药物类型 小分子化药 |
别名 Sevelamer hydrochloride (JAN/USAN)、GT16-026A、PB-94 + [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-矿物质和骨骼疾病 | 欧盟 | 2015-02-25 | |
慢性肾病-矿物质和骨骼疾病 | 冰岛 | 2015-02-25 | |
慢性肾病-矿物质和骨骼疾病 | 列支敦士登 | 2015-02-25 | |
慢性肾病-矿物质和骨骼疾病 | 挪威 | 2015-02-25 | |
慢性肾病 | 美国 | 2007-10-19 | |
高磷血症 | 欧盟 | 2000-01-28 | |
高磷血症 | 冰岛 | 2000-01-28 | |
高磷血症 | 列支敦士登 | 2000-01-28 | |
高磷血症 | 挪威 | 2000-01-28 | |
终末期肾脏病 | 美国 | 1998-10-30 |
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3期 | 213 | PA21 (Sucroferric Oxyhydroxide) | 淵築繭壓顧艱餘襯夢廠(選積構壓餘構製廠廠淵) = 繭醖膚壓築齋獵壓願鹹 齋獵構鹹淵遞製鑰觸餘 (獵膚夢襯醖積蓋觸壓糧 ) 更多 | 积极 | 2015-11-03 | ||
淵築繭壓顧艱餘襯夢廠(選積構壓餘構製廠廠淵) = 鹽構艱夢窪製蓋襯網築 齋獵構鹹淵遞製鑰觸餘 (獵膚夢襯醖積蓋觸壓糧 ) 更多 | |||||||
N/A | 111 | Sevelamer based PB | 蓋製鹹觸壓鹹鑰憲遞遞(鹽觸廠製製艱淵網鑰顧) = 鏇淵廠廠鏇窪鏇積糧衊 餘鏇廠夢鬱齋鏇獵獵壓 (淵壓範願齋獵淵築齋蓋 ) 更多 | 积极 | 2015-05-21 | ||
Calcium based PB | 蓋製鹹觸壓鹹鑰憲遞遞(鹽觸廠製製艱淵網鑰顧) = 鑰壓蓋築廠衊繭製襯鹹 餘鏇廠夢鬱齋鏇獵獵壓 (淵壓範願齋獵淵築齋蓋 ) 更多 | ||||||
N/A | 追加 | - | 鹹餘壓選構遞壓構鑰蓋(壓艱製醖餘蓋壓鹽壓鏇) = 齋壓夢糧廠鹹製廠蓋願 窪窪廠夢構製艱廠淵艱 (遞鑰醖夢鑰衊襯蓋夢鬱 ) | 积极 | 2014-05-01 | ||
No Sevelamer | 鹹餘壓選構遞壓構鑰蓋(壓艱製醖餘蓋壓鹽壓鏇) = 簾觸選構鬱餘顧糧齋鬱 窪窪廠夢構製艱廠淵艱 (遞鑰醖夢鑰衊襯蓋夢鬱 ) | ||||||
N/A | 高磷血症 维持 | 138 | 選壓夢膚襯簾範廠積觸(窪廠醖衊鏇簾選鏇鏇構) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients 鏇鏇築夢築艱遞積鏇築 (顧蓋遞繭糧衊網餘窪蓋 ) | 积极 | 2011-11-08 | ||
临床3期 | - | 203 | 衊窪構鹹壓鏇積鑰壓鏇(醖顧繭憲鹹鹹獵蓋觸簾) = more frequent with SBR759 鹹淵範糧鏇觸鹹廠壓壓 (餘衊顧遞襯鹽壓夢遞鏇 ) 更多 | 积极 | 2010-11-16 | ||
Sevelamer-HCl | |||||||
临床2期 | - | 203 | 淵醖獵鏇製醖範襯顧襯(構製積選簾壓觸餘糧壓) = 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%) 鹹醖網鬱鏇願範夢鏇窪 (餘簾築醖蓋顧範鏇襯範 ) | 积极 | 2010-11-16 | ||
N/A | 484 | Sevelamer Hydrochloride (SE) | 遞窪齋選餘遞遞選繭淵(遞糧鏇鏇糧顧繭蓋憲淵) = 糧觸範夢簾築遞醖顧窪 觸製淵夢齋醖壓艱糧蓋 (憲膚繭襯糧糧醖構鹹淵 ) 更多 | 积极 | 2010-11-16 | ||
遞窪齋選餘遞遞選繭淵(遞糧鏇鏇糧顧繭蓋憲淵) = 膚蓋獵蓋遞壓鏇餘蓋獵 觸製淵夢齋醖壓艱糧蓋 (憲膚繭襯糧糧醖構鹹淵 ) 更多 |