Menadione (Vitamin K3) Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate menadione across diverse therapeutic applications, primarily focusing on dermatologic toxicities and coagulation disorders. Early-phase studies have assessed topical formulations for mitigating epidermal growth factor receptor (EGFR) inhibitor-induced rash and cetuximab-associated folliculitis, while additional research evaluated its utility in decompensated cirrhosis, coagulation factor deficiency, and coronary artery calcification. Sponsored by pharmaceutical companies such as Spectrum Pharmaceuticals and academic institutions including the Mayo Clinic and Odense University Hospital, these completed trials highlight menadione's role as both a topical agent for chemotherapy-induced skin toxicity and a metabolic cofactor.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04247087	COMPLETED	Coronary Calcification	Instituto Mexicano del Seguro Social	2017-09-07
NCT03547895	COMPLETED	Decompensated Cirrhosis	Zagazig University	2015-06-01
NCT01094444	COMPLETED	Folliculitis	Per Pfeiffer	2010-05	PHASE2
NCT01393821	COMPLETED	Dermatologic Complications; Malignant Neoplasm; Pain	Mayo Clinic	2012-01-23
NCT01094444	Completed	Folliculitis	Per Pfeiffer\|Odense University Hospital	2010-05	Phase 2
NCT00656786	COMPLETED	EGFR Inhibitor-associated Rash	Spectrum Pharmaceuticals, Inc	2008-04-03	PHASE1
NCT00656786	Completed	EGFR Inhibitor-associated Rash	Spectrum Pharmaceuticals Inc	2008-04-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-01-29)

Check the Menadione (Vitamin K3) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Menadione inhibits Cdc25 phosphatase and mitochondrial DNA polymerase γ while acting as a provitamin precursor that undergoes in vivo alkylation to generate active vitamin K2, which serves as an essential cofactor for the gamma-carboxylation of glutamate residues on vital coagulation factors and regulatory proteins. This biochemical activation restores functional clotting cascade activity and normalizes cellular responses, providing the therapeutic rationale for its clinical evaluation in treating coagulation factor deficiencies and managing epidermal growth factor receptor inhibitor-induced dermatologic complications such as rash and folliculitis.

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>).