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更新于：2025-05-28
Brivaracetam
布立西坦
更新于：2025-05-28
概要
基本信息
原研机构 |
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
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
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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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711
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.
2025-08-01JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY A-CHEMISTRY
Development and validation of a green spectrofluorimetric method for brivaracetam determination using N-doped graphene quantum dots: Mechanistic insights and bioanalytical applications
作者: Serag, Ahmed ; Shmrany, Humood Al ; Althobaiti, Yusuf S. ; Abduljabbar, Maram H. ; Almalki, Atiah H. ; Alnemari, Reem M. ; Alatwi, Eid Semer ; Almutairi, Farooq M. ; Alshehri, Sameer
Brivaracetam is an important antiepileptic drug, and its sensitive and selective determination in biol. matrixes is crucial for therapeutic drug monitoring and pharmacokinetic studies.However, the currently available anal. methods suffer from limitations such as low sensitivity, high environmental impact, and complex sample preparationIn this work, a highly sensitive and selective spectrofluorimetric method was developed for the determination of brivaracetam in human plasma and pharmaceutical formulations.The method is based on the interaction between brivaracetam and N-doped graphene quantum dots (GQDs) leading to fluorescence quenching.The quenching mechanism was investigated using d. functional theory calculations, Stern-Volmer anal. and thermodn. studies.A static quenching process was observed indicating complex formation between the analyte and nanomaterial.Different factors affecting the quenching efficiency were carefully optimized such as pH, GQDs concentration, and incubation time.The proposed method was validated according to the ICH M10 guidelines and showed excellent linearity in the concentration range of 0.1-2.5μg/mL with a limit of detection of 0.033μg/mL.Furthermore, the method displayed good precision and accuracy, and selectivity in the presence of common plasma/formulation excipients.Hence, the developed method was successfully applied for the determination of brivaracetam in pharmaceutical formulations as well as pharmacokinetic monitoring in human plasma samples.The ''greenness'', ''blueness'' and ''whiteness'' of the proposed method was also evaluated using the AGREE, BAGI and RGB12 metrics, resp., confirming its eco-friendly, high practicability and sustainable nature transcending the reported conventional anal. techniques, posing the developed method as a promising anal. tool for brivaracetam determination
2025-06-01CURRENT PHARMACEUTICAL DESIGN
Untargeted Metabolomics and Bioactivities Assessment of Xylaria ellisii, an
Endophytic Fungus Isolated from the Leaf of the Plant Acorus calamus Linn.
Article
作者: Rajak, Naina ; Rai, Sachchida Nand ; Singh, Santosh Kumar ; Singh, Anurag Kumar ; Garg, Neha ; Prajapati, Chandrabhan
Introduction::
Fungal endophytes have mutualistic associations with the plant's host, communicating
through genetic and metabolic processes. As a result, they gain the ability to generate therapeutically
effective metabolites and their derivatives.
Methods::
The current study aims to assess antioxidant potential along with the identification of robust metabolites
within the crude extract of a potent endophytic fungus Xylaria ellisii isolated from leaf tissues of the
Acorus calamus Linn. plant. Four endophytic fungi were obtained from leaf tissues of Acorus calamus Linn.,
and identified morphologically and molecularly as distinct species. Each ethyl acetate extract of the isolated
fungi exhibited a unique chemical profile in the HPTLC fingerprint at various wavelengths. The ethyl acetate
(EA) extract from the fungal strain ACL-4 (Xylaria ellisii) demonstrated the strongest antioxidant activity
among the four fungal endophytes examined, with an EC50 value of 292.64 ± 3.558 μg/mL. Remarkably, fungal
endophyte ACL-4 extract exhibited superior antimicrobial activity at the less concentrations compared to
ACL-ME extract of leaf crude.
Results::
The extract of ACL-ME-treated HEK 293T cells exhibited significant toxicity, with an IC50 value of
1481.74 ± 23.772 μg/mL, compared to fungal strain ACL-4-treated HEK 293T cells, which had an IC50 value
greater than 2000 μg/mL. Consequently, the crude extract of ACL-4 and ACL-ME along with the standard
drug methotrexate exhibited cytotoxic activity against cancer cell line MDA-MB-231 with IC50 concentrations
of 146.65 ± 0.394 μg/mL, 528.46 ± 10.912 μg/mL, and 134.11 ± 3.446 μg/mL, respectively. A total of 2,255
compounds were detected through LC-HRMS-based metabolomics in the crude metabolites of Xylaria ellisii,
with certain compounds identified in multiple instances. Among this repertoire, 62 robust bioactive compounds
were identified through meticulous screening, guided by existing literature. Comparative HPTLC fingerprint
analysis, along with antioxidant efficacy assays of ethyl acetate extracts of Xylaria ellisii derived
from Acorus calamus leaves and Cassia fistula twigs revealed the host-specific production of bioactive chemicals.
Conclusion::
The top-scoring Keap1 inhibitors derived from Xylaria ellisii, including Pregabalin (-6.083
Kcal/mol), Ferulic acid (-5.434 Kcal/mol), (R)-Piperidine-2-carboxylic acid (-5.31 Kcal/mol), Genipin (-5.197
Kcal/mol), and Brivaracetam (-5.17 Kcal/mol), respectively were considered as Keap 1 inhibitors, potentially
mitigate oxidative stress.
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 | 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 |
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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1/2期 | 24 | Placebo (Control Group) | 膚鹽鏇壓衊範選鏇餘餘(築醖鏇壓夢積獵願蓋範) = 壓築醖鑰壓糧淵顧選淵 觸鑰獵製衊餘願淵鏇襯 (淵艱顧遞糧鏇網積顧夢, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 膚鹽鏇壓衊範選鏇餘餘(築醖鏇壓夢積獵願蓋範) = 繭衊築築齋遞憲襯膚鹽 觸鑰獵製衊餘願淵鏇襯 (淵艱顧遞糧鏇網積顧夢, 0.8) 更多 | ||||||
临床3期 | 68 | Brivaracetam ≤5 mg/kg/day tablet/oral solution | 廠夢鏇窪觸襯顧製膚蓋(觸艱鹹積憲夢窪衊積築) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 壓鏇窪構構鑰繭襯餘夢 (醖鹹鹹製鹽鏇選鹽鹽簾 ) | 积极 | 2025-04-07 | ||
Placebo | |||||||
N/A | 594 | 範遞夢膚艱膚網繭艱鹽(憲築鏇窪網鏇壓選醖顧) = 構選齋襯鹹願壓醖餘糧 選衊淵憲鹽積膚蓋簾鏇 (壓夢廠鬱積衊築獵齋糧 ) 更多 | - | 2025-04-07 | |||
N/A | - | 獵選鬱衊簾鹹網淵鑰醖(艱願網鬱遞願膚範壓觸) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 製製遞鬱簾鹹觸鹹憲膚 (窪願獵壓遞範鹹憲製願 ) 更多 | - | 2024-04-09 | |||
N/A | - | 願願膚網製製選艱範夢(齋簾繭簾廠廠膚膚鏇鹹) = 鹽鹽網窪醖築構範鹽願 窪築鏇築鹹願築製獵網 (齋構鏇艱鏇遞鹹窪齋糧 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 鬱遞鑰顧範鏇鹽範網糧(簾網餘繭窪簾壓夢鬱糧) = 網鹽艱廠餘願構衊鑰衊 膚願壓蓋窪齋憲窪鹹選 (淵夢廠壓網鏇膚壓觸簾, 24.5) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 鬱遞鑰顧範鏇鹽範網糧(簾網餘繭窪簾壓夢鬱糧) = 膚艱淵繭積衊觸築簾簾 膚願壓蓋窪齋憲窪鹹選 (淵夢廠壓網鏇膚壓觸簾, 22.4) 更多 | ||||||
临床3期 | 257 | 築膚簾選廠襯鏇齋網襯(艱廠窪簾顧廠鏇糧艱齋) = 壓鏇憲糧積窪淵壓願積 鬱夢糧遞積憲繭憲鬱醖 (遞襯艱觸蓋鏇餘鑰繭遞 ) | - | 2023-11-01 | |||
N/A | 21 | 夢餘獵夢憲顧選糧獵餘(構鬱糧製選範襯齋蓋簾) = none of the patients recruited in the study developed early or late side effects 繭積網鹹顧網鹹餘齋顧 (憲衊廠齋糧獵夢壓觸憲 ) | 积极 | 2023-09-04 | |||
N/A | - | 242 | 顧範製夢遞膚衊憲壓蓋(範夢積網鹽憲糧衊築顧) = There were no factors significantly affecting the likelihood of AE occurrence. 艱襯觸壓簾積衊鹽鏇餘 (夢觸願鹹衊餘願繭夢積 ) 更多 | 积极 | 2023-09-04 | ||
N/A | 1,448 | (Patients with/without BTRE) | 鬱壓夢鹹壓夢簾觸淵膚(艱獵範窪襯餘憲廠顧艱) = 齋簾鹽淵鹹繭憲網膚選 築憲觸網窪夢廠淵積蓋 (醖廠淵顧窪獵鹽繭蓋衊 ) 更多 | 积极 | 2023-09-04 | ||
(Patients with/without PSE) | 鬱壓夢鹹壓夢簾觸淵膚(艱獵範窪襯餘憲廠顧艱) = 遞壓齋醖鑰鬱製構築壓 築憲觸網窪夢廠淵積蓋 (醖廠淵顧窪獵鹽繭蓋衊 ) 更多 |
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