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伏诺拉生:全球首次获批

Vonoprazan: first global approval.

机构信息

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand,

出版信息

Drugs. 2015 Mar;75(4):439-43. doi: 10.1007/s40265-015-0368-z.

Abstract

Vonoprazan (Takecab(®)) is an orally bioavailable potassium-competitive acid blocker (P-CAB) being developed by Takeda for the treatment and prevention of acid-related diseases. The drug is approved in Japan for the treatment of acid-related diseases, including erosive oesophagitis, gastric ulcer, duodenal ulcer, peptic ulcer, gastro-oesophageal reflux, reflux oesophagitis and Helicobacter pylori eradication. Phase III development is underway for the prevention of recurrence of duodenal and gastric ulcer in patients receiving aspirin or NSAID therapy. Phase I development was conducted in the UK for gastro-oesophageal reflux; however, no further development has been reported. This article summarizes the milestones in the development of vonoprazan leading to this first approval for acid-related diseases.

摘要

伏诺拉生(商品名:卫采乐®)是武田制药公司开发的一种口服生物利用度的钾离子竞争性酸阻滞剂(P-CAB),用于治疗和预防与酸相关的疾病。该药已在日本获批用于治疗与酸相关的疾病,包括糜烂性食管炎、胃溃疡、十二指肠溃疡、消化性溃疡、胃食管反流病、反流性食管炎和幽门螺杆菌根除。目前正在进行 III 期临床试验,以预防接受阿司匹林或 NSAID 治疗的患者十二指肠和胃溃疡的复发。该药的 I 期临床试验在英国进行,用于胃食管反流,但目前尚无进一步的开发进展。本文总结了伏诺拉生在开发过程中的里程碑事件,最终该药获得了与酸相关疾病的首个批准。

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