Nordihydroguaiaretic acid (NDGA) Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 1,470

Clinical Trials

Several Phase I and Phase II clinical trials have evaluated nordihydroguaiaretic acid (NDGA) and its derivative, tetra-O-methyl nordihydroguaiaretic acid, for advanced cancer, brain and central nervous system tumors, cervical intraepithelial neoplasia, and prostate cancer. Sponsored by industry partners such as Erimos Pharmaceuticals alongside academic institutions including the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and the University of California, San Francisco, these studies evaluated dosage, safety, and pharmacokinetics. Across these trials, recruitment statuses are documented as either completed or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00678015	TERMINATED	Prostate Cancer	University of California, San Francisco	2008-05	PHASE2
NCT00404248	COMPLETED	Brain and Central Nervous System Tumors	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2007-01	PHASE1; PHASE2
NCT00313534	TERMINATED	Prostate Cancer	University of California, San Francisco	2005-06	PHASE1
NCT00154089	COMPLETED	Cervical Intraepithelial Neoplasia	Erimos Pharmaceuticals	2004-11	PHASE1; PHASE2
NCT00259818	COMPLETED	Cancer	Erimos Pharmaceuticals	2005-12	PHASE1

(data from https://clinicaltrials.gov, updated on 2014-04-09)

Check the Nordihydroguaiaretic acid (NDGA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nordihydroguaiaretic acid functions as a lipoxygenase inhibitor and dual IGF-1R/HER2 receptor antagonist, thereby blocking lipid mediator synthesis and downregulating downstream oncogenic phosphorylation cascades. This signaling suppression impairs cellular antioxidant defenses and triggers targeted apoptotic cell death, providing the mechanistic rationale for its clinical evaluation against prostate cancer, central nervous system tumors, and cervical intraepithelial neoplasia.

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>).