INCB054329 Clinical Trials

Size	Price	Qty
5mg	USD 257
25mg	USD 807

Clinical Trials

Several clinical trials sponsored by Incyte Corporation evaluated the therapeutic potential, safety, tolerability, and pharmacokinetics of INCB054329 in advanced solid tumors and hematologic malignancies. These early-phase evaluations included Phase I and Phase II dose-escalation studies as well as an expanded access program for metastatic renal cell carcinoma. Currently, active recruitment has ceased, and all protocols are listed as terminated or no longer available.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02431260	TERMINATED	Solid Tumors and Hematologic Malignancy	Incyte Corporation	2015-04-14	PHASE1; PHASE2
NCT02431260	Terminated	Solid Tumors and Hematologic Malignancy	Incyte Corporation	2015-04-14	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2019-06-14)

Check the INCB054329 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

INCB054329 is a selective bromodomain and extraterminal domain inhibitor that binds to the tandem bromodomains of BRD2, BRD3, BRD4, and BRDT, thereby preventing their interaction with acetylated chromatin and disrupting downstream transcriptional elongation complexes. This inhibition represses the expression of key oncogenic drivers such as MYC, suppressing cell proliferation and promoting apoptosis to exert antineoplastic activity in solid tumors and hematologic malignancies.

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>).