AGI 1067 Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

A clinical trial sponsored by AtheroGenics is evaluating AGI 1067 as an antidiabetic intervention for patients diagnosed with diabetes. This Phase 2/3 investigation assesses the efficacy and safety of the compound in disease management, though its current recruitment status is listed as unknown. Overall, these parameters highlight the clinical evaluation of AGI 1067 within late-stage trials for metabolic pathologies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00525577	Unknown status	Diabetes	AtheroGenics	2007-08	Phase 2\|Phase 3

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

Check the AGI 1067 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an intra- and extracellular phenolic antioxidant, AGI 1067 inhibits the expression of proinflammatory genes to attenuate oxidative stress and suppress inflammatory signaling cascades. By reducing cellular vascular inflammation and oxidative damage, this mechanism supports the clinical evaluation of AGI 1067 for addressing inflammatory and metabolic pathologies in diabetes.

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>).