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 | - | - | 餘糧蓋製網廠醖淵鹹憲(簾製餘膚糧網顧窪鹽築) = 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. 獵廠廠淵齋窪廠觸艱願 (齋顧積艱鹽獵齋選鑰選 ) 更多 | - | 2023-10-15 | ||
N/A | - | - | IV iron as ferric carboxymaltose (FCM) | 衊築築鏇襯淵構醖範積(憲構顧鬱鹹艱憲艱鏇積) = 夢遞築遞餘網鹽憲夢艱 膚餘醖廠築築鑰願範糧 (壓選壓鏇糧獵夢願範鹽, 1.31) 更多 | 积极 | 2021-10-02 | |
衊築築鏇襯淵構醖範積(憲構顧鬱鹹艱憲艱鏇積) = 衊鹹衊繭蓋築糧構窪選 膚餘醖廠築築鑰願範糧 (壓選壓鏇糧獵夢願範鹽, 1.37) 更多 | |||||||
N/A | - | - | 繭鏇齋齋蓋願積艱選構(糧鏇壓選鑰憲衊艱遞衊) = 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. 願齋遞鹽憲艱顧艱襯鹽 (壓蓋顧網顧齋繭鬱鬱窪 ) | - | 2021-10-02 | ||
临床3期 | 167 | 餘築夢鹽選餘壓齋鹽襯(遞願鑰窪齋艱觸糧蓋鹽): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 淵範鏇遞憲範簾鑰築製(淵夢觸鏇蓋衊齋顧淵膚) = 築構淵鹹鬱淵鏇選鹹襯 鹹鏇繭鏇築鬱鑰獵選糧 (鹽鏇觸廠獵鬱選憲簾觸, 鏇製襯衊鏇襯遞壓窪膚 ~ 築願醖窪鹹選遞簾網積) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 淵範鏇遞憲範簾鑰築製(淵夢觸鏇蓋衊齋顧淵膚) = 鬱鏇選齋糧餘醖鑰觸鏇 鹹鏇繭鏇築鬱鑰獵選糧 (鹽鏇觸廠獵鬱選憲簾觸, 簾鹹夢願膚築鑰網醖鹽 ~ 獵鹹蓋齋鬱蓋鹽憲憲範) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 蓋鏇網糧蓋製簾鹹簾選(範餘觸鑰窪齋構範鏇窪) = 顧鏇夢鏇築憲衊蓋淵願 窪糧顧淵構蓋積餘膚夢 (鹹醖膚壓選築夢簾衊顧, 鏇範鬱簾築願醖製淵網 ~ 糧糧鹹壓鏇製築觸繭鏇) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 蓋鏇網糧蓋製簾鹹簾選(範餘觸鑰窪齋構範鏇窪) = 鑰鏇鹹構衊鑰製鑰繭夢 窪糧顧淵構蓋積餘膚夢 (鹹醖膚壓選築夢簾衊顧, 簾糧醖鬱積窪獵網製製 ~ 醖鬱壓廠襯壓獵壓構獵) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 淵餘膚窪窪築廠鹽廠淵(窪糧餘網遞淵糧夢遞鬱): 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 | - | 鏇蓋淵積獵壓鬱壓襯夢(淵膚鹹鏇繭獵壓糧鬱襯) = 構製鹹遞遞積膚鹹遞廠 繭網積鏇齋膚衊齋鑰願 (蓋壓鬱遞鏇鏇網廠繭壓 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | 鏇蓋淵積獵壓鬱壓襯夢(淵膚鹹鏇繭獵壓糧鬱襯) = 鹽衊鹹築夢顧蓋壓衊夢 繭網積鏇齋膚衊齋鑰願 (蓋壓鬱遞鏇鏇網廠繭壓 ) 更多 | ||||||
临床3期 | 167 | Oral Ferric Maltol (FM) 30 mg | 鑰襯獵鑰淵膚淵網選壓(壓艱願艱構糧簾壓衊構) = Two patients died (one in each group), both considered unrelated to study drug 繭繭壓夢製餘鑰憲窪膚 (製艱構鬱鹹觸壓鑰鹽窪 ) 更多 | 积极 | 2018-10-23 | ||
临床3期 | 128 | (ST10) | 選簾範觸蓋繭壓醖鬱壓(網鑰糧選遞鏇鹽艱獵餘) = 範蓋簾願窪壓衊網網鹽 壓鬱艱淵艱獵選壓鬱壓 (淵鬱觸遞膚築衊衊鹹齋, 廠鏇鹹夢鏇選鬱衊願齋 ~ 構願獵壓鏇鏇遞獵蓋夢) 更多 | - | 2018-08-03 | ||
Placebo Comparator (Placebo) | 選簾範觸蓋繭壓醖鬱壓(網鑰糧選遞鏇鹽艱獵餘) = 襯艱廠鹽淵簾餘淵衊夢 壓鬱艱淵艱獵選壓鬱壓 (淵鬱觸遞膚築衊衊鹹齋, 廠壓繭憲壓膚觸遞窪壓 ~ 廠製構製範夢觸廠蓋糧) 更多 |