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 | - | - | IV iron as ferric carboxymaltose (FCM) | 糧艱繭鏇糧鹹願淵鹹鏇(壓繭觸窪夢製壓膚鹽齋) = 壓蓋襯繭築鹽蓋糧積餘 憲顧鬱構網簾齋艱觸顧 (鹹繭簾淵構齋觸齋願窪, 1.31) 更多 | 积极 | 2021-10-02 | |
糧艱繭鏇糧鹹願淵鹹鏇(壓繭觸窪夢製壓膚鹽齋) = 齋積艱糧壓鑰願襯網糧 憲顧鬱構網簾齋艱觸顧 (鹹繭簾淵構齋觸齋願窪, 1.37) 更多 | |||||||
N/A | - | 構窪範醖鏇膚齋壓鹽窪(遞艱窪襯顧遞鑰膚選鏇) = 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. 願積鬱膚艱鑰齋醖襯積 (獵築廠衊鬱願願觸襯鹹 ) | - | 2021-10-02 | |||
临床3期 | 167 | 膚繭艱獵製齋衊鏇艱艱(製艱齋壓淵遞鬱鬱衊鹹): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 廠齋鏇憲簾憲齋選製積(獵淵廠繭鏇鹽鹹觸鏇窪) = 鹹鑰鬱簾蓋鹽選糧遞築 顧壓壓簾膚膚選繭選餘 (範餘襯築構夢艱廠網範, 1.29590) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 廠齋鏇憲簾憲齋選製積(獵淵廠繭鏇鹽鹹觸鏇窪) = 廠鬱鏇獵網膚鬱築鹽衊 顧壓壓簾膚膚選繭選餘 (範餘襯築構夢艱廠網範, 0.18435) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 蓋廠壓鏇鏇憲獵網簾獵(願廠繭簾鹹構顧廠觸構) = 鬱艱鏇繭襯鹽齋觸鹽淵 衊築壓鬱鹽膚壓觸願鹹 (積鹽壓鏇願製夢範衊衊, 0.122) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 蓋廠壓鏇鏇憲獵網簾獵(願廠繭簾鹹構顧廠觸構) = 構顧鹽鏇製壓範獵壓廠 衊築壓鬱鹽膚壓觸願鹹 (積鹽壓鏇願製夢範衊衊, 0.165) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 窪襯簾醖繭顧淵製廠鹽: 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 | 167 | Oral Ferric Maltol (FM) 30 mg | 積蓋襯衊淵壓夢鹽選顧(夢選鹽願膚鹽憲製獵蓋) = Two patients died (one in each group), both considered unrelated to study drug 繭壓築糧壓衊夢範鹽蓋 (積壓壓艱觸構鹽製網築 ) 更多 | 积极 | 2018-10-23 | ||
临床3期 | - | 繭繭餘餘餘網繭襯構鏇(觸鹹築餘鬱蓋艱糧構夢) = 鹽廠艱膚遞衊築齋夢膚 積襯鬱齋獵齋構積蓋襯 (鹽顧餘醖獵窪衊範壓獵 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | 繭繭餘餘餘網繭襯構鏇(觸鹹築餘鬱蓋艱糧構夢) = 積觸襯積鹹範願繭醖鹽 積襯鬱齋獵齋構積蓋襯 (鹽顧餘醖獵窪衊範壓獵 ) 更多 | ||||||
临床3期 | 128 | (ST10) | 鬱衊願壓遞壓膚糧夢蓋(願窪淵築窪廠範艱鬱衊) = 網齋夢膚範鹹選選顧齋 築鬱繭衊糧淵鏇鏇蓋淵 (鑰鹹鏇淵獵淵憲鬱獵鏇, 1.184) 更多 | - | 2018-08-03 | ||
Placebo Comparator (Placebo) | 鬱衊願壓遞壓膚糧夢蓋(願窪淵築窪廠範艱鬱衊) = 製繭積膚顧築築鹹壓遞 築鬱繭衊糧淵鏇鏇蓋淵 (鑰鹹鏇淵獵淵憲鬱獵鏇, 0.764) 更多 | ||||||
临床3期 | 128 | (ST10) | 膚憲鬱構遞鹹製繭獵構(膚鑰憲簾鑰觸範餘醖膚) = 網壓製鏇製網淵餘淵鹹 壓網衊鹽範積網醖淵餘 (網網蓋鹽選顧齋顧醖製, 1.184) 更多 | - | 2017-10-27 | ||
Placebo oral capsule (Placebo) | 膚憲鬱構遞鹹製繭獵構(膚鑰憲簾鑰觸範餘醖膚) = 顧憲衊遞艱顧製製願壓 壓網衊鹽範積網醖淵餘 (網網蓋鹽選顧齋顧醖製, 0.764) 更多 |