Ciclopirox ethanolamine Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate the biological activity, safety, and therapeutic application of ciclopirox olamine across hematologic and dermatologic conditions. A completed academic Phase 1 trial, supported by the University Health Network Toronto and The Leukemia and Lymphoma Society, evaluated oral administration in patients with relapsed or refractory hematologic malignancies, including acute and chronic leukemias, myelodysplasia, and Hodgkin's disease. In contrast, an industry-sponsored Phase 4 trial by Ferrer Internacional S.A. evaluated a topical cream formulation in pediatric patients with dermatomycoses, though it was terminated prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
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

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ciclopirox ethanolamine functions primarily as a broad-spectrum iron chelator that binds intracellular trivalent iron, thereby inhibiting essential iron-dependent metalloenzymes and disrupting macromolecular DNA, RNA, and protein synthesis. This metabolic blockade causes cellular damage and rapid growth arrest, providing the pharmacological rationale for its clinical investigation in both fungal dermatomycoses and 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>).