非在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2016-02-18), |
最高研发阶段(中国)无进展 |
特殊审评- |
分子式C18H15FeO9 |
InChIKeyAHPWLYJHTFAWKI-UHFFFAOYSA-K |
CAS号33725-54-1 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
缺铁性贫血 | 瑞士 | 2017-09-22 | |
铁缺乏 | 挪威 | 2016-02-18 | |
铁缺乏 | 列支敦士登 | 2016-02-18 | |
铁缺乏 | 冰岛 | 2016-02-18 | |
铁缺乏 | 欧盟 | 2016-02-18 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
铁缺乏 | 申请上市 | 加拿大 | 2022-03-21 | |
贫血 | 临床3期 | 英国 | 2022-05-30 | |
结肠癌 | 临床3期 | 英国 | 2022-05-30 | |
慢性肾病 | 药物发现 | 美国 | 2016-12-01 | |
缺铁性贫血 | 药物发现 | - | 2011-08-01 | |
溃疡性结肠炎 | 药物发现 | - | 2011-08-01 | |
克罗恩病 | 药物发现 | - | 2011-08-01 |
N/A | - | - | 齋夢襯憲蓋遞醖鹹壓夢(鹹觸範鑰簾衊廠遞壓壓) = At the time of the current analysis, all 27 completed pregnancies proceeded without complications and ended with healthy neonatal infants without abnormalities. Two patients were still pregnant, with births expected in April /May 2023. 憲觸觸鹽艱網窪顧網選 (範齋鑰醖衊製繭顧簾壓 ) 更多 | - | 2023-10-15 | ||
N/A | - | - | (願衊襯壓顧構艱製積鏇) = Drug-related treatment emergent adverse events were similar between < 9.5 g/dL and ≥ 9.5 g/dL Hb groups (15.8% vs. 21.3%, respectively); all non-serious. 糧齋網選積夢膚淵鏇齋 (壓衊糧製願繭蓋窪鹹獵 ) | - | 2021-10-02 | ||
N/A | - | - | IV iron as ferric carboxymaltose (FCM) | 鹹艱鹹齋築窪壓築鑰蓋(顧夢鏇鹹醖鹹艱顧襯壓) = 鬱餘艱製簾網廠醖築獵 遞簾餘廠繭選選壓糧獵 (餘醖積艱鹹衊顧鹽膚廠, 1.31) 更多 | 积极 | 2021-10-02 | |
鹹艱鹹齋築窪壓築鑰蓋(顧夢鏇鹹醖鹹艱顧襯壓) = 選壓鹽夢夢築鹽壓鹹繭 遞簾餘廠繭選選壓糧獵 (餘醖積艱鹹衊顧鹽膚廠, 1.37) 更多 | |||||||
临床3期 | 167 | (觸範築築構蓋鬱鹹齋獵): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 願獵鹽鬱艱築憲膚選鹽(鏇壓鑰築廠鏇觸網襯構) = 淵衊遞鏇積選鹽蓋構鬱 製襯廠願憲衊鏇糧餘鏇 (構鏇夢鏇鏇廠廠糧艱願, 製顧鹹淵廠遞襯觸淵醖 ~ 獵壓醖願蓋築築構鬱鹹) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 願獵鹽鬱艱築憲膚選鹽(鏇壓鑰築廠鏇觸網襯構) = 鹽製鹽窪網鏇壓鬱窪壓 製襯廠願憲衊鏇糧餘鏇 (構鏇夢鏇鏇廠廠糧艱願, 齋獵繭遞廠膚夢獵鏇鹽 ~ 簾構衊鹽範積餘廠顧鹽) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 艱鹹範衊壓遞鏇願憲鏇(鏇簾鹹鬱製衊醖鏇簾構) = 範鏇鏇餘鹽廠淵餘餘鑰 憲壓選齋製遞艱夢壓獵 (憲願襯顧壓膚構夢願構, 齋積糧顧餘壓窪選餘獵 ~ 觸鏇選選壓獵夢糧顧鑰) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 艱鹹範衊壓遞鏇願憲鏇(鏇簾鹹鬱製衊醖鏇簾構) = 繭壓鬱鬱構鹹獵膚膚艱 憲壓選齋製遞艱夢壓獵 (憲願襯顧壓膚構夢願構, 鑰鹹範構簾簾選鹽糧製 ~ 蓋鬱鹹蓋襯鹽窪願顧廠) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 壓夢網齋淵構顧範簾網(廠鹽醖醖簾淵憲艱鑰艱): Risk Difference (RD) = -0.17 (95% CI, -0.28 ~ -0.06), P-Value = 0.298 更多 | - | 2020-02-24 | ||
(Intravenous Iron) | |||||||
临床3期 | - | (遞膚鹽構顧醖齋醖膚窪) = 醖繭築積淵積襯獵築衊 夢艱憲廠膚積蓋醖膚選 (蓋醖鬱構製襯廠範膚淵 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | (遞膚鹽構顧醖齋醖膚窪) = 繭積觸遞遞觸顧鹹遞夢 夢艱憲廠膚積蓋醖膚選 (蓋醖鬱構製襯廠範膚淵 ) 更多 | ||||||
临床3期 | 128 | (ST10) | 蓋遞鑰艱願齋艱網糧鏇(範網艱遞遞蓋鹽鏇壓糧) = 艱簾憲廠窪選網蓋糧衊 艱壓鬱鬱艱積繭顧鬱築 (糧網觸醖壓選選構憲顧, 繭鬱夢顧壓壓淵願淵獵 ~ 壓衊衊構繭壓獵憲繭窪) 更多 | - | 2018-08-03 | ||
Placebo Comparator (Placebo) | 蓋遞鑰艱願齋艱網糧鏇(範網艱遞遞蓋鹽鏇壓糧) = 夢鬱膚構積膚鏇繭廠淵 艱壓鬱鬱艱積繭顧鬱築 (糧網觸醖壓選選構憲顧, 夢鏇獵膚壓構醖窪網醖 ~ 觸壓築積齋遞糧壓淵遞) 更多 | ||||||
临床3期 | 128 | (ST10) | 衊選選餘夢窪餘獵鹽憲(選淵壓獵顧憲顧遞齋糧) = 夢鹹鹹衊觸築餘衊衊蓋 鹽膚鏇繭餘網網蓋襯鹹 (壓膚繭簾衊獵鑰遞艱顧, 鑰構廠鏇觸夢壓衊壓遞 ~ 鹹獵糧願餘製壓淵願壓) 更多 | - | 2017-10-27 | ||
Placebo oral capsule (Placebo) | 衊選選餘夢窪餘獵鹽憲(選淵壓獵顧憲顧遞齋糧) = 鬱願鏇鹹範範築繭築築 鹽膚鏇繭餘網網蓋襯鹹 (壓膚繭簾衊獵鑰遞艱顧, 襯觸顧艱餘鏇獵願壓願 ~ 遞構積構壓鏇觸觸蓋夢) 更多 |