Shionogi's COVID Antiviral Xocova Approved by FDA as Post‑Exposure Preventive for COVID-19 in the U.S.

Shionogi's COVID antiviral Xocova (ensitrelvir) has been approved by the U.S. FDA for use as post-exposure prophylaxis of COVID-19.

The FDA approved Xocova (ensitrelvir) on May 29, 2026, for preventing COVID-19 following contact with an infected individual, making it the first oral therapy in the U.S. specifically approved for this use.

The approval is based on the global Phase 3 SCORPIO-PEP study showing ensitrelvir significantly reduced symptomatic COVID-19 after household exposure compared to placebo.

Xocova is already approved in Japan and Singapore for treating COVID-19, and in March 2026 Japan approved an expanded indication for Xocova as post-exposure prophylaxis of COVID-19.

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026, for the U.S. post-exposure prophylaxis indication, but the drug has already been listed as approved by the FDA on May 29, 2026.