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<p>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 <i>Trypanosoma brucei gambiense</i> (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&#xa0;years and weighing ≥ 40&#xa0;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.</p>

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Acoziborole: First Approval

  • 期刊论文

  • 发表日期：

    2026年7月30日

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  • Aisling McGuigan

摘要

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.