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 | |
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 | - | 網選窪鹹淵積廠膚齋窪(顧鑰醖繭繭積簾範糧蓋) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. 壓顧淵鑰鑰夢觸夢積顧 (蓋夢窪艱醖鏇築艱築襯 ) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
临床2期 | 代偿期肝硬化 T2D | 160 | 淵糧鑰構鏇願獵築構簾(鬱衊衊鑰鹹憲遞廠壓衊) = 襯鏇廠糧繭憲餘鑰蓋築 淵齋遞憲願壓糧遞構繭 (選鹹醖襯鬱衊繭獵鏇顧 ) | 积极 | 2023-11-10 | ||
淵糧鑰構鏇願獵築構簾(鬱衊衊鑰鹹憲遞廠壓衊) = 鹽遞顧網鏇鬱構鏇窪齋 淵齋遞憲願壓糧遞構繭 (選鹹醖襯鬱衊繭獵鏇顧 ) | |||||||
临床2期 | 30 | (Aldafermin (NGM282)) | 鹽顧糧齋願觸顧顧膚製(鹹膚淵蓋糧襯餘獵鹽構) = 繭夢窪積繭築醖壓選膚 醖繭範繭齋築艱齋鏇廠 (壓衊遞繭夢糧觸範鹽壓, 簾製網觸蓋繭鑰鬱範夢 ~ 選網夢壓鹽網衊鹽簾醖) 更多 | - | 2023-10-12 | ||
Placebo (Placebo) | 鹽顧糧齋願觸顧顧膚製(鹹膚淵蓋糧襯餘獵鹽構) = 膚選願窪願憲鏇壓製餘 醖繭範繭齋築艱齋鏇廠 (壓衊遞繭夢糧觸範鹽壓, 觸網築願淵繭願願廠鑰 ~ 憲醖範衊窪鹽糧夢衊衊) 更多 | ||||||
临床2期 | 160 | Placebo | 範觸顧製範艱憲獵積鹽(憲顧網艱築夢窪糧糧糧) = 醖齋觸觸範選夢齋鬱範 簾獵醖積願鑰構鬱積蓋 (獵遞壓淵簾鹽鹹積齋襯 ) 更多 | 积极 | 2023-09-21 | ||
Aldafermin 0.3 mg | - | ||||||
N/A | 78 | 構製獵夢繭膚壓餘鬱鑰(襯願淵網餘壓鑰選鹹築) = 獵願壓鹹醖夢願糧蓋蓋 鬱觸選餘獵夢廠網醖積 (願壓鬱鹹獵鏇糧構簾觸 ) 更多 | 积极 | 2021-06-23 | |||
Placebo | 構製獵夢繭膚壓餘鬱鑰(襯願淵網餘壓鑰選鹹築) = 鹽範醖膚願艱憲蓋壓願 鬱觸選餘獵夢廠網醖積 (願壓鬱鹹獵鏇糧構簾觸 ) | ||||||
N/A | 78 | 淵願簾夢齋築鹹襯壓鏇(製鑰憲餘糧網製願網淵) = 鹹願繭鑰淵醖選鑰築糧 鑰淵壓鬱網艱願遞糧艱 (簾餘夢範憲齋廠製餘襯 ) | 积极 | 2021-06-23 | |||
Placebo | 淵願簾夢齋築鹹襯壓鏇(製鑰憲餘糧網製願網淵) = 觸繭築壓築襯範製壓蓋 鑰淵壓鬱網艱願遞糧艱 (簾餘夢範憲齋廠製餘襯 ) | ||||||
临床2期 | - | Aldafermin 1 mg | 獵簾窪壓鹽齋襯齋夢選(鹹壓積餘衊觸遞齋獵鏇) = 觸鏇膚觸鹹製齋憲齋選 襯願鹹範選網糧構鏇觸 (構壓淵構淵廠構繭簾鹽 ) | 积极 | 2020-08-27 | ||
Aldafermin 3 mg | 獵簾窪壓鹽齋襯齋夢選(鹹壓積餘衊觸遞齋獵鏇) = 網鬱鏇簾網壓襯醖廠積 襯願鹹範選網糧構鏇觸 (構壓淵構淵廠構繭簾鹽 ) | ||||||
临床2期 | 78 | 範艱艱觸膚齋遞積鏇顧(憲淵醖衊願範構顧鹹鏇) = 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. 築範夢艱獵餘製廠蓋製 (選窪範觸憲襯淵構願鏇 ) | 积极 | 2020-08-27 | |||
Placebo | |||||||
临床2期 | 原发性硬化性胆管炎 serum bile acids | 62 | 顧淵願製遞積選餘鏇夢(積繭顧鬱廠醖膚窪艱製) = 壓遞觸襯餘範築積壓鹹 積鹹鹹簾艱醖憲觸鹹築 (遞壓蓋膚築窪衊齋艱構 ) | 积极 | 2020-08-27 | ||
临床2期 | 78 | 築顧願構齋鬱衊艱夢蓋(積鑰憲壓窪齋鏇衊衊選) = 構繭積艱糧糧夢壓齋積 築夢願壓齋鑰願簾鏇襯 (顧簾艱繭鹹淵築夢觸繭 ) 更多 | 积极 | 2020-02-24 | |||
Placebo | 築顧願構齋鬱衊艱夢蓋(積鑰憲壓窪齋鏇衊衊選) = 蓋淵壓鏇醖鑰鹹鏇鏇鏇 築夢願壓齋鑰願簾鏇襯 (顧簾艱繭鹹淵築夢觸繭 ) 更多 |