Fosciclopirox Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 890

Clinical Trials

Sponsored by CicloMed LLC, several completed clinical trials have evaluated Fosciclopirox in patients with advanced solid tumors and newly diagnosed bladder cancer. A Phase 1 first-in-human study assessed safety, dose tolerance, pharmacokinetics, and pharmacodynamics in advanced solid tumors, while a Phase 2 trial evaluated similar pharmacological parameters using a window-of-opportunity design in bladder cancer. Together, these studies demonstrate a targeted evaluation of Fosciclopirox across both broad solid tumors and specific urothelial oncological indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04525131	Completed	Bladder Cancer	CicloMed LLC	2020-11-25	Phase 2
NCT04608045	Completed	Advanced Solid Tumor	CicloMed LLC	2019-05-19	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fosciclopirox selectively delivers its active metabolite, ciclopirox, which targets the gamma-secretase complex components Presenilin 1 and Nicastrin to block downstream signaling cascades and suppress oncogenic cell survival pathways. This targeted inhibition leads to reduced tumor cell proliferation and induction of apoptosis, providing direct clinical relevance for the treatment of advanced solid tumors and bladder cancer.

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>).