PLX5622 Clinical Trials

Size	Price	Qty
2mg	USD 127
5mg	USD 197

Clinical Trials

Sponsored by Plexxikon, several clinical trials have evaluated the early-stage development of PLX5622. These Phase 1 and Phase 1b studies assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and drug-drug interactions of the investigational compound in healthy volunteers and patients with rheumatoid arthritis. All of these trials have been successfully completed, reflecting the early clinical development history for this agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01329991	COMPLETED	Rheumatoid Arthritis	Plexxikon	2011-05	PHASE1
NCT01329991	Completed	Rheumatoid Arthritis	Plexxikon	2011-05	Phase 1
NCT01282684	COMPLETED	Healthy	Plexxikon	2011-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2012-04-12)

Check the PLX5622 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PLX5622 selectively binds to and inhibits colony-stimulating factor 1 receptor (CSF-1R) kinase activity, blocking receptor autophosphorylation and downstream pro-inflammatory signaling pathways necessary for the survival, proliferation, and differentiation of microglia and macrophages. By suppressing CSF-1R-mediated myeloid cell activity and depleting pathological tissue-resident macrophages, this targeted inhibition aims to attenuate chronic inflammatory responses in clinical settings such as rheumatoid arthritis.

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>).