Pharmalys welcomes the news that Ghana has become the first country worldwide to approve a groundbreaking fixed‑dose combination of ivermectin and albendazole – a single‑tablet treatment designed to combat soil‑transmitted helminths (STH), some of the most widespread parasitic infections affecting communities across Africa.
This approval marks a major advancement for countries burdened by STH and represents a significant achievement for the STOP2030 project, co‑funded by Global Health EDCTP3. It also demonstrates how long‑term scientific collaboration and investment can translate into meaningful tools that directly improve public health.
A new option for an old challenge
Soil‑transmitted helminths – such as hookworms, roundworms, whipworms and Strongyloides – affect millions of people, particularly children, across endemic regions. While albendazole and ivermectin have been used separately in deworming campaigns for decades, administering them required multiple tablets and added operational complexity.
The newly approved fixed‑dose combination offers several important advantages:
- A single, easy‑to‑administer pill, replacing multiple tablets previously required.
- A child‑friendly, mango‑flavoured, fast‑dissolving formulation, reducing choking risk and improving acceptability.
- A simplified age‑based dosing approach, eliminating the need to measure height or weight, and enabling quicker, more efficient mass drug administration.
- Enhanced effectiveness against whipworms (Trichuris trichiura), a species known to respond poorly to albendazole alone.
- Reduced risk of resistance, due to the combined therapeutic approach.
These innovations are not simply scientific enhancements, they are practical solutions tailored for real‑world delivery in schools, communities, and remote settings.
A global effort led by African leadership
This regulatory authorisation in Ghana follows a positive scientific opinion by the European Medicines Agency in early 2025, based on evidence from the ALIVE phase II/III clinical trial. That study demonstrated the combination’s safety and improved performance compared with current standard therapy.
The approval represents the culmination of more than 15 years of research, formulation development, clinical assessment and international collaboration involving nearly 20 partners across Africa, Europe, the Americas and beyond.
For Ghana, this decision moves the medicine out of the development pipeline and into real‑world planning and policy action. It also sends a clear signal to other endemic countries considering new tools to strengthen their deworming strategies.
From approval to implementation
Regulatory approval is only the beginning. The STOP2030 consortium is now advancing the REALISE study, a large implementation trial involving approximately 20,000 children in Ghana and Kenya. This next phase will assess the combination’s safety and operational performance under conditions similar to wide‑scale national campaigns.
Alongside clinical evaluation, partner organisations are examining:
- Community acceptability
- Feasibility within existing public health systems
- Cost‑effectiveness
- Equitable access strategies
- Stewardship and responsible deployment
The goal is to ensure that once rolled out, the medicine is used safely, consistently, and sustainably, delivering long‑term benefit to communities that have historically carried the heaviest burden of neglected tropical diseases.
A model of what collaboration can achieve
This milestone showcases the power of end‑to‑end product development, spanning discovery, formulation, clinical evaluation, regulatory review, and—crucially—planning for real-world access. It demonstrates what is possible when public, private, and academic partners share the same goal and work across continents to deliver solutions that matter.
At Pharmalys, we are encouraged to see such progress advancing health outcomes in Africa and reaffirm our commitment to supporting research that is ethical, community‑centred, and designed for genuine impact.
As new tools like this fixed‑dose combination reach the communities that need them, we continue to champion innovation grounded in quality, respect, and excellence in clinical development.
Source:
- Global Health EDCTP3 Joint Undertaking, February 2026, https://www.global-health-edctp3.europa.eu/news-and-events/news/ghana-becomes-first-country-approve-new-combination-medicines-treat-worm-infections-2026-02-18_en
