NDAORALTABLETPriority Review
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 13h ago · AI intelligence enriched 17h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOFLUZA (baloxavir marboxil) is an oral small-molecule antiviral approved in 2018 for the treatment of acute uncomplicated influenza in patients 12 years and older. It works by inhibiting the cap-dependent endonuclease activity of influenza viral polymerase, preventing viral replication. The drug represents a novel mechanism of action distinct from neuraminidase inhibitors and M2 inhibitors.
$0.001BPart D
Peak13.0 years to LOEProduct is at peak lifecycle stage with modest Medicare utilization; brand teams should focus on market penetration and payer access strategies as seasonal influenza demand remains variable.
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 (12)
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
A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants
Started Sep 2026
325 enrolled
Influenza, HumanRespiratory Tract InfectionsPost-exposure Prophylaxis
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
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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.