Clinical Trials

Sponsored by Bayer, several clinical trials evaluated Empesertib (BAY1161909) in patients with advanced cancers within the field of medical oncology. These open-label, dose-escalation Phase 1 studies focused on oral administration to assess safety, tolerability, pharmacokinetics, and the maximum tolerated dose. However, recruitment was ultimately terminated by the sponsor, leaving early-stage data for this compound restricted to these terminated Phase 1 investigations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02138812 TERMINATED
Medical Oncology
Bayer
 2014-05-09 PHASE1
NCT02138812 Terminated
Medical Oncology
Bayer
 2014-05-09 Phase 1

(data from https://clinicaltrials.gov, updated on 2018-10-12)

Check the Empesertib (BAY1161909) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Empesertib acts as a selective inhibitor of serine/threonine monopolar spindle 1 (Mps1) kinase, binding the enzyme with high affinity to disrupt the spindle assembly checkpoint during cell division. This loss of checkpoint control causes premature mitotic exit and catastrophic chromosome missegregation, leading to apoptosis of rapidly dividing cancer cells relevant to medical oncology trials.

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>).

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Note: Technical data last updated: Sep 1, 2026.