S-(-)-Cotinine Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials are currently evaluating contexts related to S-(-)-Cotinine exposure, shisha smoke exposure, and tobacco cigarette smoking. Sponsored by academic and public health institutions—specifically the University of Minnesota and the Johns Hopkins Bloomberg School of Public Health—these investigations aim to evaluate interventions designed to reduce household smoke exposure and support smoking cessation. Designated under the "Not Applicable" phase, these studies are currently listed as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06316947	Not yet recruiting	Shisha	University of Minnesota	2025-02-01	Not Applicable
NCT05836103	Not yet recruiting	Tobacco Cigarette Smoking	Johns Hopkins Bloomberg School of Public Health	2024-07-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

S-(-)-Cotinine binds to and stimulates nicotinic acetylcholine receptors, facilitating intracellular calcium influx that triggers the exocytotic release of dopamine in striatal tissue. This receptor-mediated neurotransmitter modulation underpins the physiological actions of nicotine metabolites, providing a mechanistic foundation for clinical investigations assessing tobacco cigarette smoking cessation interventions and shisha smoke exposure.

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>).