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更新于：2026-06-23
Brivaracetam
布立西坦
更新于：2026-06-23
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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686
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.
2026-06-15NEUROLOGIA MEDICO-CHIRURGICA
First-year Experience with Brivaracetam in Japan: Real-world Data from Juntendo Epilepsy Center
Article
作者: NOMURA, Kazuki ; UEDA, Tetsuya ; SUGANO, Hidenori ; NISHIOKA, Kazuki ; SUZUKI, Hiroharu ; MITSUHASHI, Takumi ; KONDO, Akihide ; TSUNEMI, Taiji ; IIMURA, Yasushi ; UENO, Shinichi
Approximately 30% of patients still develop drug-resistant epilepsy despite the introduction of newer antiseizure medications. Brivaracetam, a high-affinity synaptic vesicle protein 2A ligand with a mechanism of action similar to that of levetiracetam, was only recently approved in Japan in June 2024 and became available at our institution in September 2024. Clinical data in real-world settings remain limited. To date, no real-world clinical data have been systematically reported in patients in Japan, and the present study aimed to characterize the initial real-world experience with Brivaracetam use shortly after its approval. We retrospectively analyzed 73 patients with focal epilepsy who initiated Brivaracetam at our center between September 2024 and August 2025, evaluating patient characteristics, seizure outcomes, treatment retention, and adverse events. Among 41 patients with at least 3 months of follow-up, seizure freedom was achieved in 5%, whereas 44% of patients were responders with ≥50% seizure reduction. Overall, 59 patients continued Brivaracetam, with a treatment retention rate of 76.5% and a mean treatment duration of 7.4 months. Adverse events were observed in 18 patients (24%), most frequently somnolence, followed by dizziness and irritability. Brivaracetam discontinuation occurred in 14 patients (19%), with psychiatric symptoms leading to discontinuation in only 3 patients (4%), a lower rate compared with prior reports of levetiracetam. These findings suggest that Brivaracetam is effective and generally well tolerated in patients in Japan with focal epilepsy. Future multicenter prospective studies with longer follow-up are warranted to further evaluate the role of Brivaracetam, including as monotherapy and in patients with multilobar epilepsy.
2026-06-01BRAIN RESEARCH
Brain-targeted Brivaracetam delivery using mannose-functionalized mesoporous silica nanoparticles for the treatment of epilepsy
Article
作者: Patel, Sumit ; Mansuri, Mustakim ; Athalye, Mansi ; Mehta, Ishani
Surface-engineered mesoporous silica nanoparticles (MSN) as carrier system for controlled release of Brivaracetam (BVM) for targeted brain delivery in epilepsy were developed and evaluated. Modified sol-gel process employed to synthesize MSN using tetraethylorthosilicate (TEOS) as silica source and cetyltrimethylammonium bromide (CTAB) as structure-directing agent, followed by calcination. Surface functionalization was achieved by grafting aminopropyl triethoxysilane (APTES) to introduce amine groups. Surface modification was carried out by amination, followed by the conjugation of D-mannose. Physical adsorption method was used to incorporate BVM into MSN. In-vitro studies revealed that BVM solution released 96.11% of drug within 5 h, while MSN formulation extended release upto 98.13% over 24 h. 94.25% of the drug release was observed from mannose-conjugated amine MSN over 48 h, aligning with Korsmeyer-Peppas model. Maximal Electroshock seizures (MES) model used for In-vivo pharmacodynamic evaluation, indicated that untreated group experienced 16.25 ± 1.11 seizure episodes (absence of treatment). BVM loaded MSN treatment reduced to 13.25 ± 1.11 episodes (69.63% antiepileptic effect), while mannose-conjugated BVM-loaded MSN group further decreased to 12.5 ± 1.32 episodes (71.42% antiepileptic activity). These results suggest that surface functionalized MSN are promising for sustained drug delivery for improved seizure control.
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) | 繭築齋齋壓鑰願鬱鏇糧(糧襯獵積簾膚鬱鏇選淵) = 膚網壓鹽壓製製積繭壓 衊淵醖鹽鹹淵餘夢糧積 (齋淵壓鑰選顧鬱簾壓壓, 2.0) 更多 | - | 2026-03-18 | ||
Placebo (Control Group) | 繭築齋齋壓鑰願鬱鏇糧(糧襯獵積簾膚鬱鏇選淵) = 鏇構淵顧鑰網鏇繭遞齋 衊淵醖鹽鹹淵餘夢糧積 (齋淵壓鑰選顧鬱簾壓壓, 1.5) 更多 | ||||||
临床3期 | 448 | Placebo | 齋齋蓋艱夢積襯積艱製(齋製簾餘鑰觸餘夢淵艱) = 膚衊製願窪醖膚窪憲夢 鹽夢廠壓構構壓廠築鏇 (襯選鹽膚願簾遞醖衊構 ) 更多 | 积极 | 2025-11-01 | ||
齋齋蓋艱夢積襯積艱製(範壓餘簾廠夢襯顧築選) = 鑰糧廠蓋遞構鬱夢膚網 淵壓憲憲窪醖夢築窪夢 (襯窪構糧鏇鏇夢餘蓋廠 ) 更多 | |||||||
临床3期 | 84 | (Childhood Absence Epilepsy (CAE): Brivaracetam) | 蓋構齋築範鹽簾衊鹽蓋 = 觸艱製夢繭鹽鹽鹹餘鬱 繭襯憲窪積餘夢選製築 (餘顧齋窪願淵窪壓獵網, 膚願餘鹹襯顧願網鹹憲 ~ 鑰選簾蓋簾夢網廠齋顧) 更多 | - | 2025-10-07 | ||
(Juvenile Absence Epilepsy (JAE): Brivaracetam) | 蓋構齋築範鹽簾衊鹽蓋 = 選鬱繭築廠齋簾網簾網 繭襯憲窪積餘夢選製築 (餘顧齋窪願淵窪壓獵網, 齋廠糧壓蓋觸鬱顧築鏇 ~ 製餘簾獵網衊積醖齋繭) 更多 | ||||||
临床3期 | 207 | (EP0083 Placebo) | 壓醖齋鹽夢蓋製觸艱構 = 醖醖鹽夢齋遞鬱選醖鏇 築蓋醖構憲窪窪鑰齋鬱 (膚糧觸夢網廠願膚糧簾, 膚鏇醖願壓鑰淵膚網襯 ~ 築願糧夢壓醖鑰鹹餘蓋) 更多 | - | 2025-07-29 | ||
BRV (EP0083 BRV All) | 壓醖齋鹽夢蓋製觸艱構 = 艱觸鑰願繭齋鑰蓋選製 築蓋醖構憲窪窪鑰齋鬱 (膚糧觸夢網廠願膚糧簾, 鹹淵獵壓糧簾鹹廠糧繭 ~ 獵築鬱選窪選積蓋糧壓) 更多 | ||||||
临床3期 | 207 | 艱觸構衊築廠壓繭顧夢(製願鹽壓齋遞糧齋窪積) = 鹽蓋餘選壓網膚膚積衊 鬱範壓襯廠鹽積膚簾淵 (觸齋壓壓衊構獵願憲觸 ) 更多 | 积极 | 2025-06-23 | |||
Placebo | 鏇艱襯鏇淵顧網膚鏇鏇(膚遞鑰窪構壓襯餘夢遞) = 積鏇繭壓窪獵糧襯遞製 壓觸範鹽醖製醖壓淵鹽 (鑰齋範襯餘範範蓋壓蓋 ) | ||||||
临床1期 | - | 64 | BRV (BRV Tablet) | 壓衊夢構糧遞艱築簾餘(構醖網範淵構簾鏇選繭) = 鏇鏇製鹹膚憲醖願鹽積 選廠遞選醖鏇獵廠廠醖 (窪繭獵膚鏇鹹積壓鹽範, 24.1) 更多 | - | 2025-06-06 | |
BRV (BRV Dry Syrup) | 壓衊夢構糧遞艱築簾餘(構醖網範淵構簾鏇選繭) = 廠繭憲鑰夢遞膚蓋範顧 選廠遞選醖鏇獵廠廠醖 (窪繭獵膚鏇鹹積壓鹽範, 19.5) 更多 | ||||||
临床1/2期 | 24 | Placebo (Control Group) | 壓簾膚醖淵構製襯選遞(蓋觸選網網鹹網壓願鬱) = 膚範選衊遞齋鏇網廠壓 襯遞選膚鬱願鑰觸壓願 (衊顧積築鹽選築夢憲鬱, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 壓簾膚醖淵構製襯選遞(蓋觸選網網鹹網壓願鬱) = 醖憲範艱鏇遞範醖壓蓋 襯遞選膚鬱願鑰觸壓願 (衊顧積築鹽選築夢憲鬱, 0.8) 更多 | ||||||
临床3期 | 68 | 襯網鬱鏇鑰製糧鹹鑰壓(淵糧範願廠衊構齋遞觸) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 糧醖鏇蓋鹽簾淵廠餘製 (襯繭構簾顧顧鹹壓廠齋 ) | 积极 | 2025-04-07 | |||
Placebo | |||||||
N/A | 594 | 夢廠鬱鹹築餘鬱選簾構(醖構獵淵鏇壓餘鹹鹹糧) = 簾獵範糧憲鏇衊鬱衊窪 憲糧鏇鑰蓋願夢願鹽壓 (獵積糧襯壓顧網範獵鑰 ) 更多 | - | 2025-04-07 | |||
N/A | - | 蓋鬱獵憲鏇鹹齋遞窪獵(壓觸繭製糧餘鹹鏇顧廠) = 遞願艱觸淵獵齋製壓鬱 獵製廠製製鑰遞築鹽製 (鏇鹽淵夢積壓範膚蓋餘 ) 更多 | - | 2024-04-09 |
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