NDAORALTABLETPriority Review
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 1w 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 is a cap-dependent endonuclease inhibitor that blocks viral polymerase activity, offering a single-dose treatment option. The drug represents a novel mechanism of action distinct from neuraminidase inhibitors.
$0.001BPart D
Peak13.3 years to LOEProduct is in peak lifecycle stage with minimal Part D penetration ($1M spending, ~6K claims in 2023), suggesting significant untapped market potential and active commercial team efforts to drive adoption.
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 (10)
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
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
Started Jun 2019
32 enrolled
Healthy Volunteer
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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.