GDC-0623 Clinical Trials

Size	Price	Qty
5mg	USD 177
25mg	USD 497

Clinical Trials

Multiple clinical trials sponsored by Genentech, Inc. focus on the therapeutic potential of GDC-0623 in patients with solid malignancies. These Phase 1 investigations, including a completed study evaluating safety, tolerability, and pharmacokinetics, represent an initial stage of evaluation for this targeted small molecule. Overall, the research aims to establish key safety parameters and preliminary therapeutic activity in solid cancer populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01106599	COMPLETED	Solid Cancers	Genentech, Inc.	2010-04	PHASE1
NCT01106599	Completed	Solid Cancers	Genentech Inc.	2010-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2016-11-02)

Check the GDC-0623 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GDC-0623 functions as a potent, ATP-uncompetitive inhibitor that binds MEK1 with a Ki of 0.13 nM, effectively blocking MEK-mediated phosphorylation and activation of downstream ERK signaling. By disrupting this central MAPK pathway node, the compound inhibits cellular proliferation and promotes apoptosis in tumor cells, establishing its therapeutic rationale for treating advanced solid cancers.

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>).