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Lexiscan

(Regadenoson)

ApprovedSmall molecule

Regadenoson is used during stress testing of the heart in patients who cannot exercise on a treadmill; it simulates the effects of exercise on the heart to help doctors see if blood flow to the heart muscle is adequate.[2] Lexiscan is currently approved and in use across 11 indications[4].[1]

Lexiscan is one of 253 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

11

Indications

51

Total Trials

3

Active Trials

252

Competitors

13

FDA Applications

NDA/BLA/ANDA regulatory filings

2

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Chest PainActive, not recruiting

Pulmonary HypertensionActive, not recruiting

Chronic Obstructive Pulmonary DiseaseCompleted

FibrosisActive, not recruiting

Breast CancerActive, not recruiting

Hypertrophic CardiomyopathyTerminated

MRI ScanRecruiting

Heart TransplantRecruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Chest PainPreclinical

Active, not recruiting

Pulmonary HypertensionPreclinical

Active, not recruiting

Chronic Obstructive Pulmonary DiseaseApproved

Completed

FibrosisApproved

Active, not recruiting

Breast CancerPreclinical

Active, not recruiting

Hypertrophic CardiomyopathyApproved

Terminated

MRI ScanPhase 1

Recruiting

Heart TransplantApproved

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lexiscan

Voltaren

Methylthioninium Chloride

PProvepharm SAS

MS Contin

HHikma Pharmaceuticals LLC

Duragesic-100

MS Contin

HHikma Pharmaceuticals LLC

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Duragesic

Sporanox

SSebela Pharmaceuticals Development LLC

Tricor

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Pediatric Patients

NCT04604782

Q1 2027

Phase 1Recruiting

MRI Scan

NCT04600115

Clinical

Trials by Indication[1]

Imaging5 trials

A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging (MPI) Using Multidetector Computed Tomography (MDCT) Compared to Single Photon Emission Computed Tomography (SPECT)

Completed· Astellas logo

Astellas·Phase 2·NCT01334918·124 enrolled

Regadenoson R-T Perfusion Imaging Trial

Completed·UUniversity of Nebraska·Phase 1·NCT00837369·100 enrolled

ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

Completed· Gilead logo

Gilead·Phase 3·NCT00208312·787 enrolled

Show 2 more trials

ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

Completed· Gilead logo

Gilead·Phase 3·NCT00208299·1,231 enrolled

Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging

Withdrawn·UUniversity of Utah·N/A·NCT02608944

CAR4 trials

Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies

Completed·—·N/A·NCT01949844·44 enrolled

Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson

Completed·WWashington University School of Medicine·Phase 4·NCT01779869·16 enrolled

Assessment of Global Myocardial Perfusion Reserve Using Coronary Sinus Flow Measurements

Completed·UUniversity of Illinois at Chicago··NCT02697877·183 enrolled

Show 1 more trial

The MATCH Investigation: CT Myocardial Perfusion and CT-FFR vs PET MPI

Completed·EEmory University·N/A·NCT04316676·20 enrolled

Stress3 trials

Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress

Completed·MMayo Clinic·N/A·NCT01370265·12 enrolled

Maximal Bruce Protocol With the Use of Regadenoson For Myocardial Perfusion Stress Testing

Completed·UUniversity of Maryland, Baltimore·N/A·NCT01026012·40 enrolled

Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI

Completed·NNorthwestern University·Phase 2·NCT01655043·20 enrolled

Cardiac3 trials

Quantitative 13N-Ammonia Cardiac Rest/Stress Digital PET/CT

Completed·SStanford University··NCT03170817·15 enrolled

Stress Testing and Cardiac Magnetic Resonance

Completed·UUniversity of Chicago·Phase 4·NCT00871260·20 enrolled

Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)

Terminated·WWake Forest University Health Sciences·Phase 1·NCT00763035·14 enrolled

Exercise3 trials

A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)

Completed· Astellas logo

Astellas·Phase 3·NCT01618669·1,147 enrolled

Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

Completed·—·Phase 4·NCT01109992·43 enrolled

Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging

Completed·HHartford Hospital·N/A·NCT01021618·140 enrolled

30 more indications

Coronary Artery Disease2 trials

Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

Completed·UUniversity of Chicago·N/A·NCT00857792·120 enrolled

Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease

Unknown status·DDipan Shah·Phase 4·NCT01446094·50 enrolled

Magnetic Resonance Imaging2 trials

Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging

Completed·TTimothy M. Bateman·Phase 4·NCT02115308·40 enrolled

Myocardial Perfusion Magnetic Resonance Imaging Using Regadenoson

Completed·WWashington University School of Medicine·Phase 1·NCT00881218·50 enrolled

Anemia1 trial

A Phase II Trial of Regadenoson in Sickle Cell Anemia

Completed·—·Phase 2·NCT01788631·100 enrolled

Fibrosis1 trial

Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF

Completed·—·Phase 4·NCT02589977·55 enrolled

Chest pain1 trial

Stress CT Perfusion in Patients With Chest Pain

Completed·UUniversity of Chicago·N/A·NCT01969916·150 enrolled

Heart Transplant1 trial

Allograft Dysfunction in Heart Transplant

Recruiting·PPaul Kim·Phase 4·NCT03102125·376 enrolled

Chronic Obstructive Pulmonary Disease1 trial

A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease

Completed· Astellas logo

Astellas·Phase 4·NCT00862641·1,009 enrolled

PET1 trial

Phase Analysis and Obstructive CAD on Rubidium PET

Withdrawn·EEmory University·Phase 2·NCT01840696

Allograft1 trial

Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction

Completed·PPaul Kim·Phase 4·NCT02597543·14 enrolled

COVID-191 trial

Treat COVID-19 Patients With Regadenoson

Completed·UUniversity of Maryland, Baltimore·Phase 1/2·NCT04606069·5 enrolled

Caffeine1 trial

Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

Completed· Astellas logo

Astellas·Phase 3·NCT00826280·347 enrolled

Hyperemia1 trial

Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia

Completed·SSt. Louis University·Phase 1·NCT01161121·46 enrolled

Infusion1 trial

Regadenoson Infusion of Marginalized Donor Lungs in an EVLP System

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT04521569·47 enrolled

ESS1 trial

A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI

Terminated· Sanofi logo

Sanofi·Phase 2·NCT03236311·10 enrolled

Breast Cancer1 trial

Stress Test in Detecting Heart Damage in Premenopausal Women With Stage I-III Breast Cancer

Completed·WWake Forest University Health Sciences··NCT03505736·25 enrolled

Tolerance1 trial

Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01918995·36 enrolled

Oral1 trial

Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation

Completed·—·Phase 4·NCT01919450·80 enrolled

Pediatric Patients1 trial

A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients

Recruiting·GGE Healthcare·Phase 1/2·NCT04604782·54 enrolled

Sudden Cardiac Death1 trial

Heart Rate Response to Regadenoson and Sudden Cardiac Death

Completed·UUniversity of Alabama at Birmingham·N/A·NCT01842035·90 enrolled

Pulmonary Hypertension1 trial

Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension

Terminated·NNational Jewish Health·N/A·NCT02220634·10 enrolled

Glioma1 trial

Determining Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT03971734·7 enrolled

Lung Transplantation1 trial

Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation

Unknown status·—·Phase 1·NCT03072589·21 enrolled

Speckle Tracking1 trial

Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking

Completed·MM.D. Anderson Cancer Center·Phase 4·NCT02130453·161 enrolled

Renal Impairment1 trial

A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

Completed· Astellas logo

Astellas·Phase 4·NCT00863707·511 enrolled

Hypoxia1 trial

The Effect of A2A Adrenoceptor Stimulation on the Diameter of Retinal Arterioles During Hypoxia in Vivo

Unknown status·UUniversity of Aarhus·Phase 2·NCT03090087·20 enrolled

Concentration1 trial

Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02389738·6 enrolled

Echocardiography1 trial

Stress Echocardiography Study With Regadenoson

Terminated· Gilead logo

Gilead·Phase 2·NCT00907764·22 enrolled

MRI Scan1 trial

New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)

Recruiting·UUniversity of Utah·Phase 1·NCT04600115·100 enrolled

Hypertrophic Cardiomyopathy1 trial

Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve

Terminated·—·Approved·NCT03249272·31 enrolled

Unspecified2 trials

Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers

Completed·UUniversity of Michigan·Phase 1·NCT01433705·70 enrolled

Effects of Body Mass Index on the Hyperemic Response to Regadenoson

Completed·UUniversity of Utah·N/A·NCT00859833·30 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 10, 2008

LEXISCAN

NDA NDA022161

Apr 10, 2008

LEXISCAN

NDA NDA022161

Mar 17, 2009

LEXISCAN

NDA NDA022161

Dec 23, 2009

LEXISCAN

NDA NDA022161

Sep 23, 2011

LEXISCAN

NDA NDA022161

Sep 23, 2011

LEXISCAN

NDA NDA022161

Sep 23, 2011

LEXISCAN

NDA NDA022161

Sep 30, 2011

LEXISCAN

NDA NDA022161

Jan 9, 2014

LEXISCAN

NDA NDA022161

Mar 29, 2014

LEXISCAN

NDA NDA022161

Sep 19, 2014

LEXISCAN

NDA NDA022161

Jan 17, 2017

LEXISCAN

NDA NDA022161

May 31, 2018

LEXISCAN

NDA NDA022161

Sources

References

[1]
ClinicalTrials.gov — 51 trial records for Regadenoson. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lexiscan drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Regadenoson compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Regadenoson. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022161). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lexiscan. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adenosine A2a Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Astellas

Patent Landscape[6]

Patent Cliff

Feb 2, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8106183Feb 2, 2027

RE47301Feb 2, 2027

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