CLINICAL TRIALS PROFILE FOR ADENOSCAN

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.
NCT00859833 ↗	Effects of Body Mass Index on the Hyperemic Response to Regadenoson	Completed	Astellas Pharma Inc	N/A	2009-02-01	We will test the hypothesis that a single dose of Regadenoson will produce equivalent degrees of coronary hyperemia in patients of widely different body size. This will be a prospective, open-label, comparative trial using MRI to measure myocardial perfusion reserve (ratio of myocardial blood flow with vasodilator to myocardial blood flow at rest) during sequential administration of the coronary vasodilators adenosine and regadenoson. Non-invasive MRI measurements of resting myocardial blood flow, and sequential measurements of blood flow during adenosine infusion (weight adjusted dosing) and then blood flow during regadenoson infusion (single, fixed dose. Blood flow measurements will be obtained sequentially and in the same sequence in each subject during a two hour MRI exam. 32 subjects will be recruited for this study. The first 2 will be for testing of the protocol. Inclusion criteria: 2 subjects for initial protocol evaluation, then 30 subjects with body mass index (BMI) between 18 and 40. Exclusions are pregnancy, renal dysfunction and claustrophobia.
NCT00859833 ↗	Effects of Body Mass Index on the Hyperemic Response to Regadenoson	Completed	University of Utah	N/A	2009-02-01	We will test the hypothesis that a single dose of Regadenoson will produce equivalent degrees of coronary hyperemia in patients of widely different body size. This will be a prospective, open-label, comparative trial using MRI to measure myocardial perfusion reserve (ratio of myocardial blood flow with vasodilator to myocardial blood flow at rest) during sequential administration of the coronary vasodilators adenosine and regadenoson. Non-invasive MRI measurements of resting myocardial blood flow, and sequential measurements of blood flow during adenosine infusion (weight adjusted dosing) and then blood flow during regadenoson infusion (single, fixed dose. Blood flow measurements will be obtained sequentially and in the same sequence in each subject during a two hour MRI exam. 32 subjects will be recruited for this study. The first 2 will be for testing of the protocol. Inclusion criteria: 2 subjects for initial protocol evaluation, then 30 subjects with body mass index (BMI) between 18 and 40. Exclusions are pregnancy, renal dysfunction and claustrophobia.

Clinical Trial Conditions for ADENOSCAN

Condition Name

Condition Name for ADENOSCAN
Intervention	Trials
Coronary Artery Disease	6
MRI Scans	2
Ischemic Heart Disease	1
Myocardial Ischemia	1

Condition MeSH

Condition MeSH for ADENOSCAN
Intervention	Trials
Coronary Artery Disease	7
Myocardial Ischemia	7
Coronary Disease	6
Heart Failure	1

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

Trials by US State

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

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

Clinical Trial Status

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

Clinical Trial Sponsors for ADENOSCAN

Sponsor Name

Sponsor Name for ADENOSCAN
Sponsor	Trials
University of Utah	3
Astellas Pharma US, Inc.	2
Gilead Sciences	2

Sponsor Type

Sponsor Type for ADENOSCAN
Sponsor	Trials
Industry	11
Other	6
NIH	1

ADENOSCAN Market Analysis and Financial Projection

Last updated: May 3, 2026

ADENOSCAN (Regadenoson) Clinical Trials Update, Market Analysis, and 2025–2035 Projection

What is ADENOSCAN and what does its label position in cardiac imaging?

ADENOSCAN is the brand name for regadenoson, a selective adenosine A2A receptor agonist used for pharmacologic stress testing in patients unable to exercise adequately, primarily for myocardial perfusion imaging (MPI).

Core clinical use pattern (commercially important):

• Delivered as a fixed-dose IV regadenoson injection for pharmacologic stress MPI.
• Used in routine cardiology and imaging pathways where rapid, standardized stress is valued versus infusion-based alternatives.

Commercial implication: Regadenoson is embedded in imaging protocols for cardiology workflows. That places demand partly under reimbursement policy and partly under modality mix (SPECT MPI) versus competing pathways (stress echocardiography, PET, CT).

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What is the clinical-trials status and why does it matter to near-term demand?

ADENOSCAN/regadenoson has a long product lifecycle and is typically not driven by brand-new Phase 3 programs. Market traction historically depends on:

• Comparative clinical adoption versus competing pharmacologic stress agents (including adenosine and dipyridamole),
• Guideline and protocol inclusion in nuclear cardiology,
• Payer coverage and imaging reimbursement dynamics,
• Generic entry timing (not trial outcomes).

Practical clinical-trials reality for investors and R&D planners:

• For mature products, “trials update” translates into: new evidence from post-approval studies, registry data, comparative effectiveness analyses, and label expansions rather than pivotal Phase 3 readouts.
• Demand is less sensitive to incremental efficacy unless it changes how imaging is reimbursed or preferred by payers and ordering physicians.

Actionable takeaway for projections: In a mature regimen product like regadenoson, the dominant demand drivers are competitive dynamics (brand vs generics), imaging reimbursement, and site-of-care volume, not late-stage clinical breakthroughs.

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What does the competitive landscape look like (brand vs generics) and how does it drive pricing?

Regadenoson is a widely marketed pharmacologic stress agent, and generic regadenoson competition is the main pricing and share determinant versus the originator brand.

Mechanism of market pressure:

• Fixed-dose IV products experience fast wholesale price compression once generics stabilize.
• Adoption remains protocol-driven, but prescribing shifts to lowest net cost when formularies allow.

Implication for revenue:

• ADENOSCAN brand revenue typically declines after generic availability unless the brand retains coverage advantages through contracting, health-system relationships, or premium procurement terms.

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How does the MPI market shape regadenoson demand?

Regadenoson demand tracks with pharmacologic stress MPI utilization, which is influenced by:

• Cardiovascular disease prevalence,
• Number of stress tests performed in outpatient and hospital settings,
• Patient mix (age, inability to exercise),
• Imaging mix and modality substitution (PET MPI, CT, stress echo).

Market sizing logic (investable structure):

1. Total stress testing volume (pharmacologic + exercise).
2. Share of tests that use MPI.
3. Within MPI, share that uses pharmacologic stress.
4. Within pharmacologic stress, share using regadenoson.
5. Net price after discounts, rebates, and generic competition.

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Clinical and policy factors that change payer coverage (and therefore market size)

Key drivers that can shift utilization and reimbursement for nuclear cardiology include:

• CMS and payer policies affecting diagnostic coverage,
• Appropriateness criteria enforcement and utilization management,
• Shifts in coverage for nuclear MPI versus alternatives (PET MPI, CT-based evaluation, stress echo).

Commercial knock-on effects:

• If payers tighten coverage for lower-risk indications, volume falls.
• If payers promote imaging pathways that favor pharmacologic convenience, regadenoson demand can remain resilient even when overall stress testing declines.

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What is the forecast for ADENOSCAN/regadenoson through 2035?

Base-case structure (volume-weighted, net-price driven)

A credible 2025–2035 forecast for ADENOSCAN must reflect two simultaneous trends:

• Volume: tied to MPI and pharmacologic stress test utilization.
• Price: constrained by ongoing generic competition and tender dynamics.

Projection (directional, business-useful):

• Market growth: modest to low single-digit CAGR for regadenoson total market value depending on MPI volume trends and reimbursement.
• Brand ADENOSCAN revenue: declines structurally after generic penetration, then flattens at a reduced base tied to contracted accounts.

Forecast table (market and brand)

Note: No reliable, source-grounded numeric baseline for ADENOSCAN revenues or regadenoson total market value is provided in the supplied materials; projections below are therefore stated as scenario ranges rather than unverified dollar figures.

Horizon	Regadenoson total market (value)	ADENOSCAN brand revenue (value)	Dominant driver
2025	Low growth or flat	Declining to flat	Generic net-price compression
2026–2028	Low single-digit growth	Gradual decline or stabilization	MPI utilization + contracting
2029–2031	Mid single-digit volume offsets pricing	Further stabilization at low brand share	MPI protocol inertia vs substitution
2032–2035	Stable to modest growth	Flat to slow decline	Long-run reimbursement and modality mix

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What product-specific risks and upside points should be built into the model?

Risks

• Generic pricing pressure: repeated price compression in contracted channels.
• Modality substitution: growth in PET MPI and CT workflows that reduce nuclear MPI dependency.
• Reimbursement tightening: utilization management and appropriateness criteria that reduce marginal studies.
• Formulary renegotiation cycles: brand capture erodes when generics gain preferred status.

Upside

• Protocol standardization: institutions keep regadenoson as default pharmacologic agent if workflow reliability remains valued.
• Patient-level adoption: regadenoson’s fixed-dose simplicity can sustain use in centers emphasizing throughput.
• Coverage expansion: if payers broaden coverage for pharmacologic stress MPI, volume can offset price pressure.

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What R&D and BD moves are likely to matter for this molecule class?

For regadenoson, R&D strategy typically shifts from efficacy trials to:

• Formulation and device differentiation (where feasible),
• Evidence generation for subpopulations tied to reimbursement and protocol selection,
• Combination or pathway studies that support imaging appropriateness.

From a business perspective, the highest leverage often sits in:

• Access contracting and formulary strategy for brand life extension,
• Lifecycle evidence programs that defend guideline inclusion and payer confidence.

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Key Takeaways

• ADENOSCAN (regadenoson) is a mature pharmacologic stress MPI agent where demand is protocol-driven and reimbursement-sensitive rather than trial-outcome driven.
• Near-term market performance hinges on generic competition, MPI utilization, and payer reimbursement policy.
• The base-case 2025–2035 outlook is modest regadenoson market growth with ADENOSCAN brand revenue decline or stabilization at a reduced share.
• Model forecasts should be built on a volume x net-price framework, with substitution risk from PET MPI and CT workflows.

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FAQs

1. Is ADENOSCAN still clinically used for myocardial perfusion imaging?
   Yes. It remains a standard pharmacologic stress option in cardiac imaging protocols for patients unable to exercise adequately.

2. What most affects ADENOSCAN revenue: clinical outcomes or pricing?
   Pricing and access dominate once generics are available. Clinical outcomes matter most for protocol and coverage retention.

3. How does the MPI market influence regadenoson demand?
   Regadenoson demand scales with the number of pharmacologic stress MPI studies performed and the share of those studies that use regadenoson.

4. What substitution threats should be modeled?
   PET MPI and CT-based pathways can reduce nuclear MPI study share in some healthcare systems, pressuring long-run volume growth.

5. What is the most realistic long-run outlook for the brand?
   The brand typically stabilizes at a lower share post-generic penetration, with revenue driven by contracted accounts and net price rather than innovation.

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References

[1] FDA. ADENOSCAN (regadenoson) Prescribing Information. U.S. Food and Drug Administration.
[2] Label and safety information for regadenoson and pharmacologic stress myocardial perfusion imaging use. ADENOSCAN (regadenoson) product labeling. U.S. Food and Drug Administration.