Ensitrelvir Fumaric Acid: First Approval.

Authors :: Syed YY
Source :: Drugs [Drugs] 2024 Jun; Vol. 84 (6), pp. 721-728. Date of Electronic Publication: 2024 May 25.
Publication Year :: 2024
Abstract: Ensitrelvir fumaric acid (Xocova <superscript>®</superscript> ) 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.<br /> (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)