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Clofazimine Oral Product
Clofazimine Oral Product is a Antimycobacterial agent Small molecule drug developed by Wits Health Consortium (Pty) Ltd. It is currently in Phase 3 development for Leprosy (Hansen's disease), Atypical mycobacterial infections (MAC, M. marinum), Tuberculosis (as adjunctive therapy in drug-resistant cases). Also known as: Lamprene.
Clofazimine is a lipophilic antimycobacterial agent that generates reactive oxygen species and intercalates into mycobacterial DNA, disrupting bacterial replication and causing bacterial cell death.
Clofazimine is a lipophilic antimycobacterial agent that generates reactive oxygen species and intercalates into mycobacterial DNA, disrupting bacterial replication and causing bacterial cell death. Used for Leprosy (Hansen's disease), Atypical mycobacterial infections (MAC, M. marinum), Tuberculosis (as adjunctive therapy in drug-resistant cases).
At a glance
| Generic name | Clofazimine Oral Product |
|---|---|
| Also known as | Lamprene |
| Sponsor | Wits Health Consortium (Pty) Ltd |
| Drug class | Antimycobacterial agent |
| Target | Mycobacterial DNA; reactive oxygen species generation |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Clofazimine accumulates in fatty tissues and mycobacterial cells, where it undergoes redox cycling to produce reactive oxygen species that damage bacterial DNA and proteins. It also has immunomodulatory properties, enhancing macrophage function and reducing inflammatory responses. The drug is particularly effective against Mycobacterium leprae and atypical mycobacteria.
Approved indications
- Leprosy (Hansen's disease)
- Atypical mycobacterial infections (MAC, M. marinum)
- Tuberculosis (as adjunctive therapy in drug-resistant cases)
Common side effects
- Skin discoloration (red-brown to black pigmentation)
- Gastrointestinal disturbances (nausea, diarrhea, abdominal pain)
- Ichthyosis and dry skin
- Photosensitivity
- Hepatotoxicity
Key clinical trials
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- Lamprene Multiple Patient Program
- 6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province (NA)
- Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort (PHASE3)
- A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis (NA)
- Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (PHASE2, PHASE3)
- Linezolid Dosing Strategies in Drug-Resistant TB (PHASE2)
- Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Clofazimine Oral Product CI brief — competitive landscape report
- Clofazimine Oral Product updates RSS · CI watch RSS
- Wits Health Consortium (Pty) Ltd portfolio CI
Frequently asked questions about Clofazimine Oral Product
What is Clofazimine Oral Product?
How does Clofazimine Oral Product work?
What is Clofazimine Oral Product used for?
Who makes Clofazimine Oral Product?
Is Clofazimine Oral Product also known as anything else?
What drug class is Clofazimine Oral Product in?
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Related
- Drug class: All Antimycobacterial agent drugs
- Target: All drugs targeting Mycobacterial DNA; reactive oxygen species generation
- Manufacturer: Wits Health Consortium (Pty) Ltd — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Leprosy (Hansen's disease)
- Indication: Drugs for Atypical mycobacterial infections (MAC, M. marinum)
- Indication: Drugs for Tuberculosis (as adjunctive therapy in drug-resistant cases)
- Also known as: Lamprene