NDAORALFOR SUSPENSION
Approved
Nov 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
4/8 — Partial
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOFLUZA (baloxavir marboxil) is an oral antiviral small molecule approved for the treatment of influenza in patients with acute uncomplicated illness. It represents a novel mechanism of action targeting influenza virus cap-dependent endonuclease, distinct from neuraminidase inhibitors. The oral suspension formulation enables rapid treatment initiation across diverse patient populations including pediatric patients.
Peak15.0 years to LOE
Product is at peak commercial stage with growing adoption, suggesting stable commercial team size and ongoing promotional investments in primary care and retail pharmacy channels.
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.