Treats gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and…. Sold as Vermox. Every FDA application for this active ingredient: 2 branded and 1 generic.
As of Nov 14, 2026, FDA lists 3 applications for Mebendazole (sold as Vermox), first approved Jun 28, 1974, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Emverm | Part D | $9.2M | +57% | 1,564 |
| Expanding Access to Preventive Chemotherapy Among Mobile and Migrant PopulationsOnchocerciasis (River Blindness), Schistosomiasis · Uwemedimo Friday Ekpo | Not applicable | Recruiting | Jul 16, 2026 |
| Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth InfectionsTrichuris Trichiura; Infection, Hookworm Infection · Swiss Tropical & Public Health Institute | Phase 3 | Not yet recruiting | Jan 29, 2025 |
| Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With MesalamineUlcerative Colitis · Tanta University | Not applicable | Recruiting | Mar 28, 2024 |
| Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene.Malnutrition, Child · Hospital Universitari Vall d'Hebron Research Institute | Not applicable | Active, not recruiting | Oct 7, 2022 |
| Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid TumorsAnatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 · M.D. Anderson Cancer Center | Phase 2 | Recruiting | Feb 25, 2021 |
| Mebendazole as Adjuvant Treatment for Colon CancerColorectal Cancer · Sherief Abd-Elsalam | Phase 3 | Recruiting | Apr 24, 2019 |
| A Phase I Study of Mebendazole for the Treatment of Pediatric GliomasPilomyxoid Astrocytoma, Pilocytic Astrocytoma · Julie Krystal | Phase 1 / Phase 2 | Active, not recruiting | Apr 23, 2013 |
| Jun 28, 1974 | VermoxNDA 17481 · New molecular entity | Janssen Pharms | 37 | Discontinued |
| Jan 4, 1995 | EmvermANDA 73580 | Impax Labs Inc | 15 | Marketed |
| Oct 19, 2016 | VermoxNDA 208398 · New formulation or manufacturer | Janssen Pharms | 1 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Impax Labs Inc