Vonoprazan: First Global Approval

Vonoprazan: First Global Approval
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DOI:
10.1007/s40265-015-0368-z
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发表时间:
2015-03-01
期刊:
影响因子:
11.5
通讯作者:
Garnock-Jones, Karly P.
Garnock-Jones, Karly P.
中科院分区:
医学1区
文献类型:
--
作者:
Garnock-Jones, Karly P.

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沃诺拉赞(Takecab(R))是一种口服生物可利用的钾竞争性酸阻滞剂(P-CAB),由武田开发,用于治疗和预防酸相关疾病。该药在日本获批用于治疗酸相关疾病,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、反流性食管炎和根除幽门螺杆菌。正在进行III期开发,用于预防接受阿司匹林或NSAID治疗的患者的十二指肠溃疡和胃溃疡复发。在英国进行了胃食管反流的I期开发;然而,尚未报告进一步的开发。本文总结了沃诺拉赞开发过程中导致首次批准用于酸相关疾病的里程碑。
Vonoprazan (Takecab((R))) 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.