Fenbendazole Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials are currently evaluating anthelmintic interventions for parasitic conditions, including fascioliasis, filariasis, and neurocysticercosis. These Phase I and Phase II investigations—sponsored by public health and academic institutions such as the National Institute of Allergy and Infectious Diseases, Universidad Peruana Cayetano Heredia, and the Swiss Tropical and Public Health Institute—focus on safety, bioavailability, pharmacokinetics, and optimized dosing regimens. Across this research portfolio, recruitment status ranges from completed evaluations to studies that are not yet recruiting.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fenbendazole selectively binds to helminth beta-tubulin, inhibiting tubulin polymerization and disrupting microtubule structure and cellular transport mechanisms. This loss of microtubule function impairs essential metabolic processes such as glucose uptake, leading to parasite energy depletion and structural collapse, which underpins its therapeutic activity against infections like fascioliasis, filariasis, and neurocysticercosis.

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>).