NDAORALCAPSULEPriority Review
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
Priority Review
LAMPRENE (clofazimine) by Novartis. Approved for antimycobacterial [epc]. First approved in 1986.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMPRENE (clofazimine) is an oral small-molecule antimycobacterial agent approved in 1986 for the treatment of leprosy and atypical mycobacterial infections. It works through mechanisms that disrupt mycobacterial cell function, though exact MOA is not fully elucidated. The drug is primarily used in combination regimens for mycobacterial diseases in specialized patient populations.
LOE Approaching
This near-LOE specialty drug operates in a narrow niche market with limited team expansion potential; focus shifts toward supply chain and compliance rather than growth initiatives.
Mechanism of Action
Pharmacologic Class:
Antimycobacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible Tuberculosis
Started Nov 2023
94 enrolled
Tuberculosis, PulmonaryHIV
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
Started Jun 2022
271 enrolled
Tuberculosis, Multidrug-Resistant
Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study
Started Nov 2021
104 enrolled
HIVTuberculosis
Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)
Started Apr 2017
102 enrolled
Mycobacterium Avium Complex
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
Started Oct 2012
105 enrolled
Pulmonary Tuberculosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.