Acoziborole: First Approval

Funding The preparation of this review was not supported by any external funding.DeclarationsAuthorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Aisling McGuigan is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.Additional information about this Adis Drug Review can be found here.Abstract 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 gambiense human African trypanosomiasis (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) HAT due to Trypanosoma brucei gambiense in adults and adolescents aged ≥ 12 years and weighing ≥ 40 kg. Acoziborole assessment was via the EU-M4all programme 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- or second-stage g‑HAT.© Springer Nature Switzerland AG 2026