DNDi and our partners are working to deliver breakthrough treatments and expedite access to eliminate sleeping sickness – for good. We have finalized the development of acoziborole, a transformational new oral drug that can cure T.b. gambiense sleeping sickness in a single dose of three pills and may open the possibility of simplified ‘test-and-treat’ approaches in primary healthcare settings. At the same time, we are continuing work to ensure broad access to fexinidazole for sleeping sickness caused by the parasites T.b. gambiense and T.b. rhodesiense, the more acute, less common form of the disease.
Our progress in 2025 includes:
Clinical trials
Acoziborole for children (ACOZI-KIDS): DNDi and its partners successfully completed recruitment for the ACOZI-KIDS trial in March 2025, enrolling 35 children across all weight bands included in the study. For younger participants, as well as those unable to swallow whole tablets, the study medication was administered in crushed form. Final results are anticipated in 2026, following completion of 12-month follow-up visits with all participants.
Registration & access
Acoziborole: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of acoziborole as a one-day, single-dose oral treatment of the gambiense form of sleeping sickness on 27 February 2026. Meanwhile the StrogHAT study continued to generate reassuring safety data.
Fexinidazole for T.b. gambiense: The European Medicines Agency (EMA) requested an update of the Summary of Product Characteristics (SmPC) to allow home-based treatment supported by a caregiver. With the completion of the EDCTP2-funded FEX-g-HAT project and the end of the post-approval safety study, pharmacovigilance responsibilities were transitioned to national authorities in the Democratic Republic of the Congo (DRC), Guinea, Central African Republic (CAR), Angola, and South Sudan, and DNDi continued to provide support through network meetings and staff training.
A scientific article on the latest clinical trial of fexinidazole for T.b. gambiense – including pregnant and breastfeeding women and patients treated at home – was published in The Lancet Global Health in May 2025.
Fexinidazole for T.b. rhodesiense: Additional countries, including Zambia and Ethiopia, approved the extended indication of fexinidazole as first-line treatment for sleeping sickness caused by T.b. rhodesiense. Cascade training on T.b. rhodesiense sleeping sickness treatment and pharmacovigilance continued in Malawi and Zimbabwe throughout the year. By July 2025, a total of 12 patients had been treated across Malawi, Uganda, and Zimbabwe. A Post-Authorization Safety Study (PASS) of fexinidazole, sponsored by Sanofi and coordinated by WHO, is under preparation. An article evaluating fexinidazole as a first-line treatment for T.b. rhodesiense sleeping sickness was published in The Lancet Global Health in May 2025.
Photo credit: Thoko Chikondi-DNDi
