NDAORALTABLETPriority Review
Approved
Aug 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
4/8 — Partial
Priority Review
LAMPIT (nifurtimox) by Bayer is [see microbiology ()] . First approved in 2020.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMPIT (nifurtimox) is an oral small-molecule antiparasitic approved by FDA in August 2020 for treating Chagas disease, a parasitic infection caused by Trypanosoma cruzi. The drug works through a mechanism that disrupts the parasite's cellular processes, making it effective against this neglected tropical disease.
LOE Approaching1.1 years to LOE
Product is in peak commercial phase but approaching loss of exclusivity in August 2027, requiring immediate focus on market consolidation and retention strategies as team size may contract post-LOE.
Mechanism of Action
[see Microbiology ()] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
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
Started Jun 2026
50 enrolled
Chagas Disease
Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study
Started Jun 2019
36 enrolled
Chagas' Disease
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
Started Dec 2018
3,000 enrolled
Chagas' Disease
Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation
Started Dec 2018
24 enrolled
Bioequivalence
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
Started Jun 2018
48 enrolled
Chagas Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.