By Michael Gwarisa
Zimbabwe is among five African countries that have started administering the world’s first all-oral treatment for Trypanosoma brucei rhodesiense sleeping sickness—a rare but deadly disease that has long affected communities in East and Southern Africa. The development marks a turning point in the fight against this neglected tropical disease, especially in endemic regions like Zimbabwe, where tsetse fly infestations remain a concern.
The new drug, Fexinidazole Winthrop, is now being offered free of charge in specialized treatment centres in Zimbabwe, Malawi, Ethiopia, Tanzania, and Zambia. Its approval comes after groundbreaking clinical trials led by the not-for-profit medical research organization Drugs for Neglected Diseases initiative (DNDi), in collaboration with several African governments and healthcare institutions.
Until now, treatment for rhodesiense sleeping sickness relied on toxic intravenous drugs that required hospital admission and constant monitoring. Fexinidazole changes that paradigm. The new regimen is fully oral, allowing patients to take their medication at home with minimal medical supervision.
This breakthrough transforms how we care for patients suffering from this deadly disease,” said Dr Westain Nyirenda, principal investigator of the Fexinidazole clinical trial in Malawi. “It offers a safer, simpler, and more accessible option, particularly for remote communities.”
In Zimbabwe, a handful of patients have already received the treatment since early 2025. While the country has not faced a recent major outbreak, it remains at risk due to its proximity to tsetse fly habitats and the presence of wild and domestic animal reservoirs that can carry the disease.
Rhodesiense sleeping sickness, also known as Human African Trypanosomiasis (HAT), is transmitted through the bite of infected tsetse flies. It causes a range of debilitating symptoms including fever, confusion, sleep disturbances, and eventually coma and death if untreated. The rhodesiense strain progresses much faster than the gambiense form, which is common in West and Central Africa and has already been eliminated as a public health problem in several countries.
Dr Junior Matangila, Head of DNDi’s sleeping sickness programme, emphasized the urgency of expanding access to the new oral treatment. “With climate and environmental changes increasing human-animal interactions, especially in rural farming areas, the risk of new outbreaks is growing. This treatment gives us a better chance to respond quickly and save lives,” he said.
The approval of Fexinidazole Winthrop by Zimbabwe’s regulatory authorities followed a similar decision in Malawi in late 2024, after the European Medicines Agency issued a positive scientific opinion. WHO also included the drug in its 2024 guidelines as the first-line treatment for T.b. rhodesiense.
Fexinidazole is recommended for adults and children aged six years and older who weigh at least 20 kilograms. It is effective in treating both early-stage (blood and lymph system) and late-stage (central nervous system) forms of the disease. The drug is donated to the WHO by Foundation S, the philanthropic arm of pharmaceutical company Sanofi, and distributed through Médecins Sans Frontières Logistique.
The success of Fexinidazole is the result of a collaborative global effort. The clinical trials were supported by a consortium known as HAT-r-ACC, involving partners from Malawi, Uganda, France, Switzerland, Portugal, and WHO, with financial backing from the European Union and other development agencies.
Beyond treating rhodesiense sleeping sickness, DNDi and Sanofi are also developing acoziborole, a potential single-dose oral cure that could simplify treatment even further and help drive disease elimination across the continent.
