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COVID-19

Shionogi Inc. Submits New Drug Application for Oral Antiviral COVID-19 Prevention

Strategic Insights

— 2 min read

Shionogi Inc. has made significant progress in the development of an oral antiviral medication for COVID-19 prevention, submitting a New Drug Application (NDA) to the U.S. FDA for ensitrelvir fumarate. The FDA has accepted the NDA and set a target date for completion of the review (PDUFA date) as June 16, 2026. If approved, ensitrelvir will be the world's first and only oral antiviral drug available for COVID-19 prevention. This breakthrough is based on positive results from the global Phase 3 SCORPIO-PEP study, which demonstrated the efficacy of ensitrelvir in inhibiting viral replication and preventing infection.

Key Takeaways:

  • Shionogi Inc. has submitted an NDA to the U.S. FDA for ensitrelvir fumarate, an oral antiviral medication for COVID-19 prevention, with a PDUFA date set as June 16, 2026.
  • The FDA has accepted the NDA, paving the way for potential approval and commercialization of ensitrelvir.
  • Ensitrelvir is designed to be the world's first and only oral antiviral drug available for COVID-19 prevention if approved.
  • The medication is based on positive results from the global Phase 3 SCORPIO-PEP study, which demonstrated the efficacy of ensitrelvir in inhibiting viral replication and preventing infection.
  • Shionogi Inc. has also submitted applications for additional indications for the prevention of COVID-19 infection in Japan, and has received emergency approval in Japan in November 2022 and regular approval in March 2024.
  • The company has also conducted domestic Phase 3 clinical trials in children, confirming favorable safety and tolerability, and has extended the current range of administration from 12 years and older to 6 years and older and weighing 20 kg or more.

Statistics:

  • The FDA's target date for action (PDUFA date) is June 16, 2026.
  • Ensitrelvir has been granted emergency approval in Japan in November 2022 and regular approval in March 2024.
  • The medication demonstrated efficacy in improving five symptoms of COVID-19 characteristic of the Omicron strain in a Phase 3 part of a Phase 2/3 clinical trial (SCORPIO-SR trial) conducted during the Omicron strain epidemic.
  • Ensitrelvir is expected to be the world's first and only oral antiviral available for post-exposure prophylaxis in the United States.

Sources:

  • Shionogi & Co., Ltd. (2025, September 3). Shionogi & Co., Ltd. and its U.S. group company, Shionogi Inc., have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ensitrelvir fumarate (brand name in Japan: Zocova® ; hereinafter "ensitrelvir") for the treatment of COVID-19 for post-exposure prophylaxis* of COVID-19, and the NDA has been accepted.
  • [Source citation 1: https://www.shionogi.com/jp/ja/news/2025/09/20250903.html]
  • [Source citation 2: https://www.shionogi.com/jp/ja/quest.html]

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