LEXISCAN (regadenoson)
Lexiscan is a stress agent used for radionuclide myocardial perfusion imaging (MPI) in clinical settings. It helps patients who cannot perform enough physical exercise to complete a traditional stress test. By simulating the effects of exercise on the heart, it allows healthcare providers to conduct necessary cardiac imaging.
How LEXISCAN Works
This medication works by targeting and activating A2A adenosine receptors in the body. Once these receptors are triggered, they cause the coronary arteries to dilate, which increases the volume of blood flowing to the heart.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-04-10
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
LEXISCAN Approval History
What LEXISCAN Treats
1 indicationsLEXISCAN is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress
LEXISCAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
28 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05583721 | MYPERS | Ph 2 | recruiting | Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET |
| NCT04604782 Rapiscan PIP | GE-262-001 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients |
| NCT03102125 | 190053 | Ph 4 | recruiting | Allograft Dysfunction in Heart Transplant |
| NCT04606069 results posted | HP-00091372 | Ph 1, Ph 2 | completed | Treat COVID-19 Patients With Regadenoson |
| NCT00837369 results posted | 0566-08-FB | Ph 1 | completed | Regadenoson R-T Perfusion Imaging Trial |
| NCT01334918 results posted | 3606-CL-2001 | Ph 2 | completed | 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) |
| NCT00826280 results posted | 3606-CL-3002 | Ph 3 | completed | Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) |
| NCT02130453 results posted | 2013-0881 NCI-2014-01162 | Ph 4 | completed | Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking |
| NCT03236311 results posted | ACT14656 2016-000629-38, U1111-1182-1709 | Ph 2 | terminated | A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI |
| NCT00871260 results posted | 16570B | Ph 4 | completed | Stress Testing and Cardiac Magnetic Resonance |
| NCT02589977 HFpEF-PRoF results posted | 141686 | Ph 4 | completed | Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF |
| NCT03249272 results posted | Pro00082447 | Ph 4 | terminated | Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve |
| NCT01655043 results posted | STU00050900 000598 | Ph 2 | completed | Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI |
| NCT03103061 results posted | Pro00051308 | Ph 2 | completed | Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System |
| NCT01433705 | HUM00016183 | Ph 1 | completed | Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers |
| NCT02115308 results posted | Astellas CMR Tagging | Ph 4 | completed | Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging |
| NCT01919450 results posted | 13-058 | Ph 4 | completed | Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation |
| NCT01779869 PET/MR-P results posted | PET/MR-Perfusion | Ph 4 | completed | Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson |
| NCT01788631 results posted | 13-005 1P50HL110790-01 | Ph 2 | completed | A Phase II Trial of Regadenoson in Sickle Cell Anemia |
| NCT02597543 results posted | 1186278 | Ph 4 | completed | Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction |
| NCT01161121 results posted | Rega-9I06 | Ph 1 | completed | Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia |
| NCT01618669 EXERRT results posted | 3606-CL-3004 | Ph 3 | completed | 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) |
| NCT01840696 | IRB00062632 REGA12I11 | Ph 2 | withdrawn | Phase Analysis and Obstructive CAD on Rubidium PET |
| NCT01085201 results posted | 09-308 1RC2HL101367-01 | Ph 1 | completed | Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease |
| NCT00907764 | CVT 5127 | Ph 2 | terminated | Stress Echocardiography Study With Regadenoson |
| NCT01918995 | 3606-CL-1005 | Ph 1 | completed | Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects |
| NCT00862641 results posted | 3606-CL-3001 | Ph 4 | completed | A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease |
| NCT00863707 results posted | 3606-CL-3010 | Ph 4 | completed | A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEXISCAN FDA Label Details
Indications & Usage
FDA Label (PDF)LEXISCAN is indicated for the treatment of Radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Pro Intelligence Preview
Deep insights for LEXISCAN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 2 active patents
Trial Analysis
- • 28 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment