AICAR (Acadesine) Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 270

Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 2, and Phase 3 settings have evaluated AICAR (Acadesine) across diverse indications, including Lesch-Nyhan syndrome, type 2 diabetes mellitus, B-cell chronic lymphocytic leukemia, myelodysplastic syndromes, and adverse cardiovascular events during coronary artery bypass surgery. Conducted by academic institutions, clinical networks, and pharmaceutical companies, these trials are currently documented as either completed or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01813838	TERMINATED	SMD	Groupe Francophone des Myelodysplasies	2013-06	PHASE1; PHASE2
NCT00559624	COMPLETED	Leukemia, B-Cell, Chronic	Advancell - Advanced In Vitro Cell Technologies, S.A.	2007-12	PHASE1; PHASE2
NCT00872001	TERMINATED	Coronary Artery Bypass; Myocardial Infarction; Ventricular Dysfunction, Left; Stroke; Cardiopulmonary Bypass	Merck Sharp & Dohme LLC	2009-04	PHASE3
NCT00004314	COMPLETED	Lesch-Nyhan Syndrome	National Center for Research Resources (NCRR)	1996-02	PHASE2
NCT00168519	COMPLETED	Diabetes Mellitus, Type 2	Baker Heart Research Institute	2002-10

(data from https://clinicaltrials.gov, updated on 2016-11-08)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acadesine is intracellularly converted to ZMP, an AMP analog that directly binds to and activates AMP-activated protein kinase (AMPK), stimulating downstream energy-sensing signaling pathways to promote glucose uptake, mitophagy, and apoptosis. This modulation of AMPK signaling underpins the compound's clinical evaluation for managing type 2 diabetes, mitigating ischemic injury during coronary artery bypass surgery, and targeting leukemic cells in B-cell chronic lymphocytic leukemia.

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>).