Boron is thought to be essential to the parasite-killing activity of acoziborole, a new single-dose oral medicine for some people with gambiense human African trypanosomiasis (sleeping sickness). The European Medicines Agency (EMA) says the drug appears to bind to a parasite protein involved in messenger RNA processing, but the precise molecular interactions—including boron’s exact role—are not fully understood.
What is the new sleeping sickness drug?
Acoziborole, also called Acoziborole Winthrop, is a benzoxaborole developed for gambiense human African trypanosomiasis (g-HAT), the form caused by Trypanosoma brucei gambiense. It is not a treatment for every type of sleeping sickness or every patient.
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The EMA’s Committee for Medicinal Products for Human Use adopted a positive scientific opinion for the medicine on 24 February 2026 through the EU-M4all process. The medicine is intended for use outside the European Union. The opinion can help streamline World Health Organization (WHO) prequalification and support national registration in affected countries; it is not an EU-wide marketing authorization and does not mean the drug is already available everywhere.
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EMA says available data suggest that acoziborole binds to cleavage and polyadenylation specificity factor 3 (CPSF3) in T. brucei. The protein is involved in messenger RNA maturation, so disrupting its activity may interfere with the parasite’s ability to process RNA. EMA says the boron atom in the drug’s structure is thought to be essential to its trypanocidal, or parasite-killing, activity. The exact molecular interactions have not been fully characterized, so it would be inaccurate to present the mechanism as completely settled or attribute the drug’s efficacy to boron alone.
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EMA’s medicine information describes the proposed mechanism and its remaining uncertainty.
Who is it intended for, and how is it taken?
The indicated population is adults and adolescents aged 12 years and older who weigh at least 40 kg and have first- or second-stage T. b. gambiense infection, including severe second-stage disease. DNDi describes the regimen as three 320 mg tablets taken together in a single oral dose. Eligibility and treatment decisions require clinical assessment; the regimen should not be used as general advice for suspected sleeping sickness.
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What do the clinical results show?
In its 2026 opinion summary, EMA reported treatment success at 18 months for 159 of 167 people with second-stage disease (95.2%) and 41 of 41 people with first- or intermediate-stage disease (100%). DNDi separately describes success of up to 96% at 18 months across both stages in the Phase II/III study. These are different summaries; the stage-specific EMA figures retain their own denominators.
The Phase II/III study was conducted in the Democratic Republic of Congo and Guinea, and DNDi says the results were published in The Lancet Infectious Diseases in November 2022. EMA notes that the study did not compare acoziborole with another medicine or a placebo. The results therefore do not establish that it is superior to existing treatments.
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EMA reports fewer than 1,000 g-HAT cases annually in Africa. The relatively small patient population and the study’s lack of a comparator are important context when interpreting the results; the percentages describe outcomes in the studied groups, not a guarantee for an individual patient.
How does it fit with other sleeping sickness treatments?
Human African trypanosomiasis treatment depends on the parasite subspecies, disease stage and severity, and patient factors. The CDC lists fexinidazole, nifurtimox-eflornithine combination therapy (NECT), pentamidine, suramin and melarsoprol among treatment options; which medicine is appropriate varies with the clinical situation. Acoziborole’s distinct practical feature is a single oral dose for eligible patients with gambiense HAT. That alone does not make it the right option for every patient or prove comparative superiority.
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The CDC advises monitoring for relapse for up to 24 months after treatment. For an individual treatment decision, clinicians must consider the diagnosis and parasite type as well as stage, severity, age, weight, route and duration of treatment, care setting and safety.
When could patients get access?
DNDi says Sanofi plans to donate acoziborole to WHO for free distribution to patients. The EMA opinion is a step toward further access processes, not confirmation that every country has registered or supplied the medicine. Availability will depend on subsequent public-health and national registration steps; local health authorities or WHO information are the appropriate sources for current country-specific status.
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How was acoziborole developed?
According to DNDi, the initial chemical-library hit came from Anacor Pharmaceuticals, and the compound’s structure was optimized with Scynexis and Pace University. The pivotal Phase II/III trial was conducted with partners in the Democratic Republic of Congo and Guinea.
Quick Recap
Sources
- European Medicines Agency: Acoziborole Winthrop
- Drugs for Neglected Diseases initiative: Human African trypanosomiasis
- CDC: Clinical care of human African trypanosomiasis
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