Atuveciclib (BAY-1143572) Clinical Trials

Size	Price	Qty
2mg	USD 170
5mg	USD 297

Clinical Trials

Several Phase 1 clinical trials sponsored by Bayer evaluated Atuveciclib (BAY-1143572) in subjects with advanced oncological indications, including leukemia and general neoplasms. These open-label dose-escalation studies characterized the compound's safety, tolerability, pharmacokinetics, and maximum tolerated dose. All trials have completed recruitment and operations, providing essential human safety and dosage data for its therapeutic development.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02345382	COMPLETED	Leukemia	Bayer	2015-02-19	PHASE1
NCT01938638	COMPLETED	Neoplasms	Bayer	2013-09-26	PHASE1
NCT02345382	Completed	Leukemia	Bayer	2015-02-19	Phase 1
NCT01938638	Completed	Neoplasms	Bayer	2013-09-26	Phase 1

(data from https://clinicaltrials.gov, updated on 2018-06-25)

Check the Atuveciclib (BAY-1143572) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atuveciclib (BAY-1143572) selectively binds and inhibits positive transcription elongation factor b (P-TEFb)/cyclin-dependent kinase 9 (CDK9), suppressing downstream RNA polymerase II-mediated transcription elongation and downregulating anti-apoptotic proteins. This transcriptional blockage induces cell cycle arrest and apoptosis in malignant cells, providing the biological rationale for its clinical evaluation in leukemia and other 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>).