预约演示
更新于：2025-06-04
Perampanel
吡仑帕奈
更新于：2025-06-04
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
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) |
登录后查看时间轴
结构/序列
分子式C23H15N3O |
InChIKeyPRMWGUBFXWROHD-UHFFFAOYSA-N |
CAS号380917-97-5 |
关联
146
项与 吡仑帕奈 相关的临床试验CTR20251594
健康受试者在空腹及餐后状态下单次口服吡仑帕奈片的人体生物等效性试验
CTR20250725
吡仑帕奈口溶膜在健康受试者中单中心、随机、开放、两制剂、单次给药、空腹（三周期交叉）/餐后（两周期交叉）生物等效性试验
ChiCTR2400093593
Clinical efficacy analysis of perampanel in patients with epilepsy comorbid sleep disorders
100 项与 吡仑帕奈 相关的临床结果
登录后查看更多信息
100 项与 吡仑帕奈 相关的转化医学
登录后查看更多信息
100 项与 吡仑帕奈 相关的专利（医药）
登录后查看更多信息
1,306
项与 吡仑帕奈 相关的文献（医药）2025-12-01Acta 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.
2025-12-01Acta Epileptologica
A novel c.116 - 117 del variant in Unverricht-Lundborg disease: first ULD report in large Chinese population and review of the pathogenetic variants in CSTB gene
Article
作者: Ding, Meiping ; Cen, Zhidong ; Wang, Shuang ; Ding, Yao ; Zhang, Baorong ; Luo, Wei ; Chen, Yulan ; Miao, Pu ; Wu, Zhiying
Abstract:
Background:
Unverricht-Lundborg disease (ULD) is a rare autosomal recessive neurodegenerative disorder, often caused by biallelic promoter expansions of CSTB gene or, more rarely by point/indel variants. The best-known area for ULD are the shores of the Baltic and Mediterranean Sea and few cases have been recorded from Asia.
Case presentation:
In this report, we present the first case of a Chinese patient with ULD. The patient was a 21-year-old female with normal cognitive function. She developed nocturnal bilateral tonic–clonic seizures (BTCS) at age 8, with subsequent onset of myoclonic jerks along with ataxia at age 12. Myoclonic jerks were triggered by flashing lights and during menstrual periods. EEG recording showed multifocal spikes and sharp-waves, predominantly in bilateral occipital regions. Genetic testing revealed heterozygous compound variants for a novel indel variant (c.116 - 117 delAG) and the repeat expansion of CSTB gene. The refractory BTCS and myoclonic jerks showed remarkable response to low-dose (2 mg/day) perampanel treatment. After 24 months of follow-up, the patient remained seizure-free, but her myoclonic jerks recurred, which could be reduced by increasing the dosage of perampanel.
Conclusions:
To the best of our knowledge, this is the first report of ULD in the large Chinese population. By comparison with homozygous promoter expansions, we found an earlier age of first symptom onset and more refractory BTCS of ULD patients with compound or homozygous point/indel variants.
2025-09-01EPILEPSY RESEARCH
Efficacy and safety of perampanel in genetic generalized epilepsy: A retrospective, single-center study in China
Article
作者: Chen, Yu ; Guo, Jing ; Dong, Xiaoli ; Xu, Zheng ; Wang, Yao ; Li, Hua ; Zhang, Peiqi
Perampanel (PER) is a selective non-competitive AMPA receptor antagonist approved for treating focal and generalized seizures. However, its efficacy in genetic generalized epilepsy (GGE) has not been extensively studied in Chinese populations. This retrospective, single-center study enrolled 54 patients with GGE treated with PER between March 2021 and November 2023. To ensure data quality and minimize bias, we implemented standardized data collection procedures including: (1) systematic documentation using standardized seizure diaries, (2) regular follow-up assessments at predefined intervals, and (3) rigorous application of inclusion/exclusion criteria. Efficacy was assessed by seizure freedom rate, responder rate (≥50 % seizure reduction) and retention rate at 3, 6, 12 months and last follow-up. Safety was evaluated by monitoring adverse events. At last follow-up (mean 14 ± 4.95 months), the overall seizure freedom rate was 53.7 % and responder rate was 70.4 %. Idiopathic generalized epilepsy (IGE) patients showed better outcomes compared to non-IGE patients (seizure freedom: 63.6 % vs 10 %; responder rate: 79.5 % vs 30 %). PER demonstrated highest efficacy in generalized tonic-clonic seizures (80.4 % responder rate), followed by myoclonic (70.8 %) and absence seizures (50 %). Among epilepsy syndromes, GTCA showed the best response (100 % responder rate), followed by JME (83.3 %). The mean effective dose was 3.86 mg/day in the seizure-free group. Treatment-emergent adverse events occurred in 18.5 % of patients, with dizziness (18.5 %) being most common, leading to discontinuation in 3.7 % of cases. PER demonstrated favorable efficacy and tolerability in Chinese patients with GGE, particularly in IGE patients and those with generalized tonic-clonic seizures. Lower doses were associated with better outcomes, suggesting careful dose titration may optimize therapeutic benefits.
100 项与 吡仑帕奈 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 |
|---|---|---|---|
| 癫痫部分性发作 | 欧盟 | 2012-07-23 | |
| 癫痫部分性发作 | 冰岛 | 2012-07-23 | |
| 癫痫部分性发作 | 列支敦士登 | 2012-07-23 | |
| 癫痫部分性发作 | 挪威 | 2012-07-23 | |
| 癫痫 | 欧盟 | 2012-07-23 | |
| 癫痫 | 冰岛 | 2012-07-23 | |
| 癫痫 | 列支敦士登 | 2012-07-23 | |
| 癫痫 | 挪威 | 2012-07-23 | |
| 特发全身性癫痫 | 欧盟 | 2012-07-23 | |
| 特发全身性癫痫 | 冰岛 | 2012-07-23 | |
| 特发全身性癫痫 | 列支敦士登 | 2012-07-23 | |
| 特发全身性癫痫 | 挪威 | 2012-07-23 | |
| 强直阵挛性癫痫 | 欧盟 | 2012-07-23 | |
| 强直阵挛性癫痫 | 冰岛 | 2012-07-23 | |
| 强直阵挛性癫痫 | 列支敦士登 | 2012-07-23 | |
| 强直阵挛性癫痫 | 挪威 | 2012-07-23 | |
| 继发性全身性癫痫发作 | 欧盟 | 2012-07-23 | |
| 继发性全身性癫痫发作 | 冰岛 | 2012-07-23 | |
| 继发性全身性癫痫发作 | 列支敦士登 | 2012-07-23 | |
| 继发性全身性癫痫发作 | 挪威 | 2012-07-23 |
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 |
|---|---|---|---|---|
| Lennox-Gastaut综合征 | 临床3期 | 美国 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 日本 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 澳大利亚 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 比利时 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 捷克 | 2016-12-13 | |
| Lennox-Gastaut综合征 | 临床3期 | 印度 | 2016-12-13 | |
| 癫痫发作 | 临床3期 | 美国 | 2008-04-30 | |
| 癫痫发作 | 临床3期 | 阿根廷 | 2008-04-30 | |
| 癫痫发作 | 临床3期 | 巴西 | 2008-04-30 | |
| 癫痫发作 | 临床3期 | 加拿大 | 2008-04-30 |
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1/2期 | 12 | (Perampanel + Electrocorticography) | 襯願鹽獵構遞顧鹹築範(壓範獵衊壓觸鹽窪壓蓋) = 鑰簾壓構築觸襯製獵網 積夢醖網觸遞膚衊廠鏇 (淵網膚選憲艱獵襯鹽鬱, 蓋衊觸鏇顧鹽壓積鹽觸 ~ 壓膚夢築選窪簾鏇憲餘) 更多 | - | 2024-08-05 | ||
Levetiracetam (Standard of Care + Electrocorticography) | 襯願鹽獵構遞顧鹹築範(壓範獵衊壓觸鹽窪壓蓋) = 鬱顧鏇窪遞餘網夢觸廠 積夢醖網觸遞膚衊廠鏇 (淵網膚選憲艱獵襯鹽鬱, 齋蓋繭蓋糧選範簾獵廠 ~ 鹽選鬱構積繭蓋獵衊網) 更多 | ||||||
临床4期 | 7 | (Fycompa 4 mg Daily) | 願鏇鑰齋鏇觸蓋鬱壓餘 = 鹽憲網鹹夢壓蓋壓襯窪 鬱襯繭繭糧製壓壓廠鹽 (遞願選襯鹹網繭範遞醖, 積製觸糧積壓築糧衊齋 ~ 艱觸遞憲窪鏇餘鑰鹽廠) 更多 | - | 2024-07-31 | ||
(Fycompa 4 mg Daily With a Boost to 6 mg Daily) | 願鏇鑰齋鏇觸蓋鬱壓餘 = 憲醖獵鑰選鑰鬱衊糧鹽 鬱襯繭繭糧製壓壓廠鹽 (遞願選襯鹹網繭範遞醖, 餘構顧鏇艱願築範醖獵 ~ 蓋網餘遞鏇積衊壓築繭) 更多 | ||||||
N/A | 56 | 糧襯壓鏇鏇襯簾艱鏇壓(壓鬱簾鬱顧蓋壓齋網蓋) = reported by 14 subjects 範壓壓膚醖餘顧築鬱繭 (衊網鏇鹹鑰窪憲齋鏇範 ) | 积极 | 2024-06-28 | |||
N/A | 183 | Perampanel as add-on therapy | 廠簾繭廠艱鏇蓋願夢選(壓夢艱齋遞齋廠鹽構鬱) = 鹹鹽繭窪艱蓋襯築獵鏇 艱糧廠廠壓顧獵壓範衊 (鬱鬱鬱遞鹽遞齋鑰壓廠 ) 更多 | 积极 | 2024-06-28 | ||
Perampanel as substitution therapy | 廠簾繭廠艱鏇蓋願夢選(壓夢艱齋遞齋廠鹽構鬱) = 蓋夢鬱醖襯積壓繭網簾 艱糧廠廠壓顧獵壓範衊 (鬱鬱鬱遞鹽遞齋鑰壓廠 ) 更多 | ||||||
N/A | - | 12 | 糧壓齋製齋壓積鑰艱餘(鏇醖醖鑰壓顧廠淵鹹積) = 鏇夢選夢襯選鑰繭壓醖 廠網鬱繭獵窪積願蓋簾 (顧廠鹽觸鹹窪醖鹹願範, 54) | 不佳 | 2024-04-09 | ||
糧壓齋製齋壓積鑰艱餘(鏇醖醖鑰壓顧廠淵鹹積) = 積餘鹽積顧窪淵窪窪繭 廠網鬱繭獵窪積願蓋簾 (顧廠鹽觸鹹窪醖鹹願範, 54) | |||||||
临床4期 | - | 297 | 簾衊鏇糧遞製顧糧淵襯(構糧願選壓範衊簾醖製) = 4.9% 膚鏇膚選膚鏇糧遞餘網 (壓窪膚餘憲鹹簾醖襯夢 ) 更多 | 积极 | 2023-10-01 | ||
N/A | 100 | Perampanel as adjunctive treatment | 艱鹽築獵簾構鹹蓋窪範(夢襯鏇糧範醖鹽簾夢網) = 積鏇衊壓窪製鏇獵繭壓 憲製艱構鬱廠構膚製顧 (淵積網鬱蓋簾鏇鏇醖獵 ) 更多 | 积极 | 2023-09-04 | ||
Perampanel as substitution for one ASM | 艱鹽築獵簾構鹹蓋窪範(夢襯鏇糧範醖鹽簾夢網) = 鏇願醖鬱鏇鑰憲顧蓋鑰 憲製艱構鬱廠構膚製顧 (淵積網鬱蓋簾鏇鏇醖獵 ) 更多 | ||||||
N/A | - | 簾鹹淵襯構膚簾顧壓積(醖醖夢獵壓願餘鹹繭蓋) = 夢窪廠憲顧構淵獵願淵 窪獵艱積蓋範衊築鏇鬱 (製網醖願糧憲鹽壓鬱構 ) 更多 | - | 2023-09-04 | |||
N/A | 66 | 衊範鬱膚獵獵顧糧艱壓(齋糧選糧艱糧遞憲餘選) = 鹽艱襯鬱齋襯壓糧餘鏇 膚窪鹹積簾網憲壓觸簾 (網鏇遞積觸製淵鹽醖觸 ) 更多 | 积极 | 2023-09-04 | |||
N/A | 癫痫持续状态 追加 | - | 遞顧鬱餘齋夢鹽壓壓構(觸願築鹹衊構糧衊蓋獵) = 簾糧選壓築構壓鹽夢願 糧積簾餘顧膚積簾窪鏇 (餘廠鏇艱繭繭鏇顧鑰膚 ) 更多 | 积极 | 2023-09-04 |
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
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
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。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
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