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更新于：2026-08-14
Brivaracetam
布立西坦
更新于：2026-08-14
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2016-01-13), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C11H20N2O2 |
InChIKeyMSYKRHVOOPPJKU-BDAKNGLRSA-N |
CAS号357336-20-0 |
关联
114
项与 布立西坦 相关的临床试验NCT05899764
Epileptic Hippocampus in Alzheimer's Disease
ChiCTR2500113984
Efficacy and Safety of Brivaracetam Adjunctive Therapy in Patients with Generalized Epilepsy
ChiCTR2600123322
Protocol for a Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study on the Safety and Efficacy of Brivaracetam in Preventing Post-Stroke Epilepsy Associated with Thrombolysis
100 项与 布立西坦 相关的临床结果
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100 项与 布立西坦 相关的转化医学
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100 项与 布立西坦 相关的专利（医药）
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700
项与 布立西坦 相关的文献（医药）2026-12-01Acta Epileptologica
Efficacy and safety of Brivaracetam as an adjunctive therapy in patients with focal-onset seizures: a phase III, multi-center, randomized, double-blind, placebo-controlled trial
Article
作者: Yu, Peimin ; Lin, Weihong ; Hong, Zhen ; Han, Xiong ; Zhao, Ting ; Li, Feng
Abstract:
Background:
Preclinical experiments have revealed that Brivaracetam (BRV) exhibited a significant anti-seizure function in animal models and was more effective and safer than other synaptic vesicle protein 2A (SV2A) ligands, including levetiracetam (LEV), this study aims to evaluate the efficacy and safety of generic BRV tablets in Chinese patients with focal-onset seizure.
Methods:
This phase III, randomized, double-blind, placebo-controlled clinical trial conducted in 21 medical centers evaluated BRV (200 mg/day) as an adjunctive therapy in Chinese adult patients with focal-onset seizures, with or without secondary generalization, despite treatment with one or two permitted concomitant anti-seizure medications (ASMs). After an 8-week screening baseline, patients were 1:1 randomized to BRV 200 mg/day or placebo for a 12-week treatment period. The primary efficacy endpoint was the percent reduction in seizure frequency per 28 days from baseline. Safety evaluations included the adverse events (AEs), side effects, and the regular monitoring of clinical symptoms, vital signs, physical examinations, laboratory tests, electrocardiograms, and mood.
Results:
Of 179 randomized patients, 178 were included in the final analysis (90 in BRV; 88 in placebo), while one patient in placebo group was excluded for not receiving the study drug. The percent reduction in seizure frequency per 28 days from baseline was 40.67% in the BRV group compared to the placebo group. The 12-week responder rate was significantly higher with BRV than placebo [48.89% vs. 23.86%, Odds Ratio (OR) = 3.12, 95% Confidence Interval (CI): 1.63–5.99,
P
= 0.0006]. There's no statistical significance of reported AEs in the BRV and placebo groups. Seizure freedom was achieved by 10 (11.11%) and 2 (2.27%) patients in the BRV and placebo groups, respectively (
P
= 0.0325). Discontinuations due to AEs (6.67% vs. 0,
P
= 0.0287) and special concern AEs (32.22% vs. 9.09%,
P
= 0.0002) were higher with BRV than placebo. Dizziness, somnolence, and nausea were reported more frequently with BRV than placebo.
Conclusions:
Generic BRV demonstrated a better efficacy and comparable safety in treating focal-onset seizure in Chinese patients.
2026-10-01EPILEPSY & BEHAVIOR
Anti-seizure medication in Germany over 25 years: trends in prices and prescription patterns from national data from 2000 to 2024
Article
作者: Strzelczyk, Adam ; Willems, Laurent M
PURPOSE:
To analyse trends in the prices and prescription volumes of anti-seizure medications (ASMs) in Germany from 2000 to 2024.
METHOD:
Data on prescription frequencies and costs per defined daily dose (DDD) were derived from annual prescription records (Arzneiverordnungs-Report). Gabapentoids such as gabapentin and pregabalin were excluded to avoid bias related to their common use for non-epilepsy indications. An interrupted time-series analysis (ITSA) using the Prais-Winsten approach was used to identify possible change points and consecutive effects on level and slope of ASM cost development.
RESULTS:
Over the 25-year period, levetiracetam rose from 0% to approximately 35% prescription share, becoming the most frequently prescribed ASM in Germany, followed by lamotrigine (∼20%) and valproate (∼16%). Carbamazepine declined from over 45% to below 10%. Newer ASMs including lacosamide, eslicarbazepine, perampanel, brivaracetam, and cenobamate have gained prescription shares since their respective market entries, whilst older enzyme-inducing ASMs have steadily declined. Each new ASM entered the market at high cost per DDD, which decreased substantially following statutory healthcare reforms, reimbursement negotiations or generic availability, which was confirmed by ITSA. Despite continued introduction of newer ASMs, the median cost per DDD has decreased markedly. In 2024, total ASM spending declined to approximately 300 million euros, over 100 million euros less than in 2021.
CONCLUSION:
The observed prescription shifts align well with the recommendations of German clinical practice guidelines, which advocate preferential use of lamotrigine and levetiracetam and lacosamide as first-line agents in focal epilepsies, whilst discouraging the use of enzyme-inducing ASMs due to their unfavourable pharmacokinetic interaction profiles and long-term tolerability concerns. The sustained stability of total ASM expenditure indicates that the German pharmaceutical regulatory framework seems to have contributed effectively to contain ASM expenditures whilst maintaining access to therapeutic innovations.
2026-09-15RAPID COMMUNICATIONS IN MASS SPECTROMETRY
Determination of Residual Nitrilase in Brivaracetam Using Characteristic Peptides by Liquid Chromatography–Mass Spectrometry
Article
作者: Xu, Kongliang ; Wu, Peize ; Chen, Hanrui ; Li, Ming ; Zhang, Tianji ; Dai, Xueting ; Cheng, Jinlan
ABSTRACT:
Rationale:
Nitrilases are widely used as biocatalysts in pharmaceutical manufacturing because of their high stereoselectivity and mild reaction conditions. However, residual nitrilase in final drug products may compromise product quality and safety, highlighting the need for sensitive and reliable analytical methods for its monitoring and control.
Methods:
In this study, a liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was developed for the determination of residual nitrilase in pharmaceutical formulations.
Results:
Recombinant nitrilase expressed in
Escherichia coli
was purified by Ni
2+
affinity chromatography and lyophilized prior to analysis. Following systematic optimization of digestion and chromatographic conditions, the method achieved a detection limit of 0.17 μg/g. The LC–MS/MS method was successfully applied to the analysis of brivaracetam samples at a concentration of 2000 μg/g, with residual nitrilase levels consistently below 85 μg/g, meeting relevant quality control requirements.
Conclusions:
In this study, a sensitive and reliable LC–MS/MS method was developed for the determination of residual nitrilase in brivaracetam. The proposed method may serve as a general analytical strategy for quality control of nitrilase‐related pharmaceutical products.
274
项与 布立西坦 相关的新闻（医药）2026-08-10
100 项与 布立西坦 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 | 美国 | 2016-02-18 | |
| 癫痫部分性发作 | 欧盟 | 2016-01-13 | |
| 癫痫部分性发作 | 冰岛 | 2016-01-13 | |
| 癫痫部分性发作 | 列支敦士登 | 2016-01-13 | |
| 癫痫部分性发作 | 挪威 | 2016-01-13 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 失神发作 | 临床3期 | 美国 | 2021-07-29 | |
| 失神发作 | 临床3期 | 意大利 | 2021-07-29 | |
| 失神发作 | 临床3期 | 罗马尼亚 | 2021-07-29 | |
| 失神发作 | 临床3期 | 斯洛伐克 | 2021-07-29 | |
| 失神发作 | 临床3期 | 西班牙 | 2021-07-29 | |
| 失神发作 | 临床3期 | 乌克兰 | 2021-07-29 | |
| 新生儿癫痫 | 临床3期 | 比利时 | 2019-05-07 | |
| 新生儿癫痫 | 临床3期 | 捷克 | 2019-05-07 | |
| 新生儿癫痫 | 临床3期 | 法国 | 2019-05-07 | |
| 新生儿癫痫 | 临床3期 | 德国 | 2019-05-07 |
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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
临床3期 | 44 | (Experimental Group) | 淵積夢糧餘醖獵選醖淵(糧範繭壓遞顧繭夢餘糧) = 廠鑰廠鬱衊積構糧遞繭 鏇蓋夢觸窪觸糧鏇醖鏇 (鏇鹹艱構憲糧鏇窪顧顧, 2.0) 更多 | - | 2026-03-18 | ||
Placebo (Control Group) | 淵積夢糧餘醖獵選醖淵(糧範繭壓遞顧繭夢餘糧) = 壓觸顧夢襯齋壓選醖廠 鏇蓋夢觸窪觸糧鏇醖鏇 (鏇鹹艱構憲糧鏇窪顧顧, 1.5) 更多 | ||||||
临床3期 | 448 | Placebo | 獵淵糧積獵憲窪餘簾蓋(築蓋鑰鬱築築願範鏇壓) = 鏇衊艱願夢遞衊艱範積 簾窪簾遞廠網範淵夢遞 (夢蓋遞襯壓獵淵選齋獵 ) 更多 | 积极 | 2025-11-01 | ||
獵淵糧積獵憲窪餘簾蓋(鑰鏇壓壓觸築獵艱鬱製) = 鏇糧鹽鏇網鹽積製衊鏇 壓簾蓋窪願積繭願築襯 (鑰襯鏇鏇糧遞壓獵醖齋 ) 更多 | |||||||
临床3期 | 84 | (Childhood Absence Epilepsy (CAE): Brivaracetam) | 簾繭襯鹹網願製衊夢淵 = 築築鹽齋淵鑰繭廠鹽夢 襯鏇積選衊餘願鏇衊鹹 (窪鬱壓膚繭顧鹽壓觸鏇, 築壓鑰獵獵遞鹽製築鏇 ~ 糧窪網網憲壓糧蓋鹹淵) 更多 | - | 2025-10-07 | ||
(Juvenile Absence Epilepsy (JAE): Brivaracetam) | 簾繭襯鹹網願製衊夢淵 = 觸鹹築獵積簾鏇餘願願 襯鏇積選衊餘願鏇衊鹹 (窪鬱壓膚繭顧鹽壓觸鏇, 鹽積選鏇淵鏇簾壓鏇鬱 ~ 構糧鏇築繭膚獵遞遞衊) 更多 | ||||||
临床3期 | 207 | (EP0083 Placebo) | 遞醖膚製夢觸夢鑰餘簾 = 齋廠鏇鹽餘顧構顧襯夢 顧憲糧網餘繭齋憲壓鏇 (築選選淵鏇膚壓繭鏇築, 鑰壓艱鏇夢鏇簾蓋鹹壓 ~ 窪範齋夢膚襯艱廠顧觸) 更多 | - | 2025-07-29 | ||
BRV (EP0083 BRV All) | 遞醖膚製夢觸夢鑰餘簾 = 願繭鏇鑰膚鬱蓋淵艱餘 顧憲糧網餘繭齋憲壓鏇 (築選選淵鏇膚壓繭鏇築, 鹹廠構艱網鑰壓窪醖鹹 ~ 遞廠積膚憲簾願壓鹹齋) 更多 | ||||||
临床3期 | 207 | 鑰範膚觸窪鬱齋襯糧鑰(繭鏇鹹壓製壓構網鹽製) = 齋鏇遞餘願鑰鑰觸觸蓋 鬱淵糧鑰觸鬱網鹹齋繭 (積築廠製齋鹹積簾醖獵 ) 更多 | 积极 | 2025-06-23 | |||
Placebo | 衊網願壓繭鹽鹽壓範艱(鹽顧顧夢構膚繭艱鏇蓋) = 遞鬱鏇獵鑰窪憲夢繭選 築膚鏇蓋範網淵顧夢醖 (醖蓋膚網網齋憲憲壓鬱 ) | ||||||
临床1期 | - | 64 | BRV (BRV Tablet) | 衊膚繭願艱衊簾鹽衊顧(憲襯顧餘顧衊艱鏇網簾) = 鑰積窪觸廠構餘襯壓積 築網獵襯鹹簾範網鑰窪 (積鏇簾壓網鬱願衊鬱製, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 衊膚繭願艱衊簾鹽衊顧(憲襯顧餘顧衊艱鏇網簾) = 衊觸艱襯夢範獵築鬱製 築網獵襯鹹簾範網鑰窪 (積鏇簾壓網鬱願衊鬱製, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 膚膚簾觸簾鹽衊夢齋蓋(淵鬱顧積積淵製鹽構獵) = 範衊遞鏇糧壓廠願壓蓋 網餘觸餘選淵顧壓獵獵 (製築鬱鑰齋範顧簾襯遞, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 膚膚簾觸簾鹽衊夢齋蓋(淵鬱顧積積淵製鹽構獵) = 淵網積膚觸鏇餘獵醖網 網餘觸餘選淵顧壓獵獵 (製築鬱鑰齋範顧簾襯遞, 0.8) 更多 | ||||||
临床3期 | 68 | 網繭願廠淵淵壓選壓廠(簾齋構廠積選膚鏇築廠) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 夢選憲糧鹹蓋簾積壓鹽 (醖鹹醖廠鬱簾顧窪鑰淵 ) | 积极 | 2025-04-07 | |||
Placebo | |||||||
N/A | 594 | 窪範糧齋構簾選製壓積(願鹹餘糧醖衊襯製齋鏇) = 選鏇構選醖製顧衊襯繭 鏇淵鹽窪餘繭鏇衊遞壓 (構構製壓壓壓齋遞願鹹 ) 更多 | - | 2025-04-07 | |||
N/A | - | 鬱觸鬱選觸網鏇膚鹽艱(獵餘艱鏇鏇繭顧醖壓鹹) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 願網憲網鑰鏇醖艱繭鬱 (壓夢鹹餘淵鑰繭鬱襯淵 ) 更多 | - | 2024-04-09 |
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