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Clofazimine

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

Registered studies
50+
Lab records
5
Pathogens at ≥40%
1 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Leprosy

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

WHO therapeutic group
Drugs for treatment of lepra
FDA pharmacologic class
Antimycobacterial FDA label ↗
Anti-infective classification
Classified as an existing antimicrobial.WHO ATC J04BA01; FDA class Antimycobacterial

Repurposing investigation

Clofazimine is already an antimicrobial, so it is not counted among the repurposing candidates. Its AI-predicted activity is shown below for reference.

AI-predicted activity

AI prediction · nothing measured
  • MRSA39.7% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • E. coli30.1% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae20.1% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis78.6% 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 5 of 5 lab records
Show the 5 laboratory records, 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)

-8.3 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)

-8.9 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 Clofazimine 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.

  • The Individualized M(X) Drug-resistant TB Treatment Strategy Study

    NCT03237182 · start 2017-06-14

    Registered record
    Registry ID
    NCT03237182
    Conditions
    Tuberculosis, Multidrug-Resistant
    Interventions
    Individualized TB treatment with multiple drugs; Standardized TB treatment with multiple drugs
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2017-06-14
    Completion
    2022-12-19
    Enrolment
    205

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

    ConditionTuberculosis, Multidrug-Resistant
    InterventionIndividualized TB treatment with multiple drugs; Standardized TB treatment with multiple drugs
    PhasePhase 4
    Registry statusTerminated
  • Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)

    NCT02968212 · start 2017-04-11

    Registered record
    Registry ID
    NCT02968212
    Conditions
    Mycobacterium Avium Complex
    Interventions
    Clofazimine; sugar pill
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2017-04-11
    Completion
    2026-10
    Enrolment
    102

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

    ConditionMycobacterium Avium Complex
    InterventionClofazimine; sugar pill
    PhasePhase 2
    Registry statusActive not recruiting
  • Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

    NCT03009396 · start 2017-03-18

    Registered record
    Registry ID
    NCT03009396
    Conditions
    Crohn Disease
    Interventions
    RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-03-18
    Completion
    2019-08-19
    Enrolment
    54

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

    ConditionCrohn Disease
    InterventionRHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)
    PhasePhase 3
    Registry statusCompleted
  • Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

    NCT02589782 · start 2017-01

    Registered record
    Registry ID
    NCT02589782
    Conditions
    Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis; Tuberculosis, Pulmonary
    Interventions
    Bedaquiline; Pretomanid; Moxifloxacin; Linezolid; Clofazimine; Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2017-01
    Completion
    2022-08-05
    Enrolment
    552

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

    ConditionTuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis; Tuberculosis, Pulmonary
    InterventionBedaquiline; Pretomanid; Moxifloxacin; Linezolid +2 more
    PhasePhase 2 / Phase 3
    Registry statusCompleted
  • Evaluating Newly Approved Drugs for Multidrug-resistant TB

    NCT02754765 · start 2016-12

    Registered record
    Registry ID
    NCT02754765
    Conditions
    Tuberculosis, Multidrug-Resistant; Infection, Bacterial; Pulmonary Tuberculoses
    Interventions
    Bedaquiline; Delamanid; Clofazimine; Levofloxacin; Moxifloxacin; Linezolid; Pyrazinamide; Control arm MDR-TB regimen, consistent with WHO guidelines
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-12
    Completion
    2023-06
    Enrolment
    754

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

    ConditionTuberculosis, Multidrug-Resistant; Infection, Bacterial; Pulmonary Tuberculoses
    InterventionBedaquiline; Delamanid; Clofazimine; Levofloxacin +4 more
    PhasePhase 3
    Registry statusCompleted
  • The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

    NCT02409290 · start 2016-03

    Registered record
    Registry ID
    NCT02409290
    Conditions
    MDR-TB
    Interventions
    Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline); Moxifloxacin; Clofazimine; Ethambutol; Pyrazinamide; Isoniazid; Prothionamide; Kanamycin; Levofloxacin; Bedaquiline
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-03
    Completion
    2023-05-02
    Enrolment
    588

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

    ConditionMDR-TB
    InterventionRegimen A locally-used WHO-approved MDR-TB regimen (2011 guideline); Moxifloxacin; Clofazimine; Ethambutol +6 more
    PhasePhase 3
    Registry statusCompleted
  • An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis

    NCT02454205 · start 2015-11-12

    Registered record
    Registry ID
    NCT02454205
    Conditions
    Tuberculosis; Multidrug Resistant Tuberculosis; Extensively-drug Resistant Tuberculosis
    Interventions
    Linezolid; Bedaquiline; Levofloxacin; Pyrazinamide; Isoniazid; Ethionamide; Terizidone; Moxifloxacin; Kanamycin
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2015-11-12
    Completion
    2021-08-30
    Enrolment
    154

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

    ConditionTuberculosis; Multidrug Resistant Tuberculosis; Extensively-drug Resistant Tuberculosis
    InterventionLinezolid; Bedaquiline; Levofloxacin; Pyrazinamide +5 more
    PhasePhase 2 / Phase 3
    Registry statusCompleted
  • Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

    NCT01951326 · start 2013-09

    Registered record
    Registry ID
    NCT01951326
    Conditions
    Crohn's Disease
    Interventions
    RHB-104; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2013-09
    Completion
    2019-08
    Enrolment
    331

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

    ConditionCrohn's Disease
    InterventionRHB-104; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan

    NCT02496572 · start 2013-09

    Registered record
    Registry ID
    NCT02496572
    Conditions
    Multidrug Resistant Tuberculosis
    Interventions
    Short course MDR-TB treatment regimen
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2013-09
    Completion
    2016-04
    Enrolment
    110

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

    ConditionMultidrug Resistant Tuberculosis
    InterventionShort course MDR-TB treatment regimen
    PhaseNot recorded
    Registry statusUnknown
  • Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS)

    NCT01717664 · start 2013-06

    Registered record
    Registry ID
    NCT01717664
    Conditions
    Relapsing Remitting Multiple Sclerosis
    Interventions
    RHB-104
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-06
    Completion
    2016-07
    Enrolment
    18

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

    ConditionRelapsing Remitting Multiple Sclerosis
    InterventionRHB-104
    PhasePhase 2
    Registry statusCompleted
  • Virgin Coconut Oil Oral Supplementation for Leprosy Patients

    NCT01885611 · start 2013-06

    Registered record
    Registry ID
    NCT01885611
    Conditions
    Hansen's Disease
    Interventions
    Multi-Drug Therapy (Novartis Ⓡ); Virgin Coconut Oil
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Withdrawn
    Start
    2013-06
    Completion
    2018-06
    Enrolment
    0

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

    ConditionHansen's Disease
    InterventionMulti-Drug Therapy (Novartis Ⓡ); Virgin Coconut Oil
    PhasePhase 1 / Phase 2
    Registry statusWithdrawn
  • Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)

    NCT01691534 · start 2012-10

    Registered record
    Registry ID
    NCT01691534
    Conditions
    Pulmonary Tuberculosis
    Interventions
    TMC207 (J); PA-824 (PA); pyrazinamide (Z); clofazimine (C); Rifafour
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2012-10
    Completion
    2013-05
    Enrolment
    105

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

    ConditionPulmonary Tuberculosis
    InterventionTMC207 (J); PA-824 (PA); pyrazinamide (Z); clofazimine (C) +1 more
    PhasePhase 2
    Registry statusCompleted
  • Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis

    NCT00513552 · start 2007-07

    Registered record
    Registry ID
    NCT00513552
    Conditions
    Crohn's Disease
    Interventions
    Rifabutin, Clarithromycin, and Clofazimine
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2007-07
    Completion
    2007-07
    Enrolment
    0

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

    ConditionCrohn's Disease
    InterventionRifabutin, Clarithromycin, and Clofazimine
    PhasePhase 4
    Registry statusWithdrawn
  • Uniform Multidrug Therapy Regimen for Leprosy Patients

    NCT00669643 · start 2007-02

    Registered record
    Registry ID
    NCT00669643
    Conditions
    Leprosy
    Interventions
    PB 6 doses - Rifampicin and Dapsone; PB 6 doses - Rifampicin, Clofazimine and Dapsone; MB 12 doses - Rifampicin, Clofazimine and Dapsone; MB 6 doses - Rifampicin, Clofazimine and Dapsone
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2007-02
    Completion
    2016-12-31
    Enrolment
    859

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

    ConditionLeprosy
    InterventionPB 6 doses - Rifampicin and Dapsone; PB 6 doses - Rifampicin, Clofazimine and Dapsone; MB 12 doses - Rifampicin, Clofazimine and Dapsone; MB 6 doses - Rifampicin, Clofazimine and Dapsone
    PhasePhase 4
    Registry statusCompleted
  • The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

    NCT00002331 · start 1994-01

    Registered record
    Registry ID
    NCT00002331
    Conditions
    Mycobacterium Avium-intracellular Infection; HIV Infections
    Interventions
    Ethambutol hydrochloride; Clarithromycin; Clofazimine
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    1994-01
    Completion
    1995-03
    Enrolment
    Not recorded

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

    ConditionMycobacterium Avium-intracellular Infection; HIV Infections
    InterventionEthambutol hydrochloride; Clarithromycin; Clofazimine
    PhaseNot applicable
    Registry statusCompleted