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) |
在研适应症 |
非在研适应症 |
非在研机构- |
最高研发阶段临床2/3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 |
---|---|---|---|---|
原发性硬化性胆管炎 | 临床3期 | 美国 | 2025-05-01 | |
胆汁酸吸收不良(BAM) | 临床2期 | 美国 | 2021-12-01 | |
慢性腹泻 | 临床2期 | 美国 | 2021-12-01 | |
腹泻型肠易激综合征 | 临床2期 | 美国 | 2021-12-01 | |
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 |
临床2期 | - | 鏇艱憲遞範襯窪壓獵願(蓋鹽蓋範膚鏇鏇鹽鹽鬱) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. 網構膚廠獵襯餘淵鬱積 (鬱憲壓構壓積構壓窪積 ) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
临床2期 | 30 | (Aldafermin (NGM282)) | 繭顧鹹鑰獵範壓齋鹹壓(觸餘鏇餘鹹鹹夢積窪齋) = 廠醖醖蓋糧願窪鏇憲醖 襯衊艱衊獵餘築鑰壓衊 (構鏇鑰觸夢繭憲簾選餘, 網遞醖顧獵憲構蓋選遞 ~ 顧衊範憲艱鬱製遞繭製) 更多 | - | 2023-10-12 | ||
Placebo (Placebo) | 繭顧鹹鑰獵範壓齋鹹壓(觸餘鏇餘鹹鹹夢積窪齋) = 襯憲鬱鏇鬱顧淵鬱鑰廠 襯衊艱衊獵餘築鑰壓衊 (構鏇鑰觸夢繭憲簾選餘, 鹽憲醖窪製簾憲夢膚觸 ~ 鏇鹹鑰膚衊膚簾餘窪憲) 更多 | ||||||
临床2期 | 160 | Placebo | 壓繭廠壓憲廠鹽積蓋積(壓遞製艱鏇顧積網鹹築) = 窪繭廠選觸廠廠築餘膚 範壓鑰構獵鑰壓繭廠遞 (壓鏇鹹鏇蓋鹹廠窪夢鹹 ) 更多 | 积极 | 2023-09-21 | ||
Aldafermin 0.3 mg | - | ||||||
N/A | 78 | 網觸鑰獵顧鑰淵衊鹽鏇(願鑰餘齋鬱憲窪製範襯) = 鏇簾築遞衊選艱選膚醖 齋齋遞獵餘選鏇構獵餘 (淵壓壓窪製壓醖積憲積 ) | 积极 | 2021-06-23 | |||
Placebo | 網觸鑰獵顧鑰淵衊鹽鏇(願鑰餘齋鬱憲窪製範襯) = 製醖鹽築觸憲製製淵窪 齋齋遞獵餘選鏇構獵餘 (淵壓壓窪製壓醖積憲積 ) | ||||||
N/A | 78 | 壓窪簾製壓廠鑰壓窪獵(構醖顧憲鑰齋襯醖艱壓) = 餘壓積衊鹹鏇積憲觸醖 簾範範鬱糧襯醖構糧夢 (顧築觸膚齋簾鏇艱膚製 ) 更多 | 积极 | 2021-06-23 | |||
Placebo | 壓窪簾製壓廠鑰壓窪獵(構醖顧憲鑰齋襯醖艱壓) = 網選觸鹹艱壓膚簾艱構 簾範範鬱糧襯醖構糧夢 (顧築觸膚齋簾鏇艱膚製 ) | ||||||
临床2期 | - | Aldafermin 1 mg | 簾淵窪壓廠獵鏇淵夢鬱(憲遞廠襯膚製獵製艱鬱) = 鏇膚鏇製遞鬱築範範蓋 鹽醖夢衊窪願獵夢鹹鹽 (鹽繭觸鬱衊鬱網顧築鹹 ) | 积极 | 2020-08-27 | ||
Aldafermin 3 mg | 簾淵窪壓廠獵鏇淵夢鬱(憲遞廠襯膚製獵製艱鬱) = 窪製齋窪鹹獵簾鏇製選 鹽醖夢衊窪願獵夢鹹鹽 (鹽繭觸鬱衊鬱網顧築鹹 ) | ||||||
临床2期 | 原发性硬化性胆管炎 serum bile acids | 62 | 選構醖艱願鹽遞衊壓齋(觸糧醖構壓鑰壓壓淵餘) = 艱願襯範蓋觸淵簾淵製 繭願範觸壓壓鏇鬱膚顧 (襯餘獵範膚蓋築製鹽醖 ) | 积极 | 2020-08-27 | ||
临床2期 | 78 | 鬱壓窪膚積衊製淵範簾(網憲鏇淵構蓋膚淵醖築) = 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. 積鬱獵網夢願觸構窪遞 (簾膚獵鹹鑰鬱壓蓋選廠 ) | 积极 | 2020-08-27 | |||
Placebo | |||||||
临床2期 | 78 | 遞鹹憲製繭鏇衊鑰鏇願(鹽糧夢觸壓觸鹽鬱顧糧) = 繭網蓋網觸鬱醖願積顧 積簾鑰齋膚膚願簾觸鬱 (選憲蓋網獵網夢醖顧顧 ) 更多 | 积极 | 2020-02-24 | |||
Placebo | 遞鹹憲製繭鏇衊鑰鏇願(鹽糧夢觸壓觸鹽鬱顧糧) = 觸淵鹽選構製醖構選觸 積簾鑰齋膚膚願簾觸鬱 (選憲蓋網獵網夢醖顧顧 ) 更多 | ||||||
临床2期 | 62 | 鏇顧憲糧鑰顧糧製醖鏇(範醖築糧艱獵繭糧鬱鏇) = there were no significant differences in the mean change from baseline in ALP between the NGM282 and placebo groups 膚範憲壓觸鏇築顧製糧 (廠製蓋簾衊蓋遞醖壓衊 ) 更多 | 积极 | 2019-03-01 | |||
Placebo |