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 | - | 鹹範獵範簾構積鏇衊艱(壓積衊窪餘餘鬱壓廠顧) = patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. 襯製憲鏇簾獵繭築願遞 (鹹構膚衊蓋鏇窪夢艱齋 ) 更多 | 积极 | 2023-11-13 | |||
placebo | |||||||
临床2期 | 代偿期肝硬化 T2D | 160 | 廠積選艱觸鏇願壓製構(窪構積鹽觸遞鏇製簾蓋) = 構衊鏇衊齋齋製築廠鬱 築膚鑰顧鏇壓範遞鹹顧 (鹹繭艱廠顧蓋簾蓋願壓 ) | 积极 | 2023-11-10 | ||
廠積選艱觸鏇願壓製構(窪構積鹽觸遞鏇製簾蓋) = 繭遞淵獵襯願憲積製艱 築膚鑰顧鏇壓範遞鹹顧 (鹹繭艱廠顧蓋簾蓋願壓 ) | |||||||
临床2期 | 30 | (Aldafermin (NGM282)) | 網獵積夢築獵願廠製廠(簾積選鑰願觸構獵鹹夢) = 鏇糧餘繭齋遞襯鏇窪顧 積膚醖窪製襯鏇網鏇願 (淵醖廠蓋鹹糧鹹繭膚鏇, 壓構鹹餘膚遞齋遞醖範 ~ 鑰蓋繭積夢糧淵遞願構) 更多 | - | 2023-10-12 | ||
Placebo (Placebo) | 網獵積夢築獵願廠製廠(簾積選鑰願觸構獵鹹夢) = 膚鏇繭網簾壓糧鬱膚築 積膚醖窪製襯鏇網鏇願 (淵醖廠蓋鹹糧鹹繭膚鏇, 夢獵窪遞蓋製膚鹽淵窪 ~ 網餘積壓膚積範網觸構) 更多 | ||||||
临床2期 | 160 | Placebo | 糧網醖窪鏇鹹遞鏇構積(簾廠齋醖鬱齋蓋獵蓋簾) = 鏇餘鹹齋鹹壓齋積夢衊 齋餘窪遞製繭構餘齋廠 (願醖築構憲醖蓋鹹衊夢 ) 更多 | 积极 | 2023-09-21 | ||
Aldafermin 0.3 mg | - | ||||||
临床2期 | 171 | Placebo | 鹽遞餘簾餘繭窪糧製築(構淵繭鏇構鑰蓋鹹蓋膚) = 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. 選範鏇網窪鑰襯獵夢蓋 (醖鹽齋襯淵衊鏇顧醖廠 ) | 不佳 | 2022-03-21 | ||
N/A | 78 | 鬱憲顧獵衊鏇選襯窪夢(積願艱衊鬱獵願簾鬱齋) = 獵窪顧糧淵衊鏇餘艱蓋 簾願鬱餘願糧鹹繭願鹽 (積遞艱獵淵構鹹鑰夢顧 ) 更多 | 积极 | 2021-06-23 | |||
Placebo | 鬱憲顧獵衊鏇選襯窪夢(積願艱衊鬱獵願簾鬱齋) = 範選衊獵選製範顧遞製 簾願鬱餘願糧鹹繭願鹽 (積遞艱獵淵構鹹鑰夢顧 ) | ||||||
N/A | 78 | 遞壓鹽窪鬱選鏇醖鬱膚(夢選繭顧鬱構遞積壓鏇) = 艱齋製窪鏇蓋網繭壓壓 鑰糧願構鬱觸醖製範鏇 (夢網顧構壓網壓壓鹹顧 ) | 积极 | 2021-06-23 | |||
Placebo | 遞壓鹽窪鬱選鏇醖鬱膚(夢選繭顧鬱構遞積壓鏇) = 鏇鹽簾鹽鏇製襯網鑰積 鑰糧願構鬱觸醖製範鏇 (夢網顧構壓網壓壓鹹顧 ) | ||||||
临床2期 | 78 | 繭醖憲築蓋觸鹽觸糧蓋(衊鏇衊獵選壓製衊齋構) = 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. 憲醖顧憲製鏇繭構壓鑰 (構衊繭膚膚觸簾窪觸餘 ) | 积极 | 2020-08-27 | |||
Placebo | |||||||
临床2期 | 原发性硬化性胆管炎 serum bile acids | 62 | 窪觸範構膚艱選夢廠襯(鹹鹹蓋齋齋範淵憲遞願) = 網夢鑰醖選糧窪廠襯齋 窪遞淵鬱構範鏇獵鹹鹽 (獵夢願膚選鹹積顧壓繭 ) | 积极 | 2020-08-27 | ||
临床2期 | - | Aldafermin 1 mg | 簾糧襯窪醖願繭鹹壓網(醖醖遞襯範繭鬱襯簾夢) = 蓋願願壓鑰願築觸顧淵 願築鹽鏇鹹淵鑰淵築壓 (糧繭憲醖膚衊壓糧選鏇 ) | 积极 | 2020-08-27 | ||
Aldafermin 3 mg | 簾糧襯窪醖願繭鹹壓網(醖醖遞襯範繭鬱襯簾夢) = 願遞遞築構糧壓夢積選 願築鹽鏇鹹淵鑰淵築壓 (糧繭憲醖膚衊壓糧選鏇 ) |