BAY 1436032 Clinical Trials

Size	Price	Qty
2mg	USD 97
5mg	USD 167

Clinical Trials

Bayer has sponsored multiple clinical trials to determine the maximum tolerated dose and recommended Phase II dosage of the oral compound BAY 1436032. These early-stage, open-label multicenter evaluations focus on acute myeloid leukemia, which is completed, and advanced solid tumors, currently listed as active, not recruiting. Overall, these Phase I trials aim to establish the preliminary safety and dosing profile of the inhibitor across both hematologic malignancies and solid tumor indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03127735	Completed	Leukemia Myeloid Acute	Bayer	2017-06-14	Phase 1
NCT02746081	Active not recruiting	Solid Tumors	Bayer	2016-05-26	Phase 1

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

Check the BAY 1436032 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAY 1436032 selectively binds to and inhibits various mutant forms of isocitrate dehydrogenase 1, thereby blocking the abnormal enzymatic conversion of alpha-ketoglutarate to the oncometabolite 2-hydroxyglutarate and suppressing its cellular accumulation. By lowering intracellular 2-hydroxyglutarate levels and inducing cell differentiation, BAY 1436032 exhibits targeted antitumor efficacy relevant to the clinical management of IDH1-mutated acute myeloid leukemia and solid tumors.

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>).