Clinical Trials

Multiple clinical trials evaluate luliconazole across superficial fungal infections, focusing primarily on toenail onychomycosis, tinea corporis, tinea pedis, and tinea cruris. Sponsored by organizations such as SATO Pharmaceutical Co. Ltd., Bausch Health Americas Inc., and Bausch & Lomb Incorporated, the research includes an active, non-recruiting Phase I pharmacokinetic and safety study alongside completed Phase IV trials investigating safety, efficacy, and drug-drug interactions in pediatric and adult populations. Overall, this body of work reflects robust early-phase and post-marketing characterization of the antifungal agent.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05110638 Active not recruiting
Onychomycosis of Toenail
SATO Pharmaceutical Co. Ltd.
 2021-09-13 Phase 1
NCT02767947 Completed
Tinea Corporis
Bausch Health Americas Inc.
 2016-02-08 Phase 4
NCT02767271 Completed
Tinea Pedis|Tinea Cruris
Bausch Health Americas Inc.
 2015-12-02 Phase 4
NCT02394340 Completed
Tinea Pedis|Tinea Cruris
Bausch & Lomb Incorporated|Bausch Health Americas Inc.
 2015-02-03 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Luliconazole selectively inhibits fungal lanosterol 14α-demethylase, which blocks ergosterol biosynthesis and disrupts the structural integrity of the fungal cell membrane. This compromise in membrane stability inhibits fungal cell growth and leads to cell death, providing clinical efficacy against superficial fungal infections such as tinea pedis, tinea cruris, tinea corporis, and toenail onychomycosis.

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.