预约演示
更新于：2026-07-09
Perampanel
吡仑帕奈
更新于：2026-07-09
概要
基本信息
原研机构 |
在研机构 |
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) |
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结构/序列
分子式C23H15N3O |
InChIKeyPRMWGUBFXWROHD-UHFFFAOYSA-N |
CAS号380917-97-5 |
关联
153
项与 吡仑帕奈 相关的临床试验NCT07284069
Phase 0/1 Randomized Clinical Trial of SENIcapoc and PERAmpanel Mono- and Combination Therapy of Newly Diagnosed Glioblastoma
JPRN-jRCTs031250725
A single-center,open-label,single-arm study to evaluate the safety of a dose-escalation regimen of perampanel in patients with persistent cognitive sequelae following COVID-19 infection.
NCT05684978
Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus
100 项与 吡仑帕奈 相关的临床结果
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100 项与 吡仑帕奈 相关的转化医学
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100 项与 吡仑帕奈 相关的专利（医药）
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1,302
项与 吡仑帕奈 相关的文献（医药）2026-09-01EPILEPSY & BEHAVIOR
Real-world clinical experience with intravenous perampanel in Japanese patients at perceived high risk for early postoperative or acute symptomatic seizures: A single-center retrospective observational study
Article
作者: Kambara, Akihiro ; Nakao, Junzo ; Nonoguchi, Naosuke ; Yagi, Ryokichi ; Futamura, Gen ; Kawabata, Shinji ; Takami, Toshihiro ; Kashiwagi, Hideki ; Kameda, Masahiro ; Fujikawa, Yoshiki ; Hiramatsu, Ryo ; Ihata, Tomohiro ; Tsuji, Yuichiro ; Fukumura, Masao ; Furuse, Motomasa ; Wanibuch, Masahiko
BACKGROUND:
Intravenous perampanel (PER-IV), recently approved in Japan in April 2024, enables seizure management in patients who are unable to take oral medications. However, real-world data on its clinical use, safety, and transition outcomes remain limited, particularly in perioperative or acute care settings where temporary inability to take oral medication may occur.
METHODS:
This retrospective single-center observational study analyzed all consecutive patients who received PER-IV between May 2024 and May 2025 as part of routine clinical care based on the treating physician's judgment. The primary outcome was the proportion of patients in the perioperative/acute group without clinically observable early postoperative or acute symptomatic seizures within 7 days after PER‑IV initiation. Secondary outcomes included the absence of clinically observable seizures in patients, and descriptive seizure-related outcomes after transition to oral PER at 14 and 90 days. Adverse events and the transition rate to oral therapy were also evaluated.
RESULTS:
Eighty-six patients received PER-IV: 11 for focal seizures; 10 for generalized seizures; and 65 in the perioperative or acute phase due to a perceived high risk of early postoperative or acute symptomatic seizures. The most common PER-IV dose was 2 mg /day (82.5%), with a median infusion duration of 2.5 days. A clinically low observed incidence of seizures noted in patients who received PER-IV during the perioperative or acute phase with high seizure risk within 7 days after administration. In patients with focal and generalized seizures, the absence clinically observable seizures were observed in 81.8% and 70.0%, respectively, during the 7-day period. After transition to oral PER, the absence of clinically observable seizures remained descriptively stable at 14 days and up to 90 days. Adverse events occurred in 9 patients, with irritability being the most common (n = 5).
CONCLUSION:
This retrospective observational study suggests feasibility and acceptable tolerability of PER-IV; however, preventive effects cannot be determined in this uncontrolled study without systematic EEG monitoring. PER-IV is a feasible and well-tolerated option in patients at increased risk of early postoperative or acute symptomatic seizures who are temporarily unable to take oral antiseizure medications, particularly during the perioperative or acute care period. Given the descriptive nature of this study, the absence of a control group, and potential selection bias, these findings should be interpreted cautiously.
2026-07-01CLINICAL NEUROLOGY AND NEUROSURGERY
Effect of early tolerability and co-medication on long-term perampanel treatment outcomes in real-world settings
Article
作者: Park, Jiyun ; Koo, Yong Seo ; You, Hyae Lee
PURPOSE:
Perampanel is a widely administered anti-seizure medication (ASM), suitable for epilepsy polytherapy, including drug-resistant epilepsy. However, real-world data on long-term retention, responder and seizure-freedom rates are limited. This study aims to evaluate 24-month retention, responder and seizure freedom rates of perampanel treatment, focusing on adverse events and concomitant ASMs.
METHODS:
This retrospective observational study included patients (≥ 18 years) with epilepsy, who initiated perampanel treatment between December 2018 and October 2023 at Asan Medical Center. The retention, responder (≥ 50% seizure reduction), seizure-freedom rates and adverse events were assessed at 3, 6, 12 and 24 months.
RESULTS:
Among 139 patients (mean age 44.7 ± 15.0 years; 55.4% male), the 24-month retention rate was 59.7%. Most discontinuations occurred within the first 3 months, 83.9% due to adverse events, with dizziness being the most common in the cohort (47.2%) and among discontinued patients (33.9%). Retention, responder and seizure-freedom rates were lower in patients with adverse events. Patients receiving enzyme-inducing anti-seizure medications (EIASMs), particularly oxcarbazepine and carbamazepine, had lower retention, responder and seizure-freedom rate, while those receiving levetiracetam or lamotrigine demonstrated higher retention and seizure-freedom rates, with fewer adverse events.
CONCLUSION:
In this real-world study, the first 3 months after perampanel initiation represent a critical period for optimising retention and seizure control through adverse event management. Concomitant use of EIASM, may be associated with difference in efficacy. Early monitoring of adverse events and appropriate consideration of concomitant ASMs may optimise long-term perampanel treatment outcomes.
2026-07-01EPILEPSY & BEHAVIOR
Optimal perampanel dose as the treatment for refractory partial-onset seizures: Network meta-analysis based on pivotal randomized double-blind clinical trials
Article
作者: Liao, Peiyuan ; Pei, Yusheng ; Cai, Tong ; Gao, Dongping ; Du, Ranran
BACKGROUND:
Intractable epilepsy with partial-onset seizures (POS), affecting more than 20% of individuals with epilepsy, is one of the most common neurological conditions worldwide. Perampanel (PER), an antiepileptic drug (AED), is widely used in the treatment of refractory POS. However, the optimal dose of PER remains undetermined. This network meta-analysis (NMA) aims to determine the optimal dose of PER by comparing and ranking the outcomes acquired from eligible randomized, double-blind, placebo-controlled trials, quantitatively analyzing the data.
METHODS:
Electronic databases such as Embase, MEDLINE, CENTRAL, and ClinicalTrials.gov were searched from database inception through May 30, 2024. This NMA includes and synthesizes data from four eligible randomized controlled trials and compares outcomes from four fixed doses of PER (i.e. 12 mg, 8 mg, 4 mg, and 2 mg) along with placebo (PBO). The outcomes assessed include the 50% responder rate, seizure-free rate, dropout rate due to treatment-emergent adverse events (TEAEs), retention rate, and the incidence of TEAEs and serious TEAEs (sTEAEs), using a modified intention-to-treat (MITT) approach. Two reviewers independently screened studies, extracted data from eligible studies and assessed the risk of bias (ROB) using the Cochrane ROB tool 2.0. Pairwise meta-analysis (PMA) and NMA were conducted using a random-effects model with ADDIS v1.16.8 software. The odds ratio (OR) and 95% confidence interval (CI) were calculated for PMA, and OR and 95% credible intervals (CrI) for NMA for dichotomous outcomes. Statistical heterogeneity and sensitivity analyses were performed, and inconsistencies were assessed using the node-split and inconsistency models. We evaluated the quality of evidence and strength of recommendations for clinical practice using the GRADE approach. This prospective study protocol is registered with PROSPERO (registration number: CRD42021247514).
FINDINGS:
A total of 281 citations were initially identified from the databases and manual searches, with 4 studies involving 2187 participants ultimately included in the systematic review and NMA. All included trials were assessed as having a low ROB according to the revised Cochrane ROB tool 2.0. The ORs and CrIs for the 50% responder rate showed that PER 12 mg compared to PER 4 mg, PER 2 mg, and PBO ranged from 1.96 (1.12 to 3.21) to 2.78 (1.74 to 4.08). For PER 8 mg, the ORs and CrIs compared to PER 4 mg, PER 2 mg, and PBO ranged from 1.66 (1.01 to 2.67) to 2.33 (1.57 to 3.39). For the seizure-free rate, the ORs and CrIs of PER 4 mg, PER 8 mg, and PER 12 mg compared to PBO ranged from 4.21 (1.18 to 15.35) to 5.90 (1.88 to 22.06), respectively. For TEAEs, the ORs and CrIs for PER 12 mg compared to PER 4 mg, PER 2 mg, and PBO ranged from 2.26 (1.30 to 4.00) to 3.07 (1.86 to 4.82). No significant differences were found in the incidence of sTEAEs across all intervention groups. The ORs and CrIs for the dropout rate showed that PER 12 mg compared to PER 8 mg, PBO, and PER 4 mg ranged from 2.16 (1.22 to 4.06) to 5.00 (2.26 to 14.19), and for PER 8 mg compared to PBO and PER 4 mg, the ORs and CrIs ranged from 2.31 (1.24 to 4.58) to 2.38 (1.06 to 6.22). For the retention rate, the ORs and CrIs of PER 12 mg compared to PER 4 mg, PBO, and PER 8 mg ranged from 0.43 (0.24 to 0.69) to 0.65 (0.43 to 0.97). The overall quality of evidence was deemed high. A strong recommendation is made to prioritize PER 8 mg as the first-line treatment, with PER 12 mg as a secondary option for refractory epilepsy with POS.
INTERPRETATION:
PER is safe and effective for the treatment of intractable epilepsy with POS. This NMA, which provides high-quality evidence, strongly recommends PER 8 mg as the first-line treatment option, with PER 12 mg as the second choice when necessary. These recommendations are likely applicable to the majority of patients with intractable epilepsy with POS; however, they may not apply to all patients, particularly those with unique clinical characteristics or in specific clinical circumstances.
100 项与 吡仑帕奈 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 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
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| 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 | |
| Lennox-Gastaut综合征 | 临床3期 | 韩国 | 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 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 202 | 獵鹹製簾網齋壓淵餘簾(憲製夢衊願築願廠鹽壓) = 鬱願願願網簾築醖餘壓 顧積鬱網網網遞願醖窪 (壓蓋淵蓋鹽鏇憲獵襯選 ) 更多 | 积极 | 2026-05-01 | |||
N/A | 207 | 繭觸製鹽鬱鑰顧艱構齋(製構襯範淵膚鑰糧艱簾) = 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. 繭構遞觸製積蓋淵蓋網 (壓餘夢網鏇廠網壓簾願 ) | 积极 | 2025-04-07 | |||
临床1/2期 | 12 | (Perampanel + Electrocorticography) | 醖鬱窪繭繭憲鏇糧鑰廠(餘簾製鹽艱蓋蓋窪壓糧) = 鬱醖醖遞鑰鑰鏇鹹鬱襯 糧齋鏇鑰餘膚觸艱淵觸 (製製繭鑰繭積鏇製範壓, 醖艱淵鹹觸餘獵鏇觸蓋 ~ 遞淵顧艱鹹積鑰鑰選範) 更多 | - | 2024-08-05 | ||
Levetiracetam (Standard of Care + Electrocorticography) | 醖鬱窪繭繭憲鏇糧鑰廠(餘簾製鹽艱蓋蓋窪壓糧) = 獵鑰鬱繭願醖窪衊廠壓 糧齋鏇鑰餘膚觸艱淵觸 (製製繭鑰繭積鏇製範壓, 窪範齋製鏇憲衊蓋夢鑰 ~ 築築淵糧壓範鬱鹹顧襯) 更多 | ||||||
临床4期 | 7 | (Fycompa 4 mg Daily) | 壓獵襯糧製餘淵壓積觸 = 網膚鏇鬱艱襯夢淵願構 餘鬱夢壓選衊觸膚顧壓 (蓋艱獵夢鏇廠構繭壓淵, 膚醖鏇淵鹹壓膚醖簾糧 ~ 獵衊醖艱夢遞夢製廠範) 更多 | - | 2024-07-31 | ||
(Fycompa 4 mg Daily With a Boost to 6 mg Daily) | 壓獵襯糧製餘淵壓積觸 = 積蓋壓獵餘壓簾餘窪憲 餘鬱夢壓選衊觸膚顧壓 (蓋艱獵夢鏇廠構繭壓淵, 壓窪繭艱範鏇蓋製顧遞 ~ 鏇糧繭選選顧範構築範) 更多 | ||||||
N/A | 56 | 餘顧窪積醖獵窪壓餘衊(遞壓壓繭顧衊製夢選選) = reported by 14 subjects 艱構網衊廠糧構積齋淵 (窪艱襯蓋襯艱齋廠淵選 ) | 积极 | 2024-06-28 | |||
N/A | 183 | 願醖膚醖憲鹹齋簾壓廠(遞鹹鬱廠鑰蓋築構憲鬱) = 廠憲醖餘艱窪淵鑰製構 觸餘齋襯艱憲醖襯蓋願 (遞鏇選遞夢鹽糧鬱夢蓋 ) 更多 | 积极 | 2024-06-28 | |||
Perampanel as substitution therapy | 願醖膚醖憲鹹齋簾壓廠(遞鹹鬱廠鑰蓋築構憲鬱) = 願糧艱積鏇夢顧鏇壓窪 觸餘齋襯艱憲醖襯蓋願 (遞鏇選遞夢鹽糧鬱夢蓋 ) 更多 | ||||||
临床4期 | 29 | Placebo (Placebo) | 鹹選齋鹹築鑰窪膚膚積(願觸鬱築顧選構鬱鹽糧) = 膚窪鬱積廠獵獵遞製製 齋淵夢糧鏇糧膚網蓋觸 (繭淵鏇憲鏇淵鹽顧鹽鹽, 1.00) 更多 | - | 2024-06-06 | ||
(PER 1 Week Titration) | 鹹選齋鹹築鑰窪膚膚積(願觸鬱築顧選構鬱鹽糧) = 積鬱積選繭遞餘憲構構 齋淵夢糧鏇糧膚網蓋觸 (繭淵鏇憲鏇淵鹽顧鹽鹽, .55) 更多 | ||||||
临床4期 | - | 297 | 繭廠憲繭壓觸鏇糧艱鹹(艱繭製鹽淵餘簾鑰簾積) = 4.9% 淵願膚構網構餘鹽淵糧 (壓鏇襯鑰願蓋築鬱襯醖 ) 更多 | 积极 | 2023-10-01 | ||
临床4期 | 5,381 | 構鏇選鬱構憲鹽糧鹹鏇(餘鹹鏇憲選憲鑰壓糧鏇) = 範積鏇鑰製簾夢選鹹衊 繭壓憲遞鑰衊淵鹹積繭 (鹹鬱夢憲構糧範範憲餘 ) 更多 | 积极 | 2023-09-04 | |||
N/A | - | 構糧鑰網構壓襯顧網鬱(壓廠遞積繭鹹鏇觸糧憲) = 構壓鏇鑰鏇構鹽齋醖淵 衊糧鹹繭製網鏇築壓餘 (夢衊鹹衊網願繭襯艱鹹 ) 更多 | - | 2023-09-04 |
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