GSK626616 Clinical Trials

Size	Price	Qty
5mg	USD 177
25mg	USD 529

Clinical Trials

A clinical trial evaluated the safety, tolerability, and pharmacokinetic profile of GSK626616 administered as single and repeat escalating doses. Sponsored by GlaxoSmithKline, this completed Phase 1 study involved healthy human subjects and patients with anaemia. Overall, the available trial data reflect early-stage clinical development aimed at characterizing the compound for potential therapeutic use in managing anaemic conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00443170	COMPLETED	Healthy Subjects; Anaemia	GlaxoSmithKline	2006-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2012-03-19)

Check the GSK626616 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK626616 functions as a potent inhibitor of dual-specificity tyrosine-regulated kinase 3 (DYRK3), binding to the catalytic kinase domain to block downstream phosphorylation cascades that regulate erythroid progenitor maturation. By promoting erythroblast cell survival and differentiation, this targeted enzymatic inhibition provides the mechanistic basis for its therapeutic potential in treating anaemia.

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>).