Brief Recent History
Benznidazole (N- phenylmethyl-2-nitro-1H-imidazole-1-acetamide; CAS Number 22994-85- 0) is the most commonly used drug for treatment of CD. It was developed by Roche (Ro 07-1051)49 and there have been three producers of BZN so far: Roche, Lafepe (public pharmaceutical company of Brazil), and Chemo (formerly Elea, an Argentine pharmaceutical company). Roche manufactured and distributed the drug (as Radanil© or Rochagan©) from 1967 until the early 2000s, when production was discontinued due to economic reasons49. Later, encouraged by pressure from scientific and medical organizations, Roche eventually transferred BZN production technology and remaining stocks to Lafepe, which committed to re-establish supply. Lafepe developed a pediatric formulation for children weighing < 20 kg (12.5 mg tablet) that was tested in clinical pediatric study in Argentina (sponsored by Drugs for Neglected Diseases initiative)8 and this formulation was registered in Brazil in 2011 and was included on the WHO’s Essential Medicines List for children in 2013.
BNZ was the first drug approved by the United States Food and Drug Administration (FDA) in 2017 for children ages two to twelve years with CD50,51 and in April 2018, a pediatric formulation of BZN was approved in Argentina to treat children under the age of 2 year. BZN may is also prescribed off-label for adolescents, adults, and children under 2 in countries where the drug has not been registered specifically for these age groups.