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AMR Drug RepurposingSmart Screeningresearch prototype

Givinostat Hydrochloride

FDA-approved product (suspension, oral), marketed as Duvyzat.

Registered studies
23
Lab records
0
Pathogens at ≥40%
1 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Duchenne muscular dystrophy

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

WHO therapeutic group
Other drugs for disorders of the musculo-skeletal system
FDA pharmacologic class
Histone Deacetylase 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. It was surfaced computationally for further investigation; it is not an established treatment for this infection.

AI-predicted activity

AI prediction · nothing measured
  • MRSA34.2% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • E. coli33.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae16.6% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis60.0% 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

23registered 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 Givinostat Hydrochloride 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)

-7.9 kcal/mol

0better fit →-12

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

-8.4 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-9.0 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 Givinostat Hydrochloride 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.

  • Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function

    NCT06736223 · start 2025-05-29

    Registered record
    Registry ID
    NCT06736223
    Conditions
    Hepatic Impairment
    Interventions
    ITF2357
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2025-05-29
    Completion
    2025-08-14
    Enrolment
    24

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

    ConditionHepatic Impairment
    InterventionITF2357
    PhasePhase 1
    Registry statusCompleted

  • Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old

    NCT06769633 · start 2025-01-02

    Registered record
    Registry ID
    NCT06769633
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Givinostat Hydrochloride; Givinostat Hydrochloride - Cohort 2
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-01-02
    Completion
    2029-12
    Enrolment
    18

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

    ConditionDuchenne Muscular Dystrophy
    InterventionGivinostat Hydrochloride; Givinostat Hydrochloride - Cohort 2
    PhasePhase 2
    Registry statusRecruiting

  • Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

    NCT06093672 · start 2024-03-26

    Registered record
    Registry ID
    NCT06093672
    Conditions
    Polycythemia Vera
    Interventions
    Givinostat; Hydroxyurea
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-03-26
    Completion
    2026-07
    Enrolment
    220

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

    ConditionPolycythemia Vera
    InterventionGivinostat; Hydroxyurea
    PhasePhase 3
    Registry statusRecruiting

  • Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

    NCT05933057 · start 2024-02-19

    Registered record
    Registry ID
    NCT05933057
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Givinostat; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-02-19
    Completion
    2028-02
    Enrolment
    138

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

    ConditionDuchenne Muscular Dystrophy
    InterventionGivinostat; Placebo
    PhasePhase 3
    Registry statusRecruiting

  • Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity

    NCT05492318 · start 2022-03-21

    Registered record
    Registry ID
    NCT05492318
    Conditions
    Drug-Drug Interaction; Heathy Volunteer
    Interventions
    Givinostat 10 mg/mL; Midazolam 1mg/ml IV; Midazolam 2.5 mg oromucosal solution; Dabigatran etexilate 75 mg oral hard capsules
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2022-03-21
    Completion
    2022-05-24
    Enrolment
    26

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

    ConditionDrug-Drug Interaction; Heathy Volunteer
    InterventionGivinostat 10 mg/mL; Midazolam 1mg/ml IV; Midazolam 2.5 mg oromucosal solution; Dabigatran etexilate 75 mg oral hard capsules
    PhasePhase 1
    Registry statusCompleted

  • The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

    NCT05845567 · start 2022-03-21

    Registered record
    Registry ID
    NCT05845567
    Conditions
    Drug Drug Interaction
    Interventions
    Givinostat; Clarithromycin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2022-03-21
    Completion
    2022-05-24
    Enrolment
    20

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

    ConditionDrug Drug Interaction
    InterventionGivinostat; Clarithromycin
    PhasePhase 1
    Registry statusCompleted

  • Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

    NCT05860114 · start 2022-03-21

    Registered record
    Registry ID
    NCT05860114
    Conditions
    Drug Drug Interaction
    Interventions
    Givinostat
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2022-03-21
    Completion
    2022-05-24
    Enrolment
    8

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

    ConditionDrug Drug Interaction
    InterventionGivinostat
    PhasePhase 1
    Registry statusCompleted

  • Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval

    NCT04821063 · start 2021-04-13

    Registered record
    Registry ID
    NCT04821063
    Conditions
    Duchenne and Becker Muscular Dystrophy; Polycytemia Vera
    Interventions
    ITF2357 10 mg/mL; ITF2357 10 mg/mL; Placebo; Moxifloxacin Hydrochloride; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2021-04-13
    Completion
    2021-06-18
    Enrolment
    31

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

    ConditionDuchenne and Becker Muscular Dystrophy; Polycytemia Vera
    InterventionITF2357 10 mg/mL; ITF2357 10 mg/mL; Placebo; Moxifloxacin Hydrochloride +1 more
    PhasePhase 1
    Registry statusCompleted

  • Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy

    NCT03238235 · start 2018-01-09

    Registered record
    Registry ID
    NCT03238235
    Conditions
    Becker Muscular Dystrophy
    Interventions
    Givinostat; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2018-01-09
    Completion
    2021-03-19
    Enrolment
    51

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

    ConditionBecker Muscular Dystrophy
    InterventionGivinostat; Placebo
    PhasePhase 2
    Registry statusCompleted

  • Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

    NCT02851797 · start 2017-06-06

    Registered record
    Registry ID
    NCT02851797
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    givinostat; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-06-06
    Completion
    2022-02-22
    Enrolment
    179

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

    ConditionDuchenne Muscular Dystrophy
    Interventiongivinostat; placebo
    PhasePhase 3
    Registry statusCompleted

  • A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera

    NCT01901432 · start 2013-10

    Registered record
    Registry ID
    NCT01901432
    Conditions
    Polycythemia Vera
    Interventions
    Givinostat
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2013-10
    Completion
    2017-09-25
    Enrolment
    48

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

    ConditionPolycythemia Vera
    InterventionGivinostat
    PhasePhase 1 / Phase 2
    Registry statusCompleted

  • A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD

    NCT01761292 · start 2013-04

    Registered record
    Registry ID
    NCT01761292
    Conditions
    Duchenne Muscular Dystrophy (DMD)
    Interventions
    Givinostat
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2013-04
    Completion
    2017-11
    Enrolment
    20

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

    ConditionDuchenne Muscular Dystrophy (DMD)
    InterventionGivinostat
    PhasePhase 1 / Phase 2
    Registry statusCompleted

  • Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms

    NCT01761968 · start 2013-03

    Registered record
    Registry ID
    NCT01761968
    Conditions
    Chronic Myeloproliferative Neoplasms
    Interventions
    givinostat
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2013-03
    Completion
    2026-12
    Enrolment
    90

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

    ConditionChronic Myeloproliferative Neoplasms
    Interventiongivinostat
    PhasePhase 2
    Registry statusActive not recruiting

  • Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis

    NCT01557452 · start 2011-12-28

    Registered record
    Registry ID
    NCT01557452
    Conditions
    Juvenile Idiopathic Arthritis
    Interventions
    Givinostat
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Terminated
    Start
    2011-12-28
    Completion
    2014-01-27
    Enrolment
    1

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

    ConditionJuvenile Idiopathic Arthritis
    InterventionGivinostat
    PhaseNot applicable
    Registry statusTerminated

  • Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera

    NCT00928707 · start 2009-06

    Registered record
    Registry ID
    NCT00928707
    Conditions
    Polycythemia Vera
    Interventions
    GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea; GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2009-06
    Completion
    2011-10
    Enrolment
    45

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

    ConditionPolycythemia Vera
    InterventionGIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea; GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea
    PhasePhase 2
    Registry statusCompleted