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Lamprene (clofazimine)
Lamprene (clofazimine) is a small molecule antimycobacterial drug developed by Novartis, targeting the ATP-binding cassette sub-family G member 2. It is approved for various leprosy-related conditions, including dapsone-resistant leprosy and erythema nodosum leprosum. Lamprene is off-patent, but currently owned by Novartis, with no generic manufacturers. Key safety considerations include its potential for skin discoloration and gastrointestinal side effects. It has a bioavailability of 57%.
At a glance
| Generic name | clofazimine |
|---|---|
| Sponsor | Novartis |
| Drug class | Antimycobacterial |
| Target | ATP-binding cassette sub-family G member 2 |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1986 |
Approved indications
- Dapsone resistant leprosy
- Erythema nodosum leprosum
- Leprosy
- Multibacillary leprosy
- Pyoderma gangrenosum
Common side effects
Key clinical trials
- Study of Mycobacterial Infections
- 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)
- Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
- Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB (PHASE2)
- A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets (PHASE2)
- Lamprene Multiple Patient Program
- Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection (PHASE1)
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Lamprene CI brief — competitive landscape report
- Lamprene updates RSS · CI watch RSS
- Novartis portfolio CI