Clinical Trials

Multiple clinical trials, spanning Phase 1 through Phase 4, evaluate clofazimine for treating complex bacterial and parasitic infections such as multidrug-resistant tuberculosis, nontuberculous mycobacterial diseases, leprosy, and cryptosporidiosis. Sponsored by academic institutions, government bodies, and international non-profit organizations, these studies encompass completed, active, and terminated recruitment statuses. These evaluations predominantly investigate clofazimine's pharmacokinetic profile, early bactericidal activity, and combination regimen efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07485010 NOT_YET_RECRUITING
Mycobacterium Abscessus Pulmonary Disease; Mycobacterium Abscessus Infection; Non-Tuberculous Mycobacterial (NTM) Infections; Non-Tuberculous Mycobacteria Pulmonary Disease
The University of Queensland
 2027-04 PHASE2
NCT04310930 RECRUITING
Pulmonary Disease Due to Mycobacteria (Diagnosis)
The University of Queensland
 2020-03-02 PHASE2; PHASE3
NCT07228702 ENROLLING_BY_INVITATION
Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection
Vancouver Coastal Health
 2026-01-11 PHASE1
NCT07198685 NOT_YET_RECRUITING
Treat to Target; Treatment Duration
Wuhan Pulmonary Hospital
 2025-09-30
NCT07126639 NOT_YET_RECRUITING
Efficacy and Safety
Wuhan Pulmonary Hospital
 2025-09-01
NCT03828201 ACTIVE_NOT_RECRUITING
Tuberculosis, Multidrug-Resistant
Boston University
 2022-06-07 PHASE2
NCT06649721 ACTIVE_NOT_RECRUITING
Drug-resistant Tuberculosis; Pulmonary Tuberculosis; Rifampin-resistant Tuberculosis
Huashan Hospital
 2024-11-27 PHASE3
NCT06081361 ACTIVE_NOT_RECRUITING
Pulmonary Tuberculosis; Rifampicin-resistant Tuberculosis
Beijing Chest Hospital
 2023-12-22 PHASE3
NCT06418711 TERMINATED
MAC Lung Disease; Treatment Refractory MAC Lung Disease; Mycobacterium Infections, Nontuberculous
Mannkind Corporation
 2024-09-11 PHASE3
NCT02968212 ACTIVE_NOT_RECRUITING
Mycobacterium Avium Complex
Oregon Health and Science University
 2017-04-11 PHASE2
NCT05306223 UNKNOWN
Tuberculosis, Multidrug-Resistant
Beijing Chest Hospital
 2022-05-10 PHASE4
NCT05556746 ACTIVE_NOT_RECRUITING
Tuberculosis, Pulmonary; HIV
Brigham and Women's Hospital
 2023-11-24 PHASE2
NCT05007821 COMPLETED
Tuberculosis, Multidrug-Resistant; Tuberculosis; Tuberculosis, Pulmonary
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-09-27 PHASE2
NCT03896685 COMPLETED
Tuberculosis, Multidrug-Resistant; Tuberculosis; Pulmonary Tuberculoses; Mycobacterial Infections; Bacterial Infections; Gram-Positive Bacterial Infections
Médecins Sans Frontières, France
 2020-04-06 PHASE3
NCT04311502 TERMINATED
HIV; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2021-11-05 PHASE2
NCT04717908 COMPLETED
Multidrug Resistant Tuberculosis
Huashan Hospital
 2021-01-20
NCT04062201 COMPLETED
Tuberculosis; Pre-XDR-TB; Extensively Drug-Resistant Tuberculosis; Multi Drug Resistant Tuberculosis; Rifampicin Resistant Tuberculosis
Wits Health Consortium (Pty) Ltd
 2019-08-22 PHASE3
NCT02754765 COMPLETED
Tuberculosis, Multidrug-Resistant; Infection, Bacterial; Pulmonary Tuberculoses
Médecins Sans Frontières, France
 2016-12 PHASE3
NCT05294146 COMPLETED
Nontuberculous Mycobacterial Diseases
Radboud University Medical Center
 2022-02-14 PHASE2
NCT04081077 UNKNOWN
Multi-drug Resistant Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pulmonary Tuberculosis
Medecins Sans Frontieres, Netherlands
 2019-08-06 PHASE2; PHASE3
NCT04207112 COMPLETED
Multi-drug Resistant Tuberculosis; Extensively Drug-Resistant Tuberculosis; Pulmonary Tuberculoses
Medecins Sans Frontieres, Netherlands
 2020-10-20 PHASE2; PHASE3
NCT02589782 COMPLETED
Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis; Tuberculosis, Pulmonary
Medecins Sans Frontieres, Netherlands
 2017-01 PHASE2; PHASE3
NCT02409290 COMPLETED
MDR-TB
IUATLD, Inc
 2016-03 PHASE3
NCT05294146 Completed
Nontuberculous Mycobacterial Diseases
Radboud University Medical Center
 2022-02-14 Phase 2
NCT03474198 COMPLETED
Tuberculosis, Pulmonary
University College, London
 2018-03-21 PHASE2; PHASE3
NCT04465695 UNKNOWN
COVID-19
The University of Hong Kong
 2020-07-14 PHASE2
NCT04239326 Completed
Tuberculosis Multidrug-Resistant
Foundation for Innovative New Diagnostics Switzerland
 2021-04-16 --
NCT03341767 TERMINATED
Cryptosporidiosis
University of Washington
 2017-12-14 PHASE2
NCT03009396 COMPLETED
Crohn Disease
RedHill Biopharma Limited
 2017-03-18 PHASE3
NCT03341767 Terminated
Cryptosporidiosis
University of Washington|Bill and Melinda Gates Foundation|The Emmes Company LLC|Calibr a division of Scripps Research|Liverpool School of Tropical Medicine|University of Virginia|Malawi-Liverpool-Wellcome Trust Clinical Research Programme
 2017-12-14 Phase 2
NCT01290744 COMPLETED
Borderline Lepromatous Leprosy; Lepromatous Leprosy
Paul Saunderson
 2010-08 PHASE4
NCT01691534 COMPLETED
Pulmonary Tuberculosis
Global Alliance for TB Drug Development
 2012-10 PHASE2
NCT00669643 COMPLETED
Leprosy
University of Brasilia
 2007-02 PHASE4
NCT00513552 WITHDRAWN
Crohn's Disease
Medstar Health Research Institute
 2007-07 PHASE4
NCT00002331 COMPLETED
Mycobacterium Avium-intracellular Infection; HIV Infections
Abbott
 1994-01
NCT00000641 COMPLETED
Mycobacterium Avium-intracellulare Infection; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000796 COMPLETED
HIV Infections; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00002058 COMPLETED
Mycobacterium Avium-intracellulare Infection; HIV Infections
University of California, San Francisco
NCT00001047 COMPLETED
Mycobacterium Avium-intracellulare Infection; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-03-20)

Check the Clofazimine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clofazimine intercalates into bacterial DNA and activates membrane-bound phospholipase A2, causing generation of antimicrobial lysophospholipids and severe membrane disruption. This biochemical impairment inhibits cellular nucleic acid synthesis and induces lethal metabolic stress, producing bactericidal and anti-inflammatory effects that directly suppress pathogenic growth in multidrug-resistant tuberculosis and nontuberculous mycobacterial infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.