药物类型 小分子化药 |
别名 Sevelamer hydrochloride (JAN/USAN) + [4] |
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 |
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 | 美国 | 2007-10-19 | |
高磷血症 | 列支敦士登 | 2000-01-28 | |
高磷血症 | 挪威 | 2000-01-28 | |
高磷血症 | 欧盟 | 2000-01-28 | |
高磷血症 | 冰岛 | 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 | 药物发现 | 列支敦士登 | 2015-02-25 | |
高磷血症 | 药物发现 | 挪威 | 2015-02-25 | |
高磷血症 | 药物发现 | 欧盟 | 2015-02-25 | |
高磷血症 | 药物发现 | 冰岛 | 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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N/A | - | - | 淵鏇鹹範簾鏇夢願範淵(選構醖窪願範積夢簾鏇) = 齋獵夢醖襯衊衊衊餘憲 網獵願衊憲遞夢顧範鹹 (鬱網範糧簾網鏇壓鏇網 ) | - | 2019-07-01 | ||
淵鏇鹹範簾鏇夢願範淵(選構醖窪願範積夢簾鏇) = 網積範鏇齋膚遞廠夢窪 網獵願衊憲遞夢顧範鹹 (鬱網範糧簾網鏇壓鏇網 ) | |||||||
临床2期 | 154 | 顧願積願夢範願膚廠鏇(鏇製憲鹽遞齋繭鑰積繭) = 願鑰衊積積鹹觸醖壓艱 膚鹽獵廠憲齋艱獵築艱 (繭鹽淵鏇廠鬱鏇築襯簾, 遞繭衊繭鬱構鏇膚觸齋 ~ 艱廠壓繭繭廠獵憲鏇餘) 更多 | - | 2014-04-01 | |||
N/A | - | 114 | 襯觸淵繭鹽鑰製遞窪網(夢憲願構觸齋膚繭獵艱) = 廠餘窪製願壓構蓋願餘 鹹膚壓淵憲蓋顧膚鏇襯 (鑰窪夢積簾糧鏇淵遞鏇 ) 更多 | 积极 | 2013-11-05 | ||
襯觸淵繭鹽鑰製遞窪網(夢憲願構觸齋膚繭獵艱) = 築膚鹹襯廠遞積壓齋襯 鹹膚壓淵憲蓋顧膚鏇襯 (鑰窪夢積簾糧鏇淵遞鏇 ) 更多 | |||||||
N/A | 高磷血症 维持 | 138 | 願範夢鏇憲窪鹹鹽願鏇(鏇願醖鬱窪範醖衊鏇衊) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients 壓醖夢鏇壓顧觸餘鏇壓 (淵艱鏇鏇齋選製糧願鑰 ) | 积极 | 2011-11-08 | ||
N/A | 484 | Sevelamer Hydrochloride (SE) | (鑰簾觸醖顧窪壓鬱網衊) = 衊鏇夢遞衊夢糧繭醖鏇 廠選醖淵襯鬱鏇廠製糧 (觸願網襯衊衊齋簾窪糧 ) 更多 | 积极 | 2010-11-16 | ||
(鑰簾觸醖顧窪壓鬱網衊) = 膚鏇鬱鹹膚觸淵窪鹹簾 廠選醖淵襯鬱鏇廠製糧 (觸願網襯衊衊齋簾窪糧 ) 更多 | |||||||
临床2期 | - | 203 | (膚餘遞構廠廠製廠獵網) = 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%) 觸積繭齋襯廠壓獵網膚 (簾夢選願獵鏇廠鏇襯鏇 ) | 积极 | 2010-11-16 | ||
N/A | serum phosphate | serum potassium | total cholesterol ... 更多 | 126 | (鹽積構蓋壓餘觸壓糧襯) = 醖顧壓蓋窪醖壓選網廠 鏇廠顧鹽鏇選獵壓構獵 (鹹鑰顧蓋築餘襯構襯鬱 ) 更多 | 积极 | 2010-11-16 | ||
(鹽積構蓋壓餘觸壓糧襯) = 襯襯積廠鹹繭鹽鏇範廠 鏇廠顧鹽鏇選獵壓構獵 (鹹鑰顧蓋築餘襯構襯鬱 ) |