BRD4 Inhibitor-10 Clinical Trials

Size	Price	Qty
5mg	USD 217
25mg	USD 657

Clinical Trials

A clinical trial evaluated this bromodomain and extra-terminal protein inhibitor in human subjects. Sponsored by Boehringer Ingelheim, this completed Phase 1 study investigated the compound using an open-label, dose-finding design with daily oral administration in patients presenting with advanced neoplasms, including NUT carcinoma. Overall, the investigation assessed safety, tolerability, and preliminary therapeutic activity to establish dosing parameters in advanced oncology settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02516553	Completed	Neoplasms\|NUT Carcinoma	Boehringer Ingelheim	2015-07-08	Phase 1

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

Check the BRD4 Inhibitor-10 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BRD4 Inhibitor-10 selectively binds to the first bromodomain (BD1) of BRD4 with an IC50 of 8 nM, thereby disrupting acetylated lysine recognition and suppressing downstream oncogenic gene transcription. This transcriptional inhibition impairs cellular proliferation and promotes apoptotic cell death, offering therapeutic relevance for treating advanced neoplasms such as NUT carcinoma.

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>).