BI-847325 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 447

Clinical Trials

A completed Phase 1 clinical trial sponsored by Boehringer Ingelheim evaluated BI-847325 in patients with advanced solid neoplasms. This open-label study evaluated the safety, tolerability, and pharmacokinetic profiles of the orally administered compound across two daily dosing schedules. Ultimately, the trial provides foundational clinical data on the dual inhibition strategy of BI-847325 in advanced oncology settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01324830	COMPLETED	Neoplasms	Boehringer Ingelheim	2011-04-15	PHASE1

(data from https://clinicaltrials.gov, updated on 2018-12-21)

Check the BI-847325 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BI-847325 functions as a selective dual inhibitor of mitogen-activated protein kinase kinase (MEK1/2) and Aurora kinases (Aurora A, B, and C), effectively disrupting downstream MAPK signaling pathways while impairing centrosome maturation and mitotic spindle assembly. By simultaneously suppressing MEK-driven cellular proliferation and Aurora kinase-mediated mitotic progression, BI-847325 induces cell cycle arrest and apoptosis to inhibit tumor growth in advanced solid neoplasms.

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>).