TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

LAMPIT

NIFURTIMOX
Approved 2020-08-06
2
Indications
--
Phase 3 Trials
1
Priority Reviews
5
Years on Market

Details

Status
Prescription
First Approved
2020-08-06
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: NIFURTIMOX

LAMPIT Approval History

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What LAMPIT Treats

2 indications

LAMPIT is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chagas Disease
  • American Trypanosomiasis
Source: FDA Label

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LAMPIT FDA Label Details

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Indications & Usage

FDA Label (PDF)

LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi [see Clinical Studies ]. LAMPIT is a nitrofuran antiprotozoal, indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi .

LAMPIT Patents & Exclusivity

Exclusivity: Aug 2027

Exclusivity

ODE-319 Until Aug 2027
ODE-319 Until Aug 2027
ODE-319 Until Aug 2027
ODE-319 Until Aug 2027
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.