NNK Clinical Trials

Size	Price	Qty
5mg	USD 197

Clinical Trials

Several clinical trials evaluate the metabolic fate and clinical implications of the tobacco-specific carcinogen NNK in relation to tobacco smoking, tobacco use disorder, and lung cancer susceptibility. Spanning Phase 1, Phase 2, and unspecified phases, these studies are sponsored by academic institutions, including the Masonic Cancer Center at the University of Minnesota and the University of Florida, to assess dietary modifiers such as PEITC and kava alongside ethnic metabolic variations. Although most of these trials have reached completed status, an early-phase trial was withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03606655	WITHDRAWN	Kava on the Metabolism of Nicotine and NNK	University of Florida	2020-01	PHASE1
NCT02500472	COMPLETED	Tobacco Smoking	Masonic Cancer Center, University of Minnesota	2015-12-03
NCT00691132	COMPLETED	Lung Cancer; Tobacco Use Disorder	University of Minnesota	2009-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2020-01-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a potent nicotine-derived tobacco carcinogen, NNK activates signaling through extracellular signal-regulated kinase 1/2 (ERK1/2) and protein kinase C alpha (PKCα), which leads to downstream phosphorylation of Bcl2 and c-Myc. This cascade promotes the survival, proliferation, and chemoresistance of human lung cancer cells, directly underlying its clinical relevance in trial settings focused on tobacco-induced lung carcinogenesis and metabolic intervention strategies.

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>).