GSK461364 Clinical Trials

Size	Price	Qty
10mg	USD 380
1g	USD 3,990

Clinical Trials

Multiple clinical trials sponsored by GlaxoSmithKline have evaluated GSK461364 in adult patients. These early-stage phase 1 studies focused on assessing the safety, pharmacokinetic, and pharmacodynamic profiles of the compound in non-Hodgkin lymphoma, exploring polo-like kinase 1 as a therapeutic target in hematological malignancies. Recruitment for these clinical evaluations is complete, providing initial human data regarding safety and tolerability.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00536835	COMPLETED	Lymphoma, Non-Hodgkin	GlaxoSmithKline	2007-08-16	PHASE1
NCT00536835	Completed	Lymphoma Non-Hodgkin	GlaxoSmithKline	2007-08-16	Phase 1

(data from https://clinicaltrials.gov, updated on 2017-06-26)

Check the GSK461364 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK461364 selectively binds to the ATP-binding site of Polo-like kinase 1 (PLK1), blocking its downstream phosphorylation of critical cell cycle regulators required for mitotic spindle assembly. This disruption induces dose-dependent G2/M phase mitotic arrest and triggers cell death, thereby halting cellular proliferation in hematological malignancies such as non-Hodgkin lymphoma.

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>).