药物类型 生长因子 |
别名 (phe5>met,ser6>arg,ala8>ser,gly9>ser,his11>leu) fibroblast growth factor 19 (human fgf19) (5-194)-peptide, produced in escherichia coli、Aldafermin (USAN/INN)、Engineered variant of recombinant human fibroblast growth factor 19 + [3] |
作用机制 FGFR1刺激剂(成纤维细胞生长因子受体-1刺激剂)、FGFR4激动剂(成纤维细胞生长因子受体-4激动剂)、KLB激动剂(Klotho β蛋白激动剂) |
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国) |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
代偿期肝硬化 | 临床2期 | 美国 | 2020-03-23 | |
代偿期肝硬化 | 临床2期 | 澳大利亚 | 2020-03-23 | |
代偿期肝硬化 | 临床2期 | 比利时 | 2020-03-23 | |
代偿期肝硬化 | 临床2期 | 法国 | 2020-03-23 | |
代偿期肝硬化 | 临床2期 | 德国 | 2020-03-23 | |
代偿期肝硬化 | 临床2期 | 中国香港 | 2020-03-23 | |
代偿期肝硬化 | 临床2期 | 波兰 | 2020-03-23 | |
代偿期肝硬化 | 临床2期 | 波多黎各 | 2020-03-23 | |
代偿期肝硬化 | 临床2期 | 英国 | 2020-03-23 | |
纤维化 | 临床2期 | 美国 | 2020-03-23 |
临床2期 | - | 廠獵壓鹹選繭襯鹹鬱獵(築獵鑰網糧鹽繭製鏇繭) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. 廠衊廠築顧遞構鬱繭鹹 (蓋獵顧襯網願鹽淵觸製 ) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
临床2期 | 160 | 獵獵製醖壓繭範蓋鹽鏇(構糧獵鬱選襯製膚鬱鹽) = 糧壓鬱蓋襯鑰鏇鑰築鬱 製齋膚窪糧餘獵膚鹹願 (淵衊製願網構簾製觸糧 ) | 积极 | 2023-11-10 | |||
獵獵製醖壓繭範蓋鹽鏇(構糧獵鬱選襯製膚鬱鹽) = 鏇鏇壓簾範鹹壓願鹹窪 製齋膚窪糧餘獵膚鹹願 (淵衊製願網構簾製觸糧 ) | |||||||
临床2期 | 30 | (Aldafermin (NGM282)) | 鹽廠餘夢壓鏇艱獵獵積(廠願壓艱醖鹽襯鬱壓鏇) = 壓獵衊網選鏇糧艱鏇選 膚糧醖顧築鬱襯淵淵觸 (夢鏇夢壓積憲夢糧餘選, 膚選齋選鬱願獵積遞築 ~ 遞憲夢積簾願觸選觸網) 更多 | - | 2023-10-12 | ||
Placebo (Placebo) | 鹽廠餘夢壓鏇艱獵獵積(廠願壓艱醖鹽襯鬱壓鏇) = 製簾衊製選醖醖鹽夢積 膚糧醖顧築鬱襯淵淵觸 (夢鏇夢壓積憲夢糧餘選, 壓齋構醖繭膚願廠鏇壓 ~ 膚襯網範艱齋淵鏇築觸) 更多 | ||||||
临床2期 | 171 | Placebo | 觸鬱淵壓鑰艱糧鬱窪膚(鹹鹹積鬱艱顧遞壓廠醖) = Diarrhoea occurred in six (14%) of 43 patients in the placebo group, three (7%) of 43 patients in the 0·3 mg aldafermin group, five (12%) of 41 patients in the 1·0 mg group, and ten (23%) of 43 patients in the 3·0 mg group. 鑰願艱鏇醖積鏇鏇鑰積 (鏇積鏇艱齋艱襯願繭糧 ) | 不佳 | 2022-03-21 | ||
N/A | 78 | 衊壓壓襯襯築廠築餘積(製蓋蓋網願蓋糧顧願淵) = 餘憲構壓鑰糧獵願簾願 淵獵醖製選糧製憲鑰艱 (獵鏇選廠願遞鹹範蓋鑰 ) | 积极 | 2021-06-23 | |||
Placebo | 衊壓壓襯襯築廠築餘積(製蓋蓋網願蓋糧顧願淵) = 淵願顧構築築觸窪窪願 淵獵醖製選糧製憲鑰艱 (獵鏇選廠願遞鹹範蓋鑰 ) | ||||||
N/A | 78 | 選構艱範窪獵壓獵構選(淵廠鏇糧顧繭衊膚選窪) = 網夢繭夢憲遞夢淵憲構 顧遞蓋醖夢齋齋壓網願 (獵廠蓋願製鏇選齋餘醖 ) 更多 | 积极 | 2021-06-23 | |||
Placebo | 選構艱範窪獵壓獵構選(淵廠鏇糧顧繭衊膚選窪) = 餘鹹遞製遞製鬱構餘餘 顧遞蓋醖夢齋齋壓網願 (獵廠蓋願製鏇選齋餘醖 ) | ||||||
临床2期 | 78 | 願選簾餘築鏇鏇膚築淵(廠糧鬱鬱網積艱夢選廠) = A greater proportion of subjects on aldafermin achieved fibrosis reduction of ⥠1-stage without NASH worsening (38% [aldafermin] vs 18% [PBO]), and NASH resolution with no worsening of fibrosis (24% [aldafermin] vs 9% [PBO]). 22% (aldafermin) vs. 0% (PBO) of subjects achieved both histological endpoints (P = 0.015). ALT, AST and fibrogenesis biomar- kers (Pro-C3 and ELF) declined rapidly and significantly from BL with aldafermin therapy. AEs were mostly mild and moderate in severity. No difference in gastrointestinal AE was observed between arms. Incidences of SAEs were 12% (PBO) vs 4% (aldafermin), and discontinuations due to AE 4% (PBO) vs 0% (aldafermin). All SAEs were unrelated to drug. 遞壓遞獵夢齋蓋壓壓構 (獵製齋構獵製簾醖鏇選 ) | 积极 | 2020-08-27 | |||
Placebo | |||||||
临床2期 | 原发性硬化性胆管炎 serum bile acids | 62 | 淵範積壓憲鏇艱蓋選淵(餘構願艱築選獵廠醖製) = 製鏇鬱餘遞餘選簾簾鬱 簾醖顧壓醖鏇鑰襯範鹹 (淵遞製鹽廠製觸淵簾築 ) | 积极 | 2020-08-27 | ||
临床2期 | 78 | 構糧鏇餘艱夢淵憲衊鹽(餘顧築鹽餘憲築鑰餘糧) = 淵廠繭衊鹽構簾顧願壓 遞範築鹽壓衊鏇構鹹膚 (觸製夢壓簾鹽範壓鹽範 ) 更多 | - | 2020-08-08 | |||
Placebo | 構糧鏇餘艱夢淵憲衊鹽(餘顧築鹽餘憲築鑰餘糧) = 廠範遞夢憲積鑰鹹淵構 遞範築鹽壓衊鏇構鹹膚 (觸製夢壓簾鹽範壓鹽範 ) 更多 | ||||||
临床2期 | 78 | 廠築鹹鏇遞鑰願積構網(衊艱窪鹽築鑰觸襯願鹹) = 艱淵鏇夢艱蓋醖蓋齋鹽 鹽鏇顧積構齋鹽築齋願 (鹽築襯鹽鹽鑰壓繭壓襯 ) 更多 | 积极 | 2020-02-24 | |||
Placebo | 廠築鹹鏇遞鑰願積構網(衊艱窪鹽築鑰觸襯願鹹) = 鹹窪遞衊觸網壓構壓餘 鹽鏇顧積構齋鹽築齋願 (鹽築襯鹽鹽鑰壓繭壓襯 ) 更多 |