NDAORALTABLETPriority Review
Approved
Nov 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STROMECTOL (ivermectin) is an oral antiparasitic tablet approved in 1996 by Merck & Co. for treatment of parasitic infections including onchocerciasis, lymphatic filariasis, and loiasis, with emerging off-label use in rosacea, head lice, and investigational applications in malaria and COVID-19. The mechanism of action in most indications involves disruption of parasite neuromuscular function, though the exact mechanism in rosacea remains unknown. Ivermectin is administered as a single or multiple oral dose regimen depending on indication.
$0.002BPart D
LOE ApproachingAs LOE approaches, the STROMECTOL brand team will face significant portfolio pressure; downsizing and transition planning are likely underway with emphasis on generic transition management and off-label indication development.
Mechanism of Action
Pharmacologic Class:
Antiparasitic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
Started Sep 2025
20,000 enrolled
Soil-Transmitted Helminths
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
Started Oct 2023
34 enrolled
Anatomic Stage IV Breast Cancer AJCC v8Metastatic Triple-Negative Breast Carcinoma
Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
Started Mar 2022
60 enrolled
Pediculosis
Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
Started Jun 2021
100 enrolled
Scabies
Rosacea and Ivermectin
Started Apr 2021
30 enrolled
Rosacea
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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.