The latest

First clinical trial of oxfendazole in parasitic worm disease approved by regulatory authority

The Oxfendazole Development Group announces that the deworming medicine oxfendazole has been approved by the Instituto Nacional de Salud (The Peruvian National Institute of Health) for use in a clinical trial in people infected with the parasitic whipworm Trichuris trichiura.  To be conducted in the Amazonian region of Peru, the clinical trial (NCT04713787) is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the (US) National Institutes of Health, and carried out through a partnership with the Peruvian nonprofit Asociación Benéfica Prisma, the University of Iowa, the University of Virginia, and the Oxfendazole Development Group. This Phase 2 study, the first evaluation of oxfendazole’s efficacy and safety in patients, follows successful Phase 1 studies of oxfendazole in single (SAD) and multiple ascending dose (MAD) administration to healthy volunteers. Already in widespread use as a veterinary deworming treatment, oxfendazole has the potential to be more efficacious against human worm infections than some structurally related medicines, due to the higher plasma levels it achieves. It is hoped that oxfendazole will provide improved treatment of several parasitic worm diseases, prevalent in poorly resourced areas of the world.

The Oxfendazole Development Group is committed to bring the potentially game-changing medicine oxfendazole to people infected with parasitic worms. Its work is supported by AstralCodexTen, Open Philanthropy and generous individual donors.

Most recent publications:

Human Phase I SAD study: 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

Human Phase I MAD study: the results of the Phase I Multiple Ascending Dose (MAD) study of oxfendazole are now published.  See the safety profile and pharmacokinetics of oxfendazole  following its multiple dose administration in healthy volunteers: Oxfendazole MAD study 2020

Population pharmacokinetic-pharmacodynamic model of oxfendazole in healthy adults: POP PK/PD model of oxfendazole in healthy adults, created using data from the MAD and food effect clinical studies.pop PK/PD pub

Preclinical review: Our review of the evidence of oxfendazole’s safety and efficacy against both gut and tissue dwelling parasitic worms in animals, as well as more recent safety and pharmacokinetic data, supporting oxfendazole’s investigation for use as an anthelmintic in humans.  Read our review:  oxfendazole expert review