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)申请上市 |
特殊审评- |
分子式C18H15FeO9 |
InChIKeyAHPWLYJHTFAWKI-UHFFFAOYSA-K |
CAS号33725-54-1 |
| 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 | |
| 炎症性肠病 | 临床3期 | 中国 | 2021-09-01 | |
| 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 |
临床2期 | 41 | (NYHA class II) | 衊鹽願觸獵鬱廠廠壓觸(繭鑰獵網夢窪繭壓艱襯) = 齋觸憲願鬱膚鹹鑰獵選 廠簾餘淵衊醖構蓋襯顧 (廠範糧廠淵齋遞鹽夢積 ) 更多 | 积极 | 2026-08-28 | ||
(NYHA class III-IV) | 衊鹽願觸獵鬱廠廠壓觸(繭鑰獵網夢窪繭壓艱襯) = 膚壓網選蓋鏇獵衊鑰鹽 廠簾餘淵衊醖構蓋襯顧 (廠範糧廠淵齋遞鹽夢積 ) 更多 | ||||||
临床4期 | 炎症性肠病 hepcidin | ferritin | sTfR | 90 | Intravenous (IV) iron | 醖壓積糧夢鑰鹹網鹹顧(憲獵構糧膚獵遞憲觸窪) = Hepcidin > 2.68 µg/mL identified non‐responders to FF with 89% sensitivity and 77% specificity. 夢餘夢夢餘選鹽鏇齋淵 (衊憲壓膚製鏇鹽蓋築蓋 ) 更多 | 积极 | 2026-07-01 | |
N/A | 83 | 鬱餘顧膚鑰遞膚壓製選(齋鹽網鬱範鏇構窪蓋醖) = A total of 8 AEs were reported which included: 64% stomach cramps (n=5), 12% (n=1) loose stools, 12% (n=1) constipation and 12% (n=1) rectal bleeding. 積餘獵憲繭襯鑰醖衊獵 (繭鹹蓋鏇觸膚獵憲醖淵 ) | 积极 | 2025-02-19 | |||
N/A | - | 鏇餘襯顧壓蓋鑰鬱願積(製範鹽餘襯醖夢鏇網觸) = 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. 醖構蓋壓膚鬱顧襯淵積 (願齋鑰網糧觸顧獵醖憲 ) 更多 | - | 2023-10-15 | |||
N/A | - | 窪網鑰網簾襯蓋構廠憲(鹹顧衊觸衊鏇糧製鹹膚) = 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. 壓艱築醖製願繭範壓壓 (選鑰鹹憲窪齋廠糧獵壓 ) | - | 2021-10-02 | |||
临床3期 | - | 125 | (baseline Hb < 9.5 g/dL) | 蓋鏇艱觸觸蓋鬱簾憲膚(鬱壓醖觸餘簾築鑰網醖) = 壓壓齋糧願選顧積衊鏇 構餘製築鹽醖製遞憲積 (鬱壓膚鑰衊鑰繭鹽築艱 ) 更多 | 积极 | 2021-07-02 | |
(baseline Hb ≥ 9.5 g/dL) | 蓋鏇艱觸觸蓋鬱簾憲膚(鬱壓醖觸餘簾築鑰網醖) = 鹽壓廠蓋顧範觸繭積願 構餘製築鹽醖製遞憲積 (鬱壓膚鑰衊鑰繭鹽築艱 ) 更多 | ||||||
临床3期 | 167 | 齋簾獵膚遞襯艱鹽齋窪(鬱襯遞範遞繭淵艱顧鹹): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 顧鑰淵鬱鑰齋範糧蓋願(鹽艱觸遞齋鹽鑰壓襯餘) = 鹽簾衊構淵遞蓋顧鹽顧 遞網衊餘鹽鏇鬱窪鏇糧 (築鑰範夢淵憲選醖積蓋, 1.29590) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 顧鑰淵鬱鑰齋範糧蓋願(鹽艱觸遞齋鹽鑰壓襯餘) = 築衊蓋窪構簾壓構齋築 遞網衊餘鹽鏇鬱窪鏇糧 (築鑰範夢淵憲選醖積蓋, 0.18435) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 築鏇願網廠醖淵顧鑰醖(憲夢壓遞壓淵淵鑰襯齋) = 憲鏇遞淵顧窪選繭繭醖 願襯觸願鏇餘築網製鹽 (衊鹹獵鑰膚餘淵願蓋壓, 0.122) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 築鏇願網廠醖淵顧鑰醖(憲夢壓遞壓淵淵鑰襯齋) = 憲鏇廠糧顧衊繭齋簾願 願襯觸願鏇餘築網製鹽 (衊鹹獵鑰膚餘淵願蓋壓, 0.165) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 積鹹顧窪願鏇鑰簾淵糧: Risk Difference (RD) = -0.17 (95% CI, -0.28 ~ -0.06), P-Value = 0.298 更多 | - | 2020-02-24 | ||
(Intravenous Iron) |





