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Midostaurin

FDA-approved product (capsule, oral), marketed as Midostaurin, Rydapt.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Acute myeloid leukemia
  • Mast-cell leukemia
  • Mastocytosis
  • Neoplasm
  • Systemic mastocytosis

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

WHO therapeutic group
Other protein kinase inhibitors
FDA pharmacologic class
Kinase Inhibitor FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

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

AI-predicted activity

AI prediction · nothing measured
  • MRSA50.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli35.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae28.8% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis55.2% 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

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. 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)

-9.3 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-6.1 kcal/mol

0better fit →-12

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

-8.0 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-9.4 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 Midostaurin 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.

  • FLT3-ITD Targeted Therapy in Fit AML Patients

    NCT07425808 · start 2026-12-01

    Registered record
    Registry ID
    NCT07425808
    Conditions
    AML (Acute Myeloid Leukemia)
    Interventions
    Gilteritinib; Venetoclax; Azacitidine (AZA); Local standard of care (SOC)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Not yet recruiting
    Start
    2026-12-01
    Completion
    2032-02-01
    Enrolment
    230

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

    ConditionAML (Acute Myeloid Leukemia)
    InterventionGilteritinib; Venetoclax; Azacitidine (AZA); Local standard of care (SOC)
    PhasePhase 2 / Phase 3
    Registry statusNot yet recruiting
  • Salvage Haploidentical HSCT With DLI and Targeted Therapy for R/R AML

    NCT07572695 · start 2026-04-30

    Registered record
    Registry ID
    NCT07572695
    Conditions
    Acute Myeloid Leukemia; Relapsed/Refractory Acute Myeloid Leukemia; AML, Relapsed/Refractory
    Interventions
    Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (haplo-HSCT); Post-transplant Maintenance Therapy
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2026-04-30
    Completion
    2028-12
    Enrolment
    40

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

    ConditionAcute Myeloid Leukemia; Relapsed/Refractory Acute Myeloid Leukemia; AML, Relapsed/Refractory
    InterventionHaploidentical Allogeneic Hematopoietic Stem Cell Transplantation (haplo-HSCT); Post-transplant Maintenance Therapy
    PhaseNot recorded
    Registry statusNot yet recruiting
  • Revumenib in Combination With 7+3 + Midostaurin in AML

    NCT06313437 · start 2024-12-06

    Registered record
    Registry ID
    NCT06313437
    Conditions
    Acute Myeloid Leukemia; AML, Adult; AML With Gene Mutations; AML; Leukemia
    Interventions
    Revumenib; Midostaurin; Cytarabine; Daunorubicin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2024-12-06
    Completion
    2028-03-02
    Enrolment
    22

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

    ConditionAcute Myeloid Leukemia; AML, Adult; AML With Gene Mutations; AML +1 more
    InterventionRevumenib; Midostaurin; Cytarabine; Daunorubicin
    PhasePhase 1
    Registry statusRecruiting
  • Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients

    NCT06252584 · start 2024-05-02

    Registered record
    Registry ID
    NCT06252584
    Conditions
    Acute Myeloid Leukemia, Adult
    Interventions
    Vaccines, Peptide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Not yet recruiting
    Start
    2024-05-02
    Completion
    2026-11-02
    Enrolment
    20

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

    ConditionAcute Myeloid Leukemia, Adult
    InterventionVaccines, Peptide
    PhasePhase 1
    Registry statusNot yet recruiting
  • Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

    NCT04982354 · start 2022-07-05

    Registered record
    Registry ID
    NCT04982354
    Conditions
    Acute Myeloid Leukemia
    Interventions
    CPX-351; Midostaurin; Busulfan; Melphalan; Fludarabine; CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Withdrawn
    Start
    2022-07-05
    Completion
    2032-08-01
    Enrolment
    0

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

    ConditionAcute Myeloid Leukemia
    InterventionCPX-351; Midostaurin; Busulfan; Melphalan +2 more
    PhasePhase 1 / Phase 2
    Registry statusWithdrawn
  • Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)

    NCT04777916 · start 2022-04-14

    Registered record
    Registry ID
    NCT04777916
    Conditions
    Acute Myeloid Leukemia (AML)
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2022-04-14
    Completion
    2046-04-01
    Enrolment
    5,000

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

    ConditionAcute Myeloid Leukemia (AML)
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting
  • A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS

    NCT04477291 · start 2020-10-06

    Registered record
    Registry ID
    NCT04477291
    Conditions
    Acute Myeloid Leukemia; Myelodysplastic Syndromes
    Interventions
    CG-806
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2020-10-06
    Completion
    2024-04-15
    Enrolment
    45

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

    ConditionAcute Myeloid Leukemia; Myelodysplastic Syndromes
    InterventionCG-806
    PhasePhase 1
    Registry statusTerminated
  • Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)

    NCT05488613 · start 2020-09-24

    Registered record
    Registry ID
    NCT05488613
    Conditions
    Acute Myeloid Leukemia (AML)
    Interventions
    Midostaurin
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2020-09-24
    Completion
    2021-01-26
    Enrolment
    81

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

    ConditionAcute Myeloid Leukemia (AML)
    InterventionMidostaurin
    PhaseNot recorded
    Registry statusCompleted
  • Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)

    NCT04385290 · start 2020-09-04

    Registered record
    Registry ID
    NCT04385290
    Conditions
    Acute Myeloid Leukemia
    Interventions
    MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO; MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO; MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO; MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin; MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2020-09-04
    Completion
    2028-04
    Enrolment
    214

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

    ConditionAcute Myeloid Leukemia
    InterventionMODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO; MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO; MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO; MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin +1 more
    PhasePhase 1 / Phase 2
    Registry statusRecruiting
  • HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.

    NCT04496999 · start 2020-07-13

    Registered record
    Registry ID
    NCT04496999
    Conditions
    AML, Adult
    Interventions
    HDM201; Midostaurin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2020-07-13
    Completion
    2022-09-09
    Enrolment
    2

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

    ConditionAML, Adult
    InterventionHDM201; Midostaurin
    PhasePhase 1
    Registry statusTerminated
  • AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance

    NCT04174612 · start 2020-04-24

    Registered record
    Registry ID
    NCT04174612
    Conditions
    Acute Myeloid Leukemia With FLT3/ITD Mutation
    Interventions
    Cytarabine; Daunorubicin; Midostaurin; Cytarabine HD
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2020-04-24
    Completion
    2025-08-01
    Enrolment
    172

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

    ConditionAcute Myeloid Leukemia With FLT3/ITD Mutation
    InterventionCytarabine; Daunorubicin; Midostaurin; Cytarabine HD
    PhasePhase 3
    Registry statusUnknown
  • Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation

    NCT03951961 · start 2020-03-20

    Registered record
    Registry ID
    NCT03951961
    Conditions
    Acute Myeloid Leukemia, Adult
    Interventions
    Midostaurin
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2020-03-20
    Completion
    2021-02-28
    Enrolment
    1

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

    ConditionAcute Myeloid Leukemia, Adult
    InterventionMidostaurin
    PhasePhase 2
    Registry statusTerminated
  • A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

    NCT04027309 · start 2019-12-20

    Registered record
    Registry ID
    NCT04027309
    Conditions
    Acute Myeloid Leukemia; Myelodysplastic Syndrome With Excess Blasts-2
    Interventions
    Gilteritinib; Midostaurin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2019-12-20
    Completion
    2033-06
    Enrolment
    777

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

    ConditionAcute Myeloid Leukemia; Myelodysplastic Syndrome With Excess Blasts-2
    InterventionGilteritinib; Midostaurin
    PhasePhase 3
    Registry statusActive not recruiting
  • Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

    NCT03836209 · start 2019-12-06

    Registered record
    Registry ID
    NCT03836209
    Conditions
    Acute Myeloid Leukemia
    Interventions
    Gilteritinib; Midostaurin; Daunorubicin; Cytarabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2019-12-06
    Completion
    2026-06-30
    Enrolment
    181

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

    ConditionAcute Myeloid Leukemia
    InterventionGilteritinib; Midostaurin; Daunorubicin; Cytarabine
    PhasePhase 2
    Registry statusCompleted
  • Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients

    NCT04097470 · start 2019-12-05

    Registered record
    Registry ID
    NCT04097470
    Conditions
    AML/MDS
    Interventions
    Decitabine; Midostaurin
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2019-12-05
    Completion
    2026-11
    Enrolment
    140

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

    ConditionAML/MDS
    InterventionDecitabine; Midostaurin
    PhasePhase 2
    Registry statusActive not recruiting