by Kumar G, Kant R, Joshi D, Singh K, Cherian JJ, Rajan KRV, Malik S, Das S, Roy SP, Satam V, Guria RT, Kumar D, Majhee L, Kumar A, Krishnamurthy MN, Sharma LK, Chaudhary A, Scandale I, Specht S, Sahu S, Meher M, Mohapatra SG, Mukherjee A, Gupta TM. Infectious Diseases and Therapy 2026, doi:10.1007/s40121-026-01419-z.
Summary: Oxfendazole has shown promising macrofilaricidal activity in preclinical models, and Phase I clinical studies have established its safety and tolerability in humans. The authors of this manuscript describe a protocol for a Phase IIa, proof-of-concept randomised, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetic profile of oxfendazole in adults with confirmed lymphatic filariasis. The primary objective is to estimate the proportion of participants with no detectable adult worm motility on ultrasonography at 6 months post-treatment, serving as a marker of macrofilaricidal efficacy. Participants will be randomised to receive either 400 or 800 mg oxfendazole, or a matching placebo, administered orally once daily for five days. The findings from this trial will help guide the clinical development of oxfendazole.