FDA Approves Ensitrelvir to Prevent COVID-19 After Exposure - Takeaways - MDSpire

FDA Approves Ensitrelvir to Prevent COVID-19 After Exposure

Phase 3 data showed a 67% reduction in symptomatic infection among exposed household contacts who tested negative at baseline.

  • By

  • Kathryn Wighton

  • June 2, 2026

  • 3 min

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  • 1

    The FDA has approved ensitrelvir (XOCOVA) for postexposure prophylaxis of COVID-19 in individuals aged 12 and older.

  • 2

    Ensitrelvir is the first oral option approved to prevent COVID-19 following exposure to an infected individual.

  • 3

    The approval was based on the phase 3 SCORPIO-PEP trial, which enrolled 2,387 participants exposed to symptomatic COVID-19.

  • 4

    Ensitrelvir reduced the risk of symptomatic COVID-19 by 67% compared to placebo among uninfected participants.

  • 5

    The most common adverse events with ensitrelvir were headache, diarrhea, and cough, with overall rates similar to placebo.

Original Source(s)

FDA Approves Ensitrelvir to Prevent COVID-19 After Exposure

  • by Kathryn Wighton

  • June 2, 2026

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