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Gilteritinib Fumarate

FDA-approved product (tablet, oral), marketed as Xospata.

Registered studies
3
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Gilteritinib Fumarate
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Acute myeloid leukemia
  • Myeloid leukemia
  • Neoplasm

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

WHO therapeutic group
Other protein kinase inhibitors
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against 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
  • MRSA58.1% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli46.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae34.1% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis56.6% 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

3registered 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.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

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

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

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 Gilteritinib Fumarate 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.

  • Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

    NCT06667973 · start 2025-06

    Registered record
    Registry ID
    NCT06667973
    Conditions
    Acute Myeloid Leukemia; FLT3 Gene Mutation; Adult AML; Diagnosis
    Interventions
    Gilteritinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2025-06
    Completion
    2030-06
    Enrolment
    80

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

    ConditionAcute Myeloid Leukemia; FLT3 Gene Mutation; Adult AML; Diagnosis
    InterventionGilteritinib
    PhasePhase 2
    Registry statusNot yet recruiting
  • Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation

    NCT04655391 · start 2022-06-25

    Registered record
    Registry ID
    NCT04655391
    Conditions
    Recurrent Acute Myeloid Leukemia
    Interventions
    Bosutinib Monohydrate; Decitabine; Enasidenib Mesylate; Gilteritinib Fumarate; Glasdegib Maleate; Ivosidenib; Venetoclax
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Withdrawn
    Start
    2022-06-25
    Completion
    2023-12-15
    Enrolment
    0

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

    ConditionRecurrent Acute Myeloid Leukemia
    InterventionBosutinib Monohydrate; Decitabine; Enasidenib Mesylate; Gilteritinib Fumarate +3 more
    PhasePhase 1
    Registry statusWithdrawn
  • A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

    NCT04293562 · start 2020-07-21

    Registered record
    Registry ID
    NCT04293562
    Conditions
    Acute Myeloid Leukemia
    Interventions
    Allogeneic Hematopoietic Stem Cell Transplantation; Asparaginase Erwinia chrysanthemi; Biospecimen Collection; Bone Marrow Aspiration; Bone Marrow Biopsy; Computed Tomography; Cytarabine; Daunorubicin Hydrochloride; Dexrazoxane Hydrochloride; Etoposide; Fludeoxyglucose F-18; Gemtuzumab Ozogamicin; Gilteritinib Fumarate; Liposome-encapsulated Daunorubicin-Cytarabine; Magnetic Resonance Imaging; Methotrexate; Mitoxantrone Hydrochloride; Positron Emission Tomography; Questionnaire Administration; Therapeutic Hydrocortisone
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2020-07-21
    Completion
    2029-06-30
    Enrolment
    1,400

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

    ConditionAcute Myeloid Leukemia
    InterventionAllogeneic Hematopoietic Stem Cell Transplantation; Asparaginase Erwinia chrysanthemi; Biospecimen Collection; Bone Marrow Aspiration +16 more
    PhasePhase 3
    Registry statusRecruiting