Menadione bisulfite sodium Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple completed early-phase clinical trials have evaluated topical menadione bisulfite sodium for treating dermatological side effects induced by targeted therapies, specifically EGFR inhibitor-associated rash and cetuximab-induced folliculitis. Sponsored by academic institutions such as Odense University Hospital and biopharmaceutical companies like Spectrum Pharmaceuticals Inc., these studies investigated the safety, tolerability, systemic absorption, and therapeutic potential of the treatment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01094444	Completed	Folliculitis	Per Pfeiffer\|Odense University Hospital	2010-05	Phase 2
NCT00656786	Completed	EGFR Inhibitor-associated Rash	Spectrum Pharmaceuticals Inc	2008-04-03	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Menadione bisulfite sodium inhibits Cdc25 phosphatase and mitochondrial DNA polymerase γ, thereby disrupting cell cycle progression and downstream signaling cascades. This cellular inhibition mitigates epidermal toxicity caused by targeted cancer therapies, providing a mechanistic rationale for its clinical evaluation in managing EGFR inhibitor-associated 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>).