Regadenoson Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Several clinical trials evaluate regadenoson across diagnostic and therapeutic applications, primarily focusing on coronary artery disease, myocardial ischemia, myocardial blood flow reserve, and computed tomography-based myocardial perfusion imaging. Spanning Phase 1/Phase 2, Phase 4, and studies without a specified phase, these investigations range from active recruitment to completed status. Funding and support are provided by diverse sponsors, including GE Healthcare, Covance, academic and national institutions in Poland, and independent research entities.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04604782	Recruiting	Myocardial Ischemia\|Coronary Artery Disease	GE Healthcare\|Covance	2021-05-20	Phase 1\|Phase 2
NCT03917199	Completed	Myocardial Perfusion Imaging\|Computed Tomography\|Coronary Artery Disease	National Institute of Cardiology Warsaw Poland\|National Science Centre Poland	2016-11	--
NCT01919450	Completed	Myocardial Blood Flow Reserve	Timothy M. Bateman MD\|Cardiovascular Imaging Technologies	2013-07	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Regadenoson selectively binds to and activates the A2A adenosine receptor, triggering adenylate cyclase activation and increasing intracellular cyclic AMP levels within vascular smooth muscle cells. This signaling cascade induces hyperpolarization and relaxation of coronary vascular smooth muscle, resulting in rapid coronary vasodilation and increased myocardial blood flow necessary for assessing myocardial blood flow reserve and detecting coronary artery disease during myocardial perfusion imaging.

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>).