Xocova (ensitrelvir)

New molecular entity

Region: 🇺🇸 US
Active substance: ensitrelvir
Company: Shionogi
Status: Approved
FDA approval: Fri 29 May 2026
Designations: New molecular entity
Application: NDA220442
Official record: www.accessdata.fda.gov

Regulatory milestones

Fri 29 May 2026🇺🇸 FDA approval

FDA approves Xocova (ensitrelvir), a new medicine

Shionogi; NDA220442; New molecular entity; tablet · source

Same substance in other markets

🇪🇺 Zokovea Authorised · Shionogi B.V.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.