BMS-986365 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 evaluate the safety, pharmacokinetics, and efficacy of BMS-986365. Early Phase 1 studies sponsored by Celgene assessed safety, bioavailability, and drug-drug interactions in healthy volunteers, with several now completed or terminated. Currently, Phase 2 and Phase 3 trials sponsored by Celgene and Memorial Sloan Kettering Cancer Center are recruiting participants to evaluate therapeutic efficacy in localized prostate cancer and metastatic castration-resistant prostate cancer, advancing the compound to comparisons against standard therapies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07335796	RECRUITING	Prostate Cancer	Memorial Sloan Kettering Cancer Center	2026-01-09	PHASE2
NCT06764485	RECRUITING	Metastatic Castration-resistant Prostate Cancer	Celgene	2025-03-13	PHASE3
NCT07242781	TERMINATED	Healthy Volunteers	Celgene	2025-12-15	PHASE1
NCT06417229	COMPLETED	Healthy Participants	Celgene	2024-05-28	PHASE1
NCT06433505	COMPLETED	Healthy Volunteers	Celgene	2024-05-30	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-13)

Check the BMS-986365 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-986365 functions as a selective heterobifunctional ligand-directed degrader and antagonist that directly binds both wild-type and mutant forms of the androgen receptor in the cytoplasm and nucleus, inducing rapid receptor ubiquitination and proteasomal degradation. This degradation disrupts downstream androgen receptor transcriptional signaling, leading to significant inhibition of androgen-dependent cellular proliferation and tumor regression in clinical settings such as metastatic castration-resistant prostate cancer.

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>).