左乙拉西坦(Levetiracetam) - 药物靶点：SV2A_在研适应症：部分性癫痫持续状态，癫痫，癫痫发作_专利_临床

概要

基本信息

简介左乙拉西坦 (Levetiracetam) 是一种小型分子实体，已被设计用于将突触小泡蛋白 2A (SV2A) 作为调节靶标。这种药物化合物是 UCB SA 辛勤努力的成果，并于 1999 年 11 月获得首次批准。在医学领域，左乙拉西坦被广泛用作治疗癫痫的抗惊厥药。已知该化合物通过减少患者癫痫发作的频率和强度而表现出抗惊厥特性。 Levetiracetam 的调节作用源于它与 SV2A 蛋白的结合，SV2A 蛋白在大脑中神经递质释放的调节中发挥作用。此外，该化合物良好的副作用特征及其对患者的显着耐受性使其成为癫痫治疗的常用选择。

药物类型

小分子化药

别名

Levetiracetam (JAN/USP/INN)、Levetiracetame、AGB-101

+ [23]

靶点

SV2A

作用方式

调节剂

作用机制

SV2A调节剂(突触囊泡蛋白2A调节剂)

治疗领域

神经系统疾病其他疾病内分泌与代谢疾病+ [2]

在研适应症

部分性癫痫持续状态癫痫癫痫发作+ [8]

非在研适应症

急性反复癫痫发作戒酒性发作酗酒+ [35]

原研机构

UCB SA

在研机构

ratiopharm GmbHPfizer Europe MA EEIGSun Pharmaceutical Industries (Europe) BV

+ [19]

非在研机构

UCB Pharma GmbH

UCB SATeva Pharmaceuticals USA, Inc.

+ [2]

权益机构

深圳市康哲药业有限公司

Sun Pharma Advanced Research Company Ltd.Tripoint Therapeutics LLC

+ [8]

最高研发阶段批准上市

首次获批日期

美国 (1999-11-30),

癫痫部分性发作

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)

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结构/序列

分子式C8H14N2O2

InChIKeyHPHUVLMMVZITSG-LURJTMIESA-N

CAS号102767-28-2

关联

456

项与左乙拉西坦相关的临床试验

NCT07130786

/ Not yet recruiting临床2期IIT

A Phase II Randomized Open-Label Trial of Levetiracetam for Prevention of Seizures in Patients With Brain Metastases in Primary Motor Cortex

This is a randomized trial for patients with brain metastases in the primary motor cortex who have not had seizures to receive either the prophylactic anti-seizure medication levetiracetam (also known by its trade name Keppra) or proceed with standard of care management, which does not currently include prophylactic levetiracetam. Patients who enroll to this trial will be randomized to receive prophylactic levetiracetam or not receive prophylactic levetiracetam.

开始日期2025-09-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

NCT06907173

/ Not yet recruiting临床3期IIT

Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)

The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.

开始日期2025-08-01

申办/合作机构

University of Virginia

[+4]

NCT07072624

/ Recruiting临床4期IIT

Assessing Phenytoin and Levetiracetam Efficacy, Cost-Effectiveness, and CYP2C9/SV2A Polymorphism in Early Post-Traumatic Seizures: A Multicentric Prospective Randomized Trial

Rationale/gaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence. Investigators plan to conduct a high-quality, prospective, multicentric, randomized study regarding seizure prophylaxis in traumatic brain injury (TBI) with phenytoin, levetiracetam, and the placebo in three respective treatment groups, along with the effect of drug polymorphism on seizure occurrence.
Novelty: Literature is scarce regarding the ideal management of early PTS in traumatic brain injury (TBI), a major public health problem. Further, no study has evaluated the effect of genetic polymorphism on seizure occurrence in traumatic brain injury. This Multicentric study will be the first of its kind, not only in India but also globally.
Objectives: To evaluate the seizure incidence & efficacy of the respective anti-epileptic drug in each treatment arm. Assessment of clinical & functional outcomes, safety profile, and cost-effectiveness in each group. Effect of genetic polymorphisms on seizure incidence among study participants Methods: A Multicentric prospective randomized placebo-controlled double-blinded clinical trial is planned. After satisfying eligibility criteria and informed consent, TBI patients will be randomly allocated into three arms 'phenytoin arm', 'levetiracetam arm', and 'placebo'. Drug polymorphism will be analyzed in all the patients using quantitative real-time PCR.
Expected outcome: This study will provide high-quality evidence in PTS management and will establish the role of prophylactic anti-epileptics in PTS. This study also opens the plethora of undesignated roles of genetic polymorphism in the efficacy and safety of levetiracetam and phenytoin in traumatic brain injury patients.

开始日期2025-07-23

申办/合作机构

Sanjay Gandhi Post Graduate Institute of Medical Sciences

[+2]

100 项与左乙拉西坦相关的临床结果

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100 项与左乙拉西坦相关的转化医学

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100 项与左乙拉西坦相关的专利（医药）

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7,392

项与左乙拉西坦相关的文献（医药）

2026-02-01·JOURNAL OF CRITICAL CARE

Levetiracetam dosing in critically ill patients receiving prolonged intermittent renal replacement therapy

Article

作者: Sathienluckana, Thanompong ; Pattharachayakul, Sutthiporn ; Limotai, Chusak ; Charoensareerat, Taniya ; Vamananda, Jirapat ; Srisawat, Nattachai ; Sriboonruang, Tatta ; Rungkitwattanakul, Dhakrit ; Chusiri, Sirichai ; Chaijamorn, Weerachai

OBJECTIVE:

Levetiracetam can be significantly removed by prolonged intermittent renal replacement therapy (PIRRT) due to its pharmacokinetic properties. However, dosing guidance for this population is limited. This study aimed to evaluate the probability of target attainment (PTA) for various levetiracetam regimens in critically ill adults receiving PIRRT, using Monte Carlo simulation (MCS).

METHODS:

A one-compartment model with first-order elimination was developed using published pharmacokinetic data. Simulations incorporated PIRRT modalities (hemodialysis and hemofiltration), with an effluent rate of 18 L/h and varying durations (4, 6, 8, and 10 h). PIRRT was modeled as occurring early (at drug administration) or late (14-20 h post-dose). MCS was conducted in 10,000 virtual patients per regimen over 48 h. The pharmacodynamic target was an area under the concentration-time curve (AUC) of 222-666 mg·h/L. Regimens achieving ≥90 % PTA were considered optimal.

RESULTS:

Several commonly used regimens failed to achieve adequate PTA. For alternate-day PIRRT with hemofiltration, 500 mg every 12 h or 1000 mg every 24 h were optimal. For alternate-day PIRRT with hemodialysis, 750 mg every 12 h or 1250 mg every 24 h were preferred. For daily PIRRT with either modality, 750 mg every 12 h consistently met PTA targets.

CONCLUSIONS:

Standard dosing regimens may be inadequate for achieving therapeutic exposure in PIRRT. Optimal dosing varies by PIRRT modality, frequency, and timing. These findings support individualized dosing and highlight the need for clinical validation.

2025-12-31·Journal of Maternal-Fetal & Neonatal Medicine

A 10-year review of periconceptual folic acid supplementation in women with epilepsy taking antiseizure medications

Article

作者: O’Higgins, Amy ; McIntosh, Trudi ; Turner, Ciara ; Gaffney, Damon ; Hogan, Jennifer ; Germaine, Mark

BACKGROUND:

Epidemiological studies have reported that women with epilepsy who are taking antiseizure medications have an increased risk of Neural Tube Defects. Periconceptual folic acid supplementation potentially prevents two-thirds of cases. International guidelines recommend that women at increased risk of a pregnancy complicated by a Neural Tube Defect who could become pregnant should start high-dose (5 mg daily) oral folic acid at least three months before conceiving. The purpose of the study was to examine supplementation in women taking antiseizure medications who delivered a baby weighing >499 g during the ten years 2013-2022 in a large maternity hospital.

METHODS:

The hospital's computerized database contains standardized maternal clinical and sociodemographic details which were entered at the first antenatal visit in the obstetric records. The data on all women with epilepsy taking antiseizure medications was anonymized before coding.

RESULTS:

In the ten years, 75,869 women delivered a baby weighing >499 g. Of the deliveries, 632 (0.83%) were to women with epilepsy. Of these, 250 (0.33%) were taking antiseizure medications when they presented for antenatal care. The most frequently prescribed medications were lamotrigine n = 98 (33.8%) and levetiracetam n = 89 (30.7%). Monotherapy was prescribed in 211 (84.4%) women and polytherapy in 39 (15.6%). Three (1.2%) women took no folic acid before or after conception and 59 (23.6%) only took it after conception. Of the 188 (75.2%) who took folic acid before conception, 164 (65.6%) took high-dose 5 mg and 24 (9.6%) took low-dose 0.4 mg. No maternal characteristics were associated with taking high-dose folic acid before conception. Compliance with the national guidelines in the 16 women taking valproate was 30.8% compared with 76.0% for the other 234 women taking medications (p < 0.03). Compliance in the 211 women receiving monotherapy was 72.5% compared with 25.6% in the 39 women receiving polytherapy (p < 0.03).

CONCLUSIONS:

Two-thirds of women taking antiseizure medications complied with national guidelines on high-dose periconceptual folic acid supplementation. A particular concern is the suboptimal compliance in women prescribed valproate and polytherapy, which are two cohorts at higher risk of a neural tube defect. These findings need to be communicated to women with epilepsy in their reproductive years and their doctors.

KEY POINTS:

Of 75,869 women delivered over 10 years, 250 (0.33%) were on medications for epilepsy at presentation34.4% of women taking medications did not start high dose folic acid before conception23.6% of women did not start folic acid until after conceptionCompliance with recommendations was lowest in women prescribed valproate or polytherapyNo maternal characteristics were identified which were associated with suboptimal compliance.

2025-12-01·Acta Epileptologica

Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database

Article

作者: Jiang, Li ; Meng, Linxue ; Wang, Lingman ; Gui, Jianxiong ; Zhang, Xiaofang ; Ma, Jiannan

Abstract:

Background:

Epilepsy is a chronic neurological disorder marked by a persistent tendency to generate seizures, leading to substantial cognitive, behavioral, and psychosocial consequences. This study investigated psychiatric disorder-related adverse events (AEs) associated with antiseizure medications (ASMs) in children using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods:

This study conducted a comprehensive analysis of FAERS data from 2004 to 2024, focusing on psychiatric AEs in children with epilepsy or seizures treated with ASMs. Signal values were computed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

Results:

A total of 2539 preferred terms (PTs) were included, involving 25 system organ classifications (SOCs). Nervous system, skin and subcutaneous tissue, and psychiatric disorders are the three most common SOCs for ASMs in children. There were 24 ASMs, whose AEs involved psychiatric disorders, totaling 110 PTs and 214 drug-PT relationships. Psychotic symptoms (notably lorazepam and topiramate, n = 116 and 109), substance dependence and abuse (notably pregabalin and clonazepam, n = 291 and 110), and the other neuropsychiatric symptoms (notably levetiracetam and valproic acid, n = 70 and 62) were the common types of psychiatric disorder-related AEs of ASMs in children. A total of nine ASMs (brivaracetam, clonazepam, diazepam, eslicarbazepine, gabapentin, lamotrigine, lorazepam, perampanel, and tiagabine) were associated with suicidal and self-injurious behavior in children.

Conclusions:

This study highlights psychiatric AEs of ASMs in children, offering critical insights to improve clinical medication practices and enhance treatment safety. Further research with broader clinical data is needed to promote safe and rational medication use.

427

项与左乙拉西坦相关的新闻（医药）

2025-09-12

·生物谷

突破！肺癌细胞转移大脑后竟会与神经元“串通”！Nature 新研究揭致命机制，抗癫痫药或成新希望

来自斯坦福大学医学院等机构的科学家们通过研究揭示了一个惊人的现象，即转移到大脑的SCLC细胞竟能与神经元形成电连接，这种连接不仅存在且会显著促进肿瘤的生长。小细胞肺癌（SCLC）是肺癌中极具侵袭性的 “杀手”，它约占所有肺癌的 15%，每年在全球导致超过 20 万例死亡。作为一种高度恶性的神经内分泌肿瘤，SCLC 最可怕的特点就是极强的脑转移倾向——一旦癌细胞扩散到大脑，患者的生存期通常不足一年，治疗难度也随之陡增。近日，国际顶级期刊《Nature》发表了一篇题为 “Neuronal activity-dependent mechanisms of small cell lung cancer pathogenesis” 的重磅研究，来自斯坦福大学医学院、哈佛医学院等机构的科学家团队，揭露了一个颠覆认知的现象：转移到大脑的 SCLC 细胞，竟然能和大脑中的神经元形成 “电信号连接”（也就是真正的突触结构），而这种连接不仅真实存在，还会像 “给癌细胞充电” 一样，显著加速肿瘤生长。其实近年来，“神经系统影响癌症” 的研究已经逐渐成为热点。在大脑内部，比如胶质瘤这类原发脑癌，神经元活动会通过两种方式促进肿瘤生长：一种是释放信号分子（旁分泌机制），另一种是通过神经与胶质瘤细胞之间的突触，实现电信号和化学信号的整合，让癌细胞 “融入” 神经回路。而在大脑之外，像前列腺癌、头颈癌、乳腺癌、胰腺癌这些常见癌症，肿瘤周围的外周神经也会通过神经支配调节癌症进展。但一直以来，科学家们都不清楚——神经系统对 SCLC 的影响到底有多大？不管是癌细胞还在肺部时，还是转移到大脑后，神经活动是否在 “推波助澜”？这次研究终于给出了答案，而且在肺部和大脑中发现了两种截然不同但同样关键的机制。在肺部，研究团队用小鼠模型做了一个关键实验：他们切断了小鼠的迷走神经（支配肺部的重要神经），结果发现，原发性肺癌的发展速度明显变慢，肿瘤负担大幅减轻，甚至连肝转移（SCLC 常见的转移部位）也几乎消失了。更令人振奋的是，切断迷走神经的小鼠，生存期显著延长——对照组小鼠中位生存期只有 16 周，而切断迷走神经的小鼠全部活过了整个实验周期。这说明，迷走神经的 “神经支配” 对 SCLC 的早期发生和发展至关重要，就像给癌细胞提供了 “生长信号” 一样。而当癌细胞转移到大脑后，它们的 “生存策略” 变得更 “高级” 了。研究人员观察人类 SCLC 脑转移样本发现，肿瘤区域里布满了神经元的轴突，而且越靠近轴突的癌细胞，增殖速度越快、密度越高。为了弄清原因，他们做了细胞共培养实验：把小鼠或人类的 SCLC 细胞，和大脑中常见的两种神经元（谷氨酸能神经元、GABA 能神经元，后者能产生 γ- 氨基丁酸）放在一起培养。结果显示，活跃的神经元能让 SCLC 细胞增殖速度显著加快；但如果加入河豚毒素（TTX，一种能阻断神经活动的物质），这种促进作用就消失了。更关键的是，电生理实验和电子显微镜观察证实：SCLC 细胞和神经元之间真的形成了 “神经元-SCLC 突触”——就像正常神经元之间传递信号的结构一样。当神经元活动时，会通过这些突触向 SCLC 细胞传递信号：谷氨酸能神经元会引发 SCLC 细胞的兴奋性电流，而 GABA 能神经元传递的信号，竟然会让 SCLC 细胞膜 “去极化”（一种电状态变化）。更特别的是，对 SCLC 细胞来说，这种去极化不是抑制信号，而是 “生长指令”，研究人员发现，SCLC 细胞内的氯离子浓度很高，GABA 介导的去极化会引发细胞内的钙瞬变，最终促进颅内肿瘤生长。为了进一步验证，研究团队还用了光遗传学技术（通过光控制神经元活动）：他们给小鼠大脑中的神经元装上 “光控开关”，用蓝光刺激神经元后发现，和活跃神经元接触的 SCLC 细胞，不仅长得更大，还会更积极地侵袭周围的正常脑组织；如果专门刺激 GABA 能神经元，同样会加速 SCLC 增殖。这说明，大脑中的神经活动确实在 “喂养” 癌细胞。迷走神经支配对原发性小细胞肺癌的发生和发展至关重要那么，这种 “神经-癌细胞连接” 能被阻断吗？研究给出了积极答案。他们尝试用一种常见的抗癫痫药——左乙拉西坦（levetiracetam），这种药能干扰突触中的信号传递。结果显示，连续两周给携带 SCLC 脑转移的小鼠注射左乙拉西坦后，癌细胞的增殖速度显著下降，肿瘤负担也明显减轻。这意味着，针对 “神经-癌细胞连接” 的治疗，可能成为 SCLC 脑转移的新方向。 “这项研究让我们意识到，神经系统在很多癌症中都扮演着‘隐形推手’的角色。” 研究负责人之一 Michelle Monje 教授表示，“SCLC 细胞不仅会模仿神经元的基因特征，还能主动和神经元形成功能性连接。这不仅刷新了我们对癌症微环境的认知，也为开发新疗法打开了大门。” 未来，科学家们还会进一步探索迷走神经中具体哪些信号通路影响肺部 SCLC，以及是否有更精准的方法阻断脑内的 “神经-癌细胞突触”。但对 SCLC 患者来说，这项研究已经带来了新的希望：或许未来，抗癫痫药这类调节神经活动的药物，能和传统抗癌疗法联手，为晚期患者争取更长的生存期。（生物谷Bioon.com）参考文献： Savchuk, S., Gentry, K.M., Wang, W. et al. Neuronal activity-dependent mechanisms of small cell lung cancer pathogenesis. Nature (2025). doi：10.1038/s41586-025-09492-z

免疫疗法

2025-09-08

·摩熵医药

直击60亿市场！原研缺位，新型抗癫痫药首仿入局！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 9月5日，CDE官网显示，翼思生物医药（苏州）有限公司按3类化药注册申报的西诺氨酯片上市申请已获受理。该药品国内市场尚待开发，原研于2024年底递交进口申请，当前暂无其他企业进行仿制申报。翼思生物凭借先发布局，极有可能拿下首仿！截图来源：CDE官网西诺氨酯（Cenobamate ）是一款新型抗癫痫小分子药物，兼具SCNA阻滞剂与GABAAR调节剂的双重作用，能够抑制神经元异常放电，从而有效控制癫痫发作，主要用于治疗成人局灶性癫痫发作。截图来源：摩熵医药全球药物研发数据库西诺氨酯片由韩国SK（SK Life Science, Inc）生物医药原研，2019年11月获FDA批准上市（商品名：Xcopri），2021年获EMA批准进入欧洲市场。临床研究显示，在655例成年患者的随机对照试验（RCT）中，相较基线水平，西诺氨酯在不同剂量下可将发作频率降低36%-55%，显著优于安慰剂组的24%。西诺氨酯为传统药物治疗控制效果欠佳的患者开辟了新的治疗路径，提供了更适配的解决方案。截图来源：摩熵医药中国临床试验数据库癫痫是常见的慢性神经系统疾病之一，全球约有5000万人受其困扰，每年新增病例超500万。摩熵医药流行病学数据显示，截止2021年，我国癫痫患者规模约1000万，总患病率为7.0‰，是国内仅次于脑卒中的第二大神经系统疾病。截图来源：摩熵医药流行病学数据库据摩熵医药数据，近年来我国抗癫痫药物市场整体呈现稳步增长的大趋势，其中院内市场凭借临床用药需求集中的特点，占据着主导地位。截图来源：摩熵医药全国医院（全终端）销售数据库 2024年我国抗癫痫药物院内市场规模约60亿元，市场体量可观；左乙拉西坦、丙戊酸钠、奥卡西平等药物销售额名列前茅，成为抗癫痫药物院内市场的核心产品。综合来看，西诺氨酯片的市场潜力堪称巨大，未来前景十分可观。截图来源：摩熵医药全国医院（全终端）销售数据库 2021年11月，翼思生物与SK生物医药就西诺氨酯、 Solriamfetol等6个创新资产达成授权许可及长期战略合作协议，获得其在大中华区（含港澳台）的独家开发、注册、本地化生产及商业化的权利。截图来源：摩熵医药全球药物研发数据库 2024年12月10日，翼思生物与SK按5.1类联合申报的西诺氨酯片上市申请获受理，当前在审评审批中。翼思生物的仿制上市申报时间仅比原研滞后约8个月，展现出较强的研发效率和市场前瞻性。截图来源：摩熵医药中国药品审评数据库而从研发进展来看，四川奥邦古得药业率先完成西诺氨酯片的BE试验，重庆莱美药业、江苏恩华药业、杭州和康药业紧随其后稳步推进，预计将逐步形成多企业竞争的格局。截图来源：摩熵医药中国临床试验数据库此次翼思生物的西诺氨酯片申报上市，不仅是国内首款针对该品种的仿制药，更有望凭借“联合原研企业 + 抢占首仿资格”的双重布局，率先抢占国内市场，为后续商业化抢占市场主动权奠定基础。 END 本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-202505 2024年医药企业综合实力排行榜-202505 中国带状疱疹疫苗行业分析报告-202505 2023H2-2024H1中国药品分析报告-202504 数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-202503 2024年中国1类新药靶点白皮书-202503 中国AI医疗健康企业创新发展百强榜单-202502 解码护肤抗衰：消费偏好洞察与市场格局分析-202502 2024年FDA批准上市的新药分析报告-202501 小分子化药白皮书（上）-202501 2024年中国医疗健康投融资全景洞察报告-202501 2024年医保谈判及市场分析报告-202501 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准放射疗法临床研究诊断试剂

2025-09-08

·FierceBiotech

Rapport\'s seizure drug hits in phase 2, sending stock soaring

If approved, RAP-219 could compete with SK Life Science’s Xcopri and Catalyst Pharmaceuticals’ Fycompa.\n A phase 2a trial of Rapport Therapeutics’ focal onset seizure drug candidate has hit its primary endpoint, sending shares in the biotech up more than 157% in premarket trading.The study enrolled 30 people with drug-resistant seizures who were taking a median of three antiseizure medicines such as lamotrigine, levetiracetam and cenobamate. Participants received daily oral doses of RAP-219, Rapport’s TARPγ8-specific AMPA receptor negative allosteric modulator, for eight weeks. The receptor is expressed in parts of the brain associated with seizures but not areas linked to side effects.After eight weeks, 23 of the 27 patients in the primary endpoint analysis had experienced at least a 30% decline in long episodes from baseline. The episodes are an electrographic biomarker for clinical seizure reduction. Rapport reported a 71% median reduction in episode frequency from baseline. Shares in the company jumped 140% to $34.50 at one point in premarket trading.The biotech also reported reductions in clinical seizures, a key secondary endpoint. In an analysis of 25 patients, Rapport found 72% of participants experienced a 50% or greater reduction in clinical seizures from baseline. Almost one-quarter of patients achieved seizure freedom. Rapport tracked a 77.8% median reduction in clinical seizure frequency from baseline. Three patients discontinued treatment because of treatment-emergent adverse events (TEAEs). Almost 80% of TEAEs were grade 1 cases, indicating that they were mild cases. The remaining TEAEs were grade 2. Dizziness, headache and fatigue were the most common TEAEs.Based on the data, Rapport plans to start two phase 3 trials of RAP-219 in the third quarter of 2026. The next steps are to hold an end-of-phase 2 meeting with the FDA, share data from the ongoing eight-week follow-up period and start an open-label long-term safety trial. Those events are all scheduled for this year. Rapport expects to share follow-up data and preliminary long-term results next year.The biotech has predicted that a multibillion-dollar commercial opportunity is open to RAP-219. The forecast reflects an analysis that suggests 30% to 40% of the 3 million epilepsy patients in the U.S. have drug-resistant focal onset seizures.If approved, RAP-219 could compete with SK Life Science’s Xcopri and Catalyst Pharmaceuticals’ Fycompa and potentially against other assets that are currently in development. The pipeline of potential rivals in focal onset seizures includes Biohaven’s BHV-7000, Praxis Precision Medicines’ vormatrigine and Xenon Pharmaceuticals’ azetukalner.

$Rapport\'s seizure drug hits in phase 2, sending stock soaring$

临床2期临床结果

100 项与左乙拉西坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00709	左乙拉西坦	N03AX14	DB01202

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
部分性癫痫持续状态	日本	UCB Japan Co. Ltd.	2023-06-26
癫痫	中国	UCB Pharma SA	2006-11-22
癫痫	中国	康哲药业	2006-11-22
癫痫发作	澳大利亚	UCB Australia Pty Ltd.	2006-09-07
Dravet综合征	欧盟	UCB Pharma SA	2000-09-29
Dravet综合征	冰岛	UCB Pharma SA	2000-09-29
Dravet综合征	列支敦士登	UCB Pharma SA	2000-09-29
Dravet综合征	挪威	UCB Pharma SA	2000-09-29
特发全身性癫痫	欧盟	UCB Pharma SA	2000-09-29
特发全身性癫痫	冰岛	UCB Pharma SA	2000-09-29
特发全身性癫痫	列支敦士登	UCB Pharma SA	2000-09-29
特发全身性癫痫	挪威	UCB Pharma SA	2000-09-29
强直阵挛性癫痫	欧盟	UCB Pharma SA	2000-09-29
强直阵挛性癫痫	冰岛	UCB Pharma SA	2000-09-29
强直阵挛性癫痫	列支敦士登	UCB Pharma SA	2000-09-29
强直阵挛性癫痫	挪威	UCB Pharma SA	2000-09-29
青少年肌阵挛性癫痫	欧盟	UCB Pharma SA	2000-09-29
青少年肌阵挛性癫痫	冰岛	UCB Pharma SA	2000-09-29
青少年肌阵挛性癫痫	列支敦士登	UCB Pharma SA	2000-09-29
青少年肌阵挛性癫痫	挪威	UCB Pharma SA	2000-09-29

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
阿尔茨海默症	临床3期	美国	AgeneBio, Inc.	2018-12-13
阿尔茨海默症	临床3期	加拿大	AgeneBio, Inc.	2018-12-13
轻度认知障碍	临床3期	美国	AgeneBio, Inc.	2018-12-13
轻度认知障碍	临床3期	加拿大	AgeneBio, Inc.	2018-12-13
癫痫综合征	临床3期	中国	UCB SA	2013-09-26
继发性全身性癫痫发作	临床3期	中国	UCB Japan Co. Ltd.	2010-10-01
继发性全身性癫痫发作	临床3期	日本	UCB Japan Co. Ltd.	2010-10-01
创伤性脑损伤	临床3期	法国	UCB Pharma GmbH	2007-11-01
外伤后癫痫	临床3期	法国	UCB Pharma GmbH	2007-11-01
创伤后癫痫	临床3期	法国	UCB Pharma GmbH	2007-11-01

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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


NCT03689114 (STANDLOW, CTgov)	临床4期	癫痫部分性发作	58	Low dose oxcarbazepine+Low dose topiramate+Low dose carbamazepine+Low dose levetiracetam+Low dose valproate+Low dose lamotrigine+Low dose zonisamide+Low dose gabapentin (Low Dose)	餘選淵製觸鬱積網窪願 = 繭範艱艱鬱廠鑰艱積觸廠糧繭鹽鬱壓壓鹽範憲 (襯艱壓廠窪遞廠選壓糧, 鑰廠範夢鏇獵鏇獵鹽襯 ~ 築襯廠夢襯壓鑰糧積醖) 更多	-	2025-07-08
				oxcarbazepine+topiramate+carbamazepine+levetiracetam+valproate+lamotrigine+gabapentin+zonisamide (Standard Dose)	餘選淵製觸鬱積網窪願 = 繭獵範築窪遞積糧鏇蓋廠糧繭鹽鬱壓壓鹽範憲 (襯艱壓廠窪遞廠選壓糧, 簾鏇艱醖獵願鬱積鑰繭 ~ 淵繭夢願遞壓獵艱構醖) 更多
P9-9.015 (AAN2025)	N/A	白天过度嗜睡	207	Clonazepam	齋艱鏇顧憲糧範糧蓋遞(鏇窪艱鏇構廠壓廠顧觸) = Among newer ASMs, there are differences in their tendency to cause excessive daytime sleepiness, with Clonazepam and Levetiracetam being more commonly associated with this side effect, thus warranting caution. Conversely, Perampanel and Lacosamide are less likely to cause daytime sleepiness, and ASM selection should be tailored to the sleep characteristics of epileptic patients. 繭簾窪願鑰鹽醖選繭製 (餘衊鹹糧淵壓壓憲蓋窪 )	积极	2025-04-07
				Levetiracetam
NCT01801072 (SPAR, CTgov)	临床4期	癫痫发作 \| 颅内动脉瘤	82	Levetiracetam (Levetiracetam)	醖築鑰淵蓋願蓋獵夢選 = 製糧壓範淵襯壓襯鑰願獵窪觸顧鹽顧顧廠艱鹽 (繭網鹹願夢遞構鹽鹽鹹, 鏇遞遞鏇衊蓋顧糧醖製 ~ 獵簾鏇艱齋艱遞齋製餘) 更多	-	2024-11-29
				levetiracetam (No Levetiracetam)	醖築鑰淵蓋願蓋獵夢選 = 鏇製憲壓夢齋艱廠廠積獵窪觸顧鹽顧顧廠艱鹽 (繭網鹹願夢遞構鹽鹽鹹, 齋鑰獵顧淵繭淵製襯艱 ~ 淵簾鬱網願艱遞衊醖製) 更多
P27.02.A (EANO2024)	N/A	胶质瘤	240	ANTI-EPILEPTIC (AED Withdrawal)	鑰壓網鹽獵觸觸鏇製選(廠製獵選憲獵遞積網鑰) = 夢鬱鹽範願遞鹹衊簾鑰壓鏇餘選鬱膚鹹網構簾 (衊廠襯構網繭簾網範廠 )	积极	2024-10-17
NCT03340064 (PEACH, CTgov)	临床3期	癫痫发作 \| 癫痫部分性发作	38	Levetiracetam (Levetiracetam: Adjunctive Therapy)	構鬱簾網廠醖壓夢遞選(糧襯餘膚壓繭繭網窪蓋) = 觸壓齋觸選衊窪選齋構膚願獵範網淵艱餘築獵 (觸選衊遞範鏇簾鹽選鹹, 願憲醖廠廠廠簾壓夢廠 ~ 窪淵醖膚夢製製獵簾觸) 更多	-	2024-07-23
				Levetiracetam (Levetiracetam: Monotherapy)	鑰夢齋鬱繭獵積鑰淵夢(艱製鑰夢繭鬱壓蓋衊積) = 壓艱憲網簾鏇蓋衊壓鹹蓋齋選膚廠範醖願簾顧 (鹽醖壓淵獵餘願鬱鑰簾, 願蓋鹽鏇顧構遞鬱夢獵 ~ 廠積鏇鹽顧鬱膚糧憲壓) 更多
NCT03486938 (HOPE4MCI, CTgov)	临床2/3期	阿尔茨海默症 \| 轻度认知障碍	164	Placebo Oral Tablet (Placebo Oral Tablet)	構選襯淵衊艱積觸鬱願(繭獵鹽醖憲艱製選壓製) = 簾願遞遞築顧積艱淵廠鹽顧積蓋鏇齋醖淵網築 (繭鏇淵鏇積糧醖齋願壓, 2) 更多	-	2024-05-17
				AGB101 220 mg tablet (AGB101 220 mg Tablet)	構選襯淵衊艱積觸鬱願(繭獵鹽醖憲艱製選壓製) = 簾繭鏇願齋淵遞獵繭範鹽顧積蓋鏇齋醖淵網築 (繭鏇淵鏇積糧醖齋願壓, 1.5) 更多
CRD42022363844 (AAN2024)	N/A	癫痫发作	18,676	Phenytoin	網獵鏇醖蓋艱顧積蓋夢(夢遞繭顧夢夢膚憲襯壓) = 壓築膚壓獵鑰憲鑰淵積顧範遞鹹蓋築鏇築願簾 (範鑰繭簾餘衊鑰糧網鏇, 23.2–52.8)	积极	2024-04-09
				Carbamazepine	網獵鏇醖蓋艱顧積蓋夢(夢遞繭顧夢夢膚憲襯壓) = 繭鏇衊鏇獵遞蓋淵選窪顧範遞鹹蓋築鏇築願簾 (範鑰繭簾餘衊鑰糧網鏇, 1.7–5.3)
NCT04559529 (CTgov)	临床2期	精神障碍	62	Placebo+Levetiracetam (LEV) (Healthy Control Participants: Levetiracetam (LEV), Then Placebo)	選淵觸網醖網積鑰廠艱(鹽襯壓簾衊願鹽窪壓膚) = 選願網蓋選鬱觸鑰獵築餘觸鑰鹹繭構淵顧範鏇 (衊襯衊積衊窪網觸齋窪, 醖構繭選選鹽繭餘壓夢 ~ 鏇鹽獵願選衊廠醖顧繭) 更多	-	2024-02-05
				Placebo+Levetiracetam (LEV) (Healthy Control Participants: Placebo, Then Levetiracetam (LEV))	選淵觸網醖網積鑰廠艱(鹽襯壓簾衊願鹽窪壓膚) = 製鑰壓選獵鹽觸製鹽鬱餘觸鑰鹹繭構淵顧範鏇 (衊襯衊積衊窪網觸齋窪, 夢淵艱繭網窪選遞範壓 ~ 夢製糧範憲窪衊鑰餘鏇) 更多
CNS2023	N/A	癫痫部分性发作	483	Levetiracetam	壓糧夢窪鹽願壓願膚壓(選築築夢夢壓廠餘繭鏇) = Adverse effects were more often noted with LEV than with OXC (53.4% versus 41.1%) 鏇艱觸餘壓壓餘齋繭網 (選鏇遞鏇鏇膚廠構遞簾 )	-	2023-10-01
				Oxcarbazepine