by Forsyth C, Garcia-Bournissen F, Moscatelli G, Moroni S, Pereiro A, Ortiz-Daza L, Hernández Cuevas E-I, Tinajeros F, Marques T, Marchiol A, Herazo R, Seu S, Sancho J, Altcheh J, Pinazo M-J. PLOS Neglected Tropical Diseases 2026;20(1): e0013597. doi: 10.1371/journal.pntd.0013597
Summary: The authors of this target product profile (TPP) aimed to guide the development of pediatric formulations of new drugs for the treatment of Chagas disease. After reviewing the relevant literature, an expert working group was created. Essential and ideal requirements were defined for 15 attributes, which specified the required TPP performance and use characteristics. The target population was defined as newborns to 18 year-olds. The essential indication would cover acute/congenital and chronic Trypanosoma cruzi infection; the ideal indication would include chronic indeterminate, congenital and/or acute vector-borne T. cruzi infection and people who are immunosuppressed, pregnant or breastfeeding. An age-appropriate drug formulation, acceptable palatability, dose, and ease of administration were considered to be particularly important for children.
