Acoziborole: First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand. dru@adis.com.
Drugs
|July 30, 2026
Summary
Acoziborole offers a new single-dose oral treatment for human African trypanosomiasis (g-HAT). A positive opinion from the European Medicines Agency facilitates its registration in endemic African regions.
Area of Science:
- * Neglected tropical diseases
- * Tropical medicine
- * Pharmaceutical development
Background:
- * Human African trypanosomiasis due to Trypanosoma brucei gambiense (g-HAT) is a serious parasitic disease.
- * Current treatments can be complex and burdensome.
- * A single-dose oral agent is needed for effective g-HAT management.
Purpose of the Study:
- * To summarize the development of acoziborole, a novel oral antiprotozoal agent.
- * To highlight the milestones leading to a positive opinion for acoziborole.
- * To facilitate the registration and accessibility of acoziborole in endemic regions.
Main Methods:
- * Development of acoziborole by Drugs for Neglected Diseases initiative (DNDi), Sanofi, and partners.
- * Assessment via the EU-M4all procedure for medicines intended for use outside the EU.
- * Review of development milestones for first- and second-stage g-HAT treatment.
Main Results:
- * A positive opinion was adopted by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in February 2026.
- * Acoziborole is indicated for first- and second-stage (including severe second-stage) g-HAT.
- * The positive opinion applies to adolescents aged ≥12 years and weighing ≥40 kg, and adults.
Conclusions:
- * Acoziborole represents a significant advancement in g-HAT treatment.
- * The positive EMA opinion will expedite acoziborole's registration in sub-Saharan Africa.
- * This development promises improved treatment accessibility for g-HAT patients.
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