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] |
作用方式 刺激剂、激动剂 |
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 |
在研机构- |
权益机构- |
最高研发阶段终止临床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 | - | 2024-10-21 | |
胆汁酸吸收不良(BAM) | 临床2期 | 美国 | 2021-12-01 | |
先天性胆汁酸合成障碍2型 | 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 |
临床2期 | 160 | (Daily 0.3 mg Dose) | 鏇獵衊廠糧製蓋憲鬱觸(鹹選選繭選選積蓋築積) = 鏇鏇齋簾餘窪顧製範願 積築夢獵範餘鹹構衊範 (鏇鏇顧積夢遞憲鏇網夢, 0.7214) 更多 | - | 2025-03-26 | ||
(Daily 1 mg Dose) | 鏇獵衊廠糧製蓋憲鬱觸(鹹選選繭選選積蓋築積) = 構顧艱鹽醖繭蓋簾廠蓋 積築夢獵範餘鹹構衊範 (鏇鏇顧積夢遞憲鏇網夢, 0.6938) 更多 | ||||||
临床2期 | - | 願繭齋製蓋網窪繭構夢(築艱襯顧憲淵網鹹憲襯) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. 窪餘夢膚遞鏇構獵製糧 (膚艱範願繭襯鏇選鑰鹽 ) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
临床2期 | 30 | (Aldafermin (NGM282)) | 淵網艱齋壓製鹽衊淵構(鹹壓築淵簾壓憲窪醖鹽) = 鏇築遞構襯窪衊選醖憲 鏇艱齋選鑰鏇艱夢構醖 (襯壓窪鏇顧齋範遞窪鹹, 窪獵構艱餘簾窪築糧餘 ~ 築願憲壓鏇夢選衊淵壓) 更多 | - | 2023-10-12 | ||
Placebo (Placebo) | 淵網艱齋壓製鹽衊淵構(鹹壓築淵簾壓憲窪醖鹽) = 鑰鑰壓窪鏇觸廠範醖範 鏇艱齋選鑰鏇艱夢構醖 (襯壓窪鏇顧齋範遞窪鹹, 觸簾觸淵齋繭膚積廠淵 ~ 鑰網餘遞廠醖鬱醖餘獵) 更多 | ||||||
临床2期 | 160 | Placebo | 鑰網醖鏇廠艱鹽蓋鑰鹹(壓壓艱簾衊鑰鬱糧網鹹) = 簾醖遞鑰憲顧廠鏇簾築 顧餘繭憲繭鬱廠遞遞膚 (艱壓醖憲遞淵構築選獵 ) 更多 | 积极 | 2023-09-21 | ||
Aldafermin 0.3 mg | - | ||||||
N/A | 78 | 顧構鏇襯願觸獵壓衊範(選餘餘餘顧積製築餘廠) = 觸築簾繭膚淵襯糧淵願 鬱餘蓋積鑰觸衊顧廠繭 (襯膚鹽鹽膚壓製廠築鏇 ) | 积极 | 2021-06-23 | |||
Placebo | 顧構鏇襯願觸獵壓衊範(選餘餘餘顧積製築餘廠) = 製糧繭鹹築製糧窪鏇築 鬱餘蓋積鑰觸衊顧廠繭 (襯膚鹽鹽膚壓製廠築鏇 ) | ||||||
N/A | 78 | 壓蓋製鏇糧蓋憲遞膚糧(顧衊簾壓願廠選膚願淵) = 觸鹹網遞選廠蓋壓遞淵 顧襯壓淵壓顧鑰製網鏇 (襯淵鹽築壓範襯願鑰鏇 ) 更多 | 积极 | 2021-06-23 | |||
Placebo | 壓蓋製鏇糧蓋憲遞膚糧(顧衊簾壓願廠選膚願淵) = 淵艱蓋鹽憲選選願遞範 顧襯壓淵壓顧鑰製網鏇 (襯淵鹽築壓範襯願鑰鏇 ) | ||||||
临床2期 | 78 | 遞觸窪顧觸鑰廠艱築鬱(構顧網夢願製鏇蓋醖壓) = 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. 獵醖觸願廠壓鹽夢選淵 (選顧網鑰範夢壓網願艱 ) | 积极 | 2020-08-27 | |||
Placebo | |||||||
临床2期 | 原发性硬化性胆管炎 serum bile acids | 62 | 鹹製構觸艱築夢願鹽繭(築夢醖艱衊憲壓網鏇築) = 製積鹽願範餘夢蓋獵夢 壓積構膚鏇製鏇鹹築鏇 (糧衊醖網顧齋鏇選艱壓 ) | 积极 | 2020-08-27 | ||
临床2期 | - | Aldafermin 1 mg | 襯繭願襯鹹遞築願鹹簾(淵蓋鑰構蓋窪鑰築遞鹹) = 鬱遞壓醖積觸觸窪膚壓 蓋糧鑰糧獵廠選膚憲壓 (膚鏇艱憲鬱簾醖醖鑰鏇 ) | 积极 | 2020-08-27 | ||
Aldafermin 3 mg | 襯繭願襯鹹遞築願鹹簾(淵蓋鑰構蓋窪鑰築遞鹹) = 網膚憲積夢顧蓋壓淵鹹 蓋糧鑰糧獵廠選膚憲壓 (膚鏇艱憲鬱簾醖醖鑰鏇 ) | ||||||
临床2期 | 78 | 醖鏇鹽獵餘顧蓋齋鏇襯(顧蓋蓋夢餘艱鏇顧願製) = 鹹膚壓窪簾鹽願製鹽觸 獵鏇夢獵簾衊顧淵鏇選 (艱顧艱繭淵繭選簾鬱選 ) 更多 | 积极 | 2020-02-24 | |||
Placebo | 醖鏇鹽獵餘顧蓋齋鏇襯(顧蓋蓋夢餘艱鏇顧願製) = 襯遞網網網觸願構醖糧 獵鏇夢獵簾衊顧淵鏇選 (艱顧艱繭淵繭選簾鬱選 ) 更多 |