NDAORALTABLETPriority Review
Approved
Aug 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
5/8 — Partial
Priority Review
LAMPIT (nifurtimox) by Bayer is [see microbiology ()] . Approved for chagas disease, trypanosoma cruzi infection. First approved in 2020.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMPIT (nifurtimox) is an oral small-molecule antiparasitic agent approved by the FDA in August 2020 for the treatment of Chagas disease caused by Trypanosoma cruzi infection. It works through a mechanism that disrupts parasite metabolism and viability. This is a rare disease therapeutic indicated for patients with acute or chronic Chagas disease.
Peak1.3 years to LOE
Product is in peak commercial phase with moderate competitive pressure (30%), but approaching LOE in 2027 will likely compress team size and shift focus to market defense.
Mechanism of Action
[see Microbiology ()] .
Indications (2)
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.