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Xofluza (BALOXAVIR MARBOXIL)
Xofluza works by inhibiting the endonuclease activity of the influenza virus's polymerase, preventing viral replication.
Xofluza (baloxavir marboxil) is a small molecule antiviral medication developed by Genentech Inc. It is used to treat influenza and was approved by the FDA in 2018. Xofluza works by inhibiting the replication of the influenza virus, specifically targeting the endonuclease activity of the viral polymerase. It is a patented medication with no generic manufacturers available. Key safety considerations include potential gastrointestinal side effects and the risk of viral resistance.
At a glance
| Generic name | BALOXAVIR MARBOXIL |
|---|---|
| Sponsor | Roche |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
Baloxavir marboxil is an antiviral drug with activity against influenza virus [see Microbiology (12.4)].
Approved indications
- Influenza
Common side effects
- Diarrhea
- Bronchitis
- Nausea
- Sinusitis
- Nasopharyngitis
- Anaphylactic reactions
- Anaphylactic shock
- Anaphylactoid reactions
- Hypersensitivity reactions
- Angioedema
- Rash
- Urticaria
Key clinical trials
- Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
- A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts (PHASE3)
- A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza (PHASE2)
- Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients (PHASE2)
- Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza (PHASE3)
- Xofluza-Wearables Feasibility-Study (PHASE4)
- Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households (PHASE3)
- Evaluation of a Screen and Treat Protocol for Influenza
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xofluza CI brief — competitive landscape report
- Xofluza updates RSS · CI watch RSS
- Roche portfolio CI