Baloxavir marboxil - Roche/Shionogi
Alternative Names: RG 6152; RG 6152-1; S 033188; XOFLUZA; XofluzaLatest Information Update: 26 Sep 2024
At a glance
- Originator Shionogi
- Developer Roche; Shionogi
- Class Antivirals; Dibenzothiepins; Esters; Morpholines; Pyridines; Small molecules; Triazines
- Mechanism of Action Endonuclease inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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
- 19 Sep 2024 Efficacy and adverse event data from the phase IIIb CENTERSTONE trial in Influenza virus infection released by Genentech
- 16 Aug 2024 Preregistration for Influenza virus infections (In infants, In neonates) in European Union (PO) (Roche pipeline, August 2024)
- 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)