NDAORALTABLETPriority Review
Approved
Feb 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
Priority Review
EGATEN (triclabendazole) by Novartis is cytochrome p450 2c19 inhibitors [moa]. Approved for anthelmintic [epc]. First approved in 2019.
Drug data last refreshed 3d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EGATEN (triclabendazole) is an oral small-molecule anthelmintic approved by the FDA in February 2019 for the treatment of fascioliasis, a parasitic infection caused by liver flukes. It works as a cytochrome P450 2C19 inhibitor, disrupting the parasite's metabolic processes to eliminate the infection. This is a niche therapeutic addressing a neglected tropical disease with limited treatment alternatives.
PeakPost-LOE
Product is at peak lifecycle stage with moderate competitive pressure (30 intensity); commercial team focus is likely on market penetration in endemic regions and maintaining exclusivity until LOE.
Mechanism of Action
Cytochrome P450 2C19 Inhibitors
Pharmacologic Class:
Anthelmintic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis
Started Aug 2025
336 enrolled
Fascioliasis
Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).
Started Feb 2022
301 enrolled
Fascioliasis
Compassionate Use of Triclabendazole for the Treatment of Parasites (Prior to FDA Approval; Expanded Access Program)
Parasitic Disease
Career Relevance
Working on EGATEN offers exposure to global health, neglected tropical disease markets, and Novartis's infectious disease portfolio at a critical juncture—peak commercial maturity transitioning into LOE planning. This niche product provides deep expertise in parasitology, endemic-market strategy, and international regulatory navigation, with career value in specialized global health roles or as a foundation for oncology/infectious disease expertise.
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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.