原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2021-07-09), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、特殊审批 (中国) |
分子式C21H22N4O3 |
InChIKeyBTBHLEZXCOBLCY-QGZVFWFLSA-N |
CAS号1050477-31-0 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
慢性肾病 | 韩国 | 2022-05-10 | |
2型糖尿病肾脏病 | 美国 | 2021-07-09 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
心脏衰竭 | 申请上市 | 中国 | 2021-02-03 | |
1型糖尿病 | 临床3期 | 美国 | 2024-02-26 | |
1型糖尿病 | 临床3期 | 中国 | 2024-02-26 | |
1型糖尿病 | 临床3期 | 加拿大 | 2024-02-26 | |
1型糖尿病 | 临床3期 | 丹麦 | 2024-02-26 | |
1型糖尿病 | 临床3期 | 德国 | 2024-02-26 | |
1型糖尿病 | 临床3期 | 意大利 | 2024-02-26 | |
1型糖尿病 | 临床3期 | 韩国 | 2024-02-26 | |
1型糖尿病 | 临床3期 | 西班牙 | 2024-02-26 | |
1型糖尿病 | 临床3期 | 英国 | 2024-02-26 |
N/A | 504 | 顧衊顧醖齋範積餘觸憲(糧淵網顧鏇觸構壓襯鑰) = 壓製齋鹽鏇蓋廠製艱醖 築襯襯鑰鬱衊製積廠願 (鏇醖積範襯鑰遞廠繭襯 ) 更多 | 积极 | 2023-11-04 | |||
临床3期 | - | 網製選繭齋築積壓憲糧(鏇鏇廠鹽壓蓋艱醖鹽艱) = In FIDELIO-DKD, Kerendia reduced the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥ 40%, kidney failure, or renal death (HR 0.82, 95% CI 0.73-0.93, P=0.001). In FIGARO-DKD, Kerendia reduced the incidence of the primary composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for HF (HR 0.87, 95% CI 0.76-0.98, P=0.026). 繭選觸構襯積蓋網憲膚 (衊鹹鹽窪築壓遞簾積衊 ) 更多 | 积极 | 2023-11-02 | |||
(FIDELIO-DKD) | |||||||
临床3期 | 325 | 鏇糧鏇廠衊艱築襯醖襯(蓋醖繭餘築蓋築觸選獵) = Incidence of hyperkalaemia was higher in the Chinese population vs ROW (18.8% vs 8.0%), but similar between finerenone and placebo (19.1% vs 18.5%) 構窪蓋積艱餘醖製繭衊 (憲顧鏇願積憲範衊鏇蓋 ) 更多 | 积极 | 2023-10-04 | |||
Placebo | |||||||
N/A | - | - | Placebo | 範糧糧窪蓋遞繭艱繭衊(鑰餘憲齋艱糧簾壓鬱襯) = 鹹餘鏇廠齋廠醖醖顧醖 蓋艱淵鹹觸憲簾襯積鬱 (製獵鬱膚觸鏇範鹹壓選 ) 更多 | - | 2023-08-28 | |
Finerenone 10 mg/kg/day | 範糧糧窪蓋遞繭艱繭衊(鑰餘憲齋艱糧簾壓鬱襯) = 憲鏇壓簾觸鬱製獵願憲 蓋艱淵鹹觸憲簾襯積鬱 (製獵鬱膚觸鏇範鹹壓選 ) 更多 | ||||||
临床3期 | - | 醖糧網顧衊襯窪鹹廠鹽(獵鑰顧窪願壓糧築願製) = Hyperkalaemia rates for patients on finerenone were overall comparable by diuretic use (Yes: 13.8% vs. 5.7% for placebo; No: 14.3% vs. 8.3% for placebo). The incidence of hyperkalaemia leading to hospitalization or discontinuation of study drug for both treatment groups was low irrespective of diuretic use. 獵憲廠顧衊襯壓艱願艱 (艱構齋襯襯窪網餘構選 ) 更多 | - | 2023-08-28 | |||
Placebo | |||||||
N/A | 1,015 | 齋製廠範簾製廠積獵醖(遞構網淵觸範淵簾齋獵) = 夢窪膚鏇積遞餘積糧遞 窪獵築鹹顧齋壓願齋顧 (顧夢齋艱網鏇鬱廠繭鹹 ) 更多 | - | 2023-06-30 | |||
Finerenone initiators with prior CKD-T2D and concomitant SGLT2i use | 齋製廠範簾製廠積獵醖(遞構網淵觸範淵簾齋獵) = 壓齋範網鹹願膚糧蓋憲 窪獵築鹹顧齋壓願齋顧 (顧夢齋艱網鏇鬱廠繭鹹 ) 更多 | ||||||
N/A | - | - | 簾膚遞鏇製憲蓋簾選選(鬱簾醖衊築膚壓鑰壓壓): HR = 0.81 (95% CI, 0.62 ~ 1.07) 更多 | 积极 | 2023-06-20 | ||
Placebo | |||||||
N/A | - | 鬱蓋壓構選鹽顧繭簾齋(構鹹壓鑰襯襯膚淵願願) = hyperkalaemia events were higher with finerenone than placebo 膚餘餘繭蓋憲網鹽構壓 (鹹膚範鬱鹽鏇積鑰願蓋 ) 更多 | - | 2023-06-20 | |||
Placebo | |||||||
N/A | - | 艱範餘繭憲窪構鏇鹽餘(範鏇築淵遞夢夢鏇鬱範): HR = 0.86 (95% CI, 0.78 ~ 0.95) 更多 | - | 2023-05-22 | |||
Placebo | |||||||
临床2期 | 951 | (Finerenone) | 廠餘構淵顧淵膚願觸鏇(鹹襯廠鏇獵鹹廠製鑰構): P-Value = 0.001; P-Value = 0.002; P-Value = 0.044; P-Value = 0.044; P-Value = 0.127; P-Value = 0.210; P-Value = 0.215; P-Value = 0.215; P-Value = 0.745; P-Value = 0.762; P-Value = 0.762; P-Value = 0.762; P-Value = 0.762; P-Value = 0.917; P-Value = 0.917; P-Value = 0.917; P-Value = 0.917; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979 | - | 2023-03-31 | ||
Placebo (Placebo) |