Ministries of Health in three African countries have approved the use of Fexinidazole Winthrop for treating Trypanosoma brucei rhodesiense sleeping sickness, marking a revolutionary advancement in managing this deadly parasitic disease. The first all-oral treatment for this acute form of sleeping sickness is now available free of charge to patients in specialized treatment centers in Ethiopia, Malawi, and Zimbabwe.
Breakthrough in Treatment Accessibility
The approval represents a dramatic shift from previous treatment protocols that required toxic intravenous drugs and hospitalization. "Until now, the only treatment for the advanced stage of the disease involved a toxic intravenous drug that required hospitalization. Today, with this breakthrough, we have a safe and simple oral treatment that can be taken at home with minimal observation, revolutionizing care for patients," said Dr. Westain Nyirenda, principal investigator of the clinical trials for Fexinidazole Winthrop in Malawi.
Sleeping sickness, or human African trypanosomiasis (HAT), is a parasitic disease transmitted by the bite of tsetse flies. It causes neuropsychiatric symptoms, including a debilitating disruption of sleep patterns and ultimately coma and death. The disease is almost always fatal if not treated. The T.b. rhodesiense form of the disease, which occurs in East and Southern Africa, progresses more rapidly than the T.b. gambiense form, which is endemic to Western and Central Africa.
Clinical Development and Regulatory Approval
Fexinidazole Winthrop was developed through an innovative partnership that brought together Sanofi, the Drugs for Neglected Diseases initiative (DNDi), national sleeping programmes, and local communities. The clinical trials that led to Fexinidazole Winthrop's approval were sponsored by DNDi, with the organization leading a Phase II/III clinical trial in Malawi and Uganda supported by a consortium of partners known as HAT-r-ACC.
The trial results demonstrated that the treatment is a better alternative to existing drugs, leading the European Medicines Agency to issue a positive scientific opinion in December 2023. Following this decision, regulatory approval was given in May 2024 by the regulatory authorities of the Democratic Republic of the Congo, and subsequently, Malawi approved its use in December 2024. In June 2024, the World Health Organization included it as the first-choice treatment for rhodesiense sleeping sickness in its treatment guidelines.
Current Implementation and Patient Access
Since the beginning of 2025, importation and distribution of the drug have been approved in the three African countries and received shipments from WHO. Several patients have already received this life-saving treatment in Malawi and Zimbabwe. The all-oral treatment is donated to the WHO by Foundation S, Sanofi's philanthropic organization, and delivered to Africa by WHO in Geneva.
Fexinidazole Winthrop is recommended for adults and children aged six years or older and weighing at least 20 kg who have been diagnosed with either first-stage (haemolymphatic) or second-stage (meningoencephalitic) rhodesiense sleeping sickness, in addition to the treatment of gambiense sleeping sickness approved in 2018.
Addressing Climate-Related Disease Risks
Deadly outbreaks of rhodesiense sleeping sickness still occur, with recent incidents including outbreaks in Malawi from 2019 to 2021. A localized rhodesiense outbreak in Ethiopia in 2022 – the first in 30 years – has been linked to climate and environmental changes that bring humans and animals such as cattle in closer proximity to the tsetse flies that carry the disease. Safari tourists from Europe and the US visiting the region have also fallen ill with this strain of sleeping sickness and have received Fexinidazole Winthrop under compassionate use protocols in Austria, Denmark, Poland, and the United States.
"With climate and environmental changes increasing the risk of future rhodesiense outbreaks, we are now prepared to meet these challenges head-on with all-oral treatments, which will save lives and ease the burden on our healthcare systems in Africa," said Dr. Junior Matangila, Head of DNDi's sleeping sickness programme.
Pharmaceutical Partnership and Funding
The DNDi clinical trial for T.b. rhodesiense sleeping sickness was conducted by the HAT-r-ACC Consortium, with funding from the European and Developing Countries Clinical Trials Partnership (EDCTP2) programme supported by the European Union, Fundação para a Ciência e a Tecnologia in Portugal, the Swiss Agency for Development and Cooperation, Médecins Sans Frontières, UK International Development, and other private foundations and individuals.
"We are thrilled to see the access and use of Fexinidazole Winthrop as the first fully oral treatment to treat rhodesiense sleeping sickness in Africa. This milestone underscores Sanofi's unwavering long-term commitment to addressing neglected tropical diseases challenges and improving patient outcomes," said Philippe Neau, Head of the Neglected Tropical Diseases Programme at Foundation S.
