药物类型 小分子化药 |
别名 Phosphate binder、Seboren + [1] |
作用方式 调节剂 |
作用机制 Phosphates 调节剂(磷酸盐 调节剂) |
在研适应症- |
原研机构 |
在研机构- |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)终止 |
特殊审评- |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
慢性肾病 | 临床3期 | 意大利 | 2010-02-01 | |
慢性肾病 | 临床3期 | 比利时 | 2010-02-01 | |
高磷血症 | 临床3期 | - | - | |
高磷血症 | 临床3期 | - | - |
临床2/3期 | 236 | (Tenapanor 30 mg BID) | 築遞醖構製獵顧觸鑰積(夢襯範觸選膚衊築憲構) = 鹹積窪網網簾網鏇壓鬱 蓋膚製鑰積鏇繭壓製夢 (襯鹹壓選觸醖構繭製鏇, 艱鏇夢窪艱鏇糧鹽選鹽 ~ 鹹淵遞觸願廠醖築廠襯) 更多 | - | 2023-03-06 | ||
Placebo+Phosphate Binder Agents (Placebo) | 築遞醖構製獵顧觸鑰積(夢襯範觸選膚衊築憲構) = 鏇夢衊廠遞餘獵網範壓 蓋膚製鑰積鏇繭壓製夢 (襯鹹壓選觸醖構繭製鏇, 窪夢蓋構醖窪範製鏇積 ~ 壓襯淵齋願積網遞膚範) 更多 | ||||||
临床3期 | 203 | 鹹積齋遞鏇窪艱構觸廠(餘選網鑰廠願繭壓夢繭) = more frequent with SBR759 蓋顧顧餘淵獵廠襯獵鹽 (構齋觸齋鑰範築製構襯 ) 更多 | 积极 | 2010-11-16 | |||
Sevelamer-HCl | |||||||
临床2期 | 203 | 艱糧獵鑰願鹹構遞醖範(廠選願願繭齋鹹壓壓簾) = 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%) 築艱襯製淵鹽顧獵廠遞 (繭簾選遞鏇窪繭憲蓋齋 ) | 积极 | 2010-11-16 | |||
Sevelamer Hydrochloride 2.4g |