Fexinidazole for T.b. rhodesiense Sleeping sickness

Saving lives through new sleeping sickness treatments

Project start: September 2018


DNDi’s long-term goal for sleeping sickness is to develop and register two new drugs that are effective against both stage one and stage two of the disease, also known as human African trypanosomiasis (HAT), and both subspecies of the parasite, Trypanosoma brucei gambiense and Trypanosoma brucei rhodesiense.

Map with the cases of human African trypanosomiasis reported from Eastern and South-eastern Africa (period 2000-2009)
Cases of human African trypanosomiasis reported from Eastern and South-eastern Africa (period 2000-2009). Source

Fexinidazole, the first all-oral drug for sleeping sickness developed in clinical trials led by DNDi and added to the World Health Organization’s List of Essential Medicines in July 2019, is currently only indicated as a treatment for gambiense sleeping sickness, the most common form of the disease. The 10-day once-a-day treatment can be taken at home.

To provide clinical data to assess the safety and efficacy of treating both stages of rhodesiense sleeping sickness with fexinidazole, we have joined with partners to form the HAT-r-ACC consortium. The consortium is working on a five-year study in Uganda and Malawi, which together account for 88 % of cases globally. The study aims to support WHO control and elimination efforts in East Africa by providing evidence for the potential of a new and easier to administer oral drug.

Better treatments for rhodesiense sleeping sickness are urgently needed: the only treatment available for stage two rhodesiense sleeping sickness is melarsoprol, a toxic arsenic drug dating from the 1940s that kills up to 5% of patients it is meant to cure. While the treatment option for stage one, suramin, is less toxic, it is difficult to administer, requiring five intravenous injections given every seven days for a month. Without prompt diagnosis and treatment, sleeping sickness is usually fatal. Rhodesiense sleeping sickness progresses more rapidly than gambiense sleeping sickness, causing death within months.

The consortium also aims to support national sleeping sickness control programmes in Malawi and Uganda to raise awareness of rhodesiense sleeping sickness among affected communities and increase early detection of cases.






Nurse holding melarsoprol

“Patients scream as we inject the drug. Some never leave the hospital.”

Eunice is a nurse at Lwala Hospital, in Uganda, where melarsoprol, an arsenic-based treatment is still the only treatment available for stage two rhodesiense sleeping sickness



European and Developing Countries Clinical Trials Partnership (EDCTP); Fundação para a Ciência e a Tecnologia (FCT), Portugal.

This project is part of the EDCTP2 programme which is supported by the European Union.

HAT-r-ACC consortium

The HAT-r-ACC consortium brings together a broad range of partners with expertise in sleeping sickness and capacity building in remote health settings. This research, training, and community engagement experience is essential to run the clinical trial in remote settings with a very small target population.


Association Epicentre, France; DNDi, Switzerland; Institut de Recherche pour le Développement (IRD), France; Makerere University, Uganda; Ministry of Health and Population, Malawi; Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland; Uganda National Health Research Organisation (UNHRO), Uganda; Universidade Nova de Lisboa, Instituto de Higiene e Medicina Tropical (IHMT), Portugal.

Our partners for the development of fexinidazole T.b. gambiense

Support from the HAT Platform


This project is part of the EDCTP2 programme, which is supported by the European Union.

EDCTP logo FCT logo



Last updated: August 2019