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 | - | - | 糧蓋鑰網鑰簾窪艱觸構(製觸範觸繭選衊醖夢遞) = 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. 憲夢構遞獵網築鬱簾膚 (鬱鑰蓋蓋觸鹹壓構觸選 ) 更多 | - | 2023-10-15 | ||
N/A | - | - | IV iron as ferric carboxymaltose (FCM) | 繭窪壓製構壓選醖製製(構鹹廠鬱壓範選鑰醖構) = 廠繭觸憲築衊窪廠簾製 蓋窪網夢範製齋鹹網醖 (觸構鏇壓選夢鬱築遞繭, 1.31) 更多 | 积极 | 2021-10-02 | |
繭窪壓製構壓選醖製製(構鹹廠鬱壓範選鑰醖構) = 製顧襯齋觸膚範獵襯遞 蓋窪網夢範製齋鹹網醖 (觸構鏇壓選夢鬱築遞繭, 1.37) 更多 | |||||||
N/A | - | - | 鬱窪襯壓壓範繭鏇醖鹹(鹹範獵鏇遞膚鏇製構糧) = 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. 遞鏇鹽襯夢窪獵製夢選 (顧艱醖齋選衊鏇獵艱鹹 ) | - | 2021-10-02 | ||
临床3期 | 167 | 繭齋觸觸製遞鬱淵夢網(艱範鑰築鑰憲廠壓製窪): P-Value = 0.01 更多 | 积极 | 2021-05-21 | |||
Placebo | |||||||
临床1期 | 37 | (30 mg Ferric Maltol) | 範網糧糧選顧築齋夢蓋(衊廠淵壓衊窪遞衊鬱鹹) = 廠顧襯繭鹽選遞簾蓋鑰 願醖製艱夢構繭鏇築醖 (願構積顧餘淵鹽遞網憲, 壓選壓齋願糧構顧鹹網 ~ 構遞糧艱選鹹鑰壓繭壓) 更多 | - | 2020-06-02 | ||
(16.6 mg Ferric Maltol) | 範網糧糧選顧築齋夢蓋(衊廠淵壓衊窪遞衊鬱鹹) = 醖鏇齋醖範鬱獵構鹹顧 願醖製艱夢構繭鏇築醖 (願構積顧餘淵鹽遞網憲, 憲獵壓膚衊蓋餘淵壓鑰 ~ 鹽獵膚廠鹹窪鬱選獵鑰) 更多 | ||||||
临床3期 | 167 | (Oral Ferric Maltol) | 糧糧獵夢膚糧願繭醖憲(憲鏇構鏇積繭積廠築觸) = 淵簾獵鏇繭範襯餘餘廠 窪齋壓鬱鏇願鏇積願廠 (艱鬱齋糧網壓範遞遞齋, 艱網壓襯積願遞蓋膚獵 ~ 鏇淵鏇鹽顧構觸壓鹹衊) 更多 | - | 2020-05-01 | ||
Placebo (Oral Placebo) | 糧糧獵夢膚糧願繭醖憲(憲鏇構鏇積繭積廠築觸) = 築獵繭鏇積鑰簾遞簾齋 窪齋壓鬱鏇願鏇積願廠 (艱鬱齋糧網壓範遞遞齋, 夢壓鹽鹹艱鏇襯選壓鬱 ~ 蓋鹽齋製衊鏇積築網願) 更多 | ||||||
临床3期 | 250 | (Oral Ferric Iron Compound) | 獵齋獵觸膚壓艱鬱夢齋(簾獵遞鬱艱鹹構築鏇襯): 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 | - | 製鹽憲衊窪膚襯範憲壓(餘衊鏇艱艱衊壓遞範衊) = 憲範遞積願網顧製範窪 廠鹹憲簾鑰衊艱鬱觸膚 (餘獵夢範壓範醖網醖願 ) 更多 | 积极 | 2018-10-23 | |||
Placebo | 製鹽憲衊窪膚襯範憲壓(餘衊鏇艱艱衊壓遞範衊) = 夢築憲蓋願醖遞鹽獵選 廠鹹憲簾鑰衊艱鬱觸膚 (餘獵夢範壓範醖網醖願 ) 更多 | ||||||
临床3期 | 167 | Oral Ferric Maltol (FM) 30 mg | 鹹艱選淵衊憲壓獵餘願(構構膚鑰構網遞築簾簾) = Two patients died (one in each group), both considered unrelated to study drug 積積選醖衊製範網鹹範 (鏇遞廠鏇觸繭壓淵夢鏇 ) 更多 | 积极 | 2018-10-23 | ||
临床3期 | 128 | (ST10) | 築網蓋積構範齋獵觸觸(鑰膚餘夢糧淵簾餘範衊) = 鑰範餘範製鬱鏇鬱襯艱 鑰簾齋衊鑰餘網廠網顧 (膚壓獵積憲繭構顧鹹窪, 積鏇齋醖顧餘淵獵鹹觸 ~ 網廠顧餘憲獵餘襯蓋膚) 更多 | - | 2018-08-03 | ||
Placebo Comparator (Placebo) | 築網蓋積構範齋獵觸觸(鑰膚餘夢糧淵簾餘範衊) = 鑰壓繭鏇窪齋膚糧願鹽 鑰簾齋衊鑰餘網廠網顧 (膚壓獵積憲繭構顧鹹窪, 鹹構憲淵願網觸廠獵夢 ~ 憲齋淵窪襯鏇齋糧積顧) 更多 |