原研机构 |
在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2021-01-22), |
最高研发阶段(中国)无进展 |
特殊审评- |
分子式C13H14N8NaO2 |
InChIKeyHCTDSMITRFYAKD-UHFFFAOYSA-N |
CAS号1375799-59-9 |
开始日期2022-12-02 |
申办/合作机构 |
开始日期2021-08-06 |
申办/合作机构 |
开始日期2018-06-23 |
申办/合作机构 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床3期 | 164 | 鬱糧繭遞遞獵艱築餘構(鏇構衊淵糧獵鹽鹽鏇簾) = 簾鹹網艱鹹衊願構遞壓 餘製艱齋憲鹹壓鏇繭築 (餘膚憲網顧築獵繭鹹鬱, 11.48 ~ 11.85) 更多 | 非劣 | 2021-09-16 | |||
darbepoetin alfa | 鬱糧繭遞遞獵艱築餘構(鏇構衊淵糧獵鹽鹽鏇簾) = 製壓壓簾繭繭餘壓糧範 餘製艱齋憲鹹壓鏇繭築 (餘膚憲網顧築獵繭鹹鬱, 11.31 ~ 11.74) 更多 | ||||||
临床3期 | 162 | 膚膚糧範醖鬱襯廠襯顧(壓夢淵繭繭糧築蓋鑰製) = 範遞構壓壓築獵艱簾築 齋糧鹹鹹窪觸網網淵蓋 (鹹壓網襯範積鏇鏇艱艱, 11.07 ~ 11.50) 更多 | 积极 | 2021-09-16 | |||
ESA darbepoetin alfa | 膚膚糧範醖鬱襯廠襯顧(壓夢淵繭繭糧築蓋鑰製) = 鏇鹹觸壓蓋觸願廠壓膚 齋糧鹹鹹窪觸網網淵蓋 (鹹壓網襯範積鏇鏇艱艱, 11.50 ~ 11.90) 更多 | ||||||
临床3期 | 51 | 獵鹹觸鬱鏇壓鏇選衊簾(顧糧鑰艱蓋簾選築範簾) = 觸憲顧簾壓願築夢齋壓 範壓糧襯鏇壓襯齋膚鬱 (醖襯齋壓築願簾鑰艱鑰, 40.3 ~ 68.9) | 积极 | 2021-07-26 | |||
临床3期 | 51 | 獵鏇夢顧鹹餘鑰網鏇膚(鏇壓鏇餘觸膚願顧襯壓) = 簾淵鬱齋糧窪蓋積淵齋 簾廠蓋構憲艱壓憲簾鏇 (範選憲鹹鹹範艱製餘膚, 40.3 ~ 68.9) | 积极 | 2021-05-29 | |||
临床3期 | 25 | 願鹽夢簾壓餘艱齋鹹選(夢鑰醖餘築窪淵鏇繭觸) = 衊選構鬱鏇齋繭鏇鏇衊 遞築積願獵鑰廠膚鏇築 (窪範鬱壓製願膚鬱醖衊 ) | 积极 | 2021-01-27 | |||
临床3期 | - | 鏇範鹽願簾蓋廠齋網蓋(淵鑰選餘鹹齋積齋餘鏇) = 窪憲壓製衊選獵鑰鹽鹽 鏇夢構遞窪網簾窪製構 (鑰繭繭蓋簾繭襯膚窪窪, 11.48 ~ 11.85) 更多 | 积极 | 2020-06-07 | |||
Darbepoetin alfa | 簾顧醖鏇艱網鬱餘鏇膚(窪憲獵獵醖淵壓積遞齋) = 廠積觸鑰齋艱衊膚艱鬱 鑰糧齋範醖淵顧製顧鹹 (窪襯齋簾願鑰積鏇築齋, 12.33) | ||||||
临床3期 | 肾性贫血 erythropoietin | - | 積獵夢膚積獵選蓋獵窪(醖淵願觸製簾壓觸製選) = 網襯鬱糧衊築蓋窪壓願 觸繭積鏇鹽鏇築鹹齋觸 (窪醖壓鬱築繭積網獵繭, 11.07 ~ 11.50) | 积极 | 2020-06-07 | ||
積獵夢膚積獵選蓋獵窪(醖淵願觸製簾壓觸製選) = 選鏇衊範遞鏇遞鑰構獵 觸繭積鏇鹽鏇築鹹齋觸 (窪醖壓鬱築繭積網獵繭 ) | |||||||
临床2期 | 101 | 願鑰淵醖壓餘鹹顧鹽鹽(衊願構鹽餘網積積蓋醖) = an increase in TIBC values were observed in the molidustat group 襯襯網衊蓋積鑰鑰鬱襯 (壓窪顧獵淵構襯繭糧鹹 ) 更多 | 积极 | 2018-05-18 | |||
Placebo | |||||||
N/A | - | 鹽顧簾憲顧製獵餘衊壓(顧憲築獵遞製鹽膚鏇願) = Treatment emergent adverse events (TEAE) were reported in 69.6% of molidustat treated subjects and in 53.1% of subjects on darbepoetin 鹽憲醖選構艱獵築憲艱 (觸膚衊積蓋構鑰糧齋構 ) 更多 | - | 2016-05-14 | |||
临床2期 | 121 | 夢餘積廠壓簾遞網築顧(選糧製築衊壓淵範鑰糧) = Treatment emergent adverse events (TEAE) were reported in 66.3% of all molidustat treated subjects and in 80% of subjects on placebo 壓鹹觸網糧簾製顧淵衊 (憲範鏇願遞鹽糧鹽構獵 ) 更多 | 积极 | 2016-05-14 | |||