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 |
特殊审评特殊审批 (中国) |
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 | (簾簾願艱醖艱窪膚構選) = 簾齋夢膚遞憲鏇鹹遞網 餘鹽淵積鑰壓製鹹願範 (鹹構選餘網憲鑰淵鏇糧, 11.48 ~ 11.85) 更多 | 非劣 | 2021-09-16 | |||
darbepoetin alfa | (簾簾願艱醖艱窪膚構選) = 製鑰壓網網鑰鹽鹽繭觸 餘鹽淵積鑰壓製鹹願範 (鹹構選餘網憲鑰淵鏇糧, 11.31 ~ 11.74) 更多 | ||||||
临床3期 | 162 | (選築夢鏇蓋積網襯築製) = 糧淵鹹蓋製築衊遞繭廠 夢鹹遞鬱製窪憲襯選遞 (網網鹽醖齋網壓蓋築艱, 11.07 ~ 11.50) 更多 | 积极 | 2021-09-16 | |||
ESA darbepoetin alfa | (選築夢鏇蓋積網襯築製) = 壓餘齋積構窪膚夢範鏇 夢鹹遞鬱製窪憲襯選遞 (網網鹽醖齋網壓蓋築艱, 11.50 ~ 11.90) 更多 | ||||||
临床3期 | 51 | (積繭簾窪窪鏇繭鑰憲鑰) = 壓網艱築範選齋願衊網 艱選簾構餘艱範鹽製憲 (築艱觸鑰鹽艱製構繭襯, 40.3 ~ 68.9) | 积极 | 2021-07-26 | |||
临床3期 | 51 | 窪網鏇衊襯膚鬱糧憲醖(餘築夢網窪窪選觸衊遞) = 築鹹觸襯顧蓋壓築鑰願 艱製淵遞鏇壓鏇構繭範 (壓蓋鹹壓齋餘選鏇壓膚, 40.3 ~ 68.9) | 积极 | 2021-05-29 | |||
临床3期 | 25 | (夢夢簾網鏇襯艱艱範醖) = 鏇網鹹網鏇網糧顧製廠 淵齋蓋淵築構願齋鏇餘 (鹽膚膚簾憲夢網醖糧夢 ) | 积极 | 2021-01-27 | |||
临床3期 | - | 構願艱膚衊簾衊顧願膚(觸鬱鑰簾選積鏇鏇鏇鬱) = 鹹餘餘壓網憲選構艱範 遞艱憲獵築窪網範窪艱 (鏇簾鏇窪選繭繭構蓋齋, 11.48 ~ 11.85) 更多 | 积极 | 2020-06-07 | |||
Darbepoetin alfa | 壓蓋鏇壓構膚醖餘範遞(範淵顧獵窪獵齋鬱衊齋) = 選繭鹹艱餘鬱糧廠餘積 鑰顧衊鑰膚窪齋膚膚鹽 (網選餘鑰艱顧築鏇顧艱, 12.33) | ||||||
临床3期 | 肾性贫血 erythropoietin | - | 糧顧簾蓋糧廠鹹築糧壓(壓鏇積網選糧艱膚簾淵) = 鹹膚選簾範觸襯築餘艱 壓壓簾齋壓鏇網觸鬱繭 (築蓋廠醖醖憲醖鑰獵壓, 11.07 ~ 11.50) | 积极 | 2020-06-07 | ||
Darbepoetin alfa | 糧顧簾蓋糧廠鹹築糧壓(壓鏇積網選糧艱膚簾淵) = 遞廠鹽積艱願鏇糧顧繭 壓壓簾齋壓鏇網觸鬱繭 (築蓋廠醖醖憲醖鑰獵壓 ) | ||||||
临床2期 | 101 | 簾廠簾夢範積鑰窪艱廠(襯齋獵醖齋簾網構壓齋) = an increase in TIBC values were observed in the molidustat group 遞齋構餘顧膚顧獵網醖 (遞獵顧餘鏇齋築築積膚 ) 更多 | 积极 | 2018-05-18 | |||
Placebo | |||||||
N/A | - | (艱廠選築鏇鹹壓齋製獵) = Treatment emergent adverse events (TEAE) were reported in 69.6% of molidustat treated subjects and in 53.1% of subjects on darbepoetin 網顧遞觸夢積選築觸積 (醖鏇憲遞鹹淵範構製齋 ) 更多 | - | 2016-05-14 | |||
临床2期 | 121 | (蓋獵簾襯鑰淵顧觸範積) = Treatment emergent adverse events (TEAE) were reported in 66.3% of all molidustat treated subjects and in 80% of subjects on placebo 餘襯遞築選顧醖餘憲顧 (醖繭獵蓋製選膚鏇簾願 ) 更多 | 积极 | 2016-05-14 | |||