BMS-986158 Clinical Trials

Size	Price	Qty
5mg	USD 367
25mg	USD 970

Clinical Trials

BMS-986158 has been evaluated across several Phase 1 and Phase 1/2 clinical trials targeting advanced solid tumors, myelofibrosis, multiple myeloma, and pediatric malignancies, including brain tumors, lymphomas, and solid tumors. Sponsored by pharmaceutical entities such as Bristol-Myers Squibb as well as academic organizations including the Dana-Farber Cancer Institute and Stand Up To Cancer, these studies encompass various recruitment statuses, including actively recruiting, active not recruiting, and completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04817007	ACTIVE_NOT_RECRUITING	Myelofibrosis	Bristol-Myers Squibb	2021-03-22	PHASE1; PHASE2
NCT05372354	RECRUITING	Multiple Myeloma	Bristol-Myers Squibb	2022-10-18	PHASE1; PHASE2
NCT03936465	COMPLETED	Solid Tumor, Childhood; Lymphoma; Brain Tumor, Pediatric	Dana-Farber Cancer Institute	2019-09-27	PHASE1
NCT02419417	COMPLETED	Advanced Tumors	Bristol-Myers Squibb	2015-06-19	PHASE1; PHASE2
NCT03936465	Active not recruiting	Solid Tumor Childhood\|Lymphoma\|Brain Tumor Pediatric	Dana-Farber Cancer Institute\|Stand Up To Cancer	2019-09-27	Phase 1
NCT02419417	Completed	Advanced Tumors	Bristol-Myers Squibb	2015-06-19	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-05-08)

Check the BMS-986158 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-986158 selectively binds to bromodomain and extra-terminal domain (BET) proteins, disrupting their interaction with acetylated lysine residues on histones and suppressing the transcription of key oncogenic driver genes. This transcriptional downregulation inhibits cell proliferation and induces apoptosis in malignant cells, providing therapeutic rationale for its clinical investigation in hematologic malignancies such as myelofibrosis and multiple myeloma as well as advanced solid tumors.

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>).