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FDA Medication Tracker

← All approvals · Infections & vaccines · 2026

Xocova (ensitrelvir)

The FDA approved Xocova (ensitrelvir) on May 29, 2026 to use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19.
Brand name
Xocova
Generic name
ensitrelvir
FDA approval date
May 29, 2026
Approved use (FDA wording)
To use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19
Company
Shionogi
Application
NDA220442
Dosage form / route
TABLET · ORAL
Boxed warning on label
Not listed
Category on this site
Infections & vaccines

Indications and usage, from the FDA label

XOCOVA is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (M pro : also referred to as 3CL pro or nsp5 protease) inhibitor, is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID‑19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.