Ghana has become the first country to approve a new fixed-dose combination of ivermectin and albendazole to treat soil-transmitted helminths, marking a significant step forward in combating parasitic diseases that affect millions in Africa.
The Ghana Food and Drugs Authority granted approval in late December 2025 for the ivermectin and albendazole fixed-dose combination, a medication developed to treat soil-transmitted helminths. This decision positions the country at the forefront of efforts to combat these parasitic infections prevalent in endemic regions of Africa, allowing the drug to move from experimental studies into clinical practice and public health campaigns.
The approval follows the function of the STOP2030 project, co-funded by the Global Health EDCTP3 program, which leads research on this formulation. In January 2025, the European Medicines Agency issued a positive scientific opinion on the co-formulation, following the Phase II/III ALIVE clinical trial, funded by the preceding EDCTP2 program. The study demonstrated that the combination has a similar safety profile to single-dose albendazole – the standard medication in mass deworming campaigns – but with superior efficacy against Trichuris trichiura, a species often resistant to single-drug treatment.
The new medication comes in a mango-flavored, swift-dissolving tablet designed to reduce choking risks and facilitate administration in children. The ivermectin dosage strategy has shifted to be age-based, eliminating the need to measure each person’s weight or height – a time-saver in campaign settings. Previously, separate administration of the two drugs could require between two and six tablets per person, complicating logistics and increasing the risk of underdosing.
Alejandro Krolewiecki, principal investigator of the STOP2030 consortium and Director of Innovation at Mundo Sano, highlighted the paradigm shift: “This approval changes the status of this medicine. It ceases to be a drug in development or a promise for the future and becomes a tool that countries can begin to use in planning their control programs.”
The fixed-dose combination covers all major species of soil-transmitted helminths identified by the World Health Organization as priorities: hookworms (Ancylostoma duodenale, Necator americanus), roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and the Strongyloides stercoralis roundworm. The drug thus responds to the WHO’s call in the 2021-2030 Roadmap for Neglected Tropical Diseases, which advocates for the development of more effective medicines and combinations.
Michael Makanga, Chief Executive Officer of Global Health EDCTP3, emphasized the program’s commitment: “The Global Health EDCTP3 project is strongly committed to the development of end-to-end products, ensuring that the tools evaluated reach the people who need them most. This approval in Ghana is a testament to what continued investment in research and collaboration can achieve.”
The STOP2030 consortium is now conducting the REALISE trial, which evaluates the safety of the co-formulation in real-world mass drug administration programs. The study encompasses approximately 20,000 school-aged children, between 5 and 17 years old, in Ghana and Kenya, comparing the fixed-dose combination with single-dose albendazole administration. Simultaneously, studies are underway on acceptability, feasibility, cost-effectiveness, and strategies for equitable access.
The Ghanaian regulatory approval represents the culmination of more than 15 years of research, development, and clinical evaluation of the fixed-dose combination. The journey involved nearly 20 scientific and public health institutions from Latin America, Europe, Africa, and the United States, including Liconsa (Insud Pharma), responsible for manufacturing the tablet.
Silvia Gold, President of Mundo Sano and co-founder of Insud Pharma, was keen to recall the path taken: “The combined fixed-dose formulation of ivermectin and albendazole has been in development since 2010. We are proud of these recent achievements, but also of the journey. It is an example of what successful public-private partnerships can achieve when they share risks, talents, and a common goal.”
Global Health EDCTP3, a partnership between Europe and Africa supported by the European Union and more than 40 countries, has a budget of 2 billion euros for the 2021-2031 period. The program funds clinical trials, strengthens research infrastructure, and trains young African researchers, focusing on infectious diseases affecting Sub-Saharan Africa. This funding is crucial for addressing the ongoing burden of neglected tropical diseases.
With this approval, the STOP2030 consortium hopes to make available to endemic countries a practical tool to strengthen deworming campaigns, reduce the disease burden, and bring closer the elimination goals for neglected tropical diseases set by the WHO for 2030.
PR/HN/MM
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