GW501516 (GSK-516, Cardarine) Clinical Trials

Size	Price	Qty
5mg	USD 270
25mg	USD 970

Clinical Trials

Several clinical trials evaluating GW501516 have completed recruitment, investigating interventions for metabolic and cardiovascular conditions such as dyslipidaemias, hypercholesterolemia, obesity, lipid disorders, and cardiovascular disease. These studies—comprising Phase II, Phase IV, and an unspecified phase—assess the drug's efficacy in modulating lipoprotein kinetics and treating metabolic dysfunction. Sponsorship is shared between industry partners like GlaxoSmithKline and academic institutions including The University of Western Australia.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00158899	COMPLETED	Dyslipidaemias; Dyslipidaemia	GlaxoSmithKline	2004-08	PHASE2
NCT00841217	COMPLETED	Obesity; Lipid Disorders; Cardiovascular Disease	The University of Western Australia	2003-04	PHASE4

(data from https://clinicaltrials.gov, updated on 2017-05-30)

Check the GW501516 (GSK-516, Cardarine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GW501516 selectively binds to and activates peroxisome proliferator-activated receptor beta/delta (PPARβ/δ) with high potency, triggering downstream activation of AMP-activated protein kinase and stimulating fatty acid oxidation and glucose uptake in skeletal muscle cells. This enhancement of cellular metabolic flux improves systemic lipid clearance and energy expenditure, providing a biological rationale for its clinical investigation in dyslipidemia, obesity, and cardiovascular disease.

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>).