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                您當前位置:網站首頁 >> 醫藥新聞 >> 新藥上市 >> 2017年2月FDA批準上市新藥Telotristat ethyl(特羅司他乙酯)
               
               
              2017年2月FDA批準上市新藥Telotristat ethyl(特羅司他乙酯)
              2017-03-03 07:34:05 來源:有機化學網 瀏覽:7886

              致力于研發精準新藥用于治療嚴重慢性疾病的生物制藥公司Lexicon Pharmaceuticals宣布,美國FDA已批準了telotristat ethyl(特羅司他乙酯)新藥申請,telotristat ethyl是首個被批準用于類癌綜合癥(carcinoid syndrome)的口服治療藥物。

              類癌綜合征(Carcinoid Syndrome)是指由類癌細胞(神經內分泌細胞)產生的活性物質如5-羥色胺、緩激肽、組胺等進入血液而引起的皮膚潮紅,腸痙攣,腹瀉等綜合征,嚴重的可能導致心臟瓣膜的損害。目前尚無藥物能有效控制類癌綜合征的癥狀,由于神經內分泌腫瘤的患者一般的預后較好,生存時間較長,因此類癌綜合征可能長期嚴重影響患者的生活質量。

              Telotristat(特羅司他乙酯)是一種色氨酸羥化酶的抑制劑,抑制引起類癌綜合征的5-羥色胺的合成。名為TELESTAR的3期臨床試驗納入了135名罹患類癌綜合征的患者,這些患者使用長效生長抑素類似物控制癥狀效果不佳。在使用長效生長抑素類似物的基礎上研究者將患者隨機分為使用Telotristat(250mg或500mg,每天三次口服)和安慰劑對照組,治療療程為12周。臨床試驗的主要終點為日常腹瀉次數的減少,次要觀察終點為皮膚潮紅和腹痛。其結果顯示,在12周的治療周期里,Telotristat藥物組的患者腹瀉次數顯著減少(P<0.001)。

              Name: Telotristat ethyl (特羅司他乙酯)
              CAS#: 1033805-22-9
              Chemical Formula: C27H26ClF3N6O3
              Exact Mass: 574.1707
              Molecular Weight: 574.9892
              Elemental Analysis: C, 56.40; H, 4.56; Cl, 6.17; F, 9.91; N, 14.62; O, 8.35
              Synonym: LX 1032; LX-1032; LX1032; LX 1606; LX1606; LX-1606; Telotristat ethyl
              Chemical Name: ethyl (S)-2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate

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