Clinical Trials

Multiple clinical trials sponsored by Bristol-Myers Squibb have evaluated BMS-911543 as an oncological therapeutic agent across Phase 1 and Phase 2 studies. These investigations assessed the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the small molecule in patients with cancer. However, recruitment across the recorded trials was ultimately terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01236352 TERMINATED
Cancer
Bristol-Myers Squibb
2011-04-07 PHASE1; PHASE2
NCT01236352 Terminated
Cancer
Bristol-Myers Squibb
2011-04-07 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2019-07-31)

Check the BMS-911543 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-911543 functions as a potent and selective inhibitor of Janus kinase 2 (JAK2), binding to the enzyme to block downstream STAT protein phosphorylation and STAT-mediated transcription. This pathway blockade inhibits abnormal cellular proliferation and induces apoptosis in JAK2-dependent malignant cells, demonstrating therapeutic relevance in targeted cancer therapy.

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.