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Ketoconazole

FDA-approved product (tablet, oral), marketed as Extina, Ketoconazole, Ketozole and 3 more.

Registered studies
50+
Lab records
1
Pathogens at ≥40%
2 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Adrenal gland disease
  • Blastomycosis
  • Cushing syndrome
  • Seborrheic dermatitis
  • Tinea
  • Tinea pedis

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

WHO therapeutic group
Imidazole and triazole derivatives; Imidazole derivatives; Anticorticosteroids
FDA pharmacologic class
Azole Antifungal FDA label ↗
Anti-infective classification
Classified as another kind of anti-infective (for example an antifungal, antiviral or antiparasitic medicine).WHO ATC D01AC08; WHO ATC G01AF11; WHO ATC J02AB02; FDA class Azole Antifungal

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
  • MRSA63.6% AI-predicted activityAt or above 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. pneumoniae27.2% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis81.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates. This medicine was in the model's training data, so this is recall, not a new prediction.

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

  • M. tuberculosis: measured active in 1 of 1 lab record
Show the 1 laboratory record, with sources

Loading records…

“Active” means the measured value reached this project’s laboratory cutoff (10 µM or stronger). A laboratory result does not show an effect in patients.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-8.6 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-5.9 kcal/mol

0better fit →-12

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

-8.9 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.5 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 Ketoconazole 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.

  • Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor.

    NCT07333170 · start 2026-02

    Registered record
    Registry ID
    NCT07333170
    Conditions
    Pityriasis Versicolor
    Interventions
    Luliconazole Cream 1%; Topical ketoconazole 2% cream
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Not yet recruiting
    Start
    2026-02
    Completion
    2026-11
    Enrolment
    86

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

    ConditionPityriasis Versicolor
    InterventionLuliconazole Cream 1%; Topical ketoconazole 2% cream
    PhasePhase 4
    Registry statusNot yet recruiting
  • Azoles Targeting Recurrent High Grade Gliomas

    NCT03763396 · start 2024-06-01

    Registered record
    Registry ID
    NCT03763396
    Conditions
    Brain Tumor, Recurrent; Cancer, Advanced; Glioma of Brain
    Interventions
    Ketoconazole (KCZ); Posaconazole (PCZ)
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Not yet recruiting
    Start
    2024-06-01
    Completion
    2027-06
    Enrolment
    30

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

    ConditionBrain Tumor, Recurrent; Cancer, Advanced; Glioma of Brain
    InterventionKetoconazole (KCZ); Posaconazole (PCZ)
    PhaseEarly phase 1
    Registry statusNot yet recruiting
  • Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2

    NCT06560086 · start 2024-02-03

    Registered record
    Registry ID
    NCT06560086
    Conditions
    Cryptorchidism
    Interventions
    Ketoconazole; Luteinizing Hormone
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2024-02-03
    Completion
    2024-12-31
    Enrolment
    10

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

    ConditionCryptorchidism
    InterventionKetoconazole; Luteinizing Hormone
    PhaseNot applicable
    Registry statusUnknown
  • Assessment of the Efficacy of Topical Ketoconazole 2% Cream in Comparison With Topical Retinoids in the Treatment of Mild Comedonal and Papulopustular Acne

    NCT07237763 · start 2024-01-15

    Registered record
    Registry ID
    NCT07237763
    Conditions
    Acne
    Interventions
    advised to apply topical ketoconazole 2% cream twice daily on the whole face.; topical adapalene to the face
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Active not recruiting
    Start
    2024-01-15
    Completion
    2025-12
    Enrolment
    52

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

    ConditionAcne
    Interventionadvised to apply topical ketoconazole 2% cream twice daily on the whole face.; topical adapalene to the face
    PhaseNot applicable
    Registry statusActive not recruiting
  • 8% Sulphur-Aloe Vera Soap as an Adjuvant Treatment for Pityriasis Versicolor

    NCT06170333 · start 2023-08-25

    Registered record
    Registry ID
    NCT06170333
    Conditions
    Pityriasis Versicolor
    Interventions
    8% sulphur and A. vera soap
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2023-08-25
    Completion
    2024-01-31
    Enrolment
    42

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

    ConditionPityriasis Versicolor
    Intervention8% sulphur and A. vera soap
    PhasePhase 4
    Registry statusCompleted
  • Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

    NCT03907046 · start 2020-01-28

    Registered record
    Registry ID
    NCT03907046
    Conditions
    Intracerebral Hemorrhage; Atrial Fibrillation
    Interventions
    Apixaban; Aspirin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2020-01-28
    Completion
    2027-04
    Enrolment
    700

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

    ConditionIntracerebral Hemorrhage; Atrial Fibrillation
    InterventionApixaban; Aspirin
    PhasePhase 3
    Registry statusRecruiting
  • ITT-5 Mechanisms of Spermatogenesis in Man

    NCT02147964 · start 2019-06

    Registered record
    Registry ID
    NCT02147964
    Conditions
    Gonadotropin Deficiency
    Interventions
    Testosterone 1% Gel; Acyline; Dutasteride; Ketoconazole; HCG; placebo dutasteride; placebo ketoconazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2019-06
    Completion
    2026-12
    Enrolment
    0

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

    ConditionGonadotropin Deficiency
    InterventionTestosterone 1% Gel; Acyline; Dutasteride; Ketoconazole +3 more
    PhasePhase 2
    Registry statusWithdrawn
  • Observational Registry on Patients With Endogenous CS to Document Safety and Effectiveness of Ketoconazole.

    NCT04872920 · start 2018-12-20

    Registered record
    Registry ID
    NCT04872920
    Conditions
    Cushing Syndrome
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2018-12-20
    Completion
    2024-03-01
    Enrolment
    200

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

    ConditionCushing Syndrome
    InterventionNot recorded
    PhaseNot recorded
    Registry statusUnknown
  • Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

    NCT03471364 · start 2018-09-25

    Registered record
    Registry ID
    NCT03471364
    Conditions
    Malignant Neoplasm
    Interventions
    Ketoconazole; Laboratory Biomarker Analysis; Placebo Administration; Quality-of-Life Assessment; Questionnaire Administration
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2018-09-25
    Completion
    2024-09-15
    Enrolment
    58

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

    ConditionMalignant Neoplasm
    InterventionKetoconazole; Laboratory Biomarker Analysis; Placebo Administration; Quality-of-Life Assessment +1 more
    PhaseEarly phase 1
    Registry statusCompleted
  • The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial

    NCT04007237 · start 2018-09-01

    Registered record
    Registry ID
    NCT04007237
    Conditions
    Pityriasis Versicolor
    Interventions
    shampoo with different composition
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2018-09-01
    Completion
    2018-12-30
    Enrolment
    100

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

    ConditionPityriasis Versicolor
    Interventionshampoo with different composition
    PhasePhase 4
    Registry statusCompleted
  • Hormonal Mechanisms of Sleep Restriction - Axis Study

    NCT03142893 · start 2017-05-08

    Registered record
    Registry ID
    NCT03142893
    Conditions
    Sleep Restriction
    Interventions
    Ketoconazole Pill; Ganirelix; Dexamethasone; Dexamethasone Injection; Cosyntropin Injectable Product; Recombinant Human Luteinizing Hormone; Hydrocortisone Injection; Gonadorelin; Corticorelin; Placebo oral capsule; Saline Solution; Saline Solution for Injection
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2017-05-08
    Completion
    2026-06-30
    Enrolment
    80

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

    ConditionSleep Restriction
    InterventionKetoconazole Pill; Ganirelix; Dexamethasone; Dexamethasone Injection +8 more
    PhasePhase 1
    Registry statusActive not recruiting
  • Oral Calcitriol With Ketoconazole in CRPC

    NCT03261336 · start 2017-01-06

    Registered record
    Registry ID
    NCT03261336
    Conditions
    Castration-resistant Prostate Cancer
    Interventions
    Calcitriol, Ketoconazole, Hydrocortisone
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2017-01-06
    Completion
    2018-02-28
    Enrolment
    1

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

    ConditionCastration-resistant Prostate Cancer
    InterventionCalcitriol, Ketoconazole, Hydrocortisone
    PhasePhase 2
    Registry statusTerminated
  • Hormonal Mechanisms of Sleep Restriction

    NCT02256865 · start 2014-10

    Registered record
    Registry ID
    NCT02256865
    Conditions
    Insulin Resistance
    Interventions
    Ketoconazole; Hydrocortisone; Testosterone; Placebo for ketoconazole; Placebo for hydrocortisone; Placebo for testosterone
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2014-10
    Completion
    2023-10
    Enrolment
    40

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

    ConditionInsulin Resistance
    InterventionKetoconazole; Hydrocortisone; Testosterone; Placebo for ketoconazole +2 more
    PhaseEarly phase 1
    Registry statusCompleted
  • Treatment for Endogenous Cushing's Syndrome

    NCT01838551 · start 2014-08

    Registered record
    Registry ID
    NCT01838551
    Conditions
    Endogenous Cushing's Syndrome
    Interventions
    Levoketoconazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-08
    Completion
    2018-11
    Enrolment
    94

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

    ConditionEndogenous Cushing's Syndrome
    InterventionLevoketoconazole
    PhasePhase 3
    Registry statusCompleted
  • A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants

    NCT01924299 · start 2013-08

    Registered record
    Registry ID
    NCT01924299
    Conditions
    Healthy Volunteers
    Interventions
    Baricitinib; Ketoconazole; Fluconazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-08
    Completion
    2013-11
    Enrolment
    36

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

    ConditionHealthy Volunteers
    InterventionBaricitinib; Ketoconazole; Fluconazole
    PhasePhase 1
    Registry statusCompleted