Clinical development

Safety studies in human volunteers

Single ascending dose safety and pharmacokinetics study

ODG members worked with the National Institutes of Health (NIAID/DMID) to conduct First in Human studies of oxfendazole, the first clinical step in the development of oxfendazole. The design and results of this safety and pharmacokinetics study are given under NCT02234570 on the web site:  The results of the Phase I Single Ascending Dose (SAD) study of oxfendazole are now published.  See the safety profile and pharmacokinetics of oxfendazole in healthy volunteers: publication Phase I SAD study

Multiple ascending dose safety and pharmacokinetics study and food effect study

ODG worked with the National Institutes of Health (NIAID/DMID) to conduct a Multiple Ascending Dose (MAD) study of oxfendazole, as well as a food effect study. Oxfendazole was well tolerated across the range of doses studied, and the consumption of food prior to oxfendazole administration was found to increase oxfendazole plasma levels (Tmax, Cmax, AUC). The design and results of these studies is given under NCT03035760 on the web site:  and published: Oxfendazole MAD study 2020.

Population Pharmacokinetic/Pharmacodynamic study

Using the data from the SAD and MAD studies, ODG collaborated with the National Institutes of Health (NIAID/DMID) and the University of Iowa in the elaboration of a population pharmacokinetics and pharmacodynamics (popPK/PD) model of oxfendazole and used to explore target attainment in the treatment of two different parasitic infections trichuriasis and filariasis. This work is just being published: see pop PK/PD pub

Efficacy study in patients

Proof of concept study in patients

ODG is collaborating with NIH/DMID, the Universities of Iowa and Virginia, and the Peruvian nonprofit Asociacion Benefica Prisma to conduct the first study of oxfendazole in patients infected with a Neglected Tropical Disease, Trichuris trichiura, an intestinal worm. In this assessor blind, randomized Phase 2 study, the efficacy of different doses of oxfendazole will be compared to the efficacy of albendazole, the currently used medication. Albendazole is only moderately effective in curing T. trichiura infection. The design of this study is given under NCT04713787 on the website: