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Baloxavir marboxil - Roche/Shionogi

Drug Profile

Baloxavir marboxil - Roche/Shionogi

Alternative Names: RG 6152; RG 6152-1; S 033188; XOFLUZA; Xofluza

Latest Information Update: 16 Feb 2024

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At a glance

  • Originator Shionogi
  • Developer Roche; Shionogi
  • Class Antivirals; Dibenzothiepins; Esters; Morpholines; Pyridines; Small molecules; Triazines
  • Mechanism of Action Endonuclease 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 Influenza A virus infections; Influenza B virus infections; Influenza virus infections
  • No development reported Influenza A virus H5N1 subtype

Most Recent Events

  • 15 Feb 2024 Roche plans regulatory filing for Influenza virus infection (direct transmission) in 2024 (Roche pipeline, February 2024)
  • 15 Nov 2023 Hoffmann-La Roche initiates a phase IIIb Pebblestone trial in Influenza (In children) in USA (PO) (NCT06094010)
  • 21 Aug 2023 Roche plans regulatory filing for Influenza virus infection (In Infants) in 2024 (Roche pipeline, August 2023)
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