Numerous clinical trials spanning Phase 1 through Phase 4 evaluate mebendazole for parasitic helminth infections as well as various malignancies, including high-grade gliomas and gastrointestinal cancers. Supported by academic, pharmaceutical, and public health sponsors—such as Janssen Research & Development, the Swiss Tropical & Public Health Institute, and Johns Hopkins—these studies reflect recruitment statuses ranging from active to terminated. While late-stage anthelmintic trials have reached completion, early-phase evaluations continue to explore the drug's therapeutic repositioning in pediatric and adult oncology.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03925662 | RECRUITING | Colorectal Cancer |
Sherief Abd-Elsalam |
2019-04-01 | PHASE3 |
| NCT06800248 | NOT_YET_RECRUITING | Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection |
Swiss Tropical & Public Health Institute |
2026-11-06 | PHASE3 |
| NCT01837862 | ACTIVE_NOT_RECRUITING | Pilomyxoid Astrocytoma; Pilocytic Astrocytoma; Glioma, Astrocytic; Optic Nerve Glioma; Pleomorphic Xanthoastrocytoma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Gliosarcoma; Diffuse Intrinsic Pontine Glioma; DIPG; Low-grade Glioma; Brainstem Glioma |
Julie Krystal |
2013-10-22 | PHASE1; PHASE2 |
| NCT06736691 | ACTIVE_NOT_RECRUITING | Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection |
Swiss Tropical & Public Health Institute |
2025-11-25 | PHASE3 |
| NCT06335160 | RECRUITING | Ulcerative Colitis |
Tanta University |
2024-04-20 | |
| NCT06720259 | COMPLETED | Trichuris Trichiura; Infection; Hookworm Infection; Ascaris Lumbricoides Infection |
Jennifer Keiser |
2025-04-16 | PHASE2 |
| NCT04443049 | UNKNOWN | Hepatocellular Carcinoma; Liver Cirrhosis |
Institute of Liver and Biliary Sciences, India |
2020-07-10 | |
| NCT02644291 | COMPLETED | Medulloblastoma; Astrocytoma, Grade III; Glioblastoma; Anaplastic Astrocytoma; Brain Stem Neoplasms, Malignant; Oligodendroblastoma; Anaplastic Oligodendroglioma; Malignant Glioma |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2016-05 | PHASE1 |
| NCT05073562 | WITHDRAWN | Nutritional Anemia; Nutritional Deficiency; Iron Deficiency Anemia Treatment; Folic Acid Deficiency Anemia, Dietary; Adolescent Development; Knowledge, Attitudes, Practice; Food Habits |
Boston Children's Hospital |
2021-10 | |
| NCT03757403 | WITHDRAWN | Idiopathic Pruritus Ani |
RDD Pharma Ltd |
2020-05-01 | PHASE2 |
| NCT03995680 | COMPLETED | Hookworm Infections |
Swiss Tropical & Public Health Institute |
2019-07-12 | PHASE2 |
| NCT03628079 | TERMINATED | Cancer of the Gastrointestinal Tract; Cancer of Unknown Origin |
Repos Pharma |
2018-05-25 | PHASE1; PHASE2 |
| NCT03261596 | WITHDRAWN | Hookworm Infections |
PATH |
2017-09 | PHASE4 |
| NCT03278431 | COMPLETED | Hookworm Infection |
Swiss Tropical & Public Health Institute |
2017-09-27 | PHASE4 |
| NCT03245398 | COMPLETED | Hookworm |
Jennifer Keiser |
2017-07-25 | PHASE4 |
| NCT01729260 | COMPLETED | Newly Diagnosed High-Grade Glioma |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2013-04-04 | PHASE1 |
| NCT02034162 | COMPLETED | Helminth Infections |
Janssen Research & Development, LLC |
2014-12 | PHASE3 |
| NCT02051738 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2014-02 | PHASE1 |
| NCT01314937 | COMPLETED | Malnutrition; Intestinal Diseases, Parasitic |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2011-09 | PHASE4 |
| NCT01379326 | COMPLETED | Ascaris Lumbricoides; Ascaris Suum; Trichuris Trichiura; Trichuris Vulpis; Ancylostoma Duodenal; Ancylostoma Caninum; Ancylostoma Ceylanicum; Necator Americanus |
University Ghent |
2011-12 | PHASE4 |
| NCT01350271 | COMPLETED | Necator Americanus Infection |
University of Kelaniya |
2011-05 | PHASE3 |
| NCT01327469 | COMPLETED | Infection by Trichuris Trichiura |
University Ghent |
2010-12 | PHASE4 |
| NCT01173562 | COMPLETED | Healthy Volunteers |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2010-02 | PHASE3 |
| NCT01050452 | COMPLETED | Parasitic Diseases |
DBL -Institute for Health Research and Development |
2007-10 | |
| NCT01050374 | COMPLETED | Parasitic Diseases |
DBL -Institute for Health Research and Development |
2007-10 | |
| NCT00148629 | COMPLETED | Anemia; Low Birth Weight; Neonatal Mortality |
Cornell University |
2004-04 | PHASE3 |
| NCT00116493 | COMPLETED | Anemia |
Johns Hopkins Bloomberg School of Public Health |
2004-04 | PHASE3 |
| NCT02385058 | COMPLETED | Helminthiasis; Amoebiasis |
Janssen-Cilag Ltd. |
2005-10 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2019-04-24)
Check the
Mebendazole
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.