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The curious constraints on clofazimine
Maple Goh1,2,3, Daniel Eisenkraft Klein1, Aaron S Kesselheim1
1Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, 1620 Tremont, Suite 3030, Boston, MA 02120, USA.
The Journal of Antimicrobial Chemotherapy
|November 19, 2025
Summary
Clofazimine, vital for leprosy and other mycobacterial infections, faces access barriers in the USA. New policies are needed for equitable and sustainable access to this essential medicine.
Area of Science:
- Pharmacology and Public Health
- Global Health Policy
Background:
- Clofazimine is a WHO-recommended treatment for multibacillary leprosy.
- It is also an emerging option for drug-resistant tuberculosis and non-tuberculous mycobacterial infections.
- Despite decades of safe use, access in high-income countries like the USA is restricted.
Purpose of the Study:
- To examine clofazimine's regulatory history in the USA.
- To contrast global access models for clofazimine.
- To highlight issues with single-manufacturer reliance and donation programs.
Main Methods:
- Review of regulatory pathways.
- Comparative analysis of global access strategies.
- Assessment of supply chain vulnerabilities.
Main Results:
- Current systems in the USA present limitations to equitable access.
- Reliance on a single manufacturer and informal donations creates supply instability.
- Existing access models are often ill-suited for low-profit essential medicines.
Conclusions:
- Policy reforms are necessary to ensure sustainable and equitable clofazimine access.
- Recommendations include simplified access, WHO-based procurement, and public manufacturing.
- Proactive stewardship is crucial for essential medicines with limited commercial viability.
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