CLINICAL TRIALS PROFILE FOR LEXISCAN

All Clinical Trials for lexiscan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00208299 ↗	ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)	Completed	Astellas Pharma US, Inc.	Phase 3	2003-10-01	Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.
NCT00208299 ↗	ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)	Completed	Gilead Sciences	Phase 3	2003-10-01	Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.
NCT00208312 ↗	ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)	Completed	Astellas Pharma US, Inc.	Phase 3	2004-04-01	Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.
NCT00208312 ↗	ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)	Completed	Gilead Sciences	Phase 3	2004-04-01	Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.
NCT00763035 ↗	Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)	Terminated	Astellas Pharma US, Inc.	Early Phase 1	2009-01-01	The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an imaging agent with cardiac MR. If found useful, it will help us establish a protocol for regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators will compare regadenoson with dobutamine so each participant will undergo two studies. A cardiac MR stress test with regadenoson and with dobutamine. The investigators participants will include patients with history of COPD and Asthma, so it will also help us determine feasibility of Regadenoson in these patient's subgroups.

Clinical Trial Conditions for lexiscan

Condition Name

Condition Name for lexiscan
Intervention	Trials
Coronary Artery Disease	19
Coronary Artery Disease (CAD)	3
Sickle Cell Disease	3
Myocardial Ischemia	3

Condition MeSH

Condition MeSH for lexiscan
Intervention	Trials
Coronary Artery Disease	28
Myocardial Ischemia	26
Coronary Disease	23
Anemia, Sickle Cell	4

Clinical Trial Locations for lexiscan

Trials by Country

Trials by Country for lexiscan
Location	Trials
United States	147
Argentina	2
United Kingdom	1
Puerto Rico	1
Peru	1

Trials by US State

Trials by US State for lexiscan
Location	Trials
Illinois	12
Missouri	11
California	10
Massachusetts	7
Maryland	7

Clinical Trial Progress for lexiscan

Clinical Trial Phase

Clinical Trial Phase for lexiscan
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	4
Phase 2	8

Clinical Trial Status

Clinical Trial Status for lexiscan
Clinical Trial Phase	Trials
Completed	30
Recruiting	6
Terminated	3

Clinical Trial Sponsors for lexiscan

Sponsor Name

Sponsor Name for lexiscan
Sponsor	Trials
Astellas Pharma Inc	13
Astellas Pharma US, Inc.	10
National Heart, Lung, and Blood Institute (NHLBI)	6

Sponsor Type

Sponsor Type for lexiscan
Sponsor	Trials
Other	71
Industry	37
NIH	6

Lexiscan Market Analysis and Financial Projection

Lexiscan: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Lexiscan, also known as regadenoson, is a pharmacologic stress agent approved by the FDA for use in radionuclide myocardial perfusion imaging (MPI) in patients who are unable to undergo adequate exercise stress. Here, we delve into the clinical trials, market analysis, and future projections for this critical cardiovascular diagnostic tool.

Clinical Trials and Efficacy

Lexiscan has undergone rigorous clinical trials to establish its safety and efficacy. In two identically designed Phase III clinical trials, Lexiscan met primary endpoints by showing that MPI studies conducted with Lexiscan were similar to those conducted with Adenoscan (adenosine injection) with a 95% confidence level[1].

These trials demonstrated that Lexiscan is generally well-tolerated, with common adverse events including shortness of breath, headache, flushing, chest discomfort, dizziness, and others. The drug's ability to mimic the increase in coronary blood flow caused by exercise makes it a valuable option for patients who cannot undergo physical stress tests[1].

A notable Phase IV study presented at the American Society of Nuclear Cardiology (ASNC) highlighted the safety and tolerability of Lexiscan in subjects with asthma or chronic obstructive pulmonary disease (COPD). The study found that Lexiscan was comparable to placebo in causing a >15% decrease in forced expiratory volume in one second (FEV1) in these patients, indicating its safety in this population[4].

Market Analysis

Lexiscan has established itself as a market leader in the pharmacologic stress agent segment. As of 2022, it is the most widely used pharmacologic stress agent for single-photon emission computed tomography (SPECT) MPI, according to data from Symphony Health Solutions[2].

The drug's market dominance can be attributed to its efficacy, safety profile, and ease of integration into existing health system workflows. Astellas offers an economic model to assess the financial impact of varying procedures in radionuclide MPI, which helps institutions make informed decisions about incorporating Lexiscan into their practices[2].

Market Share and Competition

Lexiscan generated approximately $650 million in sales in the 12 months ending March 31, 2022. However, the market is facing competition with the approval of generic versions by companies such as Apotex, Accord, Dr. Reddy’s, Glenmark, and Amphastar. Astellas is engaged in a patent battle to extend the exclusivity of Lexiscan, but the court has allowed some generics to proceed while the case is under appeal[5].

Market Projections

Despite the emergence of generic competitors, Lexiscan is expected to maintain a significant market presence due to its established brand and clinical superiority.

Market Trends

The overall market for pharmacologic stress agents is influenced by the growing need for diagnostic tools in cardiovascular medicine. The increasing prevalence of coronary artery disease and the inability of many patients to undergo exercise stress tests drive the demand for pharmacologic stress agents like Lexiscan.

Future Outlook

The cardiovascular diagnostic market is expected to grow, driven by advancements in medical imaging and the increasing focus on precision medicine. While generic competition may impact Lexiscan's market share, its strong clinical profile and established market presence are likely to sustain its position as a leading pharmacologic stress agent.

Integration into Health Systems

Lexiscan's ease of use and integration into existing workflows are key factors in its adoption. The drug is delivered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight, making it convenient for clinical use. Astellas provides economic models and support to help health systems assess and optimize the financial impact of incorporating Lexiscan into their MPI processes[2].

Safety and Side Effects

While Lexiscan is generally well-tolerated, it does come with potential side effects and contraindications. Common adverse events include shortness of breath, headache, and flushing. Serious reactions such as hypersensitivity, including anaphylaxis, and significant changes in blood pressure can occur. Patients with certain conditions, such as second- or third-degree AV block or sinus node dysfunction without a functioning artificial pacemaker, should not be administered Lexiscan[2].

Key Takeaways

• Clinical Efficacy: Lexiscan has demonstrated efficacy in clinical trials, showing similar results to Adenoscan in MPI studies.
• Market Leadership: It is the most widely used pharmacologic stress agent for SPECT MPI.
• Safety Profile: Generally well-tolerated but with potential for serious side effects.
• Market Projections: Expected to maintain a significant market presence despite generic competition.
• Integration: Easy to integrate into existing health system workflows.

FAQs

What is Lexiscan used for?

Lexiscan is used as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI) for patients who cannot undergo adequate exercise stress.

What are the common side effects of Lexiscan?

Common side effects include shortness of breath, headache, flushing, chest discomfort, and dizziness.

Can patients with asthma or COPD use Lexiscan?

Yes, Lexiscan has been shown to be safe and tolerable in patients with asthma or COPD, although it should be used with caution and under medical supervision.

How is Lexiscan administered?

Lexiscan is delivered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight.

What are the contraindications for Lexiscan?

Lexiscan should not be administered to patients with second- or third-degree AV block or sinus node dysfunction unless these patients have a functioning artificial pacemaker.

Sources

1. CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson) Injection. Astellas US.
2. Pharmacologic Stress Market Share - Lexiscan. Astellas Pharma US, Inc.
3. Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034. Biospace.
4. News Room - News Releases - Astellas Pharma US, Inc.. Astellas Pharma US, Inc.
5. Patent fight versus Pfizer generic, Astellas gets good news and bad. FiercePharma.