The Democratic Republic of the Congo (DRC) has approved the use of acoziborole, a single-dose oral treatment for sleeping sickness, in what health experts are describing as a major breakthrough in the fight against one of Africa's most deadly neglected tropical diseases.
The new medicine, officially registered as Acoziborole Winthrop, will be used to treat both early and advanced stages of gambiense human African trypanosomiasis, commonly known as sleeping sickness, in adults and adolescents aged 12 years and above weighing at least 40 kilograms.
Health authorities say the treatment is the first of its kind: a one-time oral dose that can be administered immediately after diagnosis and does not require hospitalisation. It replaces existing treatment regimens that can take up to 10 days and, in severe cases, require injections and lengthy hospital stays.
The approval follows successful Phase II/III clinical trials conducted in the DRC and Guinea by the Drugs for Neglected Diseases initiative (DNDi) in partnership with national sleeping sickness control programmes. The studies reported cure rates of up to 96 percent across all stages of the disease.
Acoziborole was co-developed by DNDi and Sanofi and will be provided to patients free of charge, according to the announcement.
DRC health officials said the decision marks a significant step toward eliminating a disease that once affected hundreds of thousands of people across Africa. In 2024, the country reported 330 cases, accounting for more than half of all cases recorded on the continent. This represents a dramatic decline from the late 1990s, when nearly 40,000 cases were reported annually across Africa.
Sleeping sickness is transmitted through the bite of an infected tsetse fly and is almost always fatal if left untreated. The disease initially presents with symptoms such as fever, headaches and fatigue before progressing to severe neurological complications once it reaches the central nervous system.
Health experts believe the introduction of acoziborole could transform treatment in remote and hard-to-reach communities where prolonged hospitalisation and complex treatment protocols have often prevented patients from receiving timely care.
"The registration of acoziborole is fantastic news for patients. It is well tolerated, can be administered immediately after diagnosis, and will allow us to reach the most remote endemic areas," said Dr Erick Miaka, Director of the DRC National Sleeping Sickness Control Programme.
Guinea, which eliminated sleeping sickness as a public health problem in 2024, also welcomed the development, saying the new treatment would help prevent a resurgence of the disease.
"Acoziborole is safe, simple to administer, and can be taken in just one day. It will be a powerful tool to prevent any comeback of the disease," said Mamadou Camara, Guinea's national programme coordinator.
The approval in the DRC is expected to accelerate regulatory processes in other endemic countries across Central and West Africa, including Guinea, where health authorities are preparing to authorise the importation and use of the drug.
Global health partners also hailed the development as a model of successful international collaboration in neglected disease research.
"With foreign aid and global health in crisis, this represents a success for African science and global cooperation," said Chirac Bulanga, West and Central Africa Director at DNDi.
Sleeping sickness has historically been among the most difficult tropical diseases to treat. Older therapies relied on highly toxic arsenic-based compounds, while more recent treatments such as fexinidazole and nifurtimox-eflornithine combination therapy have improved survival rates and reduced treatment complexity.
Health agencies say acoziborole could represent the final major advance needed to eliminate sleeping sickness as a public health threat across Africa.