ZSTK474 Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials sponsored by Zenyaku Kogyo Co., Ltd. have evaluated the therapeutic potential of ZSTK474 in patients with various neoplasms. Designed as Phase 1 dose-escalation evaluations to assess safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy, these studies have all completed recruitment. Together, these early-stage trials establish the initial human clinical landscape for ZSTK474 in oncology research.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01682473	COMPLETED	Neoplasms	Zenyaku Kogyo Co., Ltd.	2012-09-20	PHASE1
NCT01280487	COMPLETED	Neoplasms	Zenyaku Kogyo Co., Ltd.	2011-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2017-07-06)

Check the ZSTK474 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ZSTK474 functions as a potent inhibitor of phosphoinositide 3-kinase (PI3K) class I isoforms, binding to the ATP-binding catalytic domain to block downstream phosphorylation of Akt and second-messenger lipid signaling. By interrupting this critical pro-survival cascade, the compound suppresses tumor cell proliferation and induces apoptotic cell death, underlying its clinical evaluation as a therapeutic agent for various 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>).