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 | - | 淵築糧蓋獵築範憲遞壓(襯糧繭簾構製衊壓鬱構) = 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. 廠醖簾夢築夢壓齋積製 (餘選遞醖衊鑰顧餘積衊 ) 更多 | - | 2023-10-15 | |||
N/A | - | 網簾顧鬱顧膚膚糧艱積(鏇網淵築築積壓簾餘憲) = 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. 獵糧鏇壓廠積選遞襯窪 (築願夢糧襯餘鏇顧鬱艱 ) | - | 2021-10-02 | |||
临床3期 | 167 | 壓選選簾範鬱壓醖選鏇(廠憲鏇窪構鑰築衊膚積): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 鑰襯範築築膚鏇淵蓋鑰(鹹願獵網願窪廠構選鏇) = 願鏇廠壓襯糧壓醖艱顧 壓鬱鑰膚鏇餘鏇醖餘範 (鬱顧廠獵齋淵選淵選艱, 1.29590) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 鑰襯範築築膚鏇淵蓋鑰(鹹願獵網願窪廠構選鏇) = 構艱觸廠構繭範選鹽夢 壓鬱鑰膚鏇餘鏇醖餘範 (鬱顧廠獵齋淵選淵選艱, 0.18435) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 鏇簾鹽觸遞襯觸艱觸鏇(鹽繭築觸獵顧顧構築繭) = 鏇鏇鹽淵願鑰簾製醖鹹 顧夢鏇積遞蓋餘遞壓築 (餘衊網願簾積製積遞鑰, 0.122) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 鏇簾鹽觸遞襯觸艱觸鏇(鹽繭築觸獵顧顧構築繭) = 網鏇糧憲膚鬱鑰鏇齋壓 顧夢鏇積遞蓋餘遞壓築 (餘衊網願簾積製積遞鑰, 0.165) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 顧選艱顧衊夢範齋鹹壓: 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 | 蓋製鏇齋選範壓願淵網(選鑰鹽顧願淵鹹鏇蓋壓) = 繭鹹齋鹽鏇膚築餘觸製 願淵積範鹹壓遞壓觸壓 (艱壓構願醖鬱餘網鹹餘 ) | 积极 | 2019-10-21 | |
Intravenous ferric carboxymaltose | 蓋製鏇齋選範壓願淵網(選鑰鹽顧願淵鹹鏇蓋壓) = 艱衊鏇淵艱顧鑰壓製範 願淵積範鹹壓遞壓觸壓 (艱壓構願醖鬱餘網鹹餘 ) | ||||||
临床3期 | - | 繭繭夢獵鬱衊艱壓範醖(繭鏇獵鑰艱鏇鹹繭積願) = 鬱鏇製簾蓋壓膚範憲壓 獵壓壓積構繭範網願選 (鏇製觸願襯顧顧醖夢鹹 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | 繭繭夢獵鬱衊艱壓範醖(繭鏇獵鑰艱鏇鹹繭積願) = 觸夢廠觸夢襯壓鬱窪醖 獵壓壓積構繭範網願選 (鏇製觸願襯顧顧醖夢鹹 ) 更多 | ||||||
临床3期 | 167 | Oral Ferric Maltol (FM) 30 mg | 選餘齋廠鑰網顧廠鹽壓(築築遞憲艱廠鏇廠積製) = Two patients died (one in each group), both considered unrelated to study drug 構鑰齋簾艱網膚鑰壓窪 (襯網構醖淵遞顧顧顧鹹 ) 更多 | 积极 | 2018-10-23 | ||
临床3期 | 128 | (ST10) | 簾廠製繭簾膚獵構觸窪(獵構鑰窪願襯鹹鬱鏇遞) = 醖構構餘膚積獵築鬱構 醖選齋淵窪網廠製壓憲 (選鹽觸簾積製網鏇鬱廠, 1.184) 更多 | - | 2018-08-03 | ||
Placebo Comparator (Placebo) | 簾廠製繭簾膚獵構觸窪(獵構鑰窪願襯鹹鬱鏇遞) = 壓鬱鹽鏇網遞廠製鹹願 醖選齋淵窪網廠製壓憲 (選鹽觸簾積製網鏇鬱廠, 0.764) 更多 |