Observational Cohort Study on Adult Patients with Not-adequately Controlled FOcal-onset Seizures Treated with Cenobamate As Early AdjUnctive Therapy in a Real-world Setting - FOCUS

Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).

开始日期2024-12-01

申办/合作机构

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA

[+1]

NCT06453213

/ Recruiting临床4期

Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

开始日期2024-10-14

申办/合作机构

SK Life Science, Inc.

NCT06352723

/ Not yet recruiting早期临床1期IIT

Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus

The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.
Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.

开始日期2024-04-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

100 项与 Cenobamate 相关的临床结果

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100 项与 Cenobamate 相关的转化医学

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100 项与 Cenobamate 相关的专利（医药）

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218

项与 Cenobamate 相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of cenobamate for epilepsy patients with drug-resistant focal onset seizures in the Netherlands

Article

作者: Rijkers, Kim ; Gubler, Felix ; Hiligsmann, Mickaël ; Laskier-Owens, Vicki ; Evers, Silvia ; Klarenbeek, Pim ; Li, Nannan ; Rouhl, Rob ; Majoie, Marian ; Lazeron, Richard

OBJECTIVE:

The objective of this study was to explore the financial consequences of adopting cenobamate as a treatment alternative in epilepsy patients with drug-resistant focal onset seizures (FOS) from a societal perspective in the Netherlands.

METHODS:

A previous budget impact model with a 5-year time horizon was adapted to the Dutch setting accounting for the eligible population, real-world market shares, treatment effectiveness and resource use in two scenarios: cenobamate with constant market share versus cenobamate with linearly increased market share up to 20%. Clinical inputs included treatment response, seizure reduction and adverse events. Costs consisted of drugs, medical and non-medical costs. One-way sensitivity analysis and scenario analysis were conducted to test the robustness of our results.

RESULTS:

14,723 patients were eligible for cenobamate in 2022. Although cenobamate adds a gross budget impact of €12,686,30, the displacement of other drugs yields a total impact on the drug budget of €3,722,596 over 5 years. Adopting cenobamate resulted in a medical cost savings of €13,499,498 due to less resource use, and non-medical cost savings of €22,144,054 due to reduced productivity losses. Overall, savings generated at medical and non-medical cost level offset the gross drug budget impact of cenobamate, resulting in a saving of €31,920,955 over 5 years. Results were robust in the sensitivity/scenario analyses.

CONCLUSION:

Treatment with cenobamate is associated with both medical and non-medical cost savings, which offset the increase in drug budget and result in a significant potential budget saving. The higher the market share of cenobamate, the larger the budget savings. We acknowledge several limitations; Complex scenarios such as drug interactions, stopping/switching drugs, and multiple drug use were not taken into account. The long-term efficacy and safety of cenobamate and its comparators remains uncertain. Future real-world data are needed to confirm our findings.

2025-04-01·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Adjunctive treatment for pediatric focal epilepsy: a systematic review

Review

作者: Zhang, Xiaolu ; Wang, Zhaoxuan ; Wang, Siru ; Sun, Hu ; Sun, Chunxiao ; Liu, Chang

PURPOSE:

We aim to use a network meta-analysis to evaluate the efficacy and safety of antiseizure medications and provide a theoretical basis for rational drug use for children and adolescents in adjunctive treatment.

METHODS:

The databases of PubMed, Embase, Cochrane Library, and Web of Science were systematically searched for random clinical trials about perampanel, valproic acid, carbamazepine, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, topiramate, zonisamide, brivaracetam, cenobamate, eslicarbazepine acetate, and pregabalin from their inception until December 10, 2023. The included studies' risk of bias was evaluated by the Cochrane Collaboration's tool (RoB2). The network meta-analysis was performed using Stata 15 on the included studies.

RESULTS:

Seventeen studies were identified and of these 19 randomized controlled trials evaluating 9 different antiepileptic drugs were included. In total, 2959 patients were covered in the analysis of the outcomes. For efficacy, lacosamide (OR = 1.91, 95%CI 1.14-3.20), lamotrigine (OR = 3.82, 95%CI 1.86-7.83), levetiracetam (OR = 3.01, 95%CI 1.89-4.80), oxcarbazepine (OR = 2.75, 95%CI 1.52-4.96), perampanel (OR = 2.05, 95%CI 1.15-3.65), and zonisamide (OR = 2.27, 95%CI 1.21-4.24) were more effective than placebo in the 50% responder rate. Lamotrigine ranked first on the cumulative probability curve, followed by levetiracetam. Eslicarbazepine acetate (OR = 6.44, 95%CI 1.43-29.00) and levetiracetam (OR = 5.75, 95%CI 2.45-13.50) were better than placebo in seizure freedom. For safety, topiramate (OR = 4.11, 95%CI 1.43-11.76) and oxcarbazepine (OR = 2.72, 1.28-5.76) were more likely to cause adverse effects in children or adolescents compared to placebo.

CONCLUSION:

In terms of efficacy and safety, lamotrigine and levetiracetam may be selected preferentially for the adjunctive treatment of focal epilepsy in children and adolescents. However, owing to the limited random clinical trials, our results need to be verified by further studies.

2025-03-01·NEUROLOGICAL SCIENCES

Drug-induced liver injury during valproic acid and cenobamate coadministration: a direct consequence or an unforeseen event?

Letter

作者: Giannelli, Thomas ; Falcicchio, Giovanni

项与 Cenobamate 相关的新闻（医药）

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

2024-12-17

·PRNewswire

SK Biopharmaceuticals Inks Research Collaboration Agreement with ProEn Therapeutics Further Accelerating Expansion of Oncology Research and Pipeline for Global Competitiveness in Radiopharmaceuticals

SK Biopharmaceuticals, ProEn Therapeutics aim to advance up to 2 preclinical radiopharmaceutical candidates by 2027, via ArtBody™, a bivalent binder platform designed to selectively target tumor cells SK Biopharmaceuticals eyes innovative small protein-based radiopharmaceuticals on safety and efficacy amid growing global demand through the joint research initiative building on the momentum for its radiopharmaceutical therapy business SEOUL, South Korea, Dec. 16, 2024 /PRNewswire/ -- SK Biopharmaceuticals, a biotech company focusing on the research, development and commercialization of treatments for disorders of the central nervous system and oncology worldwide, announced a research collaboration agreement with ProEn Therapeutics, a biotech company dedicated to advancing oncology treatments, to further extend its oncology research capability and expand its pipeline of radiopharmaceutical therapies (RPT). Under this agreement, both sides seek to advance up to two preclinical candidates for the development of novel radiopharmaceutical drugs by 2027 – the year when SK Biopharmaceuticals aims to become a global leading RPT player, via strengthened internal and external resources. This joint research builds on a series of SK Biopharmaceuticals' global strategic partnerships, including the in-licensing of a radiopharmaceutical compound, and a supply agreement to secure actinium-225, an alpha-particle emitting radioisotope, since the company unveiled its "RPT Roadmap" to gain a competitive edge in the rapidly growing field of nuclear medicine. SK Biopharmaceuticals will leverage ProEn Therapeutics' ArtBody™ platform, a dual-target binding technology that incorporates small proteins[1] to identify and target specific tumor antigens – enhancing tumor selectivity – for the development of potential cancer treatments, while minimizing damage to healthy tissues. ArtBody™, which has intrinsic advantages of high stability and structural robustness, can be mass-produced using bacteria, making it ideal for industrial applications. Il-Han Lee, Chief Executive Officer of ProEn Therapeutics, said, "We are pleased to enter this joint research, and positive that the ArtBody™ platform will generate synergy with and complement SK Biopharmaceuticals' radiopharmaceutical therapy business. ProEn Therapeutics will push to produce the best possible outcome that can meet not only the two companies' expectations, but also patients' needs." Donghoon Lee, Chief Executive Officer of SK Biopharmaceuticals, said, "This collaboration with ProEn Therapeutics is significant as the platform technology will help overcome the limitations of existing therapies. We will aim to develop more effective, safer treatments, while leading global RPT research and development efforts." About SK Biopharmaceuticals SK Biopharmaceuticals focuses on the research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin its expansion into oncology through research and development efforts. SK Biopharmaceuticals is the first and only Korean company to independently develop and commercialize an antiseizure medication, cenobamate (brand name: XCOPRI®), in the U.S. Cenobamate, which was commercially launched in the U.S. in 2020 by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, has successfully entered five major regions: North America, Europe, Asia, Central and South America, and the Middle East and North Africa. The company has a pipeline of eight compounds in development in both CNS disorders and oncology. For more information, visit SK Biopharmaceuticals' website at , and SK Life Science's website at . About ProEn Therapeutics ProEn Therapeutics is a biotechnology company dedicated to advancing oncology treatments through cutting-edge protein engineering. The company's innovative drug development platform, ArtBody™, focuses on bi-specific antibody-drug conjugates tailored for solid cancers. ProEn Therapeutics is also exploring next-generation therapies such as immune cell engagers and chimeric antigen receptor platforms, while extending its research in radiopharmaceuticals. The company is advancing its proprietary pipeline, while actively collaborating with partners specializing in various therapeutic modalities. For more information, visit ProEn Therapeutics' website at . SOURCE SK Biopharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准引进/卖出

2024-12-13

·凯莱英药闻

本周国内新药里程碑汇总：3款创新药获批上市，来自卫材、曙方医药、瓴路药业...

欢迎关注凯莱英药闻（收集周期：12.9-12.13，收集部分为首次申请临床、首次申请上市、首次批准上市的创新药）国内创新药IND汇总 1、微芯生物：CS12088片作用机制：HBV核衣壳组装调节剂适应症：慢性乙型肝炎 12月10日，微芯生物的CS12088片的临床试验申请（IND）获CDE受理。CS12088是HBV核衣壳组装调节剂，正在开发用于慢性乙型肝炎。临床前研究表明，CS12088具有显著的抗病毒活性、肝靶向性及良好的安全性和耐受性。该药物能够阻断HBV DNA的复制，并对多种HBV基因型保持抗病毒活性，具备直接抗病毒作用及HBsAg转阴潜力。 2、联馨药业：SAR107375E片作用机制：FII/FX抑制剂适应症：抗凝 12月10日，联馨药业的SAR107375E 片的IND获CDE受理。SAR107375E是一种新型小分子化合物，能够直接选择性抑制凝血因子Xa和凝血因子IIa。凝血因子Xa是凝血级联反应中内源性凝血和外源性凝血的共同途径，凝血因子IIa促进纤维蛋白原转化为纤维蛋白，同时抑制这两个因子可以产生有效的抗凝作用。在体外实验和动物实验中，SAR107375E表现出较强的抗凝活性和较好安全范围。 3、礼邦医药：AP306片作用机制：钠依赖性磷酸盐转运蛋白泛抑制剂适应症：高磷血症 12月11日，礼邦医药的AP306片的IND获CDE受理。AP306是口服磷酸盐转运蛋白NaPi-IIb、PiT-1、PiT-2泛抑制剂，能阻断肠道磷酸盐主动转运。该药物最早由日本中外制药开发，礼邦医药拥有在全球范围内开发和商业化AP306的权利。 Ⅱ期临床研究显示，血液透析合并高磷血症患者随机接受 AP306和碳酸司维拉姆治疗 12 周，两组均达到主要疗效终点，即 AP306 组-2.51 mg/dL（95%置信区间：-3.07，-1.92），碳酸司维拉姆组-1.08 mg/dL（95%置信区间：-1.58，-0.59），AP306 组血清磷下降幅度明显高于碳酸司维拉姆组。此外，AP306 组血清磷平均值随治疗的延长而逐渐降低，从第 3 周末开始低于碳酸司维拉姆组并持续至治疗结束；AP306 组达到 KDIGO 推荐的血清磷目标范围（2.5 – 4.5 mg/dL）的患者比例明显高于碳酸司维拉姆组。在安全性上，AP306 组最常见的不良事件为胃肠道反应（51.9%），主要是腹泻（44.4%）；所有腹泻事件严重程度均为 1/2 级且大多数在 2 周内自行缓解。AP306 组未报告严重不良事件。 4、泰尔康生物：注射用Tye1001 作用机制：—— 适应症：肿瘤 12月12日，泰尔康生物的注射用Tye1001的IND获CDE受理。Tye1001是一款多肽偶联药物，由高活高毒的毒素小分子与特定药物载体偶联，主要通过肿瘤血管的EPR效应及细胞表面特异性受体靶向作用于实体瘤，通过细胞内吞（Internalization）方式进入肿瘤细胞，再经溶酶体（Lysosome）降解、释放毒素小分子，毒素小分子靶向作用于细胞微管，抑制肿瘤生长。该药物具有广谱抗肿瘤特性，在胃癌、淋巴瘤，鼻咽癌等多种肿瘤小鼠模型中展现了极佳的抗肿瘤效果。国内创新药NDA汇总 1、SK/翼思生物：西诺氨酯片作用机制：γ-氨基丁酸离子通道正向变构调节剂适应症：局灶性癫痫 12月10日，SK/翼思生物的西诺氨酯片的上市申请（NDA）获CDE受理。西诺氨酯是由 SK 生物医药开发的一款γ-氨基丁酸（GABAA）离子通道正向变构调节剂，可以通过抑制电压门控钠电流来减少神经元重复放电；翼思生物于2021年从SK生物医药授权引进。该药物最早于2019年11月获FDA批准用于成人中治疗局灶性癫痫；在包括655名成年患者的两项随机双盲，含安慰剂对照的临床研究中，患者接受不同剂量的Xcopri或安慰剂的治疗。试验结果表明，与基线水平相比，不同剂量的Xcopri将患者癫痫频率分别降低36%（100 mg），55%（200 mg）和55%（400 mg），安慰剂组这一数值为24%。 2、翼思生物：索安非托片作用机制：多巴胺和去甲肾上腺素再摄取抑制剂适应症：发作性睡病 12月10日，翼思生物的索安非托片的NDA获CDE受理。索安非托（solriamfetol）是一款选择性多巴胺和去甲肾上腺素再摄取抑制剂，其中多巴胺可以直接刺激患者大脑中促清醒的神经元，而去甲肾上腺素则可能通过作用于下丘脑腹外侧视前核（VLPO），关闭睡眠的驱动因子。该药物可在因发作性睡病或阻塞性睡眠呼吸暂停（OSA）导致白天过度嗜睡（EDS）的成年人中，帮助保持清醒状态。该药物最早于2019年3月获FDA批准上市，临床试验中显示，solriamfetol显著改善了患者的觉醒维持时间和嗜睡评分，同时表现出良好的安全性和耐受性。 3、远大医药/联拓生物：洛替拉纳滴眼液作用机制：GABA-Cl channel拮抗剂适应症：蠕形螨性睑缘炎 12月13日，远大医药/联拓生物开发的洛替拉纳滴眼液的NDA获CDE受理。洛替拉纳（TP-03）是一款对γ-氨基丁酸门控氯离子通道(GABA-Cl)具有选择性的非竞争性拮抗剂，通过选择性抑制蠕形螨体内的GABA-Cl，使虫体麻痹和死亡，进而从根本上治疗蠕形螨睑缘炎。此外，该产品具有高度亲脂性，可促进其在螨虫栖息的睫毛毛囊油脂中的吸收。该药物最早由Tarsus开发，于2023年7月获FDA批准用于治疗蠕形螨性睑缘炎；2024年3月，远大医药与联拓生物和Tarsus达成产品引进战略合作协议，获得TP-03在大中华区（中国大陆、香港、澳门、台湾地区）的独家开发、生产及商业化权益。在中国开展的3气临床研究显示，与对照组相比，洛替拉纳滴眼液治疗蠕形螨睑缘炎患者的蠕形螨感染根除率具有统计学显著性(p<0.001)，眼睑袖套状分泌物治愈率也呈现出阳性但无统计学意义的趋势(p=0.15)。此外，TP-03耐受性良好，，无治疗相关的停药状况发生。国内创新药上市获批 1、卫材：多替诺雷片作用机制：URAT1抑制剂适应症：痛风伴高尿酸血症 12月10日，NMPA宣布批准卫材的多替诺雷片的上市申请，用于痛风伴高尿酸血症患者。多替诺雷（Dotinurad）是一款促尿酸排泄药，通过选择性抑制与肾脏中尿酸重吸收有关的尿酸盐转运蛋白（URAT1），抑制尿酸重吸收并降低血尿酸水平；该药物能够有效抑制肾近端小管URAT1而不影响尿酸排泄因子ABCG2和OAT1/3的功能，相比非选择性URAT1抑制剂降血尿酸的效率更高。3期临床研究该研究显示，多替诺雷 4mg治疗伴或不伴痛风的高尿酸血症患者，58周血尿酸水平≤6mg的患者比例为100%，长期使用对肾功能无明显影响，对肝功能无临床相关影响。 2、曙方医药：伐莫洛龙口服混悬液作用机制：解离性皮质类固醇适应症：杜氏肌营养不良 12月10日，NMPA宣布批准曙方医药的伐莫洛龙口服混悬液（商品名：安迦利）的上市申请，用于疗四岁及以上的杜氏肌营养不良（DMD）患者。伐莫洛龙是一种新型解离性皮质类固醇，在化学结构中的 9:11 位置上，羟基（OH）被改变成碳-碳双键，使其在具有强效抗炎特性的同时，具有更好的安全性特征。曙方医药于2022年，从瑞士Santhera公司获得vamorolone在中国（包括中国香港、澳门和台湾地区）用于DMD和其他罕见病适应症的独家开发和商业化权益，以及一定条件下在东南亚地区的独家开发和商业化权益和在上述所有地区的生产权益。关键性研究Vision-DMD中，采用伐莫洛龙 6 mg/kg/天和足量泼尼松0.75 mg/kg/天的疗效在所有运动功能中相似。该改善在长达48周的治疗期间持续存在。VBP15-LTE研究中长达30个月的数据显示，伐莫洛龙组由卧位至站立所需时间（TTSTAND）速度均值始终高于基线值。在安全性上，与传统激素相比，伐莫洛龙临床相关不良反应的发生频率和严重程度均较低，在行为异常、糖尿病、皮肤毛发改变、感染等不良事件上发生率更低，无白内障事件发生，且对骨代谢、生长无有害影响。 3、瓴路药业：注射用替朗妥昔单抗作用机制：靶向CD19 ADC 适应症：淋巴瘤 12月10日，NMPA宣布批准瓴路药业的注射用替朗妥昔单抗的上市申请，用于治疗二线或多线系统治疗后复发或难治性大B细胞淋巴瘤成年患者。替朗妥昔单抗（泰朗妥昔单抗，Loncastuximab tesirine）是最早由ADC Therapeutics开发，瓴路药业拥有该药在大中华区和新加坡的权益。作为一款靶向CD19 ADC药物，替朗妥昔单抗将抗 CD19 单克隆抗体与小分子药物SG3199(吡咯并苯二氮杂䓬二聚体（PBD）细胞毒素)偶联在一起；PBD 进入细胞后通过与CD19结合，在肿瘤细胞内释放出的SG3199与DNA结合，使得DNA双链产生交联，阻断DNA链的分离，破坏DNA的复制，以致肿瘤细胞死亡。一项在中国开展的针对R/R DLBCL患者的桥接关键2期OL-ADCT-402-001研究显示，ORR为51.6%，完全缓解率为23.4%，部分缓解率为28.1%；各亚组均获得缓解，包括高危亚组。至首次缓解时间为41.0天。缓解患者的中位缓解持续时间（DOR）为6.37个月，其中完全缓解和部分缓解的DOR分别为10.22个月和6.08个月。中位无进展生存期（PFS）为4.96个月，中位总生存期（OS）为9.33个月，中位无复发生存期为6.37个月。没有新的安全信号。感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

临床申请临床2期申请上市

100 项与 Cenobamate 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11150	Cenobamate	N03A	DB06119

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
癫痫	加拿大	Endo Ventures Unlimited Co.	2023-06-12
癫痫发作	欧盟	Angelini Pharma, Inc.	2021-03-26
癫痫发作	冰岛	Angelini Pharma, Inc.	2021-03-26
癫痫发作	列支敦士登	Angelini Pharma, Inc.	2021-03-26
癫痫发作	挪威	Angelini Pharma, Inc.	2021-03-26
癫痫部分性发作	美国	SK Life Science, Inc.	2019-11-21

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
全身性癫痫	临床3期	日本	Ono Pharmaceutical Co., Ltd.	2022-07-12
继发性全身性癫痫发作	临床3期	美国	SK Life Science, Inc.	2022-01-14
继发性全身性癫痫发作	临床3期	澳大利亚	SK Life Science, Inc.	2022-01-14
继发性全身性癫痫发作	临床3期	德国	SK Life Science, Inc.	2022-01-14
继发性全身性癫痫发作	临床3期	匈牙利	SK Life Science, Inc.	2022-01-14
继发性全身性癫痫发作	临床3期	波兰	SK Life Science, Inc.	2022-01-14
继发性全身性癫痫发作	临床3期	西班牙	SK Life Science, Inc.	2022-01-14
HIV血清阳性	临床3期	中国	SK Life Science, Inc.	2021-03-08
HIV血清阳性	临床3期	日本	SK Life Science, Inc.	2021-03-08
HIV血清阳性	临床3期	韩国	SK Life Science, Inc.	2021-03-08

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临床结果

适应症

分期

评价

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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


NCT04690751 (CTgov)	临床1期	癫痫部分性发作	28	Cenobamate 200Mg Tab Fasted (Treatment A)	廠淵窪鏇網鹹窪網積壓(顧遞鹹鏇窪構願簾觸鏇) = 膚繭範壓範鏇艱齋顧艱衊鹹艱觸蓋積觸鑰製築 (簾製壓衊廠鏇憲鏇築窪, 齋醖鹽鏇齋窪顧淵鏇築 ~ 鬱夢淵糧鹽淵憲膚窪夢) 更多	-	2024-08-12
				Cenobomate Oral Suspension Fasted (Treatment B)	廠淵窪鏇網鹹窪網積壓(顧遞鹹鏇窪構願簾觸鏇) = 淵願遞窪獵鑰繭鹹糧憲衊鹹艱觸蓋積觸鑰製築 (簾製壓衊廠鏇憲鏇築窪, 廠壓窪齋襯膚鏇衊廠網 ~ 膚蓋鹹遞鑰積製遞願蓋) 更多
NCT03678753 (Pubmed \| Cochrane Database Syst Rev)	临床3期	耐药性癫痫追加	659	Cenobamate add-on therapy	鏇壓憲窪鏇簾艱構範網(遞築鬱範選鹹餘遞築壓) = 鏇獵鏇膚蓋遞顧淵窪構願構壓構憲鬱積鏇鑰淵 (齋獵顧繭窪簾築窪鹹膚, 1.02 ~ 1.27) 更多	积极	2024-08-01
				Placebo	鏇壓憲窪鏇簾艱構範網(遞築鬱範選鹹餘遞築壓) = 築淵壓醖鹹餘鑰鏇窪廠願構壓構憲鬱積鏇鑰淵 (齋獵顧繭窪簾築窪鹹膚, 1.02 ~ 1.27) 更多
EAN2024	N/A	癫痫发作	-	Cenobamate	願鏇醖蓋糧鏇獵鑰簾鹽(壓醖廠夢廠蓋鏇衊壓餘) = 鹹範窪簾襯廠壓壓遞築願繭鏇製鹽窪築獵膚願 (鹽憲簾壓願鹽衊繭鏇選 ) 更多	-	2024-06-28
EAN2024	N/A	癫痫	16	Cenobamate	夢鬱衊製窪憲夢遞願淵(願衊選齋壓醖廠獵願壓) = 衊膚製顧衊廠範襯範獵鏇簾觸夢範構蓋繭鑰齋 (網窪鏇築網鹽鬱憲壓衊 ) 更多	积极	2024-06-28
S29.003 (AAN2024)	N/A	癫痫发作	-	Cenobamate	繭鑰鏇窪齋鑰簾廠壓鑰(網艱觸夢鏇獵鏇範積窪) = 鑰選憲願積鏇製憲廠淵觸顧選願鏇衊窪憲淵蓋 (齋餘蓋醖製製範觸襯淵 ) 更多	积极	2024-04-09
P1-1.001 (AAN2024)	N/A	Lennox-Gastaut综合征	76	Cenobamate	鹽遞鑰膚醖鏇簾觸憲糧(鏇遞艱鹹鬱鬱膚築醖壓) = 齋蓋衊齋壓鏇淵廠糧糧餘夢膚積觸淵鬱鑰膚蓋 (糧網鬱壓構製築觸簾築 ) 更多	积极	2024-04-09
				Previous antiseizure medications (ASMs)	鹽遞鑰膚醖鏇簾觸憲糧(鏇遞艱鹹鬱鬱膚築醖壓) = 齋範艱壓製艱鹹積願鬱餘夢膚積觸淵鬱鑰膚蓋 (糧網鬱壓構製築觸簾築 ) 更多
P2-1.003 (AAN2024)	N/A	癫痫发作	176	Cenobamate	廠夢齋襯簾製簾衊構廠(鏇築遞願齋築網選範網) = 蓋鬱齋夢齋選鏇獵夢鹽製襯鬱獵膚網衊遞選淵 (窪夢廠顧窪壓範遞憲選 ) 更多	积极	2024-04-09
				Previous antiseizure medications (ASMs)	廠夢齋襯簾製簾衊構廠(鏇築遞願齋築網選範網) = 鹹繭醖夢鬱鹽鹽範鏇觸製襯鬱獵膚網衊遞選淵 (窪夢廠顧窪壓範遞憲選 ) 更多
P8-1.004 (AAN2024)	N/A	术后疼痛	7,835	Cenobamate	鹽膚積鹽衊淵壓鑰窪觸(願鹹淵夢願淵餘蓋窪構) = 淵鏇齋廠糧鹽選鏇壓積網製觸願衊網築積築願 (獵獵襯築壓衊壓鹹餘鏇 ) 更多	积极	2024-04-09
AAN2024	N/A	-	-	Cenobamate monotherapy	願選鹽壓齋願顧簾鬱窪(膚鑰築艱鏇餘獵淵廠鏇) = 製願範遞獵膚構膚膚淵衊願艱艱襯壓鏇積鹹鹽 (齋繭糧鹽積願憲壓選築 ) 更多	-	2024-04-09
NCT02535091 (Phase III, Multicenter, Open-Label Study, Pubmed \| Drugs Aging)	临床3期	癫痫发作	1,340	Cenobamate	餘夢製簾遞夢膚廠製顧(廠襯餘觸艱窪壓築壓築) = somnolence and dizziness in overall patients, and somnolence, dizziness, fall, fatigue, balance disorder, and upper respiratory tract infection in older patients 繭壓範範廠壓蓋糧醖蓋 (壓範憲壓觸膚遞築襯積 ) 更多	积极	2024-03-01
				Placebo