ATN-161 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Multiple clinical trials sponsored by organizations including Attenuon and the National Institutes of Health Clinical Center have evaluated ATN-161 in oncology, focusing on central nervous system tumors and renal cell carcinoma. These Phase 1 and Phase 2 protocols include a completed Phase 1/2 study assessing ATN-161 combined with carboplatin for recurrent intracranial malignant glioma. In contrast, a Phase 2 dose-ranging trial examining the agent in advanced renal cell cancer was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00352313	COMPLETED	Brain and Central Nervous System Tumors	National Institutes of Health Clinical Center (CC)	2006-05	PHASE1; PHASE2
NCT00131651	TERMINATED	Carcinoma, Renal Cell	Attenuon	2005-08	PHASE2

(data from https://clinicaltrials.gov, updated on 2012-05-02)

Check the ATN-161 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ATN-161 is a small peptide antagonist that selectively binds to integrin heterodimers, including α5β1 and αvβ3, thereby blocking integrin-mediated downstream signaling cascades essential for cellular adhesion and migration. By suppressing these pro-angiogenic signals, the compound inhibits endothelial cell proliferation and tumor neovascularization, demonstrating clinical therapeutic potential against vascularized malignancies such as malignant glioma and renal cell carcinoma.

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>).