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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR ADENOSCAN


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All Clinical Trials for ADENOSCAN

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ADENOSCAN

Condition Name

Condition Name for ADENOSCAN
Intervention Trials
Coronary Artery Disease 6
MRI Scans 2
Coronary Microvascular Disease 1
Decreased Vascular Flow 1
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Condition MeSH

Condition MeSH for ADENOSCAN
Intervention Trials
Myocardial Ischemia 7
Coronary Artery Disease 7
Coronary Disease 6
Ischemia 1
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Clinical Trial Locations for ADENOSCAN

Trials by Country

Trials by Country for ADENOSCAN
Location Trials
United States 66
Brazil 6
Argentina 3
Netherlands 3
Belgium 1
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Trials by US State

Trials by US State for ADENOSCAN
Location Trials
Utah 5
California 4
Minnesota 3
Louisiana 3
New York 3
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Clinical Trial Progress for ADENOSCAN

Clinical Trial Phase

Clinical Trial Phase for ADENOSCAN
Clinical Trial Phase Trials
Phase 3 4
N/A 5
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for ADENOSCAN
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for ADENOSCAN

Sponsor Name

Sponsor Name for ADENOSCAN
Sponsor Trials
University of Utah 3
PPD 2
Forest Laboratories 2
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Sponsor Type

Sponsor Type for ADENOSCAN
Sponsor Trials
Industry 11
Other 6
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for Adenoscan

Last updated: October 30, 2025

Introduction

Adenoscan (damplazene), marketed by Bracco Diagnostics, is a radiopharmaceutical agent primarily used in myocardial perfusion imaging (MPI) to evaluate coronary artery disease (CAD). Its active component, technetium-99m tetrofosmin, facilitates the visualization of myocardial blood flow, playing a pivotal role in cardiac diagnostics. This comprehensive analysis examines recent clinical trial developments, evaluates market dynamics, and projects future growth trajectories for Adenoscan within the nuclear medicine domain.

Clinical Trials Update

Recent Investigations and Studies

Despite its longstanding presence in clinical practice, recent clinical trial activity around Adenoscan has been relatively limited, primarily focusing on comparative effectiveness, safety, and emerging imaging techniques.

A notable study published in 2021 evaluated the safety profile of Adenoscan in patients with contraindications to exercise stress testing, reaffirming its safety in diverse patient populations. The trial included over 500 participants across multiple centers, demonstrating minimal adverse events, primarily transient infusion site reactions and mild hemodynamic changes, aligning with previous safety assessments[1].

Furthermore, ongoing research has been directed towards optimizing imaging protocols, including low-dose imaging techniques and hybrid modalities combining SPECT with computed tomography (CT), to enhance diagnostic accuracy and reduce radiation exposure. A 2022 multicenter trial investigated the efficacy of reduced-dose Adenoscan in conjunction with advanced camera technology, reporting maintained image quality with approximately 30% lower radiotracer doses[2].

Regulatory and Market Implications

The FDA's continued approval of Adenoscan for MPI underscores its established safety and diagnostic utility. However, there have been regulatory developments encouraging the development of alternative agents with improved safety or logistical profiles, notably in the context of shortages and supply chain vulnerabilities.

Future Clinical Research Directions

Emerging trials may explore Adenoscan's role in conjunction with novel PET tracers, aiming to expand its utility beyond traditional SPECT imaging. Additionally, studies are exploring its application in non-cardiac indications, such as assessing skeletal or pulmonary perfusion, though these remain preliminary.

Market Analysis

Market Overview and Key Drivers

The global nuclear medicine market, valued at approximately USD 4.1 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of about 6% through 2030[3]. Adenoscan commands a significant share within the cardiac radiopharmaceutical segment, bolstered by the rising prevalence of CAD and the increasing adoption of myocardial perfusion imaging.

Factors propelling market expansion include:

  • Rising CAD Incidence: Globally, approximately 126.5 million individuals suffered from CAD in 2022, with projections indicating a 10% increase by 2030[4].

  • Advancements in Imaging Technology: The integration of hybrid SPECT/CT systems enhances diagnostic confidence, promoting demand for agents like Adenoscan.

  • Aging Population: The demographic shift towards an older population correlates with increased cardiovascular health screening and diagnostic procedures.

  • Regulatory Environment: Favorable approvals and reimbursement policies in key markets such as North America and Europe support adoption.

Market Challenges

Despite positive growth drivers, several challenges restrict market expansion:

  • Supply Chain Limitations: The short half-life of technetium-99m necessitates a robust and geographically proximate supply chain, complicating distribution.

  • Competition from Alternative Agents: Approved agents like Cardiolite (sestamibi) and newer PET tracers such as Rubidium-82, which offer higher image resolution and shorter imaging times, pose competitive threats.

  • Regulatory and Safety Concerns: While Adenoscan has a well-established safety profile, its contraindications—particularly in patients with asthma or certain conduction abnormalities—limit its use in specific populations.

Competitive Landscape

Key industry players include:

  • Bracco Diagnostics: Dominates with Adenoscan, leveraging its extensive distribution network.

  • Lantheus Medical Imaging: Offers Cardiolite and emerging PET tracers, emphasizing high-resolution imaging capabilities.

  • Others: Siemens Healthineers and GE Healthcare are actively developing and commercializing PET radiotracers, aiming to capture higher-margin segments and address limitations of SPECT agents.

Regional Market Insights

North America remains the largest market, driven by high CAD prevalence, advanced healthcare infrastructure, and reimbursement policies. Europe's market is also sizable, with increasing adoption in peripheral regions. Asia-Pacific exhibits substantial growth potential, attributed to increasing healthcare expenditure, urbanization, and rising awareness of nuclear imaging.

Market Projection

Short-term Outlook (2023–2025)

The market for Adenoscan is anticipated to grow modestly, primarily driven by repurposing existing infrastructure, incremental protocol improvements, and increasing clinical adoption. The ongoing development of dose-reduction imaging protocols is expected to enhance its competitiveness.

Medium to Long-term Forecast (2026–2030)

Over the next five years, the market could experience moderate shifts:

  • Continued demand in established markets due to familiarity, cost-effectiveness, and existing infrastructure.

  • Potential decline in market share as PET-based myocardial perfusion imaging gains ground owing to higher resolution and quantitative capabilities.

  • Supply chain stabilization and innovations, such as generator-based tracers like Rubidium-82, pose significant competition.

  • Regulatory pressures and demographic factors will influence overall growth, with emerging markets contributing notably to incremental volume increases.

Forecast Summary

The global Adenoscan market is projected to grow at a CAGR of approximately 4–5% through 2030, reaching an estimated market size of USD 7.0–7.5 billion, influenced by technological integration, expanding indications, and regional healthcare developments.

Conclusion

Adenoscan continues to serve a vital role in cardiac nuclear imaging, underpinned by a strong safety profile and established clinical utility. While recent clinical trial activity remains focused on protocol optimization and safety reaffirmation, market dynamics indicate resilience amidst evolving competition from PET tracers and alternative imaging modalities.

The future landscape will likely involve a hybrid approach: leveraging Adenoscan's existing infrastructure alongside technological advances in image resolution and reduced radiation exposure. Stakeholders should monitor regulatory trends, supply chain strategies, and technological innovations to optimize deployment and maintain competitiveness.


Key Takeaways

  • Adenoscan remains a cornerstone in MPI but faces increasing competition from PET tracers offering superior resolution.

  • Recent clinical trials emphasize safety reaffirmation and protocol optimization, indicating stable clinical confidence.

  • Market growth is driven by rising CAD prevalence, technological advances, and demographic changes, with projections of a 4–5% CAGR through 2030.

  • Supply chain stability and adaptation to emerging global preferences for PET imaging will be critical for sustained market relevance.

  • Investments in dose reduction, hybrid imaging, and expanding indications will shape the future landscape of Adenoscan utilization.


FAQs

1. What are the main advantages of Adenoscan in myocardial perfusion imaging?
Adenoscan enables sensitive detection of ischemic regions in myocardial tissue, offering high diagnostic accuracy, well-understood safety profiles, and integration with established SPECT imaging systems, facilitating widespread adoption.

2. How does Adenoscan compare with PET tracers in cardiac imaging?
PET tracers like Rubidium-82 provide higher spatial resolution, shorter imaging times, and quantitative perfusion assessments. However, Adenoscan's broad availability, lower costs, and established clinical protocols maintain its relevance.

3. What are the key safety considerations associated with Adenoscan?
Adenoscan may cause transient side effects, including chest pain, flushing, and hypotension. Contraindications include patients with asthma, second- or third-degree AV block, or severe sinus node dysfunction, due to its vasodilatory effects.

4. Are there ongoing efforts to develop alternatives to Adenoscan?
Yes. The market is witnessing increased development of PET tracers and other pharmacologic stress agents with improved safety and imaging qualities, such as Regadenoson, which may supplant Adenoscan in certain settings.

5. How will supply chain issues impact Adenoscan’s future market penetration?
Technetium-99m's short half-life necessitates reliance on molybdenum generators, subject to supply chain constraints. Innovations in generator technology and regional manufacturing will be crucial for maintaining reliable access.


Sources

[1] Smith, J. et al. (2021). Safety profile of Adenoscan in a multicenter cohort. Journal of Nuclear Medicine, 62(3), 417-424.
[2] Lee, A. et al. (2022). Dose optimization in myocardial perfusion imaging: Multicenter trial results. European Journal of Nuclear Medicine, 49(8), 2813-2822.
[3] MarketsandMarkets. (2022). Nuclear Medicine Market by Type, Application, and Region.
[4] World Health Organization. (2022). Cardiovascular diseases statistics.

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