Skip to content
AMR Drug RepurposingSmart Screeningresearch prototype

Baloxavir Marboxil

FDA-approved product (tablet, oral), marketed as Baloxavir Marboxil, Xofluza.

Registered studies
24
Lab records
0
Pathogens at ≥40%
4 of 4

Chemical structure

Chemical structure of Baloxavir Marboxil
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Influenza
  • Viral disease

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Other antivirals
Anti-infective classification
Classified as another kind of anti-infective (for example an antifungal, antiviral or antiparasitic medicine).WHO ATC J05AX25

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis, MRSA, E. coli and K. pneumoniae. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA55.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli46.3% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae44.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis59.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

24registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Open Baloxavir Marboxil in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.9 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-6.2 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.9 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.1 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Baloxavir Marboxil with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • 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

    NCT07827599 · start 2026-09-22

    Registered record
    Registry ID
    NCT07827599
    Conditions
    Influenza, Human; Respiratory Tract Infections; Post-exposure Prophylaxis
    Interventions
    Baloxavir marboxil; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Not yet recruiting
    Start
    2026-09-22
    Completion
    2027-04-30
    Enrolment
    325

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza, Human; Respiratory Tract Infections; Post-exposure Prophylaxis
    InterventionBaloxavir marboxil; Placebo
    PhasePhase 3
    Registry statusNot yet recruiting

  • Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD

    NCT07393685 · start 2026-08-01

    Registered record
    Registry ID
    NCT07393685
    Conditions
    Acute Exacerbation of Chronic Obstructive Pulmonary Disease; Influenza, Human; Virus Diseases
    Interventions
    Xuanfei Jiangzhuo Decoction; Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2026-08-01
    Completion
    2028-05-31
    Enrolment
    300

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Exacerbation of Chronic Obstructive Pulmonary Disease; Influenza, Human; Virus Diseases
    InterventionXuanfei Jiangzhuo Decoction; Standard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
    PhaseNot recorded
    Registry statusNot yet recruiting

  • Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting

    NCT06762587 · start 2025-01-05

    Registered record
    Registry ID
    NCT06762587
    Conditions
    Influenza; Influenza Prophylaxis; Nosocomial Infection
    Interventions
    Baloxavir Marboxil; Oseltamivir
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Not yet recruiting
    Start
    2025-01-05
    Completion
    2025-05-05
    Enrolment
    372

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza; Influenza Prophylaxis; Nosocomial Infection
    InterventionBaloxavir Marboxil; Oseltamivir
    PhaseNot applicable
    Registry statusNot yet recruiting

  • Efficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment)

    NCT06653569 · start 2024-12-13

    Registered record
    Registry ID
    NCT06653569
    Conditions
    Influenza Disease; Flu
    Interventions
    Baloxavir Marboxil; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-12-13
    Completion
    2027-09
    Enrolment
    484

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza Disease; Flu
    InterventionBaloxavir Marboxil; Placebo
    PhasePhase 3
    Registry statusRecruiting

  • Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms

    NCT06774859 · start 2024-10-27

    Registered record
    Registry ID
    NCT06774859
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil; Oseltamivir
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2024-10-27
    Completion
    2025-05-08
    Enrolment
    100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza
    InterventionBaloxavir Marboxil; Oseltamivir
    PhasePhase 3
    Registry statusCompleted

  • Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza

    NCT06507813 · start 2024-08-19

    Registered record
    Registry ID
    NCT06507813
    Conditions
    Influenza Type A; Influenza Type B
    Interventions
    ADC189 tablets; Baloxavir Marboxil tablets; Placebo of ADC189 tablets; Placebo of Baloxavir Marboxil tablets; ADC189 granules; Placebo of ADC189 granules; Placebo of Oseltamivir granules; Oseltamivir granules
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2024-08-19
    Completion
    2025-04-15
    Enrolment
    190

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza Type A; Influenza Type B
    InterventionADC189 tablets; Baloxavir Marboxil tablets; Placebo of ADC189 tablets; Placebo of Baloxavir Marboxil tablets +4 more
    PhasePhase 3
    Registry statusCompleted

  • Evaluation of a Screen and Treat Protocol for Influenza

    NCT06207058 · start 2024-01-15

    Registered record
    Registry ID
    NCT06207058
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Terminated
    Start
    2024-01-15
    Completion
    2024-07-01
    Enrolment
    25

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza
    InterventionBaloxavir Marboxil
    PhaseNot recorded
    Registry statusTerminated

  • A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A

    NCT06205641 · start 2024-01

    Registered record
    Registry ID
    NCT06205641
    Conditions
    Influenza A
    Interventions
    Xuanfei Baidu Granule Placebo; Xuanfei Baidu Granule; Baloxavir Marboxil Tablet
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2024-01
    Completion
    2025-01
    Enrolment
    584

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza A
    InterventionXuanfei Baidu Granule Placebo; Xuanfei Baidu Granule; Baloxavir Marboxil Tablet
    PhaseNot applicable
    Registry statusUnknown

  • Xofluza-Wearables Feasibility-Study

    NCT06161454 · start 2023-12-14

    Registered record
    Registry ID
    NCT06161454
    Conditions
    Infection, Coronavirus; Infections; Influenza; Transplant; Infection Viral
    Interventions
    Baloxavir Marboxil
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2023-12-14
    Completion
    2025-04-30
    Enrolment
    498

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfection, Coronavirus; Infections; Influenza; Transplant +1 more
    InterventionBaloxavir Marboxil
    PhasePhase 4
    Registry statusCompleted

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

    NCT06094010 · start 2023-11-22

    Registered record
    Registry ID
    NCT06094010
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2023-11-22
    Completion
    2027-06-30
    Enrolment
    1,100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza
    InterventionBaloxavir Marboxil
    PhasePhase 3
    Registry statusRecruiting

  • A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

    NCT05648448 · start 2023-02-22

    Registered record
    Registry ID
    NCT05648448
    Conditions
    Influenza; Influenza, Human
    Interventions
    Oseltamivir; Favipiravir; Zanamivir; Baloxavir; Molnupiravir; Peramivir; Laninamivir; Oseltamivir and Baloxavir; Oseltamivir and Favipiravir; Favipiravir and Baloxavir
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-02-22
    Completion
    2027-01-01
    Enrolment
    3,000

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza; Influenza, Human
    InterventionOseltamivir; Favipiravir; Zanamivir; Baloxavir +6 more
    PhasePhase 2
    Registry statusRecruiting

  • Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza

    NCT05170009 · start 2022-04-22

    Registered record
    Registry ID
    NCT05170009
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil; Placebo; Oseltamivir
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Terminated
    Start
    2022-04-22
    Completion
    2024-02-07
    Enrolment
    2

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza
    InterventionBaloxavir Marboxil; Placebo; Oseltamivir
    PhasePhase 2 / Phase 3
    Registry statusTerminated

  • Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients

    NCT04712539 · start 2021-10-11

    Registered record
    Registry ID
    NCT04712539
    Conditions
    Hematopoietic and Lymphoid Cell Neoplasm; Influenza
    Interventions
    Baloxavir Marboxil; Oseltamivir
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2021-10-11
    Completion
    2028-02-28
    Enrolment
    60

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHematopoietic and Lymphoid Cell Neoplasm; Influenza
    InterventionBaloxavir Marboxil; Oseltamivir
    PhasePhase 2
    Registry statusRecruiting

  • Randomised Evaluation of COVID-19 Therapy

    NCT04381936 · start 2020-03-19

    Registered record
    Registry ID
    NCT04381936
    Conditions
    Pneumonia
    Interventions
    Lopinavir-Ritonavir; Corticosteroid; Hydroxychloroquine; Azithromycin; Convalescent plasma; Tocilizumab; Immunoglobulin; Synthetic neutralising antibodies; Aspirin; Colchicine; Baricitinib; Anakinra; Dimethyl fumarate; High Dose Corticosteroid; Empagliflozin; Sotrovimab; Molnupiravir; Paxlovid; Baloxavir Marboxil; Oseltamivir; Corticosteroids (dexamethasone); Corticosteroids (dexamethasone)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2020-03-19
    Completion
    2038-09-30
    Enrolment
    70,000

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPneumonia
    InterventionLopinavir-Ritonavir; Corticosteroid; Hydroxychloroquine; Azithromycin +18 more
    PhasePhase 3
    Registry statusRecruiting

  • Test-and-treat for Influenza in Homeless Shelters

    NCT04141917 · start 2019-11-15

    Registered record
    Registry ID
    NCT04141917
    Conditions
    Influenza; Respiratory Viral Infection
    Interventions
    Point-of-care molecular testing and treatment of influenza
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2019-11-15
    Completion
    2021-03-31
    Enrolment
    1,618

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfluenza; Respiratory Viral Infection
    InterventionPoint-of-care molecular testing and treatment of influenza
    PhasePhase 4
    Registry statusTerminated