Clinical Trials

Bristol-Myers Squibb has sponsored multiple clinical trials evaluating BMS-813160 across Phase 1 and Phase 2 stages for distinct therapeutic applications. A completed Phase 1 trial evaluated the safety, pharmacokinetics, and pharmacodynamics of ascending single doses in healthy subjects related to accelerated intimal hyperplasia. Additionally, a Phase 2a trial assessing the compound's therapeutic effects in patients with diabetic kidney disease was terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01752985 Terminated
Diabetic Kidney Disease
Bristol-Myers Squibb
 2013-03-18 Phase 2
NCT01049165 Completed
Accelerated Intimal Hyperplasia
Bristol-Myers Squibb
 2010-02 Phase 1

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

Check the BMS-813160 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-813160 acts as a potent dual antagonist of C-C chemokine receptors 2 and 5 (CCR2 and CCR5), blocking chemokine-mediated signal transduction pathways and inhibiting inflammatory signaling, tumor cell migration, proliferation, and invasion. By suppressing CCR2/CCR5-driven inflammatory cell recruitment and vascular remodeling, this targeted inhibition provides therapeutic potential in inflammatory and vascular disorders such as diabetic kidney disease and accelerated intimal hyperplasia.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.