MedPath

Nifurtimox

Generic Name
Nifurtimox
Brand Names
Lampit
Drug Type
Small Molecule
Chemical Formula
C10H13N3O5S
CAS Number
23256-30-6
Unique Ingredient Identifier
M84I3K7C2O

Overview

Chagas disease, caused by a parasite known as Trypanosoma cruzi (T.cruzi), is a vector-transmitted disease affecting animals and humans in the Americas. It is commonly known as American Trypanosomiasis. The CDC estimates that approximately 8 million people in Central America, South America, and Mexico are infected with T. cruzi, without symptoms. If Chagas disease is left untreated, life-threatening sequelae may result. Nifurtimox, developed by Bayer, is a nitrofuran antiprotozoal drug used in the treatment of Chagas disease. On August 6 2020, accelerated FDA approval was granted for its use in pediatric patients in response to promising results from phase III clinical trials. Continued approval will be contingent upon confirmatory data. A convenient feature of Bayer's formulation is the ability to divide the scored tablets manually without the need for pill-cutting devices.

Background

Chagas disease, caused by a parasite known as Trypanosoma cruzi (T.cruzi), is a vector-transmitted disease affecting animals and humans in the Americas. It is commonly known as American Trypanosomiasis. The CDC estimates that approximately 8 million people in Central America, South America, and Mexico are infected with T. cruzi, without symptoms. If Chagas disease is left untreated, life-threatening sequelae may result. Nifurtimox, developed by Bayer, is a nitrofuran antiprotozoal drug used in the treatment of Chagas disease. On August 6 2020, accelerated FDA approval was granted for its use in pediatric patients in response to promising results from phase III clinical trials. Continued approval will be contingent upon confirmatory data. A convenient feature of Bayer's formulation is the ability to divide the scored tablets manually without the need for pill-cutting devices.

Indication

Nifurtimox is indicated in pediatric patients under 18 weighing at least 2.5 kg. Continued approval of this drug for this indication is dependent upon confirmatory clinical trial results.

Associated Conditions

  • Chagas Disease

FDA Approved Products

LAMPIT
Manufacturer:Bayer Healthcare Pharmaceuticals INC.
Route:ORAL
Strength:30 mg in 1 1
Approved: 2020/09/04
NDC:50419-750
LAMPIT
Manufacturer:Bayer Healthcare Pharmaceuticals INC.
Route:ORAL
Strength:120 mg in 1 1
Approved: 2020/09/04
NDC:50419-751

Singapore Approved Products

No Singapore products found for this drug

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