WST-8 Clinical Trials

Size	Price	Qty
25mg	USD 147
100mg	USD 297

Clinical Trials

A completed Phase I clinical trial sponsored by an academic institution, University Medicine Greifswald, evaluated WST-8 in human subjects. The study focused on conditions involving gastrointestinal hormones, specifically examining how transporter inhibition and genetic variants influence systemic disposition and biological efficacy. Overall, the clinical evaluation landscape for this compound is currently limited to early-phase academic research in metabolic and physiological systems.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02507167	Completed	Gastrointestinal Hormones	University Medicine Greifswald	2012-11	Phase 1

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

Check the WST-8 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

WST-8 acts as a cell-permeable electron acceptor that is bioreduced by intracellular dehydrogenases, producing a water-soluble formazan dye that directly measures metabolic activity. This reduction process reflects overall cell viability and metabolic capacity, serving as a key biomarker tool in clinical research involving gastrointestinal hormones.

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>).