What it is
Fexinidazole Winthrop and Acoziborole Winthrop are two revolutionary oral treatments for human African trypanosomiasis (HAT), commonly known as sleeping sickness. Fexinidazole Winthrop, taken as pills over 10 days, is the first all-oral therapy for the disease. Building on this success, Acoziborole Winthrop is the first single-dose one-day oral therapy to treat the most common form of the disease, gambiense human African trypanosomiasis (gHAT).
Why it matters
Although sleeping sickness cases have been greatly brought down over the last years, it persists in the poorest and most remote areas of Africa, where delivering care is a significant challenge. The disease is usually fatal without treatment, making these patient-friendly innovations essential. For decades, treatment relied on toxic, invasive, and logistically demanding therapies, often requiring hospitalisation and painful lumbar punctures [1].
The story
Human African trypanosomiasis (HAT), or sleeping sickness, is a parasitic disease transmitted by tsetse flies that remains endemic in 36 African countries, placing millions at risk.
A major turning point came with the development of Fexinidazole Winthrop, the first all-oral treatment for human African trypanosomiasis [2]. Initially endorsed by the European Medicines Agency (EMA) in 2018 for both first- and second-stage Trypanosoma brucei gambiense infection (gHAT), the most common form of the disease, it marked a shift away from complex, hospital-based therapies [3]. Building on this, a 2023 positive opinion from the EMA extended its use to both stages of the rhodesiense form of the disease (rHAT), confirming its efficacy across the two clinical phases of this acute variant. Supported by EDCTP programmes and other donors funding through the HAT-r-ACC consortium [4] and developed by DNDi, Sanofi, and partners, this 10-day pill-based regimen has eliminated the need for hospital-based care in many cases and has since been incorporated into WHO treatment guidelines [5].
Building on this progress, a new milestone was reached with Acoziborole Winthrop, a single-dose oral treatment for gambiense human African trypanosomiasis (gHAT). In 2026, the European Medicines Agency issued a positive scientific opinion on the medicine, marking a transformative step forward in simplifying treatment and expanding access to the people who need it most [6].
Developed through a long-standing partnership between DNDi, Sanofi, and endemic-country researchers, and supported in part by EDCTP funding, Acoziborole Winthrop addresses one of the final barriers in sleeping sickness elimination: the difficulty of delivering treatment at scale in resource-limited settings. Its single-dose one-day regimen removes the need for repeated patient follow-up and specialised infrastructure.
EDCTP-supported projects continue to play a key role in translating these innovations into real-world impact. The ACOZI-KIDS study is working to ensure that acoziborole is safe and effective for children [7], while STROGHAT, funded by Global Health EDCTP3, is evaluating a large-scale ‘screen-and-treat' strategy to reduce gHAT prevalence and advance disease elimination efforts [8]. According to the project coordinator, the Institute of Tropical Medicines (ITM), over the first two years of implementation, the STROGHAT consortium performed more than 450,000 screening tests, reaching 95% of the at-risk population in the study area [9].
Global Health EDCTP3 continues to support research, clinical development, and implementation strategies to ensure these breakthroughs translate into equitable access. By strengthening the link between innovation and delivery, these efforts are accelerating progress towards the World Health Organization’s (WHO) goal of eliminating gHAT transmission by 2030.
Sources:
[1] ACOZI-KIDS: Start of clinical trial for simplified treatment of sleeping sickness in children | EDCTP
[2] Fexinidazole as a new oral treatment for human African trypanosomiasis due to Trypanosoma brucei rhodesiense: a prospective, open-label, single-arm, phase 2–3, non-randomised study | The Lancet
[3] EMA gives positive opinion of Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness (rhodesiense) found in East and Southern Africa | EDCTP
[4] HAT-r-ACC - International partnerships against infectious diseases
[5] Fexinidazole for T.b. rhodesiense | DNDi & Guidelines for the treatment of human African trypanosomiasis | WHO
[6] New single-dose oral treatment for human African trypanosomiasis (sleeping sickness) | EMA & Acoziborole Winthrop, developed by DNDi and Sanofi, receives European Medicines Agency positive opinion as three-tablet, single-dose treatment for most common form of sleeping sickness | DNDi
[8] STROGHAT | Global Health EDCTP3
[9] New single-dose oral treatment approved to fight sleeping sickness | Global Health EDCTP3
Related links
New and better medicines already saving and improving lives
RTS,S and R21/Matrix-M are the first vaccines against malaria and, more broadly, against any parasitic disease. Both vaccines stimulate an immune response that prevents malaria infection.
Triomune Baby/Junior became the first fixed-dose combination medicine developed specifically for children with HIV and paved the way for additional improved combination therapies for first- and second-line HIV treatment in children.
This new fixed-dose combination therapy of albendazole/ivermectin targets five types of parasitic worms (four soil-transmitted helminth infections and lymphatic filariasis), which will significantly improve the efficiency and cost-effectiveness of large-scale interventions.
Coartem® Baby and Pyramax®’s new formulations for children and pregnant women are safe and effective against malaria and better suited to their specific needs.
Arpraziquantel is the first child-friendly medicine in an oro-dispersible formulation to treat and cure schistosomiasis. It is easy to administer and adapted for rural and tropical settings, offering high efficacy with minimal side effects.
Fexinidazole Winthrop and Acoziborole Winthrop are two new oral treatments for human African trypanosomiasis (HAT), known as sleeping sickness. Fexinidazole is the first all-oral therapy, while Acoziborole is the first single-dose, one-day treatment for the most common form of the disease.
This new therapy, a single high-dose of liposomal Amphotericin B, is as effective as the traditional week-long regimen, easier to administer, and causes fewer side effects. It is now the WHO-recommended therapy for cryptococcal meningitis.
Dihydroartemisinin-piperaquine (DHAPQ) is an artemisinin-based combination therapy (ACT) used to treat uncomplicated malaria.
Molbio Truenat, with MTB-Plus and RIF-Dx assays, is a portable, battery-powered molecular diagnostic tool for tuberculosis (TB) testing directly in primary health care settings.
Our added value for Europe
EDCTP boosts Europe’s competitiveness by advancing research excellence, innovation, and public–private cooperation in global health. By supporting late-stage development and Africa–Europe partnerships, it bridges the EU innovation gap and creates new market and investment opportunities.
EDCTP strengthens Europe’s health security by tackling climate-sensitive diseases and antimicrobial resistance, enhancing surveillance, and accelerating medical countermeasures. Its rapid crisis responses, from Ebola to COVID-19, show its agility in protecting Europe and global health.
EDCTP drives Europe’s science diplomacy through fair Africa–Europe partnerships that tackle global health challenges. Its equitable governance and ethical research practices strengthen EU credibility and global influence.
EDCTP strengthens Europe’s leadership in digital health by investing in AI, data, and digital technologies while training researchers in fields like bioinformatics and genomic epidemiology.
EDCTP advances the EU’s human rights goals by promoting ethical, inclusive research that addresses unmet medical needs. It ensures innovations reach vulnerable populations while strengthening local scientific and health systems.
Our added value for Africa
EDCTP improves health and prosperity in Africa by funding clinical research, strengthening local capacities, and empowering African scientists. Its investments reduce the burden of infectious diseases, boost productivity, and support sustainable development across the continent.
EDCTP builds Africa’s capacity to detect, prevent, and respond to outbreaks through training, research, and strong partnerships. Its work accelerates vaccine and diagnostic development and reinforces the continent’s health resilience.
EDCTP strengthens Africa’s clinical research ecosystem by investing in skills, infrastructure, and regulatory systems. Initiatives like CTCAN and PACTR connect researchers and regulators, expanding quality trials and fostering local leadership.
EDCTP strengthens Africa-led health partnerships with organisations like Africa CDC and WHO AFRO, aligning research and investment with continental priorities. As an AU–EU Innovation Agenda partner, it builds skills, fosters co-investment, and drives sustainable cooperation.
EDCTP promotes health equity by developing practical solutions for underserved communities, including newborns and children, women, urban poor and rural communities. It funds accessible technologies and digital tools that expand healthcare reach and improve outcomes for those most in need.