Nifurtimox

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.

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health	2022/07/28	NCT05477953	N/A	Not yet recruiting	Bayer
New Therapies and Biomarkers for Chagas Infection	2019/06/11	NCT03981523	Phase 2	Completed	University of Texas, El Paso
Study on Benefits of Therapy With Nifurtimox in Chagas Disease, a Parasitic Illness Mostly Transmitted to Humans by a Bug, Using Information From Patient Medical Records in Argentina	2018/12/21	NCT03784391	N/A	Completed	Bayer
Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation	2018/10/17	NCT03708133	Phase 1	Completed	Bayer
Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg	2017/11/22	NCT03350295	Phase 1	Completed	Bayer
Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study	2017/11/07	NCT03334838	Phase 1	Completed	Bayer
A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi	2015/12/09	NCT02625974	Phase 3	Completed	Bayer
Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients	2015/11/17	NCT02606864	Phase 1	Completed	Bayer
CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)	2015/02/24	NCT02369978	Phase 2	UNKNOWN	Universidad Autónoma de Bucaramanga
Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients	2013/08/22	NCT01927224	Phase 1	Completed	Bayer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
LAMPIT	Bayer Healthcare Pharmaceuticals INC.	50419-751	ORAL	120 mg in 1 1	9/4/2020
LAMPIT	Bayer Healthcare Pharmaceuticals INC.	50419-750	ORAL	30 mg in 1 1	9/4/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LAMPIT 30 MG COMPRIMIDOS	Bayer Hispania S.L.	89507	COMPRIMIDO	Diagnóstico Hospitalario	Not Commercialized
LAMPIT 120 MG COMPRIMIDOS	Bayer Hispania S.L.	89506	COMPRIMIDO	Diagnóstico Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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