Clinical Trials

Multiple clinical trials are evaluating oxfendazole for the treatment of parasitic helminth infections, specifically neurocysticercosis, fascioliasis, filariasis, and general helminthiasis. Sponsored by academic and public health entities—including the National Institute of Allergy and Infectious Diseases, Universidad Peruana Cayetano Heredia, and the Drugs for Neglected Diseases initiative—these Phase 1 and Phase 2 studies focus on safety, pharmacokinetics, and efficacy. Recruitment statuses across these trials range from completed early-phase studies to pending Phase 2 evaluations and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06367361 Not yet recruiting
Fascioliasis
Universidad Peruana Cayetano Heredia|National Institute of Allergy and Infectious Diseases (NIAID)
 2024-07 Phase 2
NCT04920292 Completed
Filariasis
Swiss Tropical & Public Health Institute|Ifakara Health Institute|Drugs for Neglected Diseases
 2022-04-21 Phase 1
NCT02636803 Withdrawn
Helminthiasis
Johns Hopkins Bloomberg School of Public Health|Universidad Peruana Cayetano Heredia
 2019-11 Phase 2
NCT03035760 Completed
Helminthic Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2017-05-12 Phase 1
NCT02234570 Completed
Neurocysticercosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2014-11-17 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Oxfendazole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxfendazole selectively binds to parasite beta-tubulin to inhibit microtubule polymerization, thereby disrupting essential cellular processes including glucose uptake and intracellular transport. This loss of microtubule structure leads to mitotic arrest and cellular death of the parasite, providing therapeutic efficacy against parasitic conditions such as neurocysticercosis, fascioliasis, and filariasis.

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>).

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Note: Technical data last updated: Sep 1, 2026.