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
Myocardial Ischemia	3
Coronary Artery Disease (CAD)	3
Sickle Cell Disease	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
Peru	1
Canada	1
United Kingdom	1

Trials by US State

Trials by US State for LEXISCAN
Location	Trials
Illinois	12
Missouri	11
California	10
Maryland	7
Massachusetts	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
Unknown status	3

Clinical Trial Sponsors for LEXISCAN

Sponsor Name

Sponsor Name for LEXISCAN
Sponsor	Trials
Astellas Pharma Inc	13
Astellas Pharma US, Inc.	10
Astellas Pharma Global Development, Inc.	6

Sponsor Type

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

Last updated: May 22, 2026

Lexiscan (Regadenoson) clinical trials update, market analysis and 2025–2035 projection

Lexiscan (regadenoson) is an established FDA-approved diagnostic radiopharmaceutical-adjacent vasodilator used to induce coronary vasodilation during pharmacologic stress myocardial perfusion imaging (MPI). Clinical development activity is limited versus new molecular entities, with the main market drivers now coming from (1) imaging volume trends for ischemic heart disease, (2) competitive dynamics in pharmacologic stress agents, (3) hospital/ASC contracting and imaging protocol standardization, and (4) manufacturer supply continuity.

Market outlook (high level): Regadenoson’s near-term revenue growth is expected to track procedure volume and replacement of aging competitors rather than step-change from new trials. Longer-term growth depends on diffusion of MPI workflows, payer mix, and mix shift toward higher-frequency surveillance or broader guideline adoption, offset by imaging modality substitution (notably PET where adopted) and price pressure.

Clinical trials update (current operating reality): Public clinical trial registrations and publications remain sparse relative to the decade of maturity of the drug. The majority of incremental evidence tends to be comparative protocol studies, real-world imaging workflow analyses, and label-expansion-adjacent investigations rather than major phase 3 pivot trials.

Because “Lexiscan clinical trials update, market analysis and projection” requires drug-specific, time-stamped datapoints (trial identifiers, enrollment status, endpoints, recruiting dates; revenue and unit data; and any changes to regulatory status), and because no supporting source material was provided, a complete and accurate, reference-cited market and trials update cannot be produced.

What clinical trials are ongoing or recently completed for Lexiscan (regadenoson)?

Featured snippet answer: Publicly tracked Lexiscan trials are typically protocol or comparative studies in pharmacologic stress MPI workflows; major phase 3 “registration” style trials are limited for a mature, marketed product.

Which NCT trials track regadenoson stress MPI protocols?

No trial identifiers (NCT numbers), current status (recruiting/completed), or publication links are available in the provided context to enumerate ongoing or recently completed studies.

What endpoints dominate Lexiscan studies (MPI, hemodynamics, safety)?

No source-cited study endpoint breakdown is available here.

How do Lexiscan studies address cardiac safety in comorbidity subgroups?

No subgroup safety trial datasets are available in the provided context.

What is the Lexiscan FDA status and Orange Book exclusivity posture?

Featured snippet answer: Lexiscan is FDA-approved for pharmacologic stress to produce increased coronary blood flow for MPI. Exact Orange Book listing details (listed patents, exclusivity end dates, and any Paragraph IV risk) are not available in the provided context.

Is Lexiscan’s regulatory exclusivity still active?

No exclusivity or listed-patent timeline can be cited without Orange Book data.

What labeling limitations drive clinical use?

No label-revision specifics can be provided without the current approved label text as a source.

How strong is the patent estate for regadenoson (Lexiscan) and what generic entry risks exist?

Featured snippet answer: Generic risk depends on patent and regulatory listing status. A patent-by-patent gap analysis requires specific listed patents and expiration dates.

Which patents protect regadenoson manufacturing or formulations?

No patent numbers or expiration dates can be cited without sourced patent listing data.

Are there any Paragraph IV challenges tied to Lexiscan?

No Paragraph IV litigation or ANDA filing details are provided in the input.

What is the current Lexiscan market size, growth drivers, and competitive landscape?

Featured snippet answer: Regadenoson competes in pharmacologic stress testing for MPI, with market performance driven by procedure volume and imaging protocol adoption rather than new mechanism-of-action entrants.

Which competing agents affect Lexiscan pricing and volume?

No competitor revenue shares, pricing benchmarks, or contracting effects can be cited without market data sources.

How does site of care (hospital vs ASC) affect Lexiscan demand?

No payer or contract-level utilization metrics are available in the provided context.

What substitutes can pressure Lexiscan utilization (PET MPI, dobutamine, adenosine)?

No sourced modality substitution rates can be provided here.

When does Lexiscan lose exclusivity and how do that timing affect generic launches?

Featured snippet answer: Exclusivity loss and patent expiry timing determine ANDA launch windows. Exact dates require Orange Book and patent docket data.

How many years of runway exist for brand survival?

No timeline can be stated without patent and exclusivity end dates.

What launch scenarios are most likely (authorized generic, first-to-file, settlement)?

No litigation or settlement terms are available to map scenarios.

What do regadenoson clinical outcomes and safety data show in real-world practice?

Featured snippet answer: Real-world safety and hemodynamic tolerability are key for protocol standardization in pharmacologic stress testing, but a cited, quantitative summary requires access to post-marketing studies and registry data.

What adverse events are monitored and how do they impact utilization?

No AE incidence figures can be cited without sources.

How does renal impairment or bronchospasm risk influence dosing and selection?

No label-based or observational dosing adoption data can be provided without sources.

How does Lexiscan compare with regadenoson alternatives and other pharmacologic stress drugs?

Featured snippet answer: Comparative performance typically focuses on imaging adequacy, ease of administration, hemodynamic response consistency, and tolerability.

What differences matter for clinicians (dose, infusion vs bolus, contraindications)?

No sourced comparison tables can be generated without reference data.

Which comparisons are supported by head-to-head studies?

No head-to-head evidence list is available in the provided context.

2025–2035 revenue and volume projection for Lexiscan: base, bull, and bear cases

Featured snippet answer: A defensible projection requires anchored inputs: current annual revenue, unit volumes, growth rate by procedure volume, price per dose trajectory, market share shifts, and any generic entry or supply changes.

What inputs are required for projection modeling?

No numeric inputs were supplied.

What range of annual CAGR is plausible without generics and without label changes?

No model can be stated without baseline market size and price/unit assumptions grounded in sources.

Key Takeaways

• Lexiscan (regadenoson) is a mature pharmacologic stress MPI agent with clinical trial activity that is typically protocol-focused rather than major phase 3 registration.
• Market performance is likely dominated by imaging procedure volume, site-of-care contracting, and modality substitution pressures.
• A quantified trials update and 2025–2035 market projection cannot be completed as requested without cited, drug-specific data for clinical trial identifiers/status and market sizing/pricing/volume inputs.

FAQs

1. How do you verify Lexiscan dosing and contraindications in the latest FDA label?
2. What are the top NCT-listed Lexiscan regadenoson studies by status (recruiting, completed, results posted)?
3. What does Orange Book list for regadenoson, including listed patents and exclusivity end dates?
4. Which companies market regadenoson alternatives for pharmacologic stress MPI in the US?
5. What market indicators best predict future regadenoson utilization (MPI volumes, PET adoption, payer policy)?

References

(No references provided because no drug-specific sources were supplied in the input.)