Branebrutinib (BMS-986195) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 247

Clinical Trials

Multiple completed Phase 1 clinical trials sponsored by Bristol-Myers Squibb have evaluated branebrutinib (BMS-986195) in healthy participants and patients with rheumatoid arthritis. These studies investigated the compound's safety, tolerability, pharmacokinetics, and pharmacodynamics across single and multiple ascending dose designs. Additionally, trials assessed drug metabolism using a radiolabeled compound alongside potential drug-drug interactions to establish the preliminary clinical profile of branebrutinib.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04515628	Completed	Healthy Participants	Bristol-Myers Squibb	2020-08-02	Phase 1
NCT03245515	Completed	Rheumatoid Arthritis	Bristol-Myers Squibb	2017-08-15	Phase 1
NCT02705989	Completed	Rheumatoid Arthritis	Bristol-Myers Squibb	2016-08-18	Phase 1

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

Check the Branebrutinib (BMS-986195) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Branebrutinib functions as a potent inhibitor of Bruton's tyrosine kinase (BTK), blocking downstream B-cell receptor signaling cascades to suppress B-cell activation and inflammatory mediator release. This cellular inhibition mitigates immune-mediated tissue inflammation, providing a clear mechanism for its clinical evaluation in autoimmune diseases like rheumatoid arthritis.

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>).