GSK126 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 477

Clinical Trials

GlaxoSmithKline sponsored a clinical trial to evaluate the safety profile, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of GSK126 in patients with advanced cancer and neoplasms. This Phase 1, open-label, dose-escalation study was designed to characterize the compound in human subjects but ultimately reached a terminated recruitment status. Consequently, clinical evaluation of this investigational agent within the broader oncology setting remains limited.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02082977	Terminated	Cancer\|Neoplasms	GlaxoSmithKline	2014-04-24	Phase 1

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

Check the GSK126 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK126 acts as a potent and highly selective inhibitor of EZH2 methyltransferase with an IC50 of 9.9 nM, binding the enzyme to block trimethylation of histone H3 lysine 27. This targeted epigenetic inhibition restores normal gene expression programs and suppresses cell proliferation, providing the mechanistic basis for its evaluation in cancer and neoplasms.

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>).