Ensitrelvir Fumaric Acid: First Approval.

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2024-06-01 Epub Date: 2024-05-25 DOI:10.1007/s40265-024-02039-y

Yahiya Y Syed

引用次数: 0

Abstract

Ensitrelvir fumaric acid (Xocova^®) is an oral SARS-CoV-2 main protease inhibitor developed by Shionogi for the treatment of SARS-CoV-2 infection. It is the first single-entity, nonpeptidic, noncovalent, small molecule antiviral of its kind. Following emergency regulatory approval in Japan in November 2022, ensitrelvir received standard approval in Japan on 5 March 2024 for the treatment of SARS-CoV-2 infection. This article summarizes the milestones in the development of ensitrelvir leading to this first standard approval for SARS-CoV-2 infection.

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Ensitrelvir 富马酸：首次批准。

Ensitrelvir fumaric acid (Xocova®) 是由日本盐野义制药开发的一种口服 SARS-CoV-2 主要蛋白酶抑制剂，用于治疗 SARS-CoV-2 感染。它是第一种单实体、非肽、非共价的小分子抗病毒药物。继 2022 年 11 月在日本获得紧急监管批准后，ensitrelvir 于 2024 年 3 月 5 日在日本获得标准批准，用于治疗 SARS-CoV-2 感染。本文总结了 ensitrelvir 开发过程中的里程碑事件，这些事件促成了该药首次获得治疗 SARS-CoV-2 感染的标准批准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.