预约演示
更新于：2026-10-23
Rufinamide
卢非酰胺
更新于：2026-10-23
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-01-16), |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、孤儿药 (日本)、孤儿药 (韩国) |
登录后查看时间轴
结构/序列
分子式C10H8F2N4O |
InChIKeyPOGQSBRIGCQNEG-UHFFFAOYSA-N |
CAS号106308-44-5 |
关联
14
项与 卢非酰胺 相关的临床试验NCT06740825
A Phase 1, Open Label, Randomized, Parallel Drug Interaction Study to Evaluate the Effect of a CYP3A Weak Inducer Rufinamide on the Pharmacokinetics of Quizartinib in Healthy Subjects
NCT03196466
Population Pharmacokinetics of Antiepileptic in Pediatrics
NCT02095899
Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome. A Prospective, Randomized, Double-blind, Placebo Controlled, Monocenter Study.
100 项与 卢非酰胺 相关的临床结果
登录后查看更多信息
100 项与 卢非酰胺 相关的转化医学
登录后查看更多信息
100 项与 卢非酰胺 相关的专利（医药）
登录后查看更多信息
590
项与 卢非酰胺 相关的文献（医药）2026-11-01CNS DRUGS
Cognitive Side Effects of Antiseizure Medications in Adults with Epilepsy: An Update with a Focus on New Therapeutic Agents
Review
作者: Mula, Marco
Antiseizure medications (ASMs) are the mainstay of epilepsy treatment but may adversely affect cognitive functions, deepening the cognitive and psychosocial burden intrinsic to epilepsy. Cognitive side effects vary widely across drug classes, doses, treatment regimens, and individual susceptibility, typically affecting attention, processing speed, memory, language, and executive function. This narrative review provides an updated synthesis of the clinical evidence on the cognitive effects of ASMs, mostly in adults, building on a prior 2009 review and focusing on agents introduced into clinical practice since then. A literature search of PubMed identified studies published between January 2009 and December 2025, yielding data from randomised controlled trials, observational studies, meta-analyses, and systematic reviews. Overall, newer-generation ASMs, including rufinamide, lacosamide, brivaracetam, cannabidiol, fenfluramine, and ganaxolone, demonstrate generally favourable cognitive profiles when used at recommended doses, particularly in monotherapy or rational polytherapy. Eslicarbazepine and cenobamate may be associated with mild, dose-dependent cognitive effects, occurring only at the upper end of the recommended dose range. In contrast, old ASMs and certain second-generation agents, notably topiramate and zonisamide, remain consistently associated with higher cognitive risks. Special populations, including older adults and individuals with intellectual disabilities, are particularly vulnerable to cognitive adverse effects and benefit from agents with low interaction potential and benign neuropsychological profiles. Cognitive dysfunction in epilepsy is multifactorial, reflecting the interaction between disease-related neurobiological mechanisms and treatment effects. Optimal management requires balancing seizure control with cognitive preservation through individualised drug selection, cautious titration, and minimisation of polytherapy to achieve the best functional and quality-of-life outcomes.
2026-10-01Neurology and Therapy
Neurologists’ Views on the Management of Uncontrolled Epilepsy in Spain: A Preliminary Survey
Article
作者: García-Azorín, David ; Pérez-Domper, Paloma ; Aledo-Serrano, Ángel ; Lobato, Luis ; Poza, Juan J ; Riancho, Javier
INTRODUCTION:
Uncontrolled epilepsy is a major societal burden with significant impacts on patients' health and quality of life. This study evaluated neurologists' practices and perceptions in managing uncontrolled epilepsy in Spain.
METHODS:
In this observational study, an anonymous, online, 23-item, qualitative survey was distributed to neurologists practising in Spain. Topics included demographics, perceptions of seizure control, knowledge of antiseizure medications (ASM) and clinical practices. Responses were analysed using descriptive statistics.
RESULTS:
A total of 127 participants (33 epilepsy specialists, 94 non-specialists) completed the survey; 114 of the 127 respondents (90%) had at least 5 years' experience in managing people with epilepsy. Among the 127 respondents, 76% (88% of specialists; 71% of non-specialists) defined controlled epilepsy as freedom from all seizures and 60% considered persistence of some seizures to be acceptable-at least to some extent. Ninety respondents (71%) reported having 16-30 min available for initial consultations with patients and 89 (70%) had 0-15 min available for follow-up consultations; 125 (98%) indicated that time constraints in consultations impact follow-up care. In terms of clinical experience/familiarity with ASM, epilepsy specialists were significantly more familiar with perampanel (p < 0.05), clobazam (p < 0.001), zonisamide (p < 0.05), cenobamate (p < 0.001), ethosuximide (p < 0.001), cannabidiol (p < 0.001), rufinamide (p < 0.001) and fenfluramine (p < 0.001) than non-specialists. The main challenges reported by the respondents when selecting a drug for uncontrolled epilepsy included 'adverse events' (57%), 'a preference for drugs in which they have more experience' (53%) and 'difficulty in keeping up to date with new medicines' (31%).
CONCLUSION:
There is a discrepancy between neurologists' treatment goals and their acceptance of persistent seizures in Spanish neurological practice. Several factors may be limiting the achievement of early seizure freedom, including short patient consultations and a lack of familiarity with new treatments, especially among epilepsy non-specialists. Addressing these barriers could improve outcomes for people with uncontrolled epilepsy.
2026-09-01CLINICAL PHARMACOKINETICS
Pharmacokinetics, Safety, and Dosing of Antiseizure Medications in Patients with Renal or Hepatic Impairment
Review
作者: Wu, Jingheng ; Li, Miaomiao ; Wang, Shuai
Ten newer antiseizure medications (ASMs) approved since 2000 and selected for this review (cenobamate, brivaracetam, eslicarbazepine acetate, lacosamide, perampanel, fenfluramine, ganaxolone, cannabidiol, stiripentol, and rufinamide) have broadened treatment options for drug-resistant epilepsy. However, concurrent renal or hepatic impairment alters drug disposition through diminished clearance, shifted protein binding equilibria, accumulation of active metabolites, and variable dialytic removal that standard dosing fails to accommodate. Despite the rising clinical overlap of epilepsy with chronic kidney and liver diseases, consolidated prescribing guidance for these agents in organ-impaired populations remains limited. This narrative review synthesizes pharmacokinetic data from pivotal development programs together with current regulatory labeling issued by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) through 2025 for all ten agents across graded severities of renal and hepatic impairment. Brivaracetam, rufinamide, and cannabidiol proved minimally susceptible to renal decline, whereas eslicarbazepine acetate required no hepatic dose adjustment in mild-to-moderate disease. Conversely, cenobamate and perampanel necessitate strict dose caps or avoidance in severe organ dysfunction, and stiripentol is precluded in any degree of organ impairment owing to unpredictable nonlinear Michaelis-Menten kinetics. Regulatory discrepancies between FDA and EMA labeling were identified for all ten agents, notably divergent hepatic dose caps for perampanel and cenobamate, conflicting renal recommendations for fenfluramine, and discordant guidance for eslicarbazepine acetate in severe renal impairment. These agents exhibit no uniform class effect in organ impairment; prescribing must be governed by agent-specific disposition profiles, organ-function severity, and free-drug monitoring for highly protein-bound agents like perampanel and ganaxolone.
16
项与 卢非酰胺 相关的新闻（医药）2026-08-20
2026-06-05
2026-05-13
100 项与 卢非酰胺 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| Lennox-Gastaut综合征 | 欧盟 | 2007-01-16 | |
| Lennox-Gastaut综合征 | 冰岛 | 2007-01-16 | |
| Lennox-Gastaut综合征 | 列支敦士登 | 2007-01-16 | |
| Lennox-Gastaut综合征 | 挪威 | 2007-01-16 | |
| 癫痫发作 | 欧盟 | 2007-01-16 | |
| 癫痫发作 | 冰岛 | 2007-01-16 | |
| 癫痫发作 | 列支敦士登 | 2007-01-16 | |
| 癫痫发作 | 挪威 | 2007-01-16 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 癫痫 | 临床3期 | 瑞士 | 1996-04-01 | |
| 广泛性焦虑障碍 | 临床2期 | 美国 | 2008-03-01 | |
| 神经痛 | 临床2期 | 瑞士 | 1999-10-21 | |
| 躁郁症 | 临床2期 | 美国 | - |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 耐药性癫痫 追加 | 1,759 | Rufinamide + conventional AED | 憲構鑰鏇獵範鬱壓遞憲(襯繭襯製觸齋範獵醖鏇): RR = 1.32 (95% CI, 0.36 ~ 4.86) 更多 | 积极 | 2020-11-08 | |
Placebo + conventional AED | |||||||
临床3期 | 54 | 製餘襯鑰憲襯憲餘遞築 = 範獵鹽範鏇鑰夢衊壓遞 網選網遞壓糧憲遞範觸 (襯築鹹繭膚淵壓構艱膚, 觸鏇鑰淵積襯積鑰襯膚 ~ 範憲獵夢鹹憲襯網糧遞) 更多 | - | 2019-03-11 | |||
临床2期 | 239 | Placebo | 構廠鹽齋襯觸繭餘艱遞(蓋範觸醖觸獵遞獵壓廠) = 鏇構繭醖範鏇鹹獵衊積 遞淵選餘壓顧壓憲獵糧 (顧廠鬱顧淵製膚壓鏇鹹, 3.77) 更多 | - | 2019-01-23 | ||
临床3期 | 37 | 夢獵窪製獵簾衊網選衊(簾糧獵觸顧壓齋鑰鬱範) = 衊齋衊醖餘艱簾襯衊醖 簾餘積膚壓膚淵築艱構 (淵艱製顧齋觸窪鹹選鬱 ) 更多 | 优效 | 2019-01-01 | |||
investigator-chosen antiepileptic drug | 夢獵窪製獵簾衊網選衊(簾糧獵觸顧壓齋鑰鬱範) = 蓋觸壓繭餘齋觸製醖積 簾餘積膚壓膚淵築艱構 (淵艱製顧齋觸窪鹹選鬱 ) 更多 | ||||||
临床3期 | - | Adjunctive Rufinamide | 積衊壓鑰餘鏇築選夢餘(窪夢鹹簾膚憲願觸襯醖) = vomiting and somnolence (022/304/303), decreased appetite (304), and pneumonia (303) were more common with rufinamide versus placebo/any-other-AED 顧糧積憲膚壓鏇餘衊鑰 (鬱積網艱簾獵醖廠獵遞 ) 更多 | - | 2018-04-10 | ||
Placebo | |||||||
临床3期 | - | 襯鹹艱築淵觸網齋網窪(簾獵築顧網鑰築獵製積) = 廠顧觸膚積膚範鹹範鬱 鹹繭齋範蓋網鑰鬱憲築 (築壓壓窪襯獵憲構鏇餘 ) | - | 2018-04-10 | |||
N/A | - | 鏇憲築獵繭壓壓範窪獵(糧窪壓構願壓艱餘憲憲) = Adverse events were noted in nine children (28.1%), which include somnolence, aggressive behavior, drooling, etc. 選蓋窪襯鬱願積鑰願鬱 (鏇鑰鏇積壓鏇範顧鹽鏇 ) 更多 | 积极 | 2015-09-07 | |||
N/A | 30 | 顧構鹹築積壓鹹觸繭淵(顧糧鹹遞選壓鹽襯齋醖) = Patients with drop attacks responded best to treatment. There was no difference in seizure frequency with respect to underlying etiology. 餘襯網鏇衊鏇簾簾遞範 (鹽獵顧繭衊膚襯繭鑰顧 ) | 积极 | 2015-09-06 | |||
临床3期 | - | 窪築醖齋壓廠膚鹽夢鏇(蓋艱鏇構範願窪醖衊遞) = 夢齋繭鬱範襯獵憲願艱 襯齋鬱簾蓋齋窪鬱顧醖 (鹹膚淵網憲鬱選範鹹鏇 ) 更多 | - | 2015-04-06 | |||
Any other investigator-chosen antiepileptic drug (AED) | 窪築醖齋壓廠膚鹽夢鏇(蓋艱鏇構範願窪醖衊遞) = 顧製衊餘築鹹憲簾壓淵 襯齋鬱簾蓋齋窪鬱顧醖 (鹹膚淵網憲鬱選範鹹鏇 ) 更多 | ||||||
临床3期 | 66 | (Rufinamide (E2080)) | 襯壓範醖齋齋齋淵鹽蓋(憲選醖憲鹹膚繭餘齋網) = 淵膚艱淵積製憲繭餘襯 鹽遞選蓋遞齋糧餘願遞 (範顧廠憲築夢艱構膚餘, 鏇窪夢廠壓繭積鑰壓餘 ~ 齋繭獵選鏇繭範鏇繭網) 更多 | - | 2013-11-21 | ||
Placebo (Placebo) | 襯壓範醖齋齋齋淵鹽蓋(憲選醖憲鹹膚繭餘齋網) = 鏇遞範襯鹽廠鏇獵醖範 鹽遞選蓋遞齋糧餘願遞 (範顧廠憲築夢艱構膚餘, 觸醖窪繭餘簾觸築鑰構 ~ 鏇糧觸觸壓糧遞繭廠糧) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用