Clinical Trials

Multiple clinical trials sponsored by Bristol-Myers Squibb have evaluated BMS-582949 across completed Phase I and Phase II studies. These investigations focused on inflammatory and autoimmune conditions—specifically rheumatoid arthritis and psoriasis—as well as vascular diseases. Early-phase research assessed multiple ascending doses in rheumatoid arthritis patients receiving background methotrexate therapy, while subsequent Phase II trials evaluated the compound's therapeutic efficacy, safety, and pharmacokinetics.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00570752 COMPLETED
Vascular Diseases
Bristol-Myers Squibb
2008-12 PHASE2
NCT00605735 COMPLETED
Rheumatoid Arthritis, NOS
Bristol-Myers Squibb
2008-03 PHASE2
NCT00399906 COMPLETED
Psoriasis
Bristol-Myers Squibb
2007-08 PHASE2
NCT00162292 COMPLETED
Rheumatoid Arthritis
Bristol-Myers Squibb
2005-11 PHASE1
NCT00162292 Completed
Rheumatoid Arthritis
Bristol-Myers Squibb
2005-11 Phase 1

(data from https://clinicaltrials.gov, updated on 2015-12-07)

Check the BMS-582949 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-582949 is a potent inhibitor of p38 mitogen-activated protein kinase (p38 MAPK) with an IC50 of 13 nM, directly binding the enzyme to suppress both p38 kinase activity and its activation, thereby blocking downstream pro-inflammatory cytokine production and cellular signaling cascades. By attenuating p38 MAPK-driven inflammatory signaling, this inhibition reduces local and systemic inflammatory cell recruitment and tissue damage, providing a therapeutic rationale for its clinical investigation in rheumatoid arthritis, psoriasis, and vascular diseases.

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>).

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