Overview
- Xocova (ensitrelvir) received FDA approval for post-exposure prophylaxis on Monday, June 1, 2026, for people aged 12 years and older, the manufacturer Shionogi said.
- The decision was based on phase 3 SCORPIO-PEP results that showed the drug cut COVID incidence in household contacts to 2.9% versus 9.0% with placebo when started within three days of the index case’s symptoms.
- The authorized regimen is oral and five days long, beginning with three 125-milligram tablets on day one followed by one 125-milligram tablet daily on days two through five, and treatment must start within 72 hours of exposure.
- Prescribing guidance warns against coadministration with drugs mainly metabolized by CYP3A, advises that the drug may harm a fetus, and says breastfeeding should be paused during treatment and for two weeks after the final dose.
- Ensitrelvir is a SARS-CoV-2 main protease inhibitor already used in Japan for post-exposure prevention and treatment of mild COVID, and U.S. officials and clinicians see it as a complementary tool for household exposures and outbreak control while vaccine uptake remains low.