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Ensitrelvir - Shionogi

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Drug Profile

Ensitrelvir - Shionogi

Alternative Names: Ensitrelvir fumarate - Shionogi; Ensitrelvir fumaric acid - Shionogi; S-217622; SARS-CoV2 3C-like protease inhibitor - Shionogi; Xocova

Latest Information Update: 18 Sep 2025

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At a glance

  • Originator Hokkaido University; Shionogi
  • Developer Juniper Therapeutics; Shionogi
  • Class Amines; Antivirals; Chlorine compounds; Fluorobenzenes; Indazoles; Ketones; Small molecules; Triazines; Triazoles
  • Mechanism of Action Coronavirus 3C-like proteinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed COVID 2019 infections
  • Clinical Phase Unknown Post acute COVID 19 syndrome

Most Recent Events

  • 18 Sep 2025 Preregistration for COVID-2019 infections in European Union (PO)
  • 03 Sep 2025 US FDA accepts NDA for Ensitrelvir for COVID-2019 infections for review
  • 02 Sep 2025 Preregistration for COVID-2019 infections (In children) in Japan (PO)

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