Pharmacokinetics, safety, and tolerability of an oxfendazole tablet formulation: a phase 1, randomized, placebo-controlled trial in healthy African volunteers

Jongo S, Ackermann E, Nyaulingo G, Mbaraka H, Reus E, Cicconi S, Saxena M, Kassim K, Tumbo A, Rashid MA, Robinson S, Louis M, Satam V, Barreira F, Scandale I, Assmus F, Keiser J, Specht S. Antimicrobial Agents Chemotherapy 2026, other0:e01315-25. doi: 10.1128/aac.01315-25

Summary: The authors of this manuscript conducted a phase I bioavailability study of an immediate-release tablet formulation of oxfendazole, a registered veterinary drug with broad-spectrum activity against multiple nematode species. This trial investigated the pharmacokinetics, safety, and tolerability of single or multiple doses in 30 healthy African adults. Peak plasma concentrations were reached after 2.5–3 h. The median elimination half-life (11.6-13.9 h) was consistent across cohorts. Pharmacokinetics were non-linear, with exposure increasing less than dose-proportionally and showing high variability. Oxfendazole was well tolerated, with no adverse events or clinically significant abnormalities. These findings support the further development of oxfendazole in early proof-of-concept studies, however, formulation optimization to reduce variability in exposure and improve the reliability of exposure-response assessments was suggested.

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