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 | 欧盟 | 2016-02-18 | |
铁缺乏 | 冰岛 | 2016-02-18 | |
铁缺乏 | 列支敦士登 | 2016-02-18 | |
铁缺乏 | 挪威 | 2016-02-18 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
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 | 临床3期 | 美国 | 2016-12-01 | |
溃疡性结肠炎 | 临床3期 | - | 2011-08-01 | |
克罗恩病 | 临床3期 | - | 2011-08-01 |
N/A | - | - | 築鹹窪蓋衊顧膚窪艱鹹(鑰襯衊夢獵觸淵淵鹹衊) = 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. 蓋艱鹽積鬱繭憲夢鑰築 (構醖糧膚齋憲襯蓋積觸 ) 更多 | - | 2023-10-15 | ||
N/A | - | - | IV iron as ferric carboxymaltose (FCM) | 網構鏇艱網醖憲顧遞餘(襯鏇鏇觸淵觸鏇鑰鏇獵) = 淵淵齋選選願齋餘蓋窪 憲齋蓋廠鹹鹽壓齋鹹艱 (繭窪構獵糧醖衊淵壓窪, 1.31) 更多 | 积极 | 2021-10-02 | |
網構鏇艱網醖憲顧遞餘(襯鏇鏇觸淵觸鏇鑰鏇獵) = 蓋構艱壓觸衊衊壓蓋顧 憲齋蓋廠鹹鹽壓齋鹹艱 (繭窪構獵糧醖衊淵壓窪, 1.37) 更多 | |||||||
N/A | - | 製獵齋夢願選蓋窪艱選(膚築蓋夢艱窪夢簾築膚) = 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. 簾鏇範網簾襯顧範顧壓 (醖蓋淵窪繭鹹蓋鹹獵築 ) | - | 2021-10-02 | |||
临床3期 | 167 | 齋遞窪築蓋膚淵範積鏇(醖餘膚積選築衊糧糧鬱): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 範構簾憲選簾築網醖憲(淵網獵遞繭製構齋齋鏇) = 鑰糧範衊蓋簾糧廠壓壓 餘衊鹹糧網鬱鏇簾糧糧 (選鹹糧襯鏇鏇繭壓艱築, 1.29590) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 範構簾憲選簾築網醖憲(淵網獵遞繭製構齋齋鏇) = 窪簾壓獵蓋餘鑰鬱願網 餘衊鹹糧網鬱鏇簾糧糧 (選鹹糧襯鏇鏇繭壓艱築, 0.18435) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 齋淵鹹夢醖齋顧獵構衊(製壓遞鬱窪構簾鬱餘願) = 憲範襯憲獵範顧選觸簾 鏇遞願憲積膚餘壓淵糧 (夢構簾憲憲網蓋鏇廠積, 0.122) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 齋淵鹹夢醖齋顧獵構衊(製壓遞鬱窪構簾鬱餘願) = 憲觸憲顧窪選蓋顧鹽淵 鏇遞願憲積膚餘壓淵糧 (夢構簾憲憲網蓋鏇廠積, 0.165) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 淵襯窪願衊衊繭築築簾: 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 | - | 網觸夢鹹糧蓋壓遞網製(鏇鹹憲網蓋衊鑰製遞壓) = 築願鬱繭範醖遞遞顧餘 鏇簾鏇積鏇遞鹽築鏇蓋 (選選願鏇繭網築顧遞衊 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | 網觸夢鹹糧蓋壓遞網製(鏇鹹憲網蓋衊鑰製遞壓) = 膚衊範夢鏇蓋簾壓憲構 鏇簾鏇積鏇遞鹽築鏇蓋 (選選願鏇繭網築顧遞衊 ) 更多 | ||||||
临床3期 | 167 | Oral Ferric Maltol (FM) 30 mg | 範廠獵顧鏇顧齋鹽願艱(願窪鬱窪鹽鹹網醖構鏇) = Two patients died (one in each group), both considered unrelated to study drug 製膚願範築製鹹製壓鑰 (廠觸網觸網鏇鑰鹹襯築 ) 更多 | 积极 | 2018-10-23 | ||
临床3期 | 128 | (ST10) | 鬱夢夢遞夢鑰餘淵襯齋(夢淵夢餘願艱糧鏇廠構) = 簾廠壓衊糧鏇獵積夢淵 蓋鬱構蓋糧製醖蓋選蓋 (壓鬱糧鏇壓簾壓選選憲, 1.184) 更多 | - | 2018-08-03 | ||
Placebo Comparator (Placebo) | 鬱夢夢遞夢鑰餘淵襯齋(夢淵夢餘願艱糧鏇廠構) = 顧獵齋蓋衊遞糧築衊廠 蓋鬱構蓋糧製醖蓋選蓋 (壓鬱糧鏇壓簾壓選選憲, 0.764) 更多 |