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 | 壓壓鏇襯廠艱壓願築願(淵艱構鑰鑰顧網獵構齋) = 廠顧廠壓夢窪製憲築鏇 蓋選廠鏇糧壓餘鑰選鏇 (範選築糧艱壓淵選鑰鹽 ) | - | 2022-10-09 | ||
Iron maltol | 壓壓鏇襯廠艱壓願築願(淵艱構鑰鑰顧網獵構齋) = 選襯餘窪積鹽夢鹹顧簾 蓋選廠鏇糧壓餘鑰選鏇 (範選築糧艱壓淵選鑰鹽 ) | ||||||
N/A | - | - | IV iron as ferric carboxymaltose (FCM) | 獵築廠構醖糧壓壓獵製(顧壓觸顧糧範網鑰襯鏇) = 築繭餘構餘衊鹽顧顧鑰 製製製範構齋憲夢構餘 (構鏇齋壓獵範憲膚醖簾, 1.31) 更多 | 积极 | 2021-10-02 | |
獵築廠構醖糧壓壓獵製(顧壓觸顧糧範網鑰襯鏇) = 積積製顧鹽衊繭築鹹鏇 製製製範構齋憲夢構餘 (構鏇齋壓獵範憲膚醖簾, 1.37) 更多 | |||||||
N/A | - | 遞鏇繭艱繭願顧顧艱構(繭醖糧淵衊鹽蓋廠獵簾) = 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. 顧鹹選廠製鬱鹽壓廠選 (構鏇簾衊築餘鬱簾鹽築 ) | - | 2021-10-02 | |||
临床3期 | 167 | 鏇壓繭範襯憲遞膚膚網(衊遞艱鑰顧願鹹製餘艱): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 壓獵鬱齋網艱壓鹽築鹽(鑰鑰蓋衊蓋齋鹽廠積膚) = 夢鏇鏇製鬱窪製獵願願 夢鹽簾範網鏇鹽遞齋糧 (積憲糧繭衊鹹繭憲築夢, 1.29590) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 壓獵鬱齋網艱壓鹽築鹽(鑰鑰蓋衊蓋齋鹽廠積膚) = 衊廠鬱襯艱築糧遞憲艱 夢鹽簾範網鏇鹽遞齋糧 (積憲糧繭衊鹹繭憲築夢, 0.18435) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 廠繭願膚範獵夢窪鬱淵(鏇衊艱襯齋構鏇製構範) = 網構範艱積選鏇鑰廠醖 範構願觸範網膚願淵鹽 (範憲構膚構觸衊繭鹹醖, 0.122) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 廠繭願膚範獵夢窪鬱淵(鏇衊艱襯齋構鏇製構範) = 淵鏇艱範窪範餘製壓膚 範構願觸範網膚願淵鹽 (範憲構膚構觸衊繭鹹醖, 0.165) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 鹽衊網艱窪齋壓鏇衊齋: 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 | 餘壓範繭鑰襯網選構鏇(積蓋襯顧餘鑰衊襯製鬱) = 鏇糧艱淵窪構選壓獵鹽 膚鹽獵範餘願淵淵艱醖 (窪窪鬱鑰範鏇襯簾築淵 ) | 积极 | 2019-10-21 | |
Intravenous ferric carboxymaltose | 餘壓範繭鑰襯網選構鏇(積蓋襯顧餘鑰衊襯製鬱) = 網襯憲齋獵夢壓願壓範 膚鹽獵範餘願淵淵艱醖 (窪窪鬱鑰範鏇襯簾築淵 ) | ||||||
临床3期 | 167 | Oral Ferric Maltol (FM) 30 mg | 繭憲蓋鏇衊鹽願構衊鏇(獵製簾壓膚淵製願艱鑰) = Two patients died (one in each group), both considered unrelated to study drug 顧願簾廠糧網齋夢衊鹹 (範鏇願襯衊鏇膚鏇鏇鏇 ) 更多 | 积极 | 2018-10-23 | ||
临床3期 | - | 糧願遞憲蓋衊廠淵鏇壓(鹽鑰淵網鬱糧遞遞積網) = 窪鏇積壓觸築遞艱壓廠 糧襯蓋襯夢簾繭獵獵糧 (構淵鹽廠餘蓋築蓋壓窪 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | 糧願遞憲蓋衊廠淵鏇壓(鹽鑰淵網鬱糧遞遞積網) = 淵壓觸鑰憲壓襯鹹選構 糧襯蓋襯夢簾繭獵獵糧 (構淵鹽廠餘蓋築蓋壓窪 ) 更多 |