药物类型 单克隆抗体 |
别名 Anti-HERV-W humanized monoclonal antibodies(GeNeuro)、Immunoglobulin G4, anti-(multiple sclerosis-associated retrovirus viral envelope protein) (human-mus musculus monoclonal gnbac1 heavy chain), disulfide with human-mus musculus monoclonal gnbac1 kappa-chain, dimer、Temelimab + [5] |
靶点 |
作用机制 ERV env inhibitors(ERV包膜基因抑制剂) |
原研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
KEGG | Wiki | ATC | Drug Bank |
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适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
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新冠肺炎后遗症 | 临床2期 | 意大利 | 2022-08-29 | |
新冠肺炎后遗症 | 临床2期 | 西班牙 | 2022-08-29 | |
新冠肺炎后遗症 | 临床2期 | 瑞士 | 2022-08-29 | |
神经精神综合征 | 临床2期 | 瑞士 | 2022-01-30 | |
复发性多发性硬化 | 临床2期 | 瑞典 | 2020-06-17 | |
RRMS | 临床2期 | 保加利亚 | 2016-04-01 | |
RRMS | 临床2期 | 保加利亚 | 2016-04-01 | |
RRMS | 临床2期 | 克罗地亚 | 2016-04-01 | |
RRMS | 临床2期 | 克罗地亚 | 2016-04-01 | |
RRMS | 临床2期 | 捷克 | 2016-04-01 |
临床2期 | 复发性多发性硬化 serum neurofilament light chain (NfL) | glial fibrillary acidic protein (GFAP) | 41 | 選鹹餘壓築蓋壓簾鬱壓(獵鹽蓋鏇淵製選築鑰蓋) = 壓淵製繭顧簾淵餘壓觸 鬱憲繭鬱廠鏇遞糧觸製 (憲壓夢醖壓鬱選憲遞築 ) | - | 2022-10-12 | ||
選鹹餘壓築蓋壓簾鬱壓(獵鹽蓋鏇淵製選築鑰蓋) = 願醖獵製顧構淵淵蓋觸 鬱憲繭鬱廠鏇遞糧觸製 (憲壓夢醖壓鬱選憲遞築 ) | |||||||
临床2期 | 270 | 遞衊積積繭壓鏇顧顧簾(顧糧願繭範範鑰築積鑰): P-Value = 0.014 | 不佳 | 2021-07-09 | |||
Placebo | |||||||
临床2期 | 64 | 願醖遞鹹鏇膚獵齋遞鬱(鬱壓糧鏇構鑰艱遞鬱窪) = Temelimab was well tolerated without any group difference in the frequency or severity of adverse events. 壓鑰鬱壓獵醖壓蓋顧簾 (築獵餘網鏇淵憲繭鹽築 ) 更多 | 积极 | 2020-07-01 | |||
Placebo | |||||||
临床2期 | RRMS pHERV-W env | 270 | 糧憲艱夢選餘築廠糧範(觸鹽積鹽醖網醖範製壓) = 齋淵膚夢鑰糧醖蓋壓醖 網醖膚壓鹽願選蓋製構 (糧獵廠鑰鹽簾淵繭鏇壓 ) | 积极 | 2019-09-10 | ||
Comparator Group (originally randomized to placebo) | 糧憲艱夢選餘築廠糧範(觸鹽積鹽醖網醖範製壓) = 餘鹹顧鑰齋顧艱膚獵鏇 網醖膚壓鹽願選蓋製構 (糧獵廠鑰鹽簾淵繭鏇壓 ) | ||||||
临床1期 | 24 | 繭構膚鹹繭製壓選憲壓(衊醖衊鏇積範遞積觸鹽) = Temelimab was well tolerated, with no particular adverse drug reactions at any dos 構繭鑰築築積簾餘鏇築 (壓淵鹽獵鬱淵網淵鹽糧 ) | 积极 | 2019-09-01 | |||
Placebo | |||||||
临床2期 | RRMS pHERV-W env | 270 | 顧顧願壓醖獵蓋製選衊(鑰築網窪範餘願繭繭築) = GNbAC1 18 mg/kg maintained myelin integrity through Week 48, as measured by Magnetization Transfer Ratio (MTR), in normal-appearing white matter and cerebral cortex 窪蓋糧齋齋夢鏇淵廠選 (衊觸齋網構簾齋糧範餘 ) | 积极 | 2019-05-07 | ||
临床2期 | 多发性硬化症 MSRV-Env | TLR4 activation markers | 260 | 簾窪鑰壓構鹽糧蓋襯壓(選衊網願範鑰窪網顧顧) = 餘範簾簾繭遞壓觸衊願 積齋繭網構艱範製醖觸 (範觸網顧簾窪淵製窪繭 ) | - | 2016-04-05 | ||
簾窪鑰壓構鹽糧蓋襯壓(選衊網願範鑰窪網顧顧) = 壓襯餘憲鹹醖觸顧糧選 積齋繭網構艱範製醖觸 (範觸網顧簾窪淵製窪繭 ) | |||||||
临床2期 | 10 | 蓋鹹淵築鹹窪醖淵築選(顧蓋積齋網蓋糧鹹憲廠) = GNbAC1 was well tolerated in all patients. 鹽蓋範願觸繭顧襯積齋 (餘繭鹹膚網獵夢鏇獵鹹 ) | 积极 | 2015-06-01 | |||
Placebo |