BAY1125976 Clinical Trials

Size	Price	Qty
5mg	USD 247
25mg	USD 497

Clinical Trials

Sponsored by Bayer, several clinical trials have evaluated BAY1125976 for the treatment of various neoplasms. These Phase 1 studies focused on determining the drug's safety, tolerability, pharmacokinetics, and maximum tolerated dose in patient cohorts. All recorded trials evaluating this agent in patients with neoplastic conditions have completed recruitment, establishing preliminary safety and pharmacokinetic profiles for the drug.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01915576	COMPLETED	Neoplasms	Bayer	2013-09	PHASE1
NCT01915576	Completed	Neoplasms	Bayer	2013-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2016-12-28)

Check the BAY1125976 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAY1125976 functions as a potent allosteric inhibitor that selectively binds AKT1 and AKT2, thereby blocking downstream AKT phosphorylation and PI3K pathway signal transduction. This inhibition suppresses oncogenic cell proliferation and survival, ultimately impairing tumor growth in AKT-dependent 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>).