Shionogi's ensitrelvir NDA accepted for COVID-19 prevention

Shionogi Inc., a U.S. subsidiary of Shionogi & Co., Ltd., announced on September 3, 2025, that the FDA has accepted its New Drug Application (NDA) for ensitrelvir (S-217622) for the prevention of COVID-19 following exposure. The FDA has set an action date of June 16, 2026. This application, based on results from the global SCORPIO-PEP Phase 3 study, aims to make ensitrelvir the first and only oral therapy for post-exposure prophylaxis.

Ensitrelvir, known as Xocova in Japan and Singapore, received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for COVID-19 treatment. Shionogi also submitted two new drug applications in Japan in 2025 for post-exposure prophylaxis of COVID-19 and for pediatric patients aged six to under 12 years. The drug is currently under regulatory review in Taiwan and with the European Medicines Agency for both post-exposure prophylaxis and treatment.