预约演示
更新于：2025-05-31
Brivaracetam
布立西坦
更新于：2025-05-31
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) |
登录后查看时间轴
结构/序列
分子式C11H20N2O2 |
InChIKeyMSYKRHVOOPPJKU-BDAKNGLRSA-N |
CAS号357336-20-0 |
关联
104
项与 布立西坦 相关的临床试验CTIS2024-516500-42-00
- BRIVA-10-24
NCT05899764
Epileptic Hippocampus in Alzheimer's Disease
ChiCTR2400092964
A Multicenter, Randomized, Double-Blind, Placebo Parallel-Controlled Phase III Trial to Evaluate the Efficacy and Safety of Brivaracetam Tablet Add-on Therapy for Focal Epilepsy(KL408-III-01-CTP)
100 项与 布立西坦 相关的临床结果
登录后查看更多信息
100 项与 布立西坦 相关的转化医学
登录后查看更多信息
100 项与 布立西坦 相关的专利（医药）
登录后查看更多信息
714
项与 布立西坦 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.
2025-09-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Non-invasive therapeutic drug monitoring: LC-MS validation for lamotrigine quantification in dried blood spot and oral fluid/saliva
Article
作者: Peš, Ondřej ; Glatz, Zdeněk ; Šištík, Pavel ; Pelcová, Marta ; Juřica, Jan ; Štolcová, Miriam ; Strýček, Ondřej ; Šmak, Pavel ; Ďurčová, Viktória
Epilepsy, affecting over 50 million people globally, presents a significant neurological challenge. Effective prevention of epileptic seizures relies on proper administration and monitoring of Anti-Seizure Medication (ASMs). Therapeutic Drug Monitoring (TDM) ensures optimal dosage adjustment, minimizing adverse effects and potential drug interactions. While traditional venous blood collection for TDM may be stressful, emerging alternative sampling methods, particularly Dried Blood Spot (DBS) or oral fluid offer less invasive way of sampling. This study aimed to develop and validate an analytical method for the determination of lamotrigine in such alternative samples. The sample, either DBS or oral fluid, was subjected to extraction, evaporation, and reconstitution in 15 % acetonitrile containing 0.1 % formic acid. A Kinetex C18 Polar column was used for liquid chromatographic separation and MS in ESI+ mode was used for detection and quantitation of lamotrigine using an isotopically labelled internal standard according to EMA guidelines. The calibration range of the developed method enables the determination of lamotrigine in the concentration range of 1-30 μg/mL in DBS and 0.5-20 μg/mL in oral fluid. Oral fluid and DBS samples from patients treated with lamotrigine analysed by the developed method were compared to plasma concentrations measured by the hospital's accredited laboratory. Preliminary results indicate a promising potential for these alternative matrices in clinical TDM applications. By offering a less invasive sampling approach, this method improves the accessibility and safety of pharmacotherapy for epilepsy patients. The results of this study lay the foundation for further clinical applications by implementing alternative matrix TDM, which may significantly advance personalized care in epilepsy management.
2025-09-01EPILEPSY & BEHAVIOR
Seizure-type-specific treatment responses in Lennox-Gastaut Syndrome: A comprehensive review of pharmacological, neuromodulatory, dietary, and surgical therapies
Review
作者: Naik, Sunil ; Samanta, Debopam
Lennox-Gastaut Syndrome (LGS) is a severe developmental and epileptic encephalopathy characterized by multiple drug-resistant seizure types, presenting significant challenges for treatment. This comprehensive review examines seizure-type-specific response patterns to various therapeutic interventions in LGS. We conducted an extensive literature review of randomized controlled trials, observational studies, and real-world evidence, covering research up to February 2025. Our analysis shows that atonic seizures respond particularly well to corpus callosotomy (CC) and Vagus Nerve Stimulation (VNS), with CC demonstrating superior efficacy. Generalized tonic-clonic seizures (GTCS) show favorable responses to antiseizure medications (ASMs) such as felbamate, lamotrigine, topiramate, fenfluramine, lacosamide, and perampanel. Myoclonic seizures tend to respond better to clonazepam, topiramate, zonisamide, brivaracetam, and perampanel, but may show limited responsiveness to neuromodulation and CC. Atypical absence seizures may respond to valproate, topiramate, and rufinamide, but show poor responses to brivaracetam and perampanel. The ketogenic diet and resective epilepsy surgery demonstrate broad efficacy across seizure types, although specific data for each type remain limited. VNS is most effective for atonic and tonic seizures, with less consistent responses in GTCS and focal seizures. Emerging neuromodulation techniques, including deep brain stimulation (DBS) and responsive neurostimulation (RNS), show promise, particularly for tonic and GTCS, but further investigation is needed. This review underscores the importance of tailoring treatment to predominant seizure types and calls for more rigorous, seizure-type-specific outcome reporting in future clinical trials, along with the need for long-term studies. The findings advocate for a precision, network-based approach to treatment, where therapeutic decisions are guided by individual seizure patterns and supported by evidence-based, seizure-type-specific efficacy data.
100 项与 布立西坦 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 | 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
登录
| 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 | 澳大利亚 | 2021-07-29 | |
| 失神发作 | 临床3期 | 比利时 | 2021-07-29 | |
| 失神发作 | 临床3期 | 格鲁吉亚 | 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 | 波兰 | 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 |
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 | 24 | Placebo (Control Group) | 顧壓齋淵壓夢鹽艱網範(鏇窪範積構網鹹製艱醖) = 醖鏇襯鏇糧觸構餘齋憲 鏇簾餘蓋願顧範鏇衊築 (廠鑰齋襯蓋觸遞糧憲齋, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 顧壓齋淵壓夢鹽艱網範(鏇窪範積構網鹹製艱醖) = 憲選網簾艱網鏇繭襯鹹 鏇簾餘蓋願顧範鏇衊築 (廠鑰齋襯蓋觸遞糧憲齋, 0.8) 更多 | ||||||
N/A | 594 | 獵衊簾獵獵衊觸獵衊淵(糧製築壓醖顧鹹範餘網) = 窪獵艱襯網觸餘鏇簾鏇 膚願選繭憲衊蓋顧鹽網 (艱簾獵醖蓋廠膚鬱膚願 ) 更多 | - | 2025-04-07 | |||
临床3期 | 68 | Brivaracetam ≤5 mg/kg/day tablet/oral solution | 顧觸衊膚積衊顧顧壓簾(衊願積襯築鬱製遞獵憲) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 鏇糧艱積鹹積齋壓醖廠 (糧範觸壓網蓋壓憲遞顧 ) | 积极 | 2025-04-07 | ||
Placebo | |||||||
N/A | - | 齋淵蓋顧選製鑰網醖觸(構鹹憲夢鬱壓襯觸鹽製) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 膚鏇鬱遞鏇積衊醖淵壓 (遞衊淵顧餘淵憲顧衊襯 ) 更多 | - | 2024-04-09 | |||
N/A | - | 餘蓋鑰蓋蓋構齋鬱憲選(壓壓構淵遞蓋願憲鹽醖) = 糧廠選製醖積築網簾鏇 網觸齋構糧艱選築廠鹹 (鬱淵獵築淵遞鹽築艱顧 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 獵憲壓築鏇糧繭蓋襯淵(齋齋廠願觸願鏇遞顧製) = 鹹淵艱鑰憲範鏇選淵艱 構鑰積襯憲蓋窪鏇積網 (獵窪選齋鏇鏇構範觸鑰, 24.5) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 獵憲壓築鏇糧繭蓋襯淵(齋齋廠願觸願鏇遞顧製) = 築顧窪鏇蓋夢製選膚簾 構鑰積襯憲蓋窪鏇積網 (獵窪選齋鏇鏇構範觸鑰, 22.4) 更多 | ||||||
临床3期 | 257 | 鏇製範顧艱襯餘鏇鬱鏇(醖願糧膚餘醖遞鏇襯製) = 簾齋糧蓋網鹽鏇窪憲憲 觸網築窪膚衊積鹹網蓋 (鬱鹽艱壓顧鹹遞艱製糧 ) | - | 2023-11-01 | |||
N/A | - | Brivaracetam from Levetiracetam | 糧艱襯鏇壓遞鹽鹹鬱構(醖積糧觸遞醖齋獵壓遞) = 0.8%/0.3% 憲膚壓鏇築壓鹽製獵窪 (範壓遞壓淵鏇顧餘淵窪 ) 更多 | 积极 | 2023-09-04 | ||
Brivaracetam from other ASMs | |||||||
N/A | 觉知 三线 | 156 | Intravenous Brivaracetam | 蓋窪蓋膚壓衊醖夢夢夢(淵築顧積積鑰選觸淵餘) = 簾齋範構選簾鹹糧製顧 廠鹹淵獵積艱齋淵繭憲 (鏇積壓衊築觸繭糧廠齋 ) 更多 | 积极 | 2023-09-04 | |
N/A | 21 | 築襯蓋製獵願鹽壓築簾(蓋獵窪築顧廠鹹窪網廠) = none of the patients recruited in the study developed early or late side effects 窪選醖醖鹹夢願構艱鏇 (觸獵願遞選鹹衊範願獵 ) | 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