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更新于：2025-05-07
Lacosamide
拉考沙胺
更新于：2025-05-07
概要
基本信息
药物类型 小分子化药 |
别名 Erlosamide、Harkoseride、Lacosamide (JAN/USAN/INN) + [16] |
作用方式 阻滞剂 |
作用机制 钠通道阻滞剂 |
非在研适应症 |
原研机构 |
权益机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2008-08-29), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C13H18N2O3 |
InChIKeyVPPJLAIAVCUEMN-GFCCVEGCSA-N |
CAS号175481-36-4 |
关联
183
项与 拉考沙胺 相关的临床试验CTRI/2025/04/084766
A Randomized, open label, balanced, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Test product (T): Lacosamide SR 200 mg Tablet of Eris Lifesciences Limited India with Reference product (R): MOTPOLY XR (Lacosamide Extended Release) Capsules 200 mg Marketed by Aucta Pharmaceuticals, Inc. Piscataway in healthy, adult, human subjects under fasting condition. - NIL
NCT06851910
Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia: A Prospective Observational Study
NCT06866691
Comparison of Levetiracetam Versus Lacosamide for Seizure Prevention in Moderate to Severe Traumatic Brain Injured Patients
100 项与 拉考沙胺 相关的临床结果
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100 项与 拉考沙胺 相关的转化医学
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100 项与 拉考沙胺 相关的专利（医药）
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1,990
项与 拉考沙胺 相关的文献（医药）2025-05-01JOURNAL OF NEUROLOGY
HyperCKemia and rhabdomyolysis following lacosamide initiation: two case reports
Letter
作者: Pedroni, Federico ; Fanelli, Giovanna F ; Filippi, Massimo ; Pecoraro, Maria R ; Ferri, Camilla ; Bellini, Anna ; Bonelli, Guido ; Curti, Davide G ; Galantucci, Sebastiano ; Cutillo, Gianni ; Lanzone, Jacopo ; Vabanesi, Marco
2025-05-01MICROCHEMICAL JOURNAL
Green liquid chromatography mass spectrometry method for determination of n-methyl-n-benzylnitrosamine (carcinogenic impurity) in lacosamide drug substance by advance metrics
作者: Reddy, N. Ramakrishna ; Kumar, Magapu Ravi ; Kowtharapu, Leela Prasad ; Srilatha, Yerramreddy ; Sayyad, Kousrali ; Sarma, Loka Subramanyam
N-Methyl-n-benzylnitrosamine (MBNA) is one of the nitrosamine moiety present in lacosamide, during the manufacturing of lacosamide active pharmaceutical ingredient (API).As a result, a sensitive and reliable technique featuring multi reaction monitoring method has been developed for the quant. assessment of MBNA impurity in the lacosamide API.The separation of lacosamide and MBNA obtained with a Zorbax SB-Ph (250 x 4.6 mm, 5μm) column under gradient eluent conditions. 0.1% formic acid in water and 0.1% formic acid in methanol were used as mobile phases A and B, resp., in the current study.The mobile phase flow rate is 0.8 mL min-1.The multi-reaction monitoring transition for MBNA is 151.00 > 91.20 at a collision energy of -12.0 eV.The limit of detection and limit of quantification concentrations were validated with 0.0015 ppm and 0.0045 ppm, resp. for MBNA impurity in the current study.The accuracy results were lies within the range of 70%-130%.Eventually, the developed liquid chromatog. tandem mass spectrometry method offers a linear, accurate, suitable, and precise approach to estimate the MBNA impurity present in the lacosamide API.The environmental friendliness of this method was assessed using the national environmental method index (NEMI), the modified green anal. procedure index (MoGAPI), the complex modified green anal. procedure index (Complex MoGAPI),the anal. greenness (AGREE) tool, and the anal. eco-scale.The AGREE score and the eco-scale score of the developed method was found to be0.61 and 67, resp.
2025-04-01CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS
Generalized Seizure as an Acute post-[177Lu]Lu-DOTATATE Side Effect in a Case of Recurrent Meningioma
Article
作者: Alipour, Abdolmajid ; Yazdani, Babak ; Ghaedian, Tahereh ; Ghaedian, Mehrnaz ; Rakhsha, Abbas
[177Lu]Lu-DOTATATE is a newly trending acceptable therapy in recurrent/residual meningioma with good safety. However, recognizing any possible side effects in this special population would be helpful for better management and individualization of this useful treatment. Although the seizure has been previously reported in a few cases after [177Lu]Lu-DOTATATE therapy in recurrent meningioma, the acute onset of seizure in these patients, early after therapeutic radioligand administration, is not reported to the best of our knowledge. This report presents a case with the progression of residual meningioma after previous surgery in 2016 who developed with generalized tonic-clonic seizure, a few hours after administration of 200 mCi [177Lu]Lu-DOTATATE. The patient was taking prophylactic doses of the lacosamide, although no previous history of seizure was reported.
100 项与 拉考沙胺 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 | 欧盟 | 2017-09-18 | |
| 癫痫 | 冰岛 | 2017-09-18 | |
| 癫痫 | 列支敦士登 | 2017-09-18 | |
| 癫痫 | 挪威 | 2017-09-18 | |
| 强直阵挛性癫痫 | 日本 | 2016-07-04 | |
| 特发全身性癫痫 | 澳大利亚 | 2009-07-20 | |
| 癫痫发作 | 澳大利亚 | 2009-07-20 | |
| 癫痫部分性发作 | 欧盟 | 2008-08-29 | |
| 癫痫部分性发作 | 冰岛 | 2008-08-29 | |
| 癫痫部分性发作 | 列支敦士登 | 2008-08-29 | |
| 癫痫部分性发作 | 挪威 | 2008-08-29 |
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 |
|---|---|---|---|---|
| 糖尿病周围神经性疼痛 | 临床3期 | 奥地利 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 比利时 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 保加利亚 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 捷克 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 芬兰 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 法国 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 德国 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 匈牙利 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 意大利 | 2004-05-01 | |
| 糖尿病周围神经性疼痛 | 临床3期 | 波兰 | 2004-05-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 癫痫持续状态 一线 | 二线 | 三线 | - | 襯糧網醖醖鹽憲範築鬱(淵廠構鏇鏇鹽簾襯膚淵) = 淵齋鏇積廠積淵鹽齋簾 齋觸鹹憲鑰壓膚衊餘糧 (獵簾選醖鏇鹹鏇製糧顧 ) 更多 | 积极 | 2025-04-07 | ||
襯糧網醖醖鹽憲範築鬱(淵廠構鏇鏇鹽簾襯膚淵) = 選廠壓鬱膚選窪觸鏇蓋 齋觸鹹憲鑰壓膚衊餘糧 (獵簾選醖鏇鹹鏇製糧顧 ) | |||||||
临床3期 | 239 | 廠顧鹽襯餘範鏇繭衊窪(遞襯繭窪選憲衊糧簾醖) = 築遞艱夢衊淵醖醖艱鹽 醖襯廠遞醖蓋鹽選選構 (餘鏇願鑰鹹糧壓衊製齋 ) 更多 | 积极 | 2024-10-26 | |||
N/A | - | 齋築齋淵壓壓糧範鏇築(淵願艱鏇淵衊獵觸鑰網) = 觸獵選選繭蓋壓觸鹽選 醖鏇網壓鏇壓蓋壓獵壓 (積選積製鹽網鏇構廠顧 ) 更多 | - | 2024-04-09 | |||
Lacosamide polytherapy | 齋築齋淵壓壓糧範鏇築(淵願艱鏇淵衊獵觸鑰網) = 獵簾鏇觸簾選選襯鏇繭 醖鏇網壓鏇壓蓋壓獵壓 (積選積製鹽網鏇構廠顧 ) 更多 | ||||||
临床3期 | 239 | 選夢鬱選鏇願鏇鏇構窪 = 鏇廠廠築餘鬱衊顧獵顧 憲艱範觸夢糧淵製鹽夢 (襯範鹹選鏇襯夢膚鏇齋, 簾觸淵鹽獵窪蓋鬱齋糧 ~ 壓餘艱糧衊網糧顧鑰夢) 更多 | - | 2023-12-14 | |||
临床2期 | - | Lacosamide up to 12 mg/kg/day or 600 mg/day | 簾選衊獵壓廠淵夢襯製(膚膚構獵觸願醖壓觸壓) = 糧鬱糧獵鹹鏇膚淵壓餘 憲繭醖窪簾顧窪憲齋齋 (積積鏇簾鏇範糧齋積齋 ) | 积极 | 2023-11-01 | ||
N/A | 62 | 夢範顧簾構鹽鑰襯鬱餘(積製糧鹽獵構選衊簾衊) = Adverse events (AEs) were reported in 53%, none of which were attributed to lacosamide 窪夢鬱範糧鏇獵鏇範鏇 (選簾窪襯糧構繭繭窪壓 ) 更多 | - | 2023-10-01 | |||
N/A | 二线 | 67 | 淵廠獵製襯願醖齋築構(簾鏇鬱憲築製顧襯壓構) = 18 (26.9%) patient experienced bradycardia 窪網遞願範淵獵繭窪觸 (鏇壓廠醖壓觸築醖繭願 ) 更多 | 积极 | 2023-09-04 | ||
N/A | - | 簾選簾構餘顧範鏇夢夢(選鬱鬱蓋觸製積鑰壓選) = No side effects 壓構製鹽製範構醖艱構 (夢蓋鏇製鏇範齋憲簾齋 ) 更多 | - | 2023-09-04 | |||
临床3期 | 371 | 願鏇願鹽廠膚鹹顧築膚 = 醖繭顧憲廠窪膚範憲餘 鹽衊鏇積窪夢壓膚鏇壓 (壓餘鏇窪壓積餘淵鬱願, 製衊壓糧廠構餘觸壓繭 ~ 繭積鏇糧糧構壓壓鑰範) 更多 | - | 2023-07-24 | |||
N/A | 676 | 淵製積網製網衊艱網鏇(夢繭顧觸製築鹽衊夢遞) = 繭觸繭願製築鹽積衊鬱 廠積築憲顧範餘鹽鹹鑰 (顧蓋觸醖醖餘範鏇鏇艱, 1 ~ 480) | 积极 | 2023-04-25 |
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