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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 K. pneumoniae, MRSA, E. coli and M. tuberculosis. 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.

  • Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle

    NCT04141930 · start 2019-11-01

    Registered record
    Registry ID
    NCT04141930
    Conditions
    Influenza; Respiratory Viral Infection
    Interventions
    Baloxavir Marboxil
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2019-11-01
    Completion
    2020-04-01
    Enrolment
    481

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

    ConditionInfluenza; Respiratory Viral Infection
    InterventionBaloxavir Marboxil
    PhasePhase 4
    Registry statusCompleted

  • Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

    NCT03969212 · start 2019-10-10

    Registered record
    Registry ID
    NCT03969212
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-10-10
    Completion
    2024-05-10
    Enrolment
    4,138

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

    ConditionInfluenza
    InterventionBaloxavir Marboxil; Placebo
    PhasePhase 3
    Registry statusCompleted

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

    NCT03959332 · start 2019-06-19

    Registered record
    Registry ID
    NCT03959332
    Conditions
    Healthy Volunteer
    Interventions
    Baloxavir Marboxil
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2019-06-19
    Completion
    2019-07-11
    Enrolment
    32

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

    ConditionHealthy Volunteer
    InterventionBaloxavir Marboxil
    PhaseNot applicable
    Registry statusCompleted

  • Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms

    NCT03653364 · start 2019-01-23

    Registered record
    Registry ID
    NCT03653364
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-01-23
    Completion
    2023-04-03
    Enrolment
    49

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

    ConditionInfluenza
    InterventionBaloxavir Marboxil
    PhasePhase 3
    Registry statusCompleted

  • Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

    NCT03684044 · start 2019-01-08

    Registered record
    Registry ID
    NCT03684044
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-01-08
    Completion
    2020-03-16
    Enrolment
    363

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

    ConditionInfluenza
    InterventionBaloxavir Marboxil; Placebo
    PhasePhase 3
    Registry statusCompleted

  • Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms

    NCT03629184 · start 2018-11-20

    Registered record
    Registry ID
    NCT03629184
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil; Oseltamivir
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-11-20
    Completion
    2019-04-03
    Enrolment
    173

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

    ConditionInfluenza
    InterventionBaloxavir Marboxil; Oseltamivir
    PhasePhase 3
    Registry statusCompleted

  • Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications

    NCT02949011 · start 2017-01-11

    Registered record
    Registry ID
    NCT02949011
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil; Placebo to Baloxavir Marboxil; Oseltamivir; Placebo to Oseltamivir
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-01-11
    Completion
    2018-04-20
    Enrolment
    2,184

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

    ConditionInfluenza
    InterventionBaloxavir Marboxil; Placebo to Baloxavir Marboxil; Oseltamivir; Placebo to Oseltamivir
    PhasePhase 3
    Registry statusCompleted

  • A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza

    NCT02954354 · start 2016-12-08

    Registered record
    Registry ID
    NCT02954354
    Conditions
    Influenza
    Interventions
    Baloxavir Marboxil; Placebo to Baloxavir Marboxil; Oseltamivir; Placebo to Oseltamivir
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-12-08
    Completion
    2017-04-24
    Enrolment
    1,436

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

    ConditionInfluenza
    InterventionBaloxavir Marboxil; Placebo to Baloxavir Marboxil; Oseltamivir; Placebo to Oseltamivir
    PhasePhase 3
    Registry statusCompleted

  • Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

    NCT02735707 · start 2016-04-11

    Registered record
    Registry ID
    NCT02735707
    Conditions
    Community-acquired Pneumonia, Influenza, COVID-19
    Interventions
    Ceftriaxone; Moxifloxacin or Levofloxacin; Piperacillin-tazobactam; Ceftaroline; Amoxicillin-clavulanate; Standard course macrolide; Extended course macrolide; No systemic corticosteroid; Fixed-duration Hydrocortisone; Shock-dependent hydrocortisone; Fixed-duration higher dose Hydrocortisone; No antiviral agent for influenza; Five-days oseltamivir; Ten-days oseltamivir; No antiviral agent for COVID-19; Lopinavir / Ritonavir; Hydroxychloroquine; Hydroxychloroquine + lopinavir/ritonavir; Ivermectin; No immune modulation for COVID-19; Interferon beta-1a; Anakinra; Tocilizumab; Sarilumab; Local standard venous thromboprophylaxis; Therapeutic dose anticoagulation; Conventional low dose thromboprophylaxis; Intermediate dose thromboprophylaxis; Continuation of therapeutic dose anticoagulation; No immunoglobulin; Convalescent plasma; Delayed administration of convalescent plasma; No vitamin C; Vitamin C; No antiplatelet; Aspirin; P2Y12 inhibitor; No simvastatin; Simvastatin; Eritoran; Apremila
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2016-04-11
    Completion
    2028-02
    Enrolment
    20,000

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

    ConditionCommunity-acquired Pneumonia, Influenza, COVID-19
    InterventionCeftriaxone; Moxifloxacin or Levofloxacin; Piperacillin-tazobactam; Ceftaroline +37 more
    PhasePhase 3
    Registry statusRecruiting