By Gift Briton
An oral treatment is now saving lives across East and Southern Africa, replacing painful injections and lengthy hospital stays for patients with a rare but deadly strain of sleeping sickness.
Five African countries, including Ethiopia, Malawi, Tanzania, Zambia, and Zimbabwe, have began treating patients with Fexinidazole Winthrop, the world’s first oral medication for rhodesiense sleeping sickness. If left untreated, this parasitic disease progresses rapidly to coma and death.
“Until now, the only treatment involved a toxic intravenous drug that required hospitalisation,” explains Dr. Westain Nyirenda, who led clinical trials in Malawi.
“Today, we have a safe and simple oral treatment that can be taken at home with minimal observation, revolutionising patient care.”
The breakthrough came when recent outbreaks in Malawi from 2019-2021 and Ethiopia in 2022 have health officials concerned about the disease’s potential spread. The Ethiopian outbreak – the first in 30 years – has been linked to climate and environmental changes, bringing humans and animals closer to tsetse flies that transmit the disease.
For remote villages where reaching hospitals can take days, an oral treatment means the difference between life and death.
Transmitted by tsetse fly bites, sleeping sickness causes neuropsychiatric symptoms, disrupts sleep patterns, and eventually leads to coma and death. Without treatment, it’s almost always fatal.
The drug received regulatory approval in Malawi in December 2024 and is now being distributed in Ethiopia, Tanzania, Zambia, and Zimbabwe.
The clinical trials were sponsored by the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit medical research organization, focused on developing treatments for diseases often overlooked by profit-driven pharmaceutical research.
“This breakthrough is a testament to the dedication of African doctors, clinicians, healthcare staff, and communities who contributed to its development,” Dr. Nyirenda said.
Health experts warn that climate change could increase the risk of future outbreaks. The disease is particularly concerning because it has an animal reservoir, making it difficult to eliminate.
“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 program.
The medication is already proving valuable beyond Africa. Safari tourists from Europe and the United States who contracted the disease while visiting affected regions have received the treatment under compassionate use protocols in Austria, Denmark, Poland, and the United States.
Fexinidazole Winthrop was developed through a partnership bringing together Sanofi, DNDi, national sleeping sickness programs, and local communities. The drug is donated to the World Health Organisation by Foundation S, Sanofi’s philanthropic organisation, and delivered to Africa by Médecins Sans Frontières Logistique.
“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.
The medication is approved for adults and children aged six years or older who weigh at least 20 kg and have been diagnosed with either first-stage or second-stage rhodesiense sleeping sickness.
While Rhodesiense sleeping sickness remains a challenge, significant progress has been made against the Gambiense form of the disease, which is found in Western and Central Africa. Eight countries have eliminated Gambiense sleeping sickness as a public health problem, with Guinea becoming the latest success story earlier this year.
