Infections caused by soil-transmitted helminths (STH) are part of the group of neglected tropical diseases, which are common among low-income populations around the world. There are five species of these parasites prioritised by the WHO in its 2021–2030 Road Map: Ascaris lumbricoides, Necator americanus, Ancylostoma duodenale, Trichuris trichiura and Strongyloides stercoralis, and they are estimated to affect around 1.5 billion people globally.
These infections impair the growth and cognitive development of affected children and can cause anaemia, chronic diarrhoea and a wide range of symptoms in children, adolescents and adults. They also impose a heavy disease burden on affected communities, resulting in lost workdays and schooling, with consequences for the economy and development of these regions.
To control these infections, the World Health Organization (WHO) recommends conducting periodic mass drug administration campaigns in high-prevalence areas. These consist of treating entire groups, such as school-age children or whole communities, without the need for individual diagnosis. The treatment of choice for such interventions is a single dose of a benzimidazole (albendazole or mebendazole); however, its efficacy is limited against Trichuris trichiura and Strongyloides stercoralis. Adding ivermectin, the drug of choice for S. stercoralis, improves outcomes against T. trichiura and maintains efficacy against the other species. Moreover, using multiple drugs with different mechanisms of action reduces the risk of resistance emerging.
A study conducted in 2010 by Fundación Mundo Sano, the National University of Salta, the Sabin Vaccine Institute and the Ministry of Public Health of Salta revealed a high prevalence of S. stercoralis in northern Argentina, highlighting the need to include ivermectin in deworming campaigns against this species. From this need arose the idea of a co-formulation of ivermectin and albendazole.
Whereas benzimidazoles are administered as one tablet per person, ivermectin is dosed according to the weight or height of the person, complicating its distribution and administration. While the joint use of both drugs is not new, the idea of combining them in a fixed-dose, single tablet is part of the innovation developed by Insud Pharma and Fundación Mundo Sano. This results in a product that delivers the superior efficacy of the drug combination and the logistical simplicity — one tablet per person — of benzimidazoles.
One challenge in incorporating ivermectin into mass deworming campaigns was the difficulty of accessing the drug, as no prequalified generic version for human use existed under WHO standards. Mundo Sano proposed developing this generic to Insud Pharma, which accepted the challenge and achieved prequalification in 2021.
The development of the co-formulation also considered essential aspects for successful implementation in public health contexts: the product is stable at room temperature for several years, mango-flavoured, and dissolves upon contact with saliva, which mitigates the risk of choking (the most serious danger in mass drug administration campaigns) and facilitates intake in areas with poor sanitation or limited access to clean water.
