Ciclopirox Clinical Trials

Size	Price	Qty
25mg	USD 147
200mg	USD 470

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 evaluate ciclopirox across superficial fungal dermatoses—including onychomycosis, tinea pedis, tinea capitis, and dermatomycoses—and systemic diseases such as hematologic malignancies, vulvar cancer, and congenital erythropoietic porphyria. Sponsored by academic centers and pharmaceutical entities including University Health Network Toronto, Galderma R&D, Atlas Molecular Pharma, and Ferrer Internacional S.A., these protocols exhibit recruitment statuses that include completed, recruiting, terminated, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07024316	RECRUITING	Congenital Erythropoietic Porphyria (CEP)	Atlas Molecular Pharma	2026-01-29	PHASE1; PHASE2
NCT05647343	COMPLETED	Adverse Effect of Drugs and Medicaments in Therapeutic Use	Atlas Molecular Pharma	2023-03-31	PHASE1
NCT05809297	UNKNOWN	Onychomycosis	Universidad Complutense de Madrid	2023-09-01	PHASE4
NCT02866032	COMPLETED	Distal Subungual Onychomycosis	Moberg Pharma AB	2016-09	PHASE3
NCT02961634	UNKNOWN	Onychomycosis	MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA	2017-04	PHASE3
NCT02679911	COMPLETED	Foot Dermatoses	Galderma R&D	2015-09	PHASE4
NCT00990587	COMPLETED	Hematologic Malignancy; Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Myelodysplasia; Acute Myeloid Leukemia; Chronic Myelogenous Leukemia; Hodgkin's Disease	University Health Network, Toronto	2009-10	PHASE1
NCT01139749	UNKNOWN	Seborrhea; Seborrheic Dermatitis; Quality of Life	Federal University of São Paulo	2011-10	PHASE4
NCT01646580	TERMINATED	Dermatomycoses	Ferrer Internacional S.A.	2008-10	PHASE4
NCT01014637	UNKNOWN	Onychomycosis	Pierre Fabre Dermo Cosmetique	2009-08	PHASE4
NCT00990587	Completed	Hematologic Malignancy\|Acute Lymphocytic Leukemia\|Chronic Lymphocytic Leukemia\|Myelodysplasia\|Acute Myeloid Leukemia\|Chronic Myelogenous Leukemia\|Hodgkin''s Disease	University Health Network Toronto\|The Leukemia and Lymphoma Society	2009-10	Phase 1
NCT01646580	Terminated	Dermatomycoses	Ferrer Internacional S.A.	2008-10	Phase 4
NCT00127868	COMPLETED	Tinea Capitis	Chen, Catherine, M.D.	2005-03
NCT01419847	COMPLETED	Onychomycosis	Rady Children's Hospital, San Diego	2002-03	PHASE4
NCT00804193	COMPLETED	Tinea Pedis	Padagis LLC	2004-06
NCT00802672	COMPLETED	Tinea Pedis	Padagis LLC	2003-12	PHASE3
NCT00382330	WITHDRAWN	Vulvar Cancer	University of Medicine and Dentistry of New Jersey

(data from https://clinicaltrials.gov, updated on 2026-03-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ciclopirox functions as a synthetic iron chelator that disrupts the Na+/K+ ATPase membrane transfer system and inhibits critical iron-dependent cellular enzymes. This disruption impairs intracellular transport, DNA repair mechanisms, and mitotic spindle stability, leading to impaired cell division and clinical efficacy against fungal dermatoses such as onychomycosis as well as hematologic malignancies.

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>).