Over the past 20 years, successful vector control programmes for Chagas disease in South America have reduced vector-borne transmission of the Trypanosoma cruzi parasite an non-vector-borne infections such as (vertical; pregnant mother to newborn infant) transmission have received increased attention.

In areas of successful vector control, the majority of new cases are children born with Chagas from infected mothers. With reported regional seroprevalence rates in asymptomatic women of reproductive age of 5-40% and vertical transmission rates of up to 12%, congenital infection remains a worlwide public health issue.

Despite these treatment recommendations for children, adequate available treatment options for them have been lacking. Benznidazole, developed over 30 years ago and the main drug of choice for treating Chagas, was only available in an adult tablet strength of 100 mg (Radanil®, Rochagan®, LAFEPE Benznidazol®). Most treatments for infants and young children were based on the use of tablet fractions, macerated tablets and other extemporaneous formulations, which introduce variation and imprecision in drug dosing.

Policymakers and clinicians have long stressed the urgent need for a paediatric drug formulation in Chagas control, most notably in the 2005 Scientific Working Group for Chagas Disease of the Special Programme for Research and Training in Tropical Diseases (TDR) and in the 2007 TDR Working Group on Chagas Disease.

Therefore, in July 2008, DNDi and Brazil’s Pernambuco State Pharmaceutical Laboratory (Laboratório Farmacêutico do Estado de Pernambuco; LAFEPE) joined efforts and signed an agreement to develop a paediatric dosage form of benznidazole for the treatment of children with Chagas disease.