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Flubendazole Macrofilaricide

Filarial Diseases Translation

  • Target disease: Filarial diseases
  • Partners: Johnson & Johnson, USA; Michigan State University, USA; Abbott Laboratories, USA; University of Buea, Cameroon
  • Leadership: Discovery and Pre-clinical Director: Robert Don; Project Manager: Ivan Scandale
  • Start date: April 2011
  • Funding: Bill & Melinda Gates Foundation, USA; Department for International Development (DFID), UK; Federal Ministry of Education and Research (BMBF through KfW), Germany; Médecins Sans Frontières/Doctors without Borders, International/Norway; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland

  • Objective: Determine the potential of flubendazole as a pre-clinical macrofilaricide candidate for preventive treatment of onchocerciasis and lymphatic filariasis in Loa loa co-endemic regions

  • Listen to podcast: Bernard Pécoul speaking about DNDi's portfolio expansion to helminth infections
  • Read DNDi's Press release: "DNDi expands its activities to tackle urgent unmet needs for neglected patients in the field of helminth infections"

This project aims to develop flubendazole as a safe, highly efficacious, and field-usable macrofilaricidal drug candidate for the treatment of onchocerciasis and LF. Flubendazole belongs to the benzimidazole class of molecules. Developed by Janssen Pharmaceuticals (a pharmaceutical company of Johnson & Johnson) in the mid-1970s, it is a potent and efficacious anti-helminthic drug for gastrointestinal nematode infections in swine, poultry, companion animals, and humans. In Europe, flubendazole is marketed for human use as Fluvermal. In several animal models(1) and in a small human clinical trial for onchocerciasis, in which the drug was administered parenterally,(2) flubendazole showed very specific potency against the adult stage of the worm. Despite this selective potency, it has not been considered as a treatment for filarial infections, as all of the current formulations have very low bioavailability and these oral forms would not provide sufficient systemic exposure. The first step of this project was to develop, with the help of AbbVie, a new pre-clinical formulation of flubendazole that allows oral absorption.

Non-clinical development of flubendazole is ongoing in collaboration with Janssen Pharmaceuticals: in particular, the necessary studies required to file an Investigational New Drug (IND) application followed by submission of a dossier to the FDA are supported by Janssen Pharmaceuticals, which will also provide DNDi with drug supplies to support clinical development. DNDi will conduct extensive PK/PD studies to guide/refine the selection of human therapeutic doses.

1) Zahner H., Schares G. (1993) Experimental chemotherapy of filariasis: comparative evaluation of the efficacy of filaricidal compounds in Mastomys coucha infected with Litomosoides carinii, Acanthocheilonema viteae, Brugia malayi and B. pahangi. Acta Trop 52: 221-66.

(2) Dominguez-Vazquez A. et al. (1983) Comparison of flubendazole and diethylcarbamazine in treatment of onchocerciasis. Lancet 1: 139-43.



Last update: October 2013


Tags: Filarial diseases


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