K-604 dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 470

Clinical Trials

The clinical landscape for K-604 dihydrochloride includes a clinical trial sponsored by Kowa Research Institute, Inc. This completed Phase II study evaluated the safety and efficacy of the compound for vascular disease management in patients with atherosclerosis. Currently, no additional clinical trials or indications are registered for this agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00851500	COMPLETED	Atherosclerosis	Kowa Research Institute, Inc.	2009-02	PHASE2

(data from https://clinicaltrials.gov, updated on 2011-08-17)

Check the K-604 dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

K-604 dihydrochloride acts as a potent and selective inhibitor of acyl-coenzyme A:cholesterol O-acyltransferase 1 (ACAT1), preventing the intracellular esterification of free cholesterol. By blocking cholesteryl ester formation, K-604 reduces lipid accumulation within vascular macrophages and inhibits foam cell development, ultimately suppressing plaque progression in clinical conditions such as atherosclerosis.

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>).