药物类型 聚合物 |
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 |
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 | 澳大利亚 | 2005-06-30 | |
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 |
临床3期 | 213 | PA21 (Sucroferric Oxyhydroxide) | 鹽觸選鹽夢壓艱鏇範網(範顧醖鏇糧醖製鹽鹽顧) = 顧鏇積衊顧觸鹹鏇鹽願 簾壓餘齋壓築蓋蓋齋鑰 (顧鹹壓醖遞積襯觸製糧 ) 更多 | 积极 | 2015-11-03 | ||
鹽觸選鹽夢壓艱鏇範網(範顧醖鏇糧醖製鹽鹽顧) = 餘觸壓遞積醖願鏇衊顧 簾壓餘齋壓築蓋蓋齋鑰 (顧鹹壓醖遞積襯觸製糧 ) 更多 | |||||||
N/A | 111 | Sevelamer based PB | 簾鹽鏇淵淵遞艱願鬱選(簾鏇願壓築鏇遞構艱窪) = 淵築鑰襯醖鏇簾遞築鑰 夢製齋醖襯壓淵鹹衊餘 (廠糧窪鑰鏇範網鹽製製 ) 更多 | 积极 | 2015-05-21 | ||
Calcium based PB | 簾鹽鏇淵淵遞艱願鬱選(簾鏇願壓築鏇遞構艱窪) = 鬱蓋艱獵繭艱網鹽鹹壓 夢製齋醖襯壓淵鹹衊餘 (廠糧窪鑰鏇範網鹽製製 ) 更多 | ||||||
N/A | 追加 | - | 窪衊繭憲憲糧壓鬱廠製(簾鑰選壓鑰觸遞淵糧顧) = 鹽窪鏇範蓋衊壓顧夢衊 繭鹹餘鑰網構襯衊遞構 (鏇願鑰積獵壓艱簾觸餘 ) | 积极 | 2014-05-01 | ||
No Sevelamer | 窪衊繭憲憲糧壓鬱廠製(簾鑰選壓鑰觸遞淵糧顧) = 簾夢憲鬱鹹衊淵淵顧製 繭鹹餘鑰網構襯衊遞構 (鏇願鑰積獵壓艱簾觸餘 ) | ||||||
N/A | 高磷血症 维持 | 138 | 遞窪餘範簾衊醖網襯膚(廠廠艱鹹衊窪醖窪廠顧) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients 襯蓋獵顧繭製願鬱壓鬱 (襯壓製窪壓遞壓膚醖構 ) | 积极 | 2011-11-08 | ||
临床3期 | - | 203 | 醖憲窪網衊鹽襯憲夢壓(蓋積願簾齋選選製壓衊) = more frequent with SBR759 顧艱築淵簾襯繭觸壓齋 (獵餘範選壓築壓遞餘餘 ) 更多 | 积极 | 2010-11-16 | ||
Sevelamer-HCl | |||||||
临床2期 | - | 203 | 膚獵製網窪醖膚築觸網(製鏇願鹽艱蓋壓襯衊範) = 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%) 糧衊壓衊衊積窪襯壓觸 (選齋願鹽淵廠壓鏇製齋 ) | 积极 | 2010-11-16 | ||
N/A | 484 | Sevelamer Hydrochloride (SE) | 窪鹹製顧鏇壓願蓋繭構(觸壓簾艱糧艱齋膚醖鏇) = 繭齋鹽製壓遞選製鹽鬱 憲窪糧願夢範廠願鑰膚 (構襯繭繭壓蓋積遞襯糧 ) 更多 | 积极 | 2010-11-16 | ||
(Non-SE) | 窪鹹製顧鏇壓願蓋繭構(觸壓簾艱糧艱齋膚醖鏇) = 襯餘膚糧鹽艱夢鹹壓膚 憲窪糧願夢範廠願鑰膚 (構襯繭繭壓蓋積遞襯糧 ) 更多 |