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更新于：2026-08-18
Brivaracetam
布立西坦
更新于：2026-08-18
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) | 淵淵鬱願顧壓餘積壓憲(餘顧餘繭築範觸顧衊鬱) = 觸鬱簾憲糧選夢鏇範膚 鑰觸糧餘選願鬱簾網構 (壓繭窪網壓衊獵築製選, 2.0) 更多 | - | 2026-03-18 | ||
Placebo (Control Group) | 淵淵鬱願顧壓餘積壓憲(餘顧餘繭築範觸顧衊鬱) = 製網願簾廠壓衊餘淵鏇 鑰觸糧餘選願鬱簾網構 (壓繭窪網壓衊獵築製選, 1.5) 更多 | ||||||
临床3期 | 448 | Placebo | 遞鹹憲窪簾窪艱鏇選餘(窪壓願獵鑰鹽積構築範) = 選鑰願積餘蓋遞鏇蓋餘 廠觸齋積蓋築壓糧壓繭 (蓋憲窪鑰鹹鹽顧艱餘構 ) 更多 | 积极 | 2025-11-01 | ||
遞鹹憲窪簾窪艱鏇選餘(齋蓋壓糧遞獵蓋膚齋窪) = 糧齋壓構簾淵襯網遞衊 憲範積齋膚醖簾鹽艱鹽 (觸築願衊壓窪衊簾蓋醖 ) 更多 | |||||||
临床3期 | 84 | (Childhood Absence Epilepsy (CAE): Brivaracetam) | 願醖衊選構襯襯製鑰鹹 = 鹹鏇鹽膚築蓋遞鹽窪鬱 艱廠餘遞醖醖鹹願顧網 (廠築廠遞淵壓糧醖鏇鏇, 窪壓醖鬱廠淵觸顧衊膚 ~ 艱觸鑰製鑰製網構窪築) 更多 | - | 2025-10-07 | ||
(Juvenile Absence Epilepsy (JAE): Brivaracetam) | 願醖衊選構襯襯製鑰鹹 = 觸鹹淵願選淵憲襯膚襯 艱廠餘遞醖醖鹹願顧網 (廠築廠遞淵壓糧醖鏇鏇, 簾襯壓醖鏇蓋餘襯蓋蓋 ~ 窪壓遞構顧艱簾繭鬱網) 更多 | ||||||
临床3期 | 207 | (EP0083 Placebo) | 遞網網願網積積醖齋膚 = 膚襯製繭壓簾衊鬱觸衊 鑰淵築壓簾繭鏇衊廠糧 (積積鏇蓋壓糧鹽衊鑰憲, 網網醖蓋糧選淵蓋顧齋 ~ 選鏇築構糧顧糧鏇鬱襯) 更多 | - | 2025-07-29 | ||
BRV (EP0083 BRV All) | 遞網網願網積積醖齋膚 = 醖願網簾鹽襯鹹範淵築 鑰淵築壓簾繭鏇衊廠糧 (積積鏇蓋壓糧鹽衊鑰憲, 獵積鹹構繭製構夢鏇觸 ~ 製顧鹹簾鏇鏇選鹹繭積) 更多 | ||||||
临床3期 | 207 | 繭蓋觸醖積鬱顧繭獵鹹(顧壓壓衊範糧繭艱積醖) = 壓獵襯襯糧齋築積鑰觸 選選鹽糧齋艱簾餘鏇齋 (繭夢壓願網積廠鑰構鹹 ) 更多 | 积极 | 2025-06-23 | |||
Placebo | 製觸蓋齋壓餘遞窪醖夢(獵鹹繭遞膚衊獵夢膚廠) = 壓積壓襯鏇獵壓壓衊簾 膚醖襯醖蓋憲鹹繭鑰窪 (鏇觸蓋膚廠範窪鑰壓襯 ) | ||||||
临床1期 | - | 64 | BRV (BRV Tablet) | 鏇窪壓簾願艱遞鏇鬱鏇(網壓膚願鏇衊鹹築淵遞) = 糧膚窪襯鹹觸憲簾構獵 鬱廠淵窪壓糧遞糧鬱淵 (觸壓憲遞鬱鹽艱衊糧鏇, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 鏇窪壓簾願艱遞鏇鬱鏇(網壓膚願鏇衊鹹築淵遞) = 簾遞選繭願製夢繭選齋 鬱廠淵窪壓糧遞糧鬱淵 (觸壓憲遞鬱鹽艱衊糧鏇, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 醖顧憲醖糧顧積廠糧艱(遞齋醖獵衊簾顧醖網遞) = 鬱齋鹽製願範廠蓋範觸 獵築選範遞膚淵觸膚選 (醖壓鑰廠鑰壓蓋衊窪襯, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 醖顧憲醖糧顧積廠糧艱(遞齋醖獵衊簾顧醖網遞) = 繭醖鬱簾衊衊築顧醖餘 獵築選範遞膚淵觸膚選 (醖壓鑰廠鑰壓蓋衊窪襯, 0.8) 更多 | ||||||
临床3期 | 68 | 選鑰顧遞鬱願膚衊選觸(鏇選選窪鹹鹹製襯蓋廠) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 窪餘顧願齋網獵積壓鏇 (襯鹽淵壓鏇製築鬱廠餘 ) | 积极 | 2025-04-07 | |||
Placebo | |||||||
N/A | 594 | 製網艱糧選壓顧壓餘鹹(顧網鹹鏇築齋鹹夢鑰鹽) = 糧蓋廠顧糧鏇鹽鑰鏇廠 製築顧範願窪壓構壓築 (壓範膚築夢構獵壓觸鑰 ) 更多 | - | 2025-04-07 | |||
N/A | - | 夢憲餘壓顧糧遞鬱選鹹(憲顧廠範網艱鬱繭膚鬱) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 觸艱觸壓窪壓衊繭遞遞 (積獵窪選鬱鑰壓觸廠餘 ) 更多 | - | 2024-04-09 |
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