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Baloxavir marboxil - Roche/Shionogi

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Drug Profile

Baloxavir marboxil - Roche/Shionogi

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

Latest Information Update: 06 Jun 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

  • 10 May 2024 Roche completes a phase III trial in Influenza virus infections (In adolescents, In children, In adults) in Bulgaria, China, Hungary, New Zealand, Puerto Rico, the US, Argentina, Costa Rica, Greece, Hong Kong, India, Israel, Japan, Mexico, Poland, South Africa, Singapore, Spain, Turkey, the UK (PO) (NCT03969212) (EudraCT2018-004056-37)
  • 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)
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