FDA Will Review Ensitrelvir for COVID-19 Prevention

FDA will review ensitrelvir for COVID-19 prevention

The FDA on Tuesday accepted a new drug application from Shionogi to market ensitrelvir, an oral antiviral, as post-exposure prophylaxis for COVID-19, the company announced.

FDA Accepts Shionogi’s Ensitrelvir NDA as the First Oral Therapy for the Prevention of COVID-19 Following Exposure

OSAKA, Japan--(BUSINESS WIRE)--Sep 2, 2025-

FDA Accepts Shionogi’s NDA for Ensitrelvir Oral Antiviral in COVID-19 Post-Exposure Prevention

Supported by Phase 3 SCORPIO-PEP trial data, ensitrelvir could become the first oral therapy to prevent COVID-19 following exposure, with an FDA decision due June 16, 2026.