Clinical Trials

The clinical trial landscape for BMS-986235 comprises several Phase 1 studies sponsored by Bristol-Myers Squibb to evaluate safety, pharmacokinetics, and pharmacodynamics in healthy participants and subjects assessed for inflammatory mediators. While a clinical trial successfully completed a double-blind, placebo-controlled ascending-dose evaluation targeting inflammatory mediators, multiple clinical trials examining pharmacokinetic interactions with co-administered agents—such as rifampin, fluconazole, bupropion, or itraconazole—were withdrawn prior to completion.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03335553 COMPLETED
Mediators of Inflammation
Bristol-Myers Squibb
 2017-11-15 PHASE1
NCT04464577 WITHDRAWN
Healthy Participants
Bristol-Myers Squibb
 2021-04-01 PHASE1
NCT04301310 WITHDRAWN
Healthy Participants
Bristol-Myers Squibb
 2020-03-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2022-03-31)

Check the BMS-986235 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-986235 functions as a potent and selective agonist of formyl peptide receptor 2 (FPR2), activating downstream pro-resolving signaling cascades to suppress pro-inflammatory cellular responses. This receptor activation promotes the resolution of tissue inflammation, providing mechanistic relevance for its clinical evaluation in human trials assessing mediators of inflammation.

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>).

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