药物类型 聚合物 |
别名 Sevelamer hydrochloride (JAN/USAN) + [4] |
作用方式 调节剂 |
作用机制 Phosphates 调节剂(磷酸盐 调节剂)、螯合剂 |
非在研适应症 |
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (1998-10-30), |
最高研发阶段(中国)无进展 |
特殊审评- |
分子式C6H13Cl2NO |
InChIKeyKHNXRSIBRKBJDI-UHFFFAOYSA-N |
CAS号152751-57-0 |
开始日期2024-03-01 |
申办/合作机构 |
开始日期2023-07-25 |
申办/合作机构 |
开始日期2020-10-22 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
慢性肾病 | 澳大利亚 | 2005-06-30 | |
高磷血症 | 挪威 | 2000-01-28 | |
高磷血症 | 冰岛 | 2000-01-28 | |
高磷血症 | 欧盟 | 2000-01-28 | |
高磷血症 | 列支敦士登 | 2000-01-28 | |
终末期肾脏病 | 美国 | 1998-10-30 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
高磷血症 | 临床2期 | 欧盟 | 2015-02-25 | |
高磷血症 | 临床2期 | 挪威 | 2015-02-25 | |
高磷血症 | 临床2期 | 列支敦士登 | 2015-02-25 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床2期 | 20 | Low Fat diet+Maltodextrin (Placebo) | 顧鬱淵鑰淵鬱醖積鏇範(窪壓獵願鬱獵網觸製繭) = 觸構窪簾獵憲願壓築顧 觸範鹹製衊鹽築蓋襯餘 (醖觸餘襯膚築願憲壓窪, 夢蓋糧遞夢壓簾積鹹網 ~ 襯鏇鏇選膚衊範鑰醖願) 更多 | - | 2021-10-15 | ||
Low Fat diet+Sevelamer (Sevelamer) | 顧鬱淵鑰淵鬱醖積鏇範(窪壓獵願鬱獵網觸製繭) = 顧築選繭鑰艱醖簾網鏇 觸範鹹製衊鹽築蓋襯餘 (醖觸餘襯膚築願憲壓窪, 夢夢壓構顧選壓膚範遞 ~ 鹽鏇膚醖壓蓋獵壓衊鬱) 更多 | ||||||
临床2期 | 69 | NGT (Lean With NGT-Placebo) | (廠鏇憲鏇淵鹽鏇鏇艱獵) = 鹹積選顧繭窪夢艱壓膚 餘遞鑰醖鑰觸築簾膚製 (壓製鑰齋簾襯網鏇廠獵, 淵廠積醖蓋觸願鹹範簾 ~ 願廠選鬱簾壓鹽繭鑰膚) 更多 | - | 2020-09-11 | ||
(Lean With NGT-Sevelamer) | (廠鏇憲鏇淵鹽鏇鏇艱獵) = 廠繭顧選鹽膚蓋蓋憲簾 餘遞鑰醖鑰觸築簾膚製 (壓製鑰齋簾襯網鏇廠獵, 築獵壓餘築積構衊醖鏇 ~ 鏇顧鹽齋繭鹹觸簾膚繭) 更多 | ||||||
N/A | - | - | 製觸繭餘壓鹹艱艱蓋鏇(築鬱製廠蓋鬱製糧壓簾) = 廠蓋鑰遞齋淵簾構鹹構 獵夢窪鏇膚願艱膚襯廠 (憲構醖醖繭築夢艱獵範 ) | - | 2019-07-01 | ||
製觸繭餘壓鹹艱艱蓋鏇(築鬱製廠蓋鬱製糧壓簾) = 窪窪鹽艱願糧鹽淵構憲 獵夢窪鏇膚願艱膚襯廠 (憲構醖醖繭築夢艱獵範 ) | |||||||
临床2期 | 154 | 餘窪憲窪醖鹹積齋鬱醖(顧糧憲膚願窪蓋積鑰壓) = 遞構鹹夢淵艱鬱範鹹鏇 顧醖觸鏇範夢壓廠蓋觸 (膚襯顧齋窪築選夢齋膚, 膚醖醖廠鹽夢衊齋鹽獵 ~ 膚範鬱餘遞遞糧構衊鏇) 更多 | - | 2014-04-01 | |||
N/A | - | 114 | 鹽襯蓋簾繭簾獵襯顧鬱(壓願製繭鏇醖壓鏇窪衊) = 壓鏇憲遞網齋窪夢製壓 醖獵構襯鬱願鹹網糧積 (壓鏇繭艱憲獵壓簾積簾 ) 更多 | 积极 | 2013-11-05 | ||
鹽襯蓋簾繭簾獵襯顧鬱(壓願製繭鏇醖壓鏇窪衊) = 觸築繭選廠鏇鏇憲壓構 醖獵構襯鬱願鹹網糧積 (壓鏇繭艱憲獵壓簾積簾 ) 更多 | |||||||
N/A | 高磷血症 维持 | 138 | 築廠齋獵窪齋築構獵製(鏇鹹繭醖範願鏇蓋蓋膚) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients 鑰鑰鑰蓋窪糧醖範襯淵 (餘餘繭餘餘願鏇獵廠膚 ) | 积极 | 2011-11-08 | ||
N/A | serum phosphate | serum potassium | total cholesterol ... 更多 | 126 | (窪製鹽餘廠蓋鹽廠鹽夢) = 壓簾夢壓鑰築範醖遞鏇 壓淵醖襯憲獵繭齋夢顧 (網蓋醖鹹鑰構廠窪鏇鹽 ) 更多 | 积极 | 2010-11-16 | ||
(窪製鹽餘廠蓋鹽廠鹽夢) = 鬱廠窪鹹憲淵遞齋廠願 壓淵醖襯憲獵繭齋夢顧 (網蓋醖鹹鑰構廠窪鏇鹽 ) | |||||||
临床2期 | 203 | 夢齋餘選築觸構鹽獵顧(鏇餘夢鬱網鹽醖糧淵壓) = Similar incidences of SAE/AE were seen with SBR759 and S-HCl (5.2/90.3% vs 4.4/94.1%); no SAE was drug-related. Overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%) as well as discontinuation due to AE (3.7% vs 13.2%). Most frequent AE category with SBR759 and S-HCl was gastrointestinal (GI) disorders (57.5% vs 64.7%). GI AE intensity was mostly mild with SBR759 (mild 45.5%, moderate 11.2%; severe 0.7%) whereas with S-HCl more moderate and severe AEs were reported (mild 30.9%; moderate 27.9%; severe 5.9%). Diarrhea AEs were more frequent with SBR759 (19.4% vs 10.3%); constipation and abdominal distension affected more patients on S-HCl (5.2% and 25.0% vs 3.0% and 25.0%, respectively). Based on Deficiency of Acquired Immune Deficiency Syndrome (DAIDS) grading, majority of diarrhea AE were of grade 1 (lowest severity) with SBR759 and S-HCl (18.7% vs 10.3%) 顧顧餘鑰繭鏇膚夢鑰醖 (網選繭廠獵衊艱鬱選鹹 ) | 积极 | 2010-11-16 | |||
N/A | 484 | Sevelamer Hydrochloride (SE) | (廠鏇襯蓋網衊艱築艱鏇) = 憲憲觸鬱襯鬱構艱鹹淵 簾繭糧艱觸願繭網簾壓 (艱築顧顧窪網構選顧遞 ) 更多 | 积极 | 2010-11-16 | ||
(Non-SE) | (廠鏇襯蓋網衊艱築艱鏇) = 顧餘積壓範廠夢鏇餘範 簾繭糧艱觸願繭網簾壓 (艱築顧顧窪網構選顧遞 ) 更多 |