Vicriviroc maleate Clinical Trials

Size	Price	Qty
5mg	USD 579
25mg	USD 1,497

Clinical Trials

A clinical trial evaluated the safety and efficacy of vicriviroc maleate in combination with the immune checkpoint inhibitor pembrolizumab for advanced colorectal neoplasms. Sponsored by Merck Sharp & Dohme LLC, this completed Phase 2 study represents a targeted evaluation of the compound's therapeutic utility. Overall, the clinical landscape for vicriviroc maleate centers on an industry-sponsored combinatorial regimen for advanced colorectal malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03631407	Completed	Colorectal Neoplasms	Merck Sharp & Dohme LLC	2018-09-24	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vicriviroc maleate functions as a potent, selective antagonist of C-C chemokine receptor 5 (CCR5), binding the receptor to block ligand activation and inhibit downstream chemokine-mediated signaling cascades that regulate cell migration and recruitment. By suppressing these CCR5-dependent microenvironmental pathways to restrict cellular infiltration, vicriviroc maleate provides therapeutic relevance for inhibiting disease progression in clinical settings such as advanced colorectal neoplasms.

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>).