In the last days of December 2025, the Ghana Food and Drug Authority (Ghana FDA) approved the fixed-dose coformulation (FDC) of ivermectin and albendazole. This is a major milestone for the STOP2030 project, and makes Ghana the first country to register the FDC for clinical use.

The registration of the FDC in Ghana marks 2025 as an outstanding year for the STOP2030 Consortium. On January, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive scientific opinion on the FDC. This was the project’s first regulatory success after the completion of the ALIVE phase 2-3 trial, which demonstrated a similar safety profile and superior efficacy against T. trichiura compared to single-dose albendazole, the standard in mass drug administration (MDA) campaigns.

“It is an important moment for us”, said Dr. Alejandro Krolewiecki, Principal Investigator and Scientific Coordinator of the STOP2030 project. “We want to make the FDC available to endemic countries because we believe it will allow them to aim for more ambitious public health goals”.

With Ghana FDA’s approval, the FDC is no longer limited to experimental settings, and can be both prescribed by physicians and considered for use by the country’s public health programmes.

A better tool for STH control and elimination goals

The fixed-dose coformulation of ivermectin and albendazole was developed in direct response to World Health Organization’s call to “develop more effective medicines and drug combinations” for soil-transmitted helminths (STH) found in their 2021-2030 Roadmap for Neglected Tropical Diseases (page 160). Its development has spanned over 15 years and involved the collaboration of over a dozen partner organisations from Latin America, Africa, Europe and the United States. The support of the EDCTP Association, and Global Health EDCTP3, together with the Swiss Government, has been instrumental for advancing the FDC to this stage.

The newly approved medicine is developed and produced by Liconsa (a partner in the STOP2030 consortium), and builds a set of innovations on top of albendazole and ivermectin, two widely used drugs with decades of clinical and public health experience. It is a mango-flavoured tablet that dissolves in contact with saliva to mitigate the choking risk. Previous clinical trials have shown that, compared to single-dose albendazole, the FDC has a similar safety profile and superior efficacy against more parasite species. The combination can control all STH species considered by WHO –hookworm, A. lumbricoides, T. trichiura and S. stercoralis– and may reduce the risk of resistance emergence, a problem exacerbated by reliance on a single drug.

One of the key innovations of the FDC is a novel ivermectin dosing strategy, based on age group, that eliminates the need for individual measuring of height or weight. This drastically simplifies the logistics of campaigns, as well as the actual administration of the medicine. When given separately, treating with albendazole and ivermectin can mean between 2 and 6 tablets per person, which increases the operational complexity and the risk of dosing errors —mostly underdosing. By combining both medicines on a single tablet, the FDC enables a one-pill-per-person delivery strategy that makes it easy to integrate with many public health programmes.

As important as this milestone is, the work of the STOP2030 to advance the FDC and make it available to endemic countries does not end. As of this publication, the REALISE trial, that evaluates the safety of the FDC in real-life setting by comparing it to albendazole in 20,000 school-aged children (from 5 to 17 years old) in Ghana and Kenya, is currently in its clinical phase. Our acceptability, feasibility and cost-effectiveness studies are advancing too, and work is underway on an access and stewardship plan.