Last reviewed · How we verify
Xofluza (BALOXAVIR)
Xofluza works by inhibiting the endonuclease activity of the influenza virus, preventing it from replicating.
At a glance
| Generic name | BALOXAVIR |
|---|---|
| Sponsor | Genentech Inc |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Baloxavir marboxil is an antiviral drug with activity against influenza virus [see Microbiology (12.4) ].
Approved indications
- Treatment of acute uncomplicated influenza
- Post-exposure prophylaxis of influenza
- Treatment of Influenza
- Post-Exposure Prophylaxis of Influenza
Common side effects
- Vomiting
- Diarrhea
- Bronchitis
- Nausea
- Sinusitis
- Headache
- Anaphylactic reactions
- Anaphylactic shock
- Anaphylactoid reactions
- Hypersensitivity reactions
- Angioedema
- Rash
Drug interactions
- dairy products
- calcium-fortified beverages
- polyvalent cation-containing laxatives
- antacids
- oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc)
- live attenuated influenza vaccines
- inactivated influenza vaccines
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/Texas Flu Challenge (PHASE1)
- 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)
- Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) (PHASE3)
- Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza (PHASE3)
- Xofluza-Wearables Feasibility-Study (PHASE4)
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
- Genentech Inc portfolio CI