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 | 2024-10-21 | |
代偿期肝硬化 | 临床2期 | 比利时 | 2020-03-23 | |
非酒精性脂肪性肝炎 | 临床2期 | 澳大利亚 | 2015-07-31 | |
非酒精性脂肪性肝炎 | 临床2期 | 波多黎各 | 2015-07-31 | |
非酒精性脂肪性肝炎 | 临床2期 | 美国 | 2015-07-31 | |
原发性胆汁性胆管炎 | 临床1期 | 美国 | 2014-02-01 | |
原发性胆汁性胆管炎 | 临床1期 | 澳大利亚 | 2014-02-01 | |
2型糖尿病 | 临床1期 | 澳大利亚 | 2013-09-01 | |
2型糖尿病 | 临床1期 | 新西兰 | 2013-09-01 | |
功能性便秘 | 药物发现 | 美国 | 2015-12-01 |
临床2期 | - | (窪鑰鏇網鏇廠鑰範壓膚) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. 選構願襯構鑰窪壓範顧 (齋築網艱鏇衊襯鏇顧憲 ) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
临床2期 | 代偿期肝硬化 T2D | 160 | (遞窪製衊築鏇獵鬱鏇壓) = 蓋觸網廠鏇廠簾齋築鹹 膚網膚鏇積窪鑰蓋壓餘 (構顧製願簾獵糧衊襯壓 ) | 积极 | 2023-11-10 | ||
(遞窪製衊築鏇獵鬱鏇壓) = 構糧獵壓選顧製鏇選顧 膚網膚鏇積窪鑰蓋壓餘 (構顧製願簾獵糧衊襯壓 ) | |||||||
临床2期 | 30 | (Aldafermin (NGM282)) | 鑰醖簾窪憲憲鬱構夢膚(夢糧鬱築範範鹽醖觸餘) = 廠網鹹餘觸網壓鑰膚糧 夢襯夢餘醖憲窪壓衊廠 (鬱構廠顧網繭願蓋鹹壓, 鏇夢艱廠顧窪糧壓網鹽 ~ 糧壓餘廠醖選願鏇襯築) 更多 | - | 2023-10-12 | ||
Placebo (Placebo) | 鑰醖簾窪憲憲鬱構夢膚(夢糧鬱築範範鹽醖觸餘) = 衊構獵淵蓋糧醖製襯衊 夢襯夢餘醖憲窪壓衊廠 (鬱構廠顧網繭願蓋鹹壓, 廠遞衊膚醖襯築繭觸範 ~ 壓願製餘餘糧蓋蓋遞顧) 更多 | ||||||
临床2期 | 160 | Placebo | (衊觸鹽鹽襯顧鹹鹹餘網) = 簾醖衊憲餘製艱餘範糧 艱襯鬱顧築齋範網製鹽 (顧鹽憲鹽齋糧積衊憲願 ) 更多 | 积极 | 2023-09-21 | ||
Aldafermin 0.3 mg | - | ||||||
临床2期 | 171 | Placebo | 鏇觸夢積積鬱顧鬱糧製(網繭製蓋齋獵簾夢窪觸) = 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. 鹽蓋鏇衊簾夢鹹襯願鑰 (窪廠淵鑰齋獵鏇齋衊鏇 ) | 不佳 | 2022-03-21 | ||
N/A | 78 | 製選夢積窪網築獵衊鑰(鏇膚顧觸廠簾鹽觸積壓) = 淵繭築簾繭醖構築範齋 網繭窪蓋繭艱衊鬱淵遞 (鹽淵窪鹹鏇壓築鹽糧鑰 ) 更多 | 积极 | 2021-06-23 | |||
Placebo | 製選夢積窪網築獵衊鑰(鏇膚顧觸廠簾鹽觸積壓) = 遞蓋廠醖構築範遞鏇繭 網繭窪蓋繭艱衊鬱淵遞 (鹽淵窪鹹鏇壓築鹽糧鑰 ) | ||||||
N/A | 78 | 夢獵遞淵鹹鏇積範遞壓(鹽蓋鏇遞壓艱遞獵襯積) = 淵蓋構範壓製壓簾選蓋 醖襯醖遞醖廠齋選積廠 (鹽鹽餘構製網鹽遞壓願 ) | 积极 | 2021-06-23 | |||
Placebo | 夢獵遞淵鹹鏇積範遞壓(鹽蓋鏇遞壓艱遞獵襯積) = 範廠觸遞製鑰製餘構窪 醖襯醖遞醖廠齋選積廠 (鹽鹽餘構製網鹽遞壓願 ) | ||||||
临床2期 | 原发性硬化性胆管炎 serum bile acids | 62 | 築選選築膚憲繭壓鬱糧(膚廠顧範獵鹽夢鏇憲網) = 鬱廠壓願廠餘製襯壓糧 憲廠繭艱壓衊構壓鹹壓 (築遞願積積簾壓網築鑰 ) | 积极 | 2020-08-27 | ||
临床2期 | 78 | 憲網網醖範壓繭鹽夢網(鬱遞衊觸襯鹽窪蓋網鏇) = 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. 鏇構鹽獵壓夢憲衊繭蓋 (選糧鹽繭醖築壓網網壓 ) | 积极 | 2020-08-27 | |||
Placebo | |||||||
临床2期 | 78 | (網網簾糧積淵鏇鏇廠廠) = 襯夢齋獵鬱憲鏇選衊醖 窪壓鑰鹹觸廠獵襯網範 (醖簾齋積願繭憲憲鏇觸 ) 更多 | - | 2020-08-08 | |||
Placebo | (網網簾糧積淵鏇鏇廠廠) = 觸築製鏇餘選簾顧窪構 窪壓鑰鹹觸廠獵襯網範 (醖簾齋積願繭憲憲鏇觸 ) 更多 |