SGX-523 Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 450

Clinical Trials

Several Phase 1 clinical trials sponsored by SGX Pharmaceuticals, Inc. evaluated the safety, pharmacokinetics, and pharmacodynamics of the orally administered small molecule SGX-523 in patients with advanced cancer. However, these early-stage oncology studies were officially terminated prior to full completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00606879	TERMINATED	Advanced Cancer	SGX Pharmaceuticals, Inc.	2008-01	PHASE1
NCT00607399	TERMINATED	Advanced Cancer	SGX Pharmaceuticals, Inc.	2008-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2008-07-24)

Check the SGX-523 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SGX-523 is a selective, ATP-competitive inhibitor of MET receptor tyrosine kinase that stabilizes the kinase in an inactive conformation, thereby blocking downstream MET-mediated autophosphorylation and signaling cascades. This molecular inhibition suppresses cancer cell proliferation and migration, providing a therapeutic rationale for targeting MET-driven tumor growth in clinical studies of advanced cancer.

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>).