XOFLUZA

Peak

baloxavir marboxil

NDAORALTABLETPriority Review
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8

Mechanism of Action

12.1 Mechanism of Action Baloxavir marboxil is an antiviral drug with activity against influenza virus [see ]. 12.2 Pharmacodynamics Cardiac Electrophysiology At twice the expected exposure from recommended dosing, XOFLUZA did not prolong the QTc interval. Exposure-Response Relationships In…

Clinical Trials (5)

NCT06774859Phase 3Completed

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
NCT06161454Phase 4Completed

Xofluza-Wearables Feasibility-Study

Started Dec 2023
498 enrolled
Infection, CoronavirusInfectionsInfluenza+2 more
NCT06094010Phase 3Recruiting

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Started Nov 2023
750 enrolled
Influenza
NCT03969212Phase 3Completed

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
NCT03959332N/ACompleted

Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants

Started Jun 2019
32 enrolled
Healthy Volunteer

Loss of Exclusivity

LOE Date
Oct 9, 2039
165 months away
Patent Expiry
Oct 9, 2039
Exclusivity Expiry
Dec 19, 2027

Patent Records (5)

Patent #ExpiryTypeUse Code
9815835
Jun 14, 2030
Product
8927710
May 5, 2031
Product
8987441
Oct 24, 2032
SubstanceProduct
10392406
Apr 27, 2036
Substance
10633397
Apr 27, 2036
U-3000