Navarixin (SCH-527123) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Merck Sharp & Dohme LLC have evaluated the therapeutic profile of Navarixin (SCH-527123). These studies targeted CXCR1/CXCR2 inhibition across inflammatory and respiratory conditions—including chronic obstructive pulmonary disease, neutrophilic asthma, asthma, and psoriasis—as well as advanced solid malignancies such as non-small cell lung cancer, castration-resistant prostate cancer, and microsatellite stable colorectal cancer. Recruitment outcomes varied, with completed trials examining safety and efficacy alongside several studies that were terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03473925	COMPLETED	Solid Tumors; Non-small Cell Lung Cancer; Castration Resistant Prostate Cancer; Microsatellite Stable Colorectal Cancer	Merck Sharp & Dohme LLC	2018-04-10	PHASE2
NCT01006161	WITHDRAWN	Asthma	Merck Sharp & Dohme LLC	2010-01	PHASE2
NCT01006616	TERMINATED	COPD	Merck Sharp & Dohme LLC	2009-10-01	PHASE2
NCT01068145	TERMINATED	Chronic Obstructive Pulmonary Disease	Merck Sharp & Dohme LLC	2010-02	PHASE1
NCT01068145	Terminated	Chronic Obstructive Pulmonary Disease	Merck Sharp & Dohme LLC	2010-02	Phase 1
NCT00688467	COMPLETED	Asthma	Merck Sharp & Dohme LLC	2008-06-01	PHASE2
NCT00632502	COMPLETED	Neutrophilic Asthma	Merck Sharp & Dohme LLC	2008-05-01	PHASE2
NCT00441701	TERMINATED	Chronic Obstructive Pulmonary Disease	Merck Sharp & Dohme LLC	2006-12-01	PHASE2
NCT00684593	COMPLETED	Psoriasis	Merck Sharp & Dohme LLC	2007-06-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2024-08-28)

Check the Navarixin (SCH-527123) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Navarixin (SCH-527123) is a potent, orally bioavailable antagonist that selectively binds to chemokine receptors CXCR2 and CXCR1 with IC50 values of 2.6 nM and 36 nM, respectively, thereby blocking ligand-induced receptor activation and downstream signaling cascades required for neutrophil chemotaxis. By suppressing neutrophil recruitment and modulating pro-inflammatory cascades within tissues and the microenvironment, this targeted blockade addresses the inflammatory and oncologic pathologies studied in clinical trials, including chronic obstructive pulmonary disease, asthma, psoriasis, and solid tumors.

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>).