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.