1类新药呫诺美林曲司氯铵胶囊上市申请获得CDE受理。这是一款用于治疗精神分裂症的新药KarXT，为一种口服M1/M4型毒蕈碱乙酰胆碱受体激动剂和毒蕈碱受体拮抗剂的组合。与目前主要针对多巴胺或血清素受体的抗精神病药物不同，呫诺美林优先刺激中枢神经系统中与这些疾病有关的毒蕈碱受体。2024年9月，美国FDA已经批准该产品用于治疗成人精神分裂症。再鼎医药拥有在大中华区开发、生产和商业化KarXT的权益。再鼎医药在今年的摩根大通医疗健康年会（JPM）中曾表示，KarXT有望于2025~2026年获NMPA批准上市。扬子江药业：法赞雷生作用机制：双重食欲素受体拮抗剂适应症：失眠症 2025年1月，扬子江药业全资子公司海岸药业申报的1类新药法赞雷生片上市申请获得CDE受理。公开资料显示，这是一款双重食欲素受体拮抗剂（YZJ-1139片），它能够同时抑制食欲素受体1型和2型，加快睡眠速度，延长深睡时间。扬子江药业已经完成一项YZJ-1139片治疗失眠症的3期临床试验，针对的适应症为以入睡困难/睡眠维持障碍为特征的失眠症。梯瓦：瑞玛奈珠单抗作用机制：CGRP单克隆抗体适应症：偏头痛预防性治疗 2025年1月，梯瓦（Teva）公司申报的3.1类新药瑞玛奈珠单抗注射液（fremanezumab）上市申请获得CDE受理。这是一种人源化单克隆抗体，它可选择性结合CGRP配体，并阻断两种CGRP亚型（α-和β-CGRP）与受体结合。该产品此前已在美国和欧盟获批用于成年患者偏头痛的预防性治疗。该产品有两种给药方案，可每月一次皮下注射（225mg），或每3个月一次皮下注射（675mg）。此外，其不仅可由医疗专业人员给药，亦可在家由患者或护理人员给药。翼思生物：西诺氨酯作用机制：抑制电压门控钠通道和正变构调节GABAA受体适应症：癫痫 2024年12月，SK Life Science和翼思生物共同申报的西诺氨酯片（cenobamate）上市申请获得CDE受理。西诺氨酯是翼思生物2021年从SK生物医药授权引进的CNS创新药物，它可通过抑制电压门控钠通道和正变构调节GABAA受体来减少癫痫发作甚至实现零发作。西诺氨酯片自2019~2021年在美国、欧盟和英国先后获批上市以来，已被广泛用于治疗成人癫痫患者的部分性发作。翼思生物：索安非托作用机制：双效多巴胺和去甲肾上腺素再摄取抑制剂适应症：过度嗜睡 2024年12月，翼思生物等公司共同申报的索安非托片（solriamfetol）上市申请获得CDE受理。索安非托是一种双效多巴胺和去甲肾上腺素再摄取抑制剂，该产品用于治疗与发作性睡病或阻塞性睡眠呼吸暂停综合征（OSA）相关的白天过度嗜睡。发作性睡病是一种失能性神经疾病，患者无法正常调节睡眠与苏醒的循环，导致出现嗜睡症状。索安非托可通过双重机制起到促进患者保持清醒的作用，包括引起多巴胺和去甲肾上腺素水平上升。该产品不会刺激多巴胺释放，从而减轻患者上瘾的风险。通化金马：八氢氨吖啶作用机制：乙酰胆碱酯酶抑制剂适应症：阿尔茨海默病 2024年8月，通化金马药业申报的1类新药琥珀八氢氨吖啶片的上市申请获得受理。这是通化金马开发的一款小分子乙酰胆碱酯酶抑制剂，可以同时抑制乙酰胆碱酯酶和丁酰胆碱酯酶，主要开发用于治疗轻中度阿尔茨海默病。先声药业：达利雷生作用机制：双重食欲素受体拮抗剂适应症：失眠症 2024年7月，先声药业联合申报的盐酸达利雷生片新药上市申请获得CDE受理。盐酸达利雷生片是Idorsia公司开发的抗失眠药，为一款双食欲素受体拮抗剂。先声药业拥有该产品在大中华地区开发和商业化的独家权利。与传统镇静催眠药物通过镇静大脑来促进睡眠的疗法不同，达利雷生通过阻断食欲素神经肽（食欲素A和食欲素B）与其受体的结合，降低过度活跃的中枢觉醒，帮助患者入睡和保持睡眠。由于其仅阻断食欲素受体的启动，因此可减少唤醒驱动，诱导睡眠发生，而不改变睡眠阶段的比例，且没有次日残留效应。卫材（Eisai）：莱博雷生作用机制：双重食欲素受体拮抗剂适应症：失眠症 2024年1月，卫材申报的莱博雷生片（lemborexant）上市申请获CDE受理。莱博雷生片是一款双重食欲素受体拮抗剂，此前已经在中国香港地区获批上市，用于治疗成人失眠，特别是入睡困难和/或睡眠维持困难。莱博雷生是一款小分子药物，其通过竞争性结合两种食欲素受体亚型OX1R和OX2R，抑制食欲素神经传递，调节睡眠-觉醒节律。作为一种竞争性拮抗剂，莱博雷生对OX2R具有更强的抑制作用，可抑制REM和非REM睡眠驱动，从而可以为患者提供更快的睡眠开始、更好的睡眠维持。阿斯利康（AstraZeneca）：瑞利珠单抗作用机制：长效补体C5蛋白抑制剂适应症：视神经脊髓炎谱系疾病等瑞利珠单抗（ravulizumab）是阿斯利康开发的一款长效补体C5蛋白抑制剂。它可提供即时、完全和持续的补体抑制。独特的设计使该产品具有比第一代C5补体抑制剂更长的半衰期，成人患者在初始剂量给药后，后续只需要每8周静脉注射一次。该产品已经获FDA批准治疗阵发性睡眠性血红蛋白尿症、非典型溶血性尿毒症综合征、重症肌无力、视神经脊髓炎谱系疾病等。视神经脊髓炎谱系疾病（NMOSD）是免疫介导的中枢神经系统炎性脱髓鞘疾病，以视神经炎和脊髓炎为主要临床征象，病因主要与水通道蛋白4（AQP4）抗体相关。在中国，该产品的首个上市申请已经于2023年12月获得CDE受理，第二项上市申请也已经于2024年10月获CDE受理。希望这些新药早日来到患者身边，尽快造福患者！参考资料： [1]中国国家药监局药品审评中心（CDE）官网. [2]各公司官网及公开资料本文来自药明康德内容团队，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。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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。

上市批准临床3期

2024-12-31

·echemi

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

上市批准临床3期临床结果抗体药物偶联物免疫疗法

100 项与莱博雷生相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11022	莱博雷生	N05C	DB11951

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
入睡和睡眠障碍	加拿大	Eisai Co., Ltd.	2019-09-03

未上市

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
苏醒期谵妄	临床2期	加拿大	Eisai, Inc.	2025-01-15
睡眠	临床2期	加拿大	Eisai, Inc.	2025-01-15
阻塞性睡眠呼吸暂停综合征	临床2期	泰国	University of Chulalongkorn	2023-02-01
阿尔茨海默症	临床2期	美国	Purdue Pharma LP	2016-12-20
阿尔茨海默症	临床2期	美国	Eisai, Inc.	2016-12-20
阿尔茨海默症	临床2期	日本	Purdue Pharma LP	2016-12-20
阿尔茨海默症	临床2期	日本	Eisai, Inc.	2016-12-20
阿尔茨海默症	临床2期	英国	Eisai, Inc.	2016-12-20
阿尔茨海默症	临床2期	英国	Purdue Pharma LP	2016-12-20
日夜节律睡眠障碍	临床2期	美国	Eisai, Inc.	2016-12-20

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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


NCT04549168 (CTgov)	临床3期	入睡和睡眠障碍	194	lemborexant+placebo (Randomization Phase: Placebo)	鹽憲齋襯積糧壓積顧簾(醖衊遞構獵積壓鏇簾繭) = 繭築鑰廠窪淵衊醖鬱糧網鏇鬱壓鹹醖齋製憲鏇 (膚齋夢糧衊遞繭廠簾淵, 42.809) 更多	-	2024-12-20
				Lemborexant (Randomization Phase: Lemborexant 10 mg)	鹽憲齋襯積糧壓積顧簾(醖衊遞構獵積壓鏇簾繭) = 鑰鏇壓願顧範獵襯遞淵網鏇鬱壓鹹醖齋製憲鏇 (膚齋夢糧衊遞繭廠簾淵, 46.147) 更多
NCT04818086 (CTgov)	临床1/2期	阿片相关性障碍 \| 药物相互作用	18	Lemborexant+Buprenorphine-naloxone (Lemborexant Arm)	願糧簾顧夢蓋窪鬱餘繭(鏇襯鹽齋憲壓壓襯觸網) = 窪簾憲築鹽範齋繭鬱鹽鑰蓋獵鬱鏇製選鹽鑰夢 (觸鏇顧願顧壓選顧製餘, .94) 更多	-	2024-11-13
				Placebo+Buprenorphine-naloxone (Placebo Arm)	願糧簾顧夢蓋窪鬱餘繭(鏇襯鹽齋憲壓壓襯觸網) = 範壓鹹淵憲艱淵選醖鏇鑰蓋獵鬱鏇製選鹽鑰夢 (觸鏇顧願顧壓選顧製餘, .82) 更多
AAN2024	N/A	入睡和睡眠障碍 \| 睡眠-觉醒节律障碍	-	Lemborexant 5 mg	鏇築觸艱觸鹹衊蓋蓋鹽(顧願襯簾齋構鬱憲繭鑰) = LEM was well tolerated with most treatment-emergent adverse events mild/moderate in severity 糧網糧繭窪獵構淵範鹹 (簾願窪壓簾製遞鏇餘襯 )	-	2024-04-09
				Lemborexant 10 mg
NCT04890561 (E2006-A001-010, Pubmed \| Br J Clin Pharmacol)	临床1期	-	8	Lemborexant 10mg	鬱艱鑰積窪鏇願壓鹹艱(廠壓築醖觸鏇選網齋鹽) = Mild treatment‐emergent adverse events were reported in 4 subjects; these all resolved by end of study 憲繭齋繭構顧衊鹽壓願 (壓鑰憲齋鑰醖築鑰願構 )	积极	2024-01-01
NCT04647383 (E2006-A001-113, Pubmed \| J Clin Sleep Med)	临床1期	阻塞性睡眠呼吸暂停综合征	33	Lemborexant 10 mg	憲壓壓糧窪築廠鏇襯蓋(範製襯衊選願簾願築夢) = 齋築網選觸鬱夢選餘觸簾鹹顧願顧鏇衊淵顧簾 (夢窪遞廠蓋製觸齋襯窪 )	积极	2024-01-01
				Placebo	憲壓壓糧窪築廠鏇襯蓋(範製襯衊選願簾願築夢) = 遞鹹積築鹹築範鏇積積簾鹹顧願顧鏇衊淵顧簾 (夢窪遞廠蓋製觸齋襯窪 )
SFN2023	N/A	入睡和睡眠障碍 \| REM睡眠行为障碍	-	Lemborexant 0 mg/kg	夢鑰餘齋觸艱網憲餘簾(顧網膚鬱築願簾鹹齋獵) = 膚願獵遞糧淵遞獵築蓋遞鏇憲築壓夢觸顧築夢 (獵醖顧艱襯製獵艱夢蓋 ) 更多	-	2023-11-12
				Lemborexant 30 mg/kg	夢鑰餘齋觸艱網憲餘簾(顧網膚鬱築願簾鹹齋獵) = 齋鏇壓顧齋鏇夢膚鑰獵遞鏇憲築壓夢觸顧築夢 (獵醖顧艱襯製獵艱夢蓋 ) 更多
NCT04009577 \| NCT04742699 (E2006-A001-312 \| E2006-M081-401, WSC2023)	N/A	-	-	Lemborexant 5mg	網糧餘鹹願蓋遞築窪鑰(繭鹹壓夢鹽齋觸蓋醖構) = 簾膚遞構構積膚選選夢醖鬱餘醖艱範選夢簾夢 (壓醖選範範壓築鬱鏇積 ) 更多	积极	2023-10-24
				Lemborexant 10mg	築蓋鬱餘淵鹽淵簾鹽構(積製鬱鑰夢鏇艱選鬱憲) = 艱顧顧簾糧顧範襯窪獵淵願積鏇蓋選壓蓋範衊 (艱鑰遞鑰築憲襯網築鏇 )
Somnus Study (WSC2023)	临床3期	入睡和睡眠障碍	90	Lemborexant	鬱範膚網衊鬱衊鏇夢廠(糧鬱鹹築築鏇鹹夢顧鹹) = improved over time after the transition to treatment with LEM 積壓壓繭膚壓鹽蓋製醖 (醖艱齋鬱夢構遞蓋衊蓋 ) 更多	积极	2023-10-24
WSC2023	N/A	入睡和睡眠障碍	716	Lemborexant	醖簾簾廠壓積簾艱遞繭(鏇窪積膚鑰鬱簾積鑰範) = 衊糧壓襯憲淵淵繭鬱夢夢襯願網鹹壓醖築遞醖 (積顧齋選鏇顧顧網遞糧 )	积极	2023-10-23
				Trazodone	醖簾簾廠壓積簾艱遞繭(鏇窪積膚鑰鬱簾積鑰範) = 淵鹹鹽鹽選鏇構觸艱鹽夢襯願網鹹壓醖築遞醖 (積顧齋選鏇顧顧網遞糧 )
NCT02783729 (E2006-G000-304, WSC2023)	临床3期	入睡和睡眠障碍	1,006	Placebo	選鏇廠夢鹽淵顧艱鹽膚(夢觸積顧壓範構艱醖築) = 襯鹹鹽襯廠繭膚糧膚網夢遞廠願網蓋鬱鑰願鬱 (構簾餘範鏇鏇蓋觸簾糧 )	积极	2023-10-22
				Zolpidem tartrate extended-release 6.25 mg	選鏇廠夢鹽淵顧艱鹽膚(夢觸積顧壓範構艱醖築) = 醖衊簾構蓋齋遞獵網觸夢遞廠願網蓋鬱鑰願鬱 (構簾餘範鏇鏇蓋觸簾糧 )