BAY 87-2243 Clinical Trials

Size	Price	Qty
10mg	USD 177
50mg	USD 747

Clinical Trials

Several Phase I clinical trials sponsored by Bayer evaluated BAY 87-2243 in patients with advanced neoplasms to assess its safety, tolerability, pharmacokinetics, and maximum tolerated dose. However, recruitment across these early-stage studies was designated as terminated, resulting in the discontinuation of Phase I clinical investigations for neoplastic diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01297530	TERMINATED	Neoplasms	Bayer	2011-04	PHASE1
NCT01297530	Terminated	Neoplasms	Bayer	2011-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2013-07-30)

Check the BAY 87-2243 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAY 87-2243 functions as a selective inhibitor of hypoxia-inducible factor-1 (HIF-1) by suppressing mitochondrial complex I activity, which subsequently triggers a mitophagy-dependent elevation of reactive oxygen species to induce cell death via necroptosis and ferroptosis. By inhibiting HIF-1 accumulation and promoting ROS-mediated cytotoxic pathways under hypoxic cellular conditions, this compound exhibits potent antitumor activity relevant to the therapeutic targeting of 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>).