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A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of S-217622 in the Prevention of Symptomatic SARS-CoV-2 Infection in Household Contacts of an Individual With Symptomatic COVID-19

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Trial Profile

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of S-217622 in the Prevention of Symptomatic SARS-CoV-2 Infection in Household Contacts of an Individual With Symptomatic COVID-19

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Ensitrelvir (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SCORPIO-PEP
  • Sponsors Shionogi

Most Recent Events

  • 01 Apr 2025 According to a Shionogi media release, company has announced that it has initiated the rolling submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for oral antiviral ensitrelvir. The rolling submission of ensitrelvir for Post-Exposure Prophylaxis is being made based on the positive results from the Global Phase 3 SCORPIO-PEP trial.
  • 27 Mar 2025 According to a Shionogi media release, based on the results from this study the company has submitted supplemental New Drug Application (sNDA) in Japan for oral antiviral ensitrelvir.
  • 12 Mar 2025 According to a Shionogi media release, data from this trial were presented at the Conference of Retroviruses and Opportunistic Infections (CROI) 2025.

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