Clinical Trials

Several clinical trials sponsored by academic research institutions, such as Yale University, the University of Manchester, and the University of Kansas Medical Center, evaluate WS3 formulations across psychiatric, cardiovascular, and substance use conditions. Ranging from recruiting to completed status, these unassigned phase studies investigate nicotine use disorder, tobacco dependence, electronic cigarette use, cardiac rehabilitation, depression, anxiety, and psychological distress. The investigations primarily focus on assessing constituent appeal, abuse liability, and home-based psychological interventions within target patient populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05932745 RECRUITING
Nicotine Use Disorder
Yale University
2025-06-20
NCT05932693 COMPLETED
E-Cig Use
Yale University
2024-09-03
NCT06477601 COMPLETED
Tobacco Dependence
University of Kansas Medical Center
2024-06-24
NCT03129282 COMPLETED
Depression; Anxiety; Cardiac Rehabilitation; Psychological Distress
University of Manchester
2017-04-04

(data from https://clinicaltrials.gov, updated on 2026-06-16)

Check the WS3 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

WS3 binds to and modulates Erb3 binding protein-1 (EBP1) while regulating the IκB kinase pathway, which suppresses downstream inhibitory signaling and induces pancreatic β-cell proliferation. This cellular regeneration mechanism provides the primary biological activity for β-cell expansion, while clinical investigations evaluate WS3 in human studies concerning nicotine use disorder, tobacco dependence, e-cigarette usage, depression, anxiety, and cardiac rehabilitation.

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>).

Note: Technical data last updated: Sep 1, 2026.