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Levoketoconazole

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

Registered studies
6
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Adrenal gland disease
  • Adrenal gland hyperfunction
  • Cushing syndrome

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

WHO therapeutic group
Anticorticosteroids
FDA pharmacologic class
Cortisol Synthesis 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
  • 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. A stereoisomer of this medicine was in the model's training data.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

6registered 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)

-9.0 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.1 kcal/mol

0better fit →-12

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

-7.8 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.3 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 Levoketoconazole 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.

  • Bioavailability of Levoketoconazole and Ketoconazole Tablets

    NCT04212000 · start 2019-12-16

    Registered record
    Registry ID
    NCT04212000
    Conditions
    Healthy
    Interventions
    Levoketoconazole; Ketoconazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-12-16
    Completion
    2020-01-23
    Enrolment
    34

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

    ConditionHealthy
    InterventionLevoketoconazole; Ketoconazole
    PhasePhase 1
    Registry statusCompleted
  • Drug Interaction Study of Levoketoconazole and Metformin

    NCT03880825 · start 2019-03-28

    Registered record
    Registry ID
    NCT03880825
    Conditions
    Healthy Subjects
    Interventions
    Metformin 500 mg Oral Tablet; Levoketoconazole 150 - 600 mg (BID)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-03-28
    Completion
    2019-05-03
    Enrolment
    32

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

    ConditionHealthy Subjects
    InterventionMetformin 500 mg Oral Tablet; Levoketoconazole 150 - 600 mg (BID)
    PhasePhase 1
    Registry statusCompleted
  • Open-label Treatment in Cushing's Syndrome

    NCT03621280 · start 2019-01-07

    Registered record
    Registry ID
    NCT03621280
    Conditions
    Cushing Syndrome; Cushing Disease
    Interventions
    Levoketoconazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-01-07
    Completion
    2022-12-31
    Enrolment
    51

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

    ConditionCushing Syndrome; Cushing Disease
    InterventionLevoketoconazole
    PhasePhase 3
    Registry statusCompleted
  • Levoketoconazole Food Effect Study in Healthy Subjects

    NCT03768388 · start 2018-11-30

    Registered record
    Registry ID
    NCT03768388
    Conditions
    Healthy Subjects
    Interventions
    levoketoconazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-11-30
    Completion
    2018-12-24
    Enrolment
    22

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

    ConditionHealthy Subjects
    Interventionlevoketoconazole
    PhasePhase 1
    Registry statusCompleted
  • A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

    NCT03277690 · start 2017-09-26

    Registered record
    Registry ID
    NCT03277690
    Conditions
    Endogenous Cushing's Syndrome
    Interventions
    Levoketoconazole; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-09-26
    Completion
    2020-08-31
    Enrolment
    84

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

    ConditionEndogenous Cushing's Syndrome
    InterventionLevoketoconazole; Placebo
    PhasePhase 3
    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