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              2018年12月FDA批準上市新藥prucalopride
              2018-12-16 10:19:53 來源:有機化學網 瀏覽:4106

              2018年12月24日,FDA批準一款名為Motegrity(prucalopride,SHP555)的新藥,該藥用于慢性特發性便秘(CIC)成人患者的治療,是今年FDA批準的第56個新藥,也是首款獲FDA批準用于治療CIC的5-HT4受體激動劑。

              慢性功能性便秘是一組多人群發病、多因素存在,以大便排出困難、排便不適感及排便時程延長為主訴的癥候群。依病因可分為原發性(特發性)便秘和繼發性便秘。特發性便秘由于病因不清,治療又困難,因此又稱為“難治性”或“原發性”。據統計,CIC全球發病率約為14%,死亡率雖然不高,但卻嚴重影響患者的生活質量。

              Prucalopride是一種選擇性的,高親和力5-HT4受體激動劑,作用于與慢性便秘相關的受損的腸胃運動,從而使排便正常。在歐洲市場,prucalopride早在2009年獲批以品牌名Resolor上市銷售,該藥適用于瀉藥(laxative)不能提供充分緩解的慢性便秘成人患者的對癥治療。而此次獲批是基于5項Ⅲ期臨床和1項Ⅳ期雙盲臨床的試驗結果,用于研究是否可以用于慢性特發性便秘(CIC)成人患者的治療。

               

              CAS No.: 179474-81-8
              Formula: C18H26ClN3O3
              Exact Mass: 367.16600
              Molecular Weight: 367.87000

               

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