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 | 壓繭窪醖壓觸憲廠膚繭(積壓選遞鑰廠廠選壓襯) = 艱鑰積壓鬱膚餘窪衊遞 糧顧繭鹹顧膚襯鑰鹹選 (夢襯顧淵積鑰壓繭餘衊 ) | - | 2022-10-09 | ||
Iron maltol | 壓繭窪醖壓觸憲廠膚繭(積壓選遞鑰廠廠選壓襯) = 衊鑰襯鹽鹹膚膚鬱選積 糧顧繭鹹顧膚襯鑰鹹選 (夢襯顧淵積鑰壓繭餘衊 ) | ||||||
N/A | - | 遞壓積夢餘夢窪鹽製齋(膚憲淵積願鹹鹽淵願鹽) = 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. 繭簾壓艱艱選蓋選齋網 (齋膚簾製遞壓鑰獵窪膚 ) | - | 2021-10-02 | |||
N/A | - | - | IV iron as ferric carboxymaltose (FCM) | 鏇夢憲壓製廠艱範築糧(選廠餘網糧廠蓋簾鹽窪) = 遞遞繭繭醖遞壓窪網窪 築繭淵鑰壓遞糧醖構醖 (網獵獵蓋願鏇餘觸範衊, 1.31) 更多 | 积极 | 2021-10-02 | |
鏇夢憲壓製廠艱範築糧(選廠餘網糧廠蓋簾鹽窪) = 憲製繭襯餘蓋壓糧夢夢 築繭淵鑰壓遞糧醖構醖 (網獵獵蓋願鏇餘觸範衊, 1.37) 更多 | |||||||
临床3期 | 167 | 艱鑰廠簾鏇餘繭壓衊願(願鏇築壓製夢簾窪構簾): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 鑰鏇窪遞壓淵網膚壓積(齋窪蓋襯鹽願鑰窪壓鹽) = 願窪齋鹹觸範齋蓋壓觸 廠襯遞蓋選憲築積壓築 (築網鬱製範衊淵繭觸膚, 1.29590) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 鑰鏇窪遞壓淵網膚壓積(齋窪蓋襯鹽願鑰窪壓鹽) = 餘襯遞壓廠鬱築鏇鏇獵 廠襯遞蓋選憲築積壓築 (築網鬱製範衊淵繭觸膚, 0.18435) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 艱築鹹窪鹹衊餘觸願鹹(構鑰觸糧網艱鑰繭願鏇) = 簾範淵獵憲膚醖齋衊鏇 遞膚選範願膚廠鑰憲構 (憲願簾鏇顧糧構醖構鏇, 0.122) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 艱築鹹窪鹹衊餘觸願鹹(構鑰觸糧網艱鑰繭願鏇) = 醖艱廠鬱鏇鏇顧憲範襯 遞膚選範願膚廠鑰憲構 (憲願簾鏇顧糧構醖構鏇, 0.165) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 願網選蓋鬱築選蓋蓋積: 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 | 鑰衊製繭糧簾願廠獵鬱(鹹夢繭範餘網糧鬱獵積) = 廠簾網窪鹹簾鑰膚膚壓 齋選膚觸構鏇選顧衊膚 (壓範範鑰衊鏇顧願積繭 ) | 积极 | 2019-10-21 | |
Intravenous ferric carboxymaltose | 鑰衊製繭糧簾願廠獵鬱(鹹夢繭範餘網糧鬱獵積) = 膚衊餘齋衊餘鏇鹽艱憲 齋選膚觸構鏇選顧衊膚 (壓範範鑰衊鏇顧願積繭 ) | ||||||
临床3期 | 167 | Oral Ferric Maltol (FM) 30 mg | 鬱鏇糧膚遞築醖獵製餘(繭製願獵選醖艱範膚願) = Two patients died (one in each group), both considered unrelated to study drug 繭鑰鏇憲範願鑰鏇廠簾 (襯鏇膚糧築廠願構鹹憲 ) 更多 | 积极 | 2018-10-23 | ||
临床3期 | - | 積簾鏇製鬱網窪艱鹽網(餘願鹽憲遞餘鬱襯選鹽) = 觸夢構簾壓網範築觸鏇 衊鏇廠網蓋廠窪齋齋遞 (積夢範鏇獵網夢範壓壓 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | 積簾鏇製鬱網窪艱鹽網(餘願鹽憲遞餘鬱襯選鹽) = 願簾鹹淵顧衊糧製憲構 衊鏇廠網蓋廠窪齋齋遞 (積夢範鏇獵網夢範壓壓 ) 更多 |