NDAORALTABLET, CHEWABLEPriority Review
Approved
Oct 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
VERMOX (mebendazole) by Johnson & Johnson. Approved for anthelmintic [epc]. First approved in 2016.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VERMOX (mebendazole) is an oral anthelmintic small molecule approved by the FDA in 2016 for treating parasitic worm infections. It works by disrupting microtubule formation in helminths, causing paralysis and expulsion. The drug is formulated as a chewable tablet for ease of administration in pediatric and adult populations.
Peak
Product is at peak lifecycle maturity with moderate competitive pressure (30%), indicating stable team composition and focus on market maintenance rather than growth-stage expansion.
Mechanism of Action
Pharmacologic Class:
Anthelmintic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
Started Dec 2014
295 enrolled
Helminth Infections
A Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Participants
Started Feb 2014
1 enrolled
Healthy
A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas
Started Oct 2013
10 enrolled
Pilomyxoid AstrocytomaPilocytic AstrocytomaGlioma, Astrocytic+9 more
A Safety Study of Mebendazole in Children 2 to 10 Years of Age
Started Feb 2010
397 enrolled
Healthy Volunteers
Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
Started Oct 2005
100 enrolled
HelminthiasisAmoebiasis
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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.