CLINICAL TRIALS PROFILE FOR REGADENOSON

All Clinical Trials for REGADENOSON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00763035 ↗	Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)	Terminated	Wake Forest Baptist Health	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.
NCT00763035 ↗	Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)	Terminated	Wake Forest University Health Sciences	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.
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.
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.

Clinical Trial Conditions for REGADENOSON

Condition Name

Condition Name for REGADENOSON
Intervention	Trials
Coronary Artery Disease	25
Myocardial Ischemia	4
Coronary Artery Disease (CAD)	3
Myocardial Perfusion Abnormalities	2

Condition MeSH

Condition MeSH for REGADENOSON
Intervention	Trials
Coronary Artery Disease	35
Myocardial Ischemia	33
Coronary Disease	29
Ischemia	6

Clinical Trial Locations for REGADENOSON

Trials by Country

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−

Trials by Country for REGADENOSON
Location	Trials
United States	168
Argentina	2
Netherlands	2
United Kingdom	2
Canada	1

Trials by US State

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−

Trials by US State for REGADENOSON
Location	Trials
Illinois	14
California	13
Maryland	10
Missouri	9
Massachusetts	8

Clinical Trial Progress for REGADENOSON

Clinical Trial Phase

Clinical Trial Phase for REGADENOSON
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	5
Phase 2	8

Clinical Trial Status

Clinical Trial Status for REGADENOSON
Clinical Trial Phase	Trials
Completed	36
Recruiting	9
Terminated	5

Clinical Trial Sponsors for REGADENOSON

Sponsor Name

Sponsor Name for REGADENOSON
Sponsor	Trials
Astellas Pharma Inc	15
Astellas Pharma US, Inc.	11
Astellas Pharma Global Development, Inc.	6

Sponsor Type

Sponsor Type for REGADENOSON
Sponsor	Trials
Other	77
Industry	43
NIH	6

Regadenoson: Clinical Trials, Market Analysis, and Projections

Introduction

Regadenoson, marketed under the brand name Lexiscan, is a pharmacologic stress agent used in radionuclide myocardial perfusion imaging (MPI) for patients who are unable to undergo adequate exercise stress. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

ADVANCE MPI Trials

The efficacy and safety of regadenoson were evaluated in two phase 3, randomized, double-blind, noninferiority studies known as the ADenoscan Versus reg Adenoso N Comparative Evaluation for Myocardial Perfusion Imaging (ADVANCE MPI) trials. These studies involved 2015 patients with known or suspected coronary artery disease and compared regadenoson to adenosine. The results showed that regadenoson was noninferior to adenosine in terms of diagnostic efficacy and safety[1][4].

EXERRT Trial

The EXErcise to Regadenoson in Recovery Trial (EXERRT) was a phase 3b, open-label, randomized, multicenter study that assessed the administration of regadenoson following an inadequate exercise stress test. This trial demonstrated that regadenoson could be effectively used in patients who did not achieve adequate exercise stress, providing a viable alternative for myocardial perfusion imaging[1][4].

Safety and Tolerability Studies

Regadenoson's safety and tolerability were further evaluated in several studies, including a phase 4, multicenter, randomized, double-blind, placebo-controlled study in patients with asthma or chronic obstructive pulmonary disease (COPD), and another in patients with stage 3 or stage 4 renal impairment. These studies generally supported the safety profile of regadenoson, although they highlighted potential risks such as hypotension, AV block, and hypersensitivity reactions[1][4].

Adverse Reactions and Safety Considerations

Regadenoson is associated with several adverse reactions, including:

• Hypotension: Regadenoson can induce arterial vasodilation and hypotension, with a higher risk in patients with autonomic dysfunction, hypovolemia, or certain cardiovascular conditions[1][2].
• AV Block: Regadenoson can cause first-, second-, or third-degree AV block, and sinus bradycardia. It is contraindicated in patients with second- or third-degree AV block or sinus node dysfunction unless they have a functioning artificial pacemaker[2][4].
• Hypersensitivity Reactions: Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported, although they are rare[1][4].

Market Analysis

Current Market

Regadenoson is a significant player in the pharmacologic stress agent market. According to IQVIA, the U.S. sales of Lexiscan (regadenoson injection) were approximately $668 million in the 12 months ending February 2023[2].

Market Players

Several pharmaceutical companies are involved in the production and distribution of regadenoson. Hikma Pharmaceuticals, for example, has launched regadenoson injection in prefilled syringes, expanding the product's availability[2]. Amphastar Pharmaceuticals also received FDA approval for regadenoson, further increasing market competition[3].

Market Size and Growth

The U.S. generic injectables pharmaceutical contract manufacturing market, which includes regadenoson, is projected to grow significantly. The market size was estimated at USD 3.0 billion in 2024 and is expected to reach USD 3.34 billion in 2025, growing at a CAGR of 10.8% from 2025 to 2030. This growth is driven by factors such as patent expirations, streamlined regulatory pathways, and the increasing demand for generic injectables[5].

Projections and Future Outlook

Market Expansion

The increasing demand for generic injectables, particularly in the cardiovascular segment, is expected to drive the growth of regadenoson sales. As more patients require pharmacologic stress agents for myocardial perfusion imaging, the market for regadenoson is likely to expand[5].

Competitive Landscape

The competitive landscape is expected to remain dynamic with multiple players entering the market. Companies like Hikma and Amphastar are continuously expanding their portfolios, which may lead to increased competition and potentially lower prices, making the drug more accessible to a wider patient population[2][3].

Regulatory and Clinical Developments

Future clinical trials and regulatory approvals will play a crucial role in shaping the market for regadenoson. Any new indications or improved formulations could further enhance the drug's market position and patient acceptance.

Key Takeaways

• Clinical Efficacy: Regadenoson has been shown to be noninferior to adenosine in clinical trials, making it a viable option for myocardial perfusion imaging.
• Safety Profile: While generally safe, regadenoson is associated with risks such as hypotension, AV block, and hypersensitivity reactions.
• Market Growth: The U.S. generic injectables market, including regadenoson, is projected to grow significantly due to increasing demand and patent expirations.
• Competitive Landscape: Multiple pharmaceutical companies are involved in the production and distribution of regadenoson, indicating a competitive market.

FAQs

What is regadenoson used for?

Regadenoson is used as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients who are unable to undergo adequate exercise stress.

What are the common adverse reactions to regadenoson?

Common adverse reactions include dyspnea, headache, flushing, chest discomfort, angina pectoris or ST-segment depression, dizziness, chest pain, nausea, and abdominal discomfort. Most of these reactions resolve within 15 minutes, except for headache, which typically resolves within 30 minutes[1][4].

Can regadenoson be used in patients with asthma or COPD?

Regadenoson has been evaluated in patients with asthma or COPD in a phase 4 study, which generally supported its safety in these patient populations, although caution is advised[1][4].

What are the contraindications for regadenoson?

Regadenoson is contraindicated in patients with second- or third-degree AV block or sinus node dysfunction unless they have a functioning artificial pacemaker. It should also be used with caution in patients with certain cardiovascular conditions[2][4].

How is the market for regadenoson expected to grow?

The market for regadenoson is expected to grow as part of the broader U.S. generic injectables pharmaceutical contract manufacturing market, driven by increasing demand, patent expirations, and streamlined regulatory pathways[5].

Sources

1. Lexiscan Clinical Data Overview: Clinical results of Lexiscan (regadenoson) injection across multiple studies[1].
2. Hikma Launches Regadenoson Injection: Hikma's launch of regadenoson injection in prefilled syringes and market data[2].
3. Amphastar Receives FDA Approval for Regadenoson: Amphastar's FDA approval and market data for regadenoson[3].
4. Clinical Trial Publications | Lexiscan: Published data from Lexiscan clinical trials[4].
5. U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market: Market size, share, and trends analysis for the U.S. generic injectables market[5].