Publication date: Jul 31, 2025

Ensitrelvir is a novel antiviral drug that has been evaluated for its effectiveness against Coronavirus disease 2019 (COVID-19). This study aims to gather relevant evidence regarding the efficacy and safety of ensitrelvir in patients diagnosed with COVID-19. A systematic search was conducted in databases including PubMed, the Cochrane Library, Web of Science, and Scopus to identify pertinent studies on ensitrelvir’s role in COVID-19 treatment up to September 2024. Nine studies were included in the analysis, comprising two retrospective studies, two phase 1 trials, three phase 2/3 trials, and two phase 3 trials. The findings indicated that ensitrelvir is associated with a reduced risk of death and shorter hospital stays for COVID-19 patients compared to control groups. Additionally, ensitrelvir demonstrated the ability to lower SARS-CoV-2 viral titers and RNA levels while accelerating the time to viral clearance compared to placebo. Reported adverse events were predominantly mild, with no serious adverse events noted. Ensitrelvir exhibited consistent pharmacokinetics across different populations, eliminating the need for dose adjustments. Ensitrelvir appears to be an effective and safe option for managing mild to moderate COVID-19 infections. However, further studies are needed to establish its efficacy and safety in treating COVID-19.

Semantics

Original Article