Enitociclib (BAY 1251152) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 227

Clinical Trials

Multiple Phase I clinical trials sponsored by industry partners Bayer and Vincerx Pharma, Inc. have evaluated Enitociclib (BAY 1251152) across diverse oncological indications, including hematologic and broader neoplasms. These studies, all of which have completed recruitment, assessed the compound's safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Overall, they established the initial clinical characterization of Enitociclib.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02635672	COMPLETED	Neoplasms	Vincerx Pharma, Inc.	2016-02-10	PHASE1
NCT02745743	COMPLETED	Hematologic Neoplasms	Bayer	2016-06-17	PHASE1
NCT02745743	Completed	Hematologic Neoplasms	Bayer	2016-06-17	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-11-15)

Check the Enitociclib (BAY 1251152) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enitociclib (BAY 1251152) selectively binds to CDK9 within the positive transcription elongation factor b complex, suppressing RNA polymerase II phosphorylation and halting the transcription of critical anti-apoptotic genes. This transcriptional inhibition promotes apoptotic cell death in oncogenic cells, directly supporting its therapeutic evaluation in Phase 1 trials for patients with hematologic and advanced 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>).