Acoziborole: First Approval.

Acoziborole (Acoziborole Winthrop), a single-dose, oral antiprotozoal agent, has been developed by Drugs for Neglected Diseases initiative (DNDi), Sanofi and partners for the treatment of human African trypanosomiasis due to Trypanosoma brucei gambiense (g-HAT). In February 2026, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for acoziborole for the treatment of first- and second-stage (including severe second-stage) g-HAT in adolescents aged ≥ 12 years and weighing ≥ 40 kg and in adults. Acoziborole was assessed via the EU-M4all procedure for medicines intended for use outside of the EU, and the positive opinion will facilitate the registration of acoziborole in sub-Saharan African countries where g-HAT is endemic. This article summarizes the milestones in the development of acoziborole leading to this positive opinion for the treatment of first- and second-stage g-HAT.