Shionogi announces FDA approval of Xocova (ensitrelvir), the first and only oral option to help prevent COVID-19 following exposure

Shionogi

1 June 2026 - Approval is based on SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the primary outcome of preventing symptomatic COVID-19 following exposure to an infected individual.

Shionogi announced that the US FDA has approved Xocova (ensitrelvir), an oral antiviral, for post-exposure prophylaxis of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.

Read Shionogi press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration