Bindarit (AF 2838) Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Multiple completed Phase II clinical trials have evaluated Bindarit for cardiovascular and renal indications, primarily sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. in collaboration with the Mario Negri Institute for Pharmacological Research. These studies assessed the safety and efficacy of targeting inflammatory pathways to prevent coronary restenosis following stent implantation and to treat albuminuria in patients with diabetic nephropathy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01269242	COMPLETED	Coronary Restenosis	Aziende Chimiche Riunite Angelini Francesco S.p.A	2009-01	PHASE2
NCT01269242	Completed	Coronary Restenosis	Aziende Chimiche Riunite Angelini Francesco S.p.A	2009-01	Phase 2
NCT01109212	COMPLETED	Diabetic Nephropathy	Aziende Chimiche Riunite Angelini Francesco S.p.A	2007-03	PHASE2
NCT01109212	Completed	Diabetic Nephropathy	Aziende Chimiche Riunite Angelini Francesco S.p.A\|Mario Negri Institute for Pharmacological Research	2007-03	Phase 2

(data from https://clinicaltrials.gov, updated on 2016-08-05)

Check the Bindarit (AF 2838) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bindarit acts as a selective inhibitor of monocyte chemotactic proteins MCP-1/CCL2, MCP-3/CCL7, and MCP-2/CCL8, suppressing downstream inflammatory signaling cascades and monocyte recruitment. By mitigating localized monocyte infiltration and tissue inflammation, this mechanism targets inflammatory drivers underlying vascular remodeling and renal damage in clinical conditions such as coronary restenosis and diabetic nephropathy.

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>).