Pharmacokinetics of Clofazimine Tablet Formulation in Children with Rifampicin-Resistant Tuberculosis in CATALYST, a Multi-Site International Trial

Authors

• Yuanxi Zou, Uppsala Universitet
• Megan Palmer, Stellenbosch University, Faculty of Medicine and Health Sciences
• Melchor V.G. Frias, De La Salle Medical and Health Sciences Institute
• Dessa J.O. Casalme, De La Salle Medical and Health Sciences Institute
• Aarti A. Kinikar, BJ Government Medical College
• Mandar Paradkar, BJ Government Medical College
• Vandana Kulkarni, BJ Government Medical College
• Pragathi Kamath, BJ Government Medical College
• Ingrid Courtney, Stellenbosch University, Faculty of Medicine and Health Sciences
• Heather Draper, Stellenbosch University, Faculty of Medicine and Health Sciences
• Lubbe Wiesner, University of Cape Town
• Mats O. Karlsson, Uppsala Universitet
• Paolo Denti, University of Cape Town
• Louvina van der Laan, Stellenbosch University, Faculty of Medicine and Health Sciences
• Anthony J. Garcia-Prats, Stellenbosch University, Faculty of Medicine and Health Sciences
• Anneke C. Hesseling, Stellenbosch University, Faculty of Medicine and Health Sciences
• Elin M. Svensson, Uppsala Universitet

Publication Date

9-1-2026

Document Type

Article

Publication Title

Journal of the Pediatric Infectious Diseases Society

Abstract

We evaluated the pharmacokinetics of a novel child-friendly 50 mg clofazimine tablet formulation that disperses quickly in water, compared to traditional gel capsules, in 36 children routinely treated for rifampicin-resistant tuberculosis. No substantial pharmacokinetic difference was observed between tablets and gel capsules, supporting the tablet formulation use for paediatric dosing.

APA Citation

Zou, Y., Palmer, M., Frias, M. V. G., Casalme, D. J. O., Kinikar, A. A., Paradkar, M., Kulkarni, V., Kamath, P., Courtney, I., Draper, H., Wiesner, L., Karlsson, M. O., Denti, P., van der Laan, L., Garcia-Prats, A. J., Hesseling, A. C., & Svensson, E. M. (2026). Pharmacokinetics of Clofazimine Tablet Formulation in Children with Rifampicin-Resistant Tuberculosis in CATALYST, a Multi-Site International Trial. Journal of the Pediatric Infectious Diseases Society, 15(9), piag089. https://doi.org/10.1093/jpids/piag089