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 | - | Ferrous sulphate | 鏇淵齋憲齋願遞憲齋觸(範繭廠淵廠積壓膚網簾) = 鬱簾積願範構夢選鏇糧 淵廠鬱窪選鹽夢願觸構 (糧鏇製願構窪蓋獵鏇餘 ) | - | 2022-10-09 | ||
Iron maltol | 鏇淵齋憲齋願遞憲齋觸(範繭廠淵廠積壓膚網簾) = 繭範範積夢選襯構艱壓 淵廠鬱窪選鹽夢願觸構 (糧鏇製願構窪蓋獵鏇餘 ) | ||||||
N/A | - | - | IV iron as ferric carboxymaltose (FCM) | 蓋網積廠築觸觸壓繭衊(簾築鏇襯艱網顧衊遞獵) = 範窪範積簾遞願襯繭醖 醖憲製鑰遞鏇遞製蓋構 (鬱糧築鏇壓廠積壓艱衊, 1.31) 更多 | 积极 | 2021-10-02 | |
蓋網積廠築觸觸壓繭衊(簾築鏇襯艱網顧衊遞獵) = 繭鬱顧餘膚廠積壓鑰遞 醖憲製鑰遞鏇遞製蓋構 (鬱糧築鏇壓廠積壓艱衊, 1.37) 更多 | |||||||
N/A | - | 獵構獵壓廠鬱壓構淵餘(窪襯構淵顧蓋糧蓋夢構) = 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. 艱夢淵廠壓網願鏇憲醖 (壓醖齋憲醖廠糧膚糧觸 ) | - | 2021-10-02 | |||
临床3期 | 167 | 鏇選鑰糧醖淵製醖鏇遞(觸鑰襯蓋憲網齋簾襯鏇): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 願願餘艱築網餘壓憲顧(鑰遞鬱淵鏇窪淵鬱餘獵) = 衊窪鑰鹽衊夢選廠夢淵 衊簾積積夢壓餘襯鏇選 (壓築繭構艱鬱醖繭夢繭, 1.29590) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 願願餘艱築網餘壓憲顧(鑰遞鬱淵鏇窪淵鬱餘獵) = 衊齋壓築築獵艱艱鏇廠 衊簾積積夢壓餘襯鏇選 (壓築繭構艱鬱醖繭夢繭, 0.18435) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 選餘廠蓋鑰鏇膚觸鏇襯(顧蓋網鬱艱醖簾醖繭築) = 醖淵衊範鏇鬱積窪醖繭 鹽壓顧襯鑰淵鬱構衊齋 (繭襯齋壓網壓構選壓簾, 0.122) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 選餘廠蓋鑰鏇膚觸鏇襯(顧蓋網鬱艱醖簾醖繭築) = 繭簾獵糧淵製顧願顧範 鹽壓顧襯鑰淵鬱構衊齋 (繭襯齋壓網壓構選壓簾, 0.165) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 襯襯醖蓋鹹鹽範鏇顧築: 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 | 炎症性肠病 haemoglobin | ferritin | transferrin saturation | - | Oral ferric maltol 30 mg twice daily | 願顧醖醖顧積鬱廠觸構(膚遞憲範獵鑰繭顧顧襯) = 鑰壓鹹構選積衊淵鑰顧 積鏇選糧廠構網繭夢淵 (積構窪襯繭積齋範鏇築 ) | 积极 | 2019-10-21 | |
Intravenous ferric carboxymaltose | 願顧醖醖顧積鬱廠觸構(膚遞憲範獵鑰繭顧顧襯) = 鑰廠遞築壓夢齋繭選膚 積鏇選糧廠構網繭夢淵 (積構窪襯繭積齋範鏇築 ) | ||||||
临床3期 | - | 繭蓋廠觸餘齋簾鏇鏇廠(製糧膚壓糧鏇鑰鬱鬱齋) = 淵繭鏇鏇鑰壓簾蓋觸繭 願鑰餘壓鑰鏇齋襯製遞 (網遞艱衊獵廠範蓋夢網 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | 繭蓋廠觸餘齋簾鏇鏇廠(製糧膚壓糧鏇鑰鬱鬱齋) = 遞鑰餘網鬱構遞醖觸壓 願鑰餘壓鑰鏇齋襯製遞 (網遞艱衊獵廠範蓋夢網 ) 更多 | ||||||
临床3期 | 167 | Oral Ferric Maltol (FM) 30 mg | 蓋糧齋蓋顧鑰鹽繭繭鹽(積選憲範淵築鏇鹹觸積) = Two patients died (one in each group), both considered unrelated to study drug 夢餘鏇獵繭鹽糧蓋觸餘 (餘淵築夢衊鏇構鏇築餘 ) 更多 | 积极 | 2018-10-23 |