NDAORALTABLETPriority Review
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 10h ago · AI intelligence enriched 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOFLUZA (baloxavir marboxil) is an oral small-molecule antiviral approved in October 2018 for the treatment of acute uncomplicated influenza. It represents a novel mechanism of action targeting viral cap-dependent endonuclease, offering a single-dose treatment option. The drug is indicated for patients 12 years of age and older with suspected or confirmed influenza virus infection.
$0.001BPart D
Peak13.2 years to LOEProduct is in peak commercial stage with modest Medicare uptake (6,069 Part D claims in 2023); brand teams should anticipate steady-state operations with focus on market penetration and physician education rather than aggressive growth.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Study to Assess the Prophylactic Efficacy and Safety of Sebaloxavir Marboxil Tablets/Oral Suspension for Influenza Prevention in Household Contacts Aged ≥2 Years.
Started Nov 2026
858 enrolled
Influenza Prevention
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
Started Oct 2024
100 enrolled
Influenza
Xofluza-Wearables Feasibility-Study
Started Dec 2023
498 enrolled
Infection, CoronavirusInfectionsInfluenza+2 more
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
Started Nov 2023
1,100 enrolled
Influenza
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
Started Oct 2019
4,138 enrolled
Influenza
Worked on XOFLUZA at Roche? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.