TheraRadar
Data updated: Jun 28, 2026

BALOXAVIR MARBOXIL

Approved 2018-10-24
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-10-24
Routes
ORAL
Dosage Forms
TABLET

Companies

NORWICH
Active Ingredient: BALOXAVIR MARBOXIL

BALOXAVIR MARBOXIL Approval History

Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
Jun 2026 ORIGINAL
Update
FDA Letter

What BALOXAVIR MARBOXIL Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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Clinical Trial Registry

15 trials
Trial Sponsor ID Phase Status Title
NCT06653569 INFLUENT 2024-01535 33IC30_221790 Ph 3 recruiting Efficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment)
NCT06094010 Pebblestone CV44536 2023-504672-22-00 Ph 3 recruiting A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
NCT06774859 results posted YV44465 Ph 3 completed Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
NCT04381936 RECOVERY NDPHRECOVERY 2020-001113-21, ISRCTN50189673 Ph 3 recruiting Randomised Evaluation of COVID-19 Therapy
NCT04712539 2020-0919 NCI-2020-13918, 2020-0919 Ph 2 recruiting Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
NCT06161454 22-020440 Ph 4 completed Xofluza-Wearables Feasibility-Study
NCT03969212 results posted MV40618 2018-004056-37 Ph 3 completed Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
NCT05170009 results posted 20-12023076 Ph 2, Ph 3 terminated Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza
NCT02735707 REMAP-CAP U1111-1189-1653 2015-002340-14, 602525 Ph 3 recruiting Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
NCT03653364 results posted CP40559 2018-002154-70 Ph 3 completed Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
NCT04141930 pCHIMES results posted STUDY00008200 Ph 4 completed Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle
NCT03684044 results posted CP40617 2018-001416-30 Ph 3 completed Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
NCT03629184 results posted CP40563 2018-002169-21 Ph 3 completed Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
NCT02949011 CAPSTONE 2 results posted 1602T0832 2016-002688-32 Ph 3 completed Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
NCT02954354 CAPSTONE 1 results posted 1601T0831 Ph 3 completed A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BALOXAVIR MARBOXIL FDA Label Details

Looking for the branded version?

XOFLUZA

Full clinical data, patents, trials, and competitive landscape for baloxavir marboxil.

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Data Sources

FDA Approval: ANDA217449 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.