06/17/2026
The FDA has approved ensitrelvir, sold as Xocova, as the first oral antiviral for post-exposure prevention of COVID-19 in people aged 12 years and older after close contact with someone who has COVID-19.
The approval was based on a phase 3 study (linked below) published in The New England Journal of Medicine, which tested a 5-day course of ensitrelvir in household contacts enrolled within 72 hours of exposure to SARS-CoV-2.
The study found that ensitrelvir significantly reduced symptomatic COVID-19 compared with placebo: 2.4% vs 9.9%. It also reduced overall SARS-CoV-2 infections, including asymptomatic infections, and showed evidence of suppressing viral replication.
Side effects were similar between groups, and serious adverse events were uncommon.
Ensitrelvir is already approved in Japan for treating mild-to-moderate COVID-19, but in the U.S., it is only FDA-approved for post-exposure prevention, not acute COVID-19 treatment.
Read the full study: https://doi.org/10.1056/NEJMoa2509306