GSK-923295 Clinical Trials

Size	Price	Qty
5mg	USD 187
50mg	USD 970

Clinical Trials

Multiple clinical trials sponsored by GlaxoSmithKline have evaluated GSK-923295 for therapeutic applications in oncology. These early-stage, Phase 1 dose-escalation studies assessed the safety profile, pharmacokinetics, and pharmacodynamics of the agent in patients with cancer. Recruitment for these trials is listed as completed, with clinical development focusing primarily on initial human safety and pharmacological assessment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00504790	COMPLETED	Cancer	GlaxoSmithKline	2007-06-25	PHASE1
NCT00504790	Completed	Cancer	GlaxoSmithKline	2007-06-25	Phase 1

(data from https://clinicaltrials.gov, updated on 2018-07-12)

Check the GSK-923295 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK-923295 selectively binds to an allosteric site on the CENP-E kinesin motor ATPase with high affinity, thereby inhibiting its enzymatic motor activity and disrupting mitotic spindle dynamics during cell division. This targeted inhibition leads to chromosome missegregation, mitotic arrest, and post-mitotic apoptosis, thereby suppressing tumor cell proliferation in the context of cancer clinical studies.

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>).