What it is
Fexinidazole is the first all-oral treatment for sleeping sickness. Taken as simple pills over 10 days, it eliminates the need for hospitalisation and painful lumbar punctures, and has become the most widely used therapy for this disease.
Why it matters
Although sleeping sickness is nearing eradication, 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 this patient-friendly innovation essential.
The story
Human African trypanosomiasis, or sleeping sickness, is a deadly parasitic disease transmitted by tsetse flies. Although nearing eradication, the disease remains endemic in 36 African countries, placing millions of people at risk. Existing treatments have been complex, toxic, and painful.[1]
EDCTP has supported the HAT-r-ACC consortium,[2] enabling the development of Fexinidazole Winthrop, the first all-oral treatment for T.b. rhodesiense sleeping sickness[3]. This innovative medicine received a positive opinion from the European Medicines Agency in 2023, prompting WHO to update its guideline to recommend fexinidazole for the treatment of HAT caused by T.b. rhodesiense. In 2024, fexinidazole was registered for treating T.b. rhodesiense sleeping sickness by the Democratic Republic of the Congo and approval for its use was granted by Malawi.
Developed by DNDi, Sanofi, and partners,[4]Fexinidazole represents a major advance in the treatment of sleeping sickness, including severe cases, with a simple 10-day, exclusively oral regimen. Today, it accounts for approximately 70% of all sleeping sickness treatments, bringing the continent closer to eradication and offering a simpler, safer, and more effective therapy for affected populations. Global Health EDCTP3 continues to support research and innovation for enhanced interventions against sleeping sickness[5] to advance towards its eradication by 2030.
Sources:
[1] https://www.who.int/news-room/fact-sheets/detail/trypanosomiasis-human-african-(sleeping-sickness) & ACOZI-KIDS: Start of clinical trial for simplified treatment of sleeping sickness in children - EDCTP
[2] HAT-r-ACC - International partnerships against infectious diseases
[3] https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(25)00016-6/fulltext
[4] Fexinidazole for T.b. rhodesiense | DNDi & 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
[5] The STROGHAT study protocol: An intervention ... | Open Research Europe
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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.