TheraRadar
Data updated: May 26, 2026

LAMPIT (nifurtimox)

Trial Activity: Declining
Orphan Drug Priority Review Accelerated Approval
Infectious Disease Approved 2020-08-06

Lampit helps pediatric patients, from birth to less than 18 years of age, who have Chagas disease. This medication is used for children weighing at least 2.5 kg to address infections caused by the Trypanosoma cruzi parasite. It provides a therapeutic option for managing American Trypanosomiasis in this specific population.

Source: FDA Label • Bayer

How LAMPIT Works

Lampit works as a nitrofuran antiprotozoal agent. This medication acts against the Trypanosoma cruzi parasite to help clear the infection from the patient's system.

Development Insights

Giselle Sholler conducting 1 trials (33%)
6 indications explored (Moderate)
neuroblastoma (1 trials)
medulloblastoma (1 trials)
trypanosoma cruzi infection (1 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
5
Years on Market

Details

Status
Prescription
First Approved
2020-08-06
Patent Cliff
2027

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Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: NIFURTIMOX

LAMPIT Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2020 to 2023 · 1 indication expansions
Jun 2023 SUPPL
Efficacy
Feb 2023 SUPPL
Label · Labeling
Jan 2022 SUPPL
Label · Labeling

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

LAMPIT Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to LAMPIT

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BENZNIDAZOLE
BENZNIDAZOLE
2 shared
CHEMO RESEARCH SL
Shared indications:
Chagas DiseaseAmerican Trypanosomiasis
📋

Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT00601003 results posted V0706 Ph 2 completed Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma
NCT03981523 TESEO 743474 U01AI129783 Ph 2 completed New Therapies and Biomarkers for Chagas Infection
NCT01685827 DNDiFEX004 Ph 2, Ph 3 completed Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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

Indications & Usage

FDA Label (PDF)

LAMPIT is indicated for the treatment of Chagas Disease; American Trypanosomiasis.

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.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment