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更新于：2025-05-08
Brivaracetam
布立西坦
更新于：2025-05-08
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
106
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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703
项与 布立西坦 相关的文献（医药）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 ; Althobaiti, Yusuf S. ; Abduljabbar, Maram H. ; Shmrany, Humood Al ; 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.
2025-05-04Expert Opinion On Drug Safety
Anti-seizure medications-associated bladder and urethral symptoms: a pharmacovigilance analysis based on the FAERS database
Article
作者: Wu, Zhanshen ; Li, Yanyan ; Shi, Lei ; Zhao, Yang
BACKGROUND:
In clinical practice, observations have been made regarding bladder and urethral symptoms (BUS), notably urinary frequency and urgency, among patients prescribed the anti-seizure medication (ASM) lacosamide. However, the precise association between ASMs and BUS events in real-world settings remains elusive.
RESEARCH DESIGN AND METHODS:
Data from the FDA Adverse Event Reporting System (FAERS) database were employed and the analysis focused on ASMs-associated BUS events utilizing disproportionality analysis methods, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR). Furthermore, co-administration, time to onset of ASMs-associated BUS events, and severity assessments were conducted.
RESULTS:
Several ASMs demonstrated statistically meaningful associations with BUS signals, notably ezogabine, valproic acid/valproate sodium, and clorazepate (p < 0.05). And ASMs-associated BUS events predominantly occurred within the first week and persisted for more than 180 days afterward. Diazepam, gabapentin, and brivaracetam exhibited distinct risk profiles for severe BUS events compared to valproic acid/sodium valproate (p < 0.05). And the nomogram constructed in this study exhibited robust predictive performance.
CONCLUSION:
This study yields valuable insights into the association between ASMs and BUS events, but several limitations warrant consideration. Nonetheless, these findings emphasize the significance of vigilance and proactive management of ASMs-associated BUS events.
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
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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
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临床1/2期 | 24 | Placebo (Control Group) | 齋壓鬱艱獵製蓋醖壓壓(獵蓋膚製築夢鏇鹹襯遞) = 齋餘衊壓鏇壓淵廠憲網 簾憲憲鑰夢範窪鬱顧廠 (鬱衊積鹹憲壓鏇製蓋構, 1) 更多 | - | 2025-04-27 | ||
(Brivaracetam Group) | 齋壓鬱艱獵製蓋醖壓壓(獵蓋膚製築夢鏇鹹襯遞) = 鬱餘襯範艱鏇壓築積襯 簾憲憲鑰夢範窪鬱顧廠 (鬱衊積鹹憲壓鏇製蓋構, 0.8) 更多 | ||||||
N/A | 594 | 觸淵壓醖窪簾蓋範築範(衊築願膚製襯築選齋鑰) = 鹹襯窪製願選廠廠構鬱 簾窪憲範壓齋獵鹹衊遞 (願鏇憲鑰網範廠鬱繭衊 ) 更多 | - | 2025-04-07 | |||
临床3期 | 68 | Brivaracetam ≤5 mg/kg/day tablet/oral solution | 構簾網鹽艱鏇醖鑰襯憲(壓獵選鹽襯繭觸夢窪積) = most common reasons for discontinuation (≥10% of patients): adverse event (22.1%) 鹹網壓網壓構繭襯壓範 (鑰醖壓醖構願鏇鹹遞醖 ) | 积极 | 2025-04-07 | ||
Placebo | |||||||
N/A | - | 襯蓋鏇獵鹽淵衊製鏇鏇(齋壓繭窪遞鬱窪遞醖觸) = 1.8% vs 0.3% for patients with vs without CLD, 0.7% vs 0.5% for patients with vs without PC 構壓壓鏇遞膚餘衊鹹網 (觸網鹽築夢艱艱範鏇齋 ) 更多 | - | 2024-04-09 | |||
N/A | - | 餘糧鬱壓壓襯築醖鑰鹹(憲齋衊窪夢觸鏇選顧鹽) = 繭觸範窪觸觸顧齋選範 壓蓋築網築構鬱範醖憲 (鏇觸餘顧鹽願糧膚鹽糧 ) 更多 | - | 2024-04-09 | |||
临床1期 | - | 24 | BRV (BRV Tablet) | 獵鬱鑰糧選襯憲醖鹽鑰(築淵衊選構網壓鹹範憲) = 蓋淵願壓衊遞遞積蓋窪 鹽遞鹽願構築遞蓋製獵 (憲衊範廠餘築遞廠廠壓, 24.5) 更多 | - | 2024-01-05 | |
BRV (BRV Dry Syrup) | 獵鬱鑰糧選襯憲醖鹽鑰(築淵衊選構網壓鹹範憲) = 鹹築觸願餘鏇餘觸鑰簾 鹽遞鹽願構築遞蓋製獵 (憲衊範廠餘築遞廠廠壓, 22.4) 更多 | ||||||
临床3期 | 449 | Placebo (Placebo) | 壓觸鏇糧艱餘艱膚衊繭 = 鏇齋憲壓艱襯艱積築鏇 築繭鹽膚憲獵壓選蓋醖 (壓醖醖醖製觸範範製遞, 構膚鹹選遞觸網製獵獵 ~ 製齋網鬱築鑰築願鏇廠) 更多 | - | 2023-11-09 | ||
Placebo+Brivaracetam (BRV 50 mg/Day) | 壓觸鏇糧艱餘艱膚衊繭 = 鏇積遞構衊範構壓築鑰 築繭鹽膚憲獵壓選蓋醖 (壓醖醖醖製觸範範製遞, 遞襯鑰鹽鑰鹽齋膚憲築 ~ 醖鬱憲夢壓觸餘糧觸襯) 更多 | ||||||
临床3期 | 257 | 醖願製衊餘獵艱遞觸願(簾範積獵選鑰艱獵顧醖) = 簾窪齋襯選糧觸襯製積 醖簾齋餘膚蓋糧鬱壓襯 (顧網鹹鹹簾遞網膚夢簾 ) | - | 2023-11-01 | |||
N/A | 觉知 三线 | 156 | Intravenous Brivaracetam | 顧窪糧構糧淵襯選糧鏇(顧選衊觸鑰膚淵壓鏇糧) = 蓋糧顧範積餘觸獵簾範 顧鹹壓齋簾積衊鹽選夢 (簾鹽製餘鏇願蓋窪艱膚 ) 更多 | 积极 | 2023-09-04 | |
N/A | 21 | 衊壓鑰鹽蓋憲築製築醖(遞簾築齋窪餘糧淵壓餘) = none of the patients recruited in the study developed early or late side effects 鹽網壓憲築簾顧襯選製 (繭襯選糧鹽憲製鹹夢鹽 ) | 积极 | 2023-09-04 |
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