BAY 2666605 Clinical Trials

Size	Price	Qty
5mg	USD 457
25mg	USD 1,370

Clinical Trials

The clinical development of BAY 2666605 includes a clinical trial sponsored by Bayer. This open-label Phase 1 study aimed to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose in patients diagnosed with metastatic melanoma and other solid tumors. However, recruitment for this initial evaluation was listed as terminated, leaving early-stage clinical data for the drug limited.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04809805	Terminated	Metastatic Melanoma and Other Solid Tumors	Bayer	2021-04-15	Phase 1

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

Check the BAY 2666605 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAY 2666605 selectively binds to and inhibits phosphodiesterase 3A (PDE3A) and phosphodiesterase 3B (PDE3B), preventing cyclic adenosine monophosphate (cAMP) degradation and disrupting downstream cellular survival pathways. This enzymatic blockade triggers cell death and suppresses cellular proliferation, providing a potential mechanism to inhibit tumor growth in metastatic melanoma and other 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>).