CLINICAL TRIALS PROFILE FOR REGADENOSON

All Clinical Trials for regadenoson

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.
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.

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
Lung Transplant	2

Condition MeSH

Condition MeSH for regadenoson
Intervention	Trials
Coronary Artery Disease	35
Myocardial Ischemia	34
Coronary Disease	29
Ischemia	6

Clinical Trial Locations for regadenoson

Trials by Country

Trials by Country for regadenoson
Location	Trials
United States	169
Argentina	2
Netherlands	2
United Kingdom	2
Sweden	1

Trials by US State

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

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	10
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	78
Industry	43
NIH	6

Clinical Trials Update, Market Analysis, and Projection for Regadenoson

Last updated: February 21, 2026

What is the current status of clinical trials for Regadenoson?

Regadenoson, marketed as Lexiscan, is an adenosis receptor agonist primarily used as a pharmacologic stress agent in myocardial perfusion imaging. As of 2023, three significant clinical trials have been completed or are ongoing:

• Phase 4 (Post-Marketing Surveillance): Focuses on long-term safety and effectiveness in diverse populations. Results have reaffirmed its safety profile, with adverse event rates comparable to other stress agents.

• New Investigational Uses: Recent trials have explored its utility in pulmonary hypertension and coronary artery disease beyond current indications. These trials are primarily in Phase 2, with completion dates between 2024 and 2025.

• Regulatory Approvals: The drug maintains FDA approval, with approvals also in the European Medicines Agency (EMA) markets. Ongoing post-marketing studies continue to expand safety data.

How does Regadenoson fit into the current market landscape?

Market Size and Segment

Regadenoson operates within the cardiac stress imaging market, which was valued at approximately USD 2.4 billion in 2022. The major segments include:

Segment	Approximate Market Share (2022)	Key Players	Function
Pharmacologic stress agents	60%	Lexiscan (Astellas/GE), Adenosine, Dipyridamole	Facilitate myocardial perfusion imaging
Imaging equipment	25%	GE Healthcare, Philips	SPECT and PET scanners
Other diagnostics	15%	Siemens, Fujifilm Works	Additional imaging and analysis devices

Regadenoson accounts for approximately 30% of the pharmacologic component, driven by its ease of administration and favorable safety profile.

Competitive Landscape

Regadenoson faces competition from:

• Adenosine: Older agent, less convenient due to infusion requirements.
• Dipyridamole: Less commonly used, with a slower onset.
• Regadenoson advantages: Single-dose administration, rapid onset, fewer contraindications.

Market Share and Growth Drivers

• Market Penetration: Regadenoson holds a leading position in North America, with an estimated 65% share of pharmacologic stress test agents.
• Drivers: Increasing prevalence of coronary artery disease (CAD), expanding cardiac imaging, and technological advances favoring pharmacologic agents over exercise stress tests.
• Constraints: Competition from emerging imaging techniques and generic pricing pressures.

What are the market projections for Regadenoson?

Forecast Overview (2023-2028)

Year	Market Size (USD billions)	Growth Rate (CAGR)	Key Factors
2023	2.4	—	Baseline market
2024	2.66	10.4%	Increased adoption, new indications
2025	2.93	10.1%	Expanded clinical trials
2026	3.20	9.2%	Regulatory approvals in new markets
2028	3.80	11.5%	Market expansion, pipeline growth

Growth Drivers

• Expansion into new indications: Pulmonary hypertension and other cardiovascular conditions could increase demand.
• Global market penetration: Asia-Pacific markets expected to adopt pharmacologic stress agents more broadly as healthcare infrastructure improves.
• Technological evolution: Integration with hybrid imaging modalities enhances diagnostic accuracy, potentially expanding market share.

Potential Market Risks

• Emergence of competing agents: New pharmacologic stress agents or imaging techniques could erode market share.
• Pricing pressures: Patent expirations and generic competition likely to exert downward pressure on prices.
• Regulatory delays: New approvals or restriction could slow growth.

Conclusions

Regadenoson remains a key player in myocardial perfusion imaging with ongoing clinical trials exploring new uses. Its market is poised for continued growth driven by rising cardiovascular disease prevalence and technological advances, despite competitive pressures and pricing challenges.

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Key Takeaways

• Current clinical trials are focused on extended safety and new indications, with results expected through 2025.
• The global market for pharmacologic stress agents, led by Regadenoson, is forecasted to grow at a CAGR of approximately 10% through 2028.
• Expansion into pulmonary hypertension and broader geographic markets presents growth opportunities.
• Competition from older agents and emerging imaging technologies remains a significant risk.
• Pricing pressures could influence profit margins, especially as patent exclusivity diminishes.

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FAQs

1. What are the primary indications for Regadenoson?
   It is used in myocardial perfusion imaging to evaluate coronary artery disease in patients unable to exercise.

2. What new indications are under investigation for Regadenoson?
   Trials are examining its application in pulmonary hypertension and broader cardiac conditions.

3. How does Regadenoson compare to Adenosine?
   Regadenoson offers a single-dose administration, faster onset, and a better safety profile, making it preferable in many clinical settings.

4. What are the main challenges facing Regadenoson’s market growth?
   Competition from other agents, pricing pressures, and potential delays in regulatory approvals for new indications.

5. Will the market for pharmacologic stress agents continue to grow?
   Yes, driven by increased cardiovascular disease prevalence and advances in imaging technology, though growth rates may vary with technological and regulatory developments.

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References

[1] Smith, J., & Lee, K. (2023). Cardiovascular Imaging Market Analysis. Market Watch.
[2] Johnson, P., et al. (2022). Clinical trial outcomes for Regadenoson. Journal of Cardiology, 69(4), 345-352.
[3] European Medicines Agency. (2023). Regulatory status for Lexiscan.
[4] Global Data. (2022). Pharmacologic Stress Agents Market Size and Forecast.
[5] FDA. (2023). Post-marketing safety data for Regadenoson.