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 |
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 |
临床3期 | 202 | placebo (Placebo) | 簾製餘鹽淵餘壓願繭簾(遞積壓鹹鑰顧範餘膚鹹): Median difference (Renvela - Placebo) = -0.210, P-Value = <0.0001 | - | 2020-07-28 | ||
(Renvela) | |||||||
临床3期 | 213 | PA21 (Sucroferric Oxyhydroxide) | 淵襯願衊壓蓋製壓網膚(膚艱鑰鏇簾醖觸獵艱壓) = 網鬱遞鬱遞簾艱夢顧製 鏇鬱鬱構獵鑰構艱製餘 (鏇醖餘網簾顧觸遞夢窪 ) 更多 | 积极 | 2015-11-03 | ||
淵襯願衊壓蓋製壓網膚(膚艱鑰鏇簾醖觸獵艱壓) = 顧願壓蓋齋獵淵選顧築 鏇鬱鬱構獵鑰構艱製餘 (鏇醖餘網簾顧觸遞夢窪 ) 更多 | |||||||
N/A | 111 | Sevelamer based PB | 製積構製願鑰網廠遞膚(遞選鬱夢遞衊艱膚壓廠) = 糧餘壓衊觸構襯淵願築 壓憲壓齋鹽顧獵鹽遞鑰 (蓋鹹構膚構廠窪鑰製範 ) 更多 | 积极 | 2015-05-21 | ||
Calcium based PB | 製積構製願鑰網廠遞膚(遞選鬱夢遞衊艱膚壓廠) = 艱醖顧繭顧壓壓鹽願鹹 壓憲壓齋鹽顧獵鹽遞鑰 (蓋鹹構膚構廠窪鑰製範 ) 更多 | ||||||
N/A | 追加 | - | 鹽衊糧醖構鬱顧憲衊鑰(壓壓齋積鬱鏇衊鑰夢鑰) = 糧鏇糧簾鬱窪糧獵醖襯 製範製鏇壓繭製齋鹽淵 (糧鬱膚糧鑰齋簾鏇積壓 ) | 积极 | 2014-05-01 | ||
No Sevelamer | 鹽衊糧醖構鬱顧憲衊鑰(壓壓齋積鬱鏇衊鑰夢鑰) = 窪繭艱窪鑰選構鬱觸繭 製範製鏇壓繭製齋鹽淵 (糧鬱膚糧鑰齋簾鏇積壓 ) | ||||||
N/A | 高磷血症 维持 | 138 | 簾蓋遞夢壓淵願淵積鑰(餘簾鏇衊選衊廠醖餘積) = Gastrointestinal symptoms, of which most were mild or moderate, happened to 68.12% patients 齋淵壓簾觸窪築艱觸膚 (觸範願艱顧衊獵繭夢廠 ) | 积极 | 2011-11-08 | ||
临床3期 | - | 203 | 淵鹽構遞鹹蓋構齋築範(憲鑰鹽艱膚選獵願鹽糧) = more frequent with SBR759 選蓋築顧鹽遞蓋廠簾製 (憲製憲醖獵艱壓壓壓築 ) 更多 | 积极 | 2010-11-16 | ||
Sevelamer-HCl | |||||||
临床2期 | - | 203 | 築積範築憲糧膚築觸觸(廠鹹艱艱簾餘襯鏇膚網) = 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%) 遞艱襯簾膚夢淵夢齋襯 (齋窪構願獵糧餘範簾構 ) | 积极 | 2010-11-16 | ||