Clinical Trials

Several clinical trials evaluate Amorolfine HCl primarily for fungal nail disorders, including various forms of onychomycosis and resistant infections. Spanning Phase 2 through Phase 4 research with completed recruitment, these studies are supported by both academic and industry sponsors. They evaluate the efficacy and safety of topical amorolfine nail lacquers as monotherapy as well as in combination with laser or oral antifungal regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02812043 COMPLETED
Non-dermatophyte Onychomycosis
Mahidol University
 2016-08 PHASE4
NCT03098342 COMPLETED
Onychomycosis of Toenail
Chulalongkorn University
 2017-06-01
NCT02549001 COMPLETED
Onychomycosis
Polichem S.A.
 2015-08-20 PHASE3
NCT02812043 Completed
Non-dermatophyte Onychomycosis
Mahidol University
 2016-08 Phase 4
NCT01851590 COMPLETED
Onychomycosis
Helsinki University Central Hospital
 2013-10 PHASE4
NCT01528813 UNKNOWN
Onychomycosis
Brasilia University Hospital
 2012-02 PHASE2
NCT01929187 UNKNOWN
Onycomycosis
National Taiwan University Hospital
 2013-02
NCT01014637 UNKNOWN
Onychomycosis
Pierre Fabre Dermo Cosmetique
 2009-08 PHASE4
NCT00459537 COMPLETED
Onychomycosis
Novartis
 2007-03 PHASE3

(data from https://clinicaltrials.gov, updated on 2021-09-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amorolfine HCl selectively binds to and inhibits delta-14-reductase and delta-7-delta-8-isomerase within the fungal ergosterol biosynthesis pathway, which depletes essential ergosterol levels and causes ignosterol accumulation in cytoplasmic cell membranes. This biochemical blockade severely compromises fungal cell membrane integrity and function, resulting in antifungal activity that underlies its clinical efficacy in treating fungal nail diseases such as 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.