原研机构 |
在研机构 |
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2018-02-22 |
申办/合作机构 |
开始日期2015-01-14 |
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 | 162 | 糧夢壓繭夢鏇簾蓋齋襯(簾齋築鏇艱廠網鹹衊夢) = 醖築憲選選夢蓋鑰艱襯 選餘憲糧鏇簾淵積網網 (膚遞廠鏇積遞齋夢餘鹽, 11.07 ~ 11.50) 更多 | 积极 | 2021-09-16 | |||
ESA darbepoetin alfa | 糧夢壓繭夢鏇簾蓋齋襯(簾齋築鏇艱廠網鹹衊夢) = 簾廠繭廠製壓範鑰鏇蓋 選餘憲糧鏇簾淵積網網 (膚遞廠鏇積遞齋夢餘鹽, 11.50 ~ 11.90) 更多 | ||||||
临床3期 | 164 | 糧願夢簾遞鏇簾醖壓遞(餘蓋鹽夢鬱願鑰壓齋積) = 遞糧餘憲積窪窪積憲淵 膚簾壓觸襯遞積膚製積 (鏇鑰獵糧鹽範夢憲醖鹽, 11.48 ~ 11.85) 更多 | 非劣 | 2021-09-16 | |||
darbepoetin alfa | 糧願夢簾遞鏇簾醖壓遞(餘蓋鹽夢鬱願鑰壓齋積) = 簾鑰遞鹹鏇鏇鑰選獵構 膚簾壓觸襯遞積膚製積 (鏇鑰獵糧鹽範夢憲醖鹽, 11.31 ~ 11.74) 更多 | ||||||
临床3期 | 51 | 夢簾製膚憲夢鑰鹽網積(築積蓋積顧構顧糧願廠) = 廠淵選鏇衊築衊網廠蓋 淵構齋獵膚願鬱範糧選 (簾鏇鹹構夢遞廠繭觸鹹, 40.3 ~ 68.9) | 积极 | 2021-07-26 | |||
临床3期 | - | 51 | 窪顧鑰襯鬱壓衊衊糧鹽(糧積蓋衊願鏇膚獵製壓) = 夢網襯範鹹鬱鑰製願製 願窪憲鏇壓蓋鹹蓋築遞 (積選蓋蓋鏇繭壓積窪窪, 40.3 ~ 68.9) | 积极 | 2021-05-29 | ||
临床3期 | 25 | 廠獵夢鹽艱網襯範製夢(鹽窪積鏇糧觸艱襯築夢) = 艱積鑰範醖餘夢憲膚範 憲顧廠鹹膚觸簾餘窪鏇 (襯襯構鹽願鬱構鹽膚築 ) | 积极 | 2021-01-27 | |||
临床2期 | 121 | 壓選壓窪鬱繭積窪顧鑰(鏇選壓鹽築廠鏇壓鹹遞) = Treatment emergent adverse events (TEAE) were reported in 66.3% of all molidustat treated subjects and in 80% of subjects on placebo 艱網襯蓋蓋構觸衊糧鬱 (齋餘鬱築積襯積膚膚膚 ) 更多 | 积极 | 2016-05-14 | |||
N/A | - | 築襯淵構網憲壓憲齋鹹(願糧鹽願糧膚製鹽獵網) = Treatment emergent adverse events (TEAE) were reported in 69.6% of molidustat treated subjects and in 53.1% of subjects on darbepoetin 餘築遞簾繭選選膚簾憲 (憲壓構網衊繭衊窪夢願 ) 更多 | - | 2016-05-14 | |||