Regadenoson

Overview

Regadenoson is an A2A adenosine receptor agonist that causes coronary vasodilation and used for myocardial perfusion imagining. Manufactured by Astellas and FDA approved April 10, 2008.

Background

Regadenoson is an A2A adenosine receptor agonist that causes coronary vasodilation and used for myocardial perfusion imagining. Manufactured by Astellas and FDA approved April 10, 2008.

Indication

Diagnostic agent for radionuclide myocardial perfusion imaging (MPI)

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET	2022/10/18	NCT05583721	Phase 2	Recruiting	St. Jude Children's Research Hospital
Treat COVID-19 Patients With Regadenoson	2020/10/28	NCT04606069	Phase 1	Completed	University of Maryland, Baltimore
A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients	2020/10/27	NCT04604782	Phase 1	Recruiting	GE Healthcare
New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)	2020/10/23	NCT04600115	Early Phase 1	UNKNOWN	University of Utah
Regadenoson Infusion of Marginalized Donor Lungs in an EVLP System	2020/08/20	NCT04521569	Early Phase 1	Completed	University of Maryland, Baltimore
The MATCH Investigation: CT Myocardial Perfusion and CT-FFR vs PET MPI	2020/03/20	NCT04316676	Not Applicable	Completed	Emory University
Determining Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas	2019/06/03	NCT03971734	Phase 1	Terminated	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Stress Test in Detecting Heart Damage in Premenopausal Women With Stage I-III Breast Cancer	2018/04/23	NCT03505736	N/A	Completed	Wake Forest University Health Sciences
Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve	2017/08/15	NCT03249272	Phase 4	Terminated	Duke University
A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI	2017/08/01	NCT03236311	Phase 2	Terminated	Sanofi

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
LEXISCAN(R) (REGADENOSON)	HF Acquisition Co LLC, DBA HealthFirst	51662-1448	INTRAVENOUS	0.08 mg in 1 mL	1/28/2024
Regadenoson	Gland Pharma Limited	68083-175	INTRAVENOUS	0.08 mg in 1 mL	7/15/2022
Regadenoson	Dr. Reddy's Laboratories Inc.	43598-616	INTRAVENOUS	0.08 mg in 1 mL	3/25/2019
Regadenoson	International Medication Systems, Limited	76329-3321	INTRAVENOUS	0.08 mg in 1 mL	4/20/2023
Regadenoson	Apotex Corp.	60505-6116	INTRAVENOUS	0.08 mg in 1 mL	3/14/2023
Regadenoson	Almaject, Inc.	72611-874	INTRAVENOUS	0.08 mg in 1 mL	7/15/2022
Regadenoson	Mylan Institutional LLC	67457-994	INTRAVENOUS	0.4 mg in 5 mL	8/9/2021
Regadenoson	Meitheal Pharmaceuticals Inc.	71288-201	INTRAVENOUS	0.08 mg in 1 mL	4/15/2022
regadenoson	Eugia US LLC	55150-443	INTRAVENOUS	0.08 mg in 1 mL	6/8/2023
Regadenoson	Hospira, Inc.	0409-1401	INTRAVENOUS	0.08 mg in 1 mL	3/2/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Rapiscan	GE Healthcare AS,GE Healthcare AS,Nycoveien 1,NO-0485 Oslo,Norway	Authorised	9/6/2010
Rapiscan	GE Healthcare AS,GE Healthcare AS,Nycoveien 1,NO-0485 Oslo,Norway	Authorised	9/6/2010

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
BIPHOZYL SOLUTION FOR HAEMODIALYSIS / HAEMOFILTRATION	Bieffe Medital S.p.A	SIN15514P	SOLUTION, STERILE	0.187 g/L	7/20/2018
PHOXILIUM 1.2 MMOL/L PHOSPHATE SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION	Bieffe Medital S.p.A.	SIN15730P	SOLUTION, STERILE	0.225 g/L	6/27/2019

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Regadenoson Injection	南京健友生化制药股份有限公司	国药准字H20244139	化学药品	注射剂	6/25/2024
Regadenoson Injection	南京瑞克卫生物医药有限公司	国药准字H20213800	化学药品	注射剂	10/26/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
RAPISCAN SOLUTION FOR INJECTION 400MCG/5ML	N/A	GE MEDICAL SYSTEMS HONG KONG LIMITED	N/A	N/A	2/27/2020

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Indies Pharma Secures FDA Approval for Generic Regadenoson, Targeting $400M Market

10 months ago

Indies Pharma Jamaica has received FDA approval for its generic drug, Regadenoson, marking a historic milestone as the first Jamaican company to achieve this feat.

Astellas Faces Setback as US Court Invalidates Key Myrbetriq Patent

2 years ago

• A Delaware district court has invalidated Astellas' key patent for Myrbetriq (mirabegron), their blockbuster overactive bladder medication that generated $1.35 billion in revenue last fiscal year. • Multiple generic versions of mirabegron have received approval, including from Zydus Cadila and Lupin Labs, though immediate launches are unlikely due to Astellas' planned appeal. • The patent invalidation adds to Astellas' upcoming revenue challenges, including recent Lexiscan generic competition and the anticipated 2027 US patent expiration of their top-selling drug Xtandi.

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