LXR-623 (WAY-252623) Clinical Trials

Size	Price	Qty
10mg	USD 147
200mg	USD 997

Clinical Trials

Multiple Phase 1 clinical trials sponsored by Wyeth, a subsidiary of Pfizer, have evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered LXR-623 in healthy volunteers, including healthy Japanese male subjects. These early-phase investigations comprised single ascending dose studies that successfully completed recruitment, as well as a multiple ascending dose trial that was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00385489	COMPLETED	Healthy	Wyeth is now a wholly owned subsidiary of Pfizer	2006-08	PHASE1
NCT00366522	COMPLETED	Healthy	Wyeth is now a wholly owned subsidiary of Pfizer	2006-08	PHASE1
NCT00379860	TERMINATED	Healthy Subjects	Wyeth is now a wholly owned subsidiary of Pfizer	2006-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2009-08-07)

Check the LXR-623 (WAY-252623) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LXR-623 functions as a synthetic liver X-receptor agonist that potently activates both LXR-α and LXR-β to induce the transcription of target genes involved in cellular cholesterol efflux and lipid transport. By stimulating these lipid metabolic pathways, LXR-623 regulates systemic cholesterol homeostasis, establishing the mechanistic basis for its Phase 1 clinical evaluation of safety, pharmacokinetics, and pharmacodynamics in healthy subjects.

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>).