Clinical Trials

Multiple completed Phase 1 through Phase 4 clinical trials have evaluated the safety, pharmacokinetics, and therapeutic application of econazole formulations in healthy volunteers and populations with fungal infections. The investigated conditions primarily included superficial fungal disorders such as tinea pedis, onychomycosis, and otomycosis. These trials were supported by diverse sponsors, ranging from academic institutions like Zhongshan Hospital Xiamen University to commercial entities including AmDerma Pharmaceuticals, Mylan, and Abeona Therapeutics.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06431542 COMPLETED
Otomycosis
Zhongshan Hospital Xiamen University
 2024-06-01 PHASE4
NCT03129321 COMPLETED
Tinea Pedis
Mylan Inc.
 2016-03-15 PHASE3
NCT02720783 COMPLETED
Healthy Women
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2016-03-04 PHASE1
NCT02713893 COMPLETED
Healthy
Aziende Chimiche Riunite Angelini Francesco S.p.A
 2015-09 PHASE1
NCT01696799 COMPLETED
Interdigital Tinea Pedis
AmDerma
 2011-09 PHASE2
NCT01353976 COMPLETED
Tinea Pedis; Athlete's Foot
AmDerma
 2011-05 PHASE3
NCT01358240 COMPLETED
Tinea Pedis; Athlete's Foot
AmDerma
 2011-06 PHASE3
NCT01696799 Completed
Interdigital Tinea Pedis
AmDerma|AmDerma Pharmaceuticals LLC
 2011-09 Phase 2
NCT00768599 COMPLETED
Tinea Pedis; Athlete's Foot
AmDerma
 2008-03 PHASE2
NCT00385502 COMPLETED
Onychomycosis
Abeona Therapeutics, Inc
 2006-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2024-11-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Econazole binds to and selectively inhibits fungal lanosterol 14α-demethylase, blocking the enzymatic biosynthesis of ergosterol and compromising fungal cell membrane integrity. This disruption of membrane structure and increased permeability leads to fungal cell lysis and growth inhibition, providing therapeutic efficacy in managing superficial fungal conditions such as tinea pedis, onychomycosis, and otomycosis.

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.