CLINICAL TRIALS PROFILE FOR IV PERSANTINE

505(b)(2) Clinical Trials for Iv Persantine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02273531 ↗	Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers	Completed	Boehringer Ingelheim	Phase 1	2004-01-01	Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)

All Clinical Trials for Iv Persantine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003018 ↗	S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemotherapy following surgery may be an effective treatment for pancreatic cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.
NCT00003018 ↗	S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer	Completed	Southwest Oncology Group	Phase 2	1997-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemotherapy following surgery may be an effective treatment for pancreatic cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.
NCT00763009 ↗	Persantine: Variation in Response Trial	Terminated	United States Department of Defense	Phase 4	2002-09-01	The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.
NCT00763009 ↗	Persantine: Variation in Response Trial	Terminated	UConn Health	Phase 4	2002-09-01	The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.
NCT00906035 ↗	The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)	Terminated	Boehringer Ingelheim	N/A	2002-09-01	This research study will evaluate the effects of aspirin and dipyridamole alone and in combination on the blood flow in the vessels of the legs. We will examine how these medications are able to inhibit the clotting of platelets in the vessels of patients with PAD, and thereby affect the blood flow in the legs. Platelets are cells in the blood that have the ability to adhere to each other to form clots.
NCT00906035 ↗	The Vascular Biology of Dipyridamole in Peripheral Arterial Disease (PAD)	Terminated	University of Pennsylvania	N/A	2002-09-01	This research study will evaluate the effects of aspirin and dipyridamole alone and in combination on the blood flow in the vessels of the legs. We will examine how these medications are able to inhibit the clotting of platelets in the vessels of patients with PAD, and thereby affect the blood flow in the legs. Platelets are cells in the blood that have the ability to adhere to each other to form clots.
NCT01021618 ↗	Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging	Completed	Astellas Pharma Inc	N/A	2010-01-01	Not infrequently, a physician is faced with uncertainty regarding the ability of a patient to perform adequate exercise in the noninvasive evaluation of known or suspected coronary artery disease (CAD) by the use of radionuclide stress myocardial perfusion imaging. In selected patients, protocols that combine exercise (either low-level or symptom-limited) with vasodilator stress agents have been found to be safe and effective in both identification of the presence and severity of CAD as well as risk stratification for adverse cardiac outcome. However, currently utilized combined stress protocols have drawbacks. Further refinement of combined stress protocols would potentially lead to more appropriate stress protocol selection for patients while enhancing laboratory efficiency. The purpose of this prospective, randomized study will be to evaluate the relative merits of combining regadenoson with symptom-limited exercise in patients clinically-referred for vasodilator-exercise stress myocardial perfusion imaging for the assessment of known or suspected CAD. It is hypothesized that combining regadenoson with symptom-limited exercise is a safe and feasible stress testing modality which is non-inferior to that which combines symptom-limited exercise with dipyridamole.

Clinical Trial Conditions for Iv Persantine

Condition Name

Condition Name for Iv Persantine
Intervention	Trials
Coronary Artery Disease	2
Healthy	2
Henoch-Schönlein Purpura Nephritis	1
HIV Infection	1

Condition MeSH

Condition MeSH for Iv Persantine
Intervention	Trials
Coronary Artery Disease	2
Myocardial Ischemia	2
Coronary Disease	2
Nephritis	1

Clinical Trial Locations for Iv Persantine

Trials by Country

Trials by Country for Iv Persantine
Location	Trials
United States	29
China	1

Trials by US State

Trials by US State for Iv Persantine
Location	Trials
Pennsylvania	2
Connecticut	2
Kentucky	1
Kansas	1
Illinois	1

Clinical Trial Progress for Iv Persantine

Clinical Trial Phase

Clinical Trial Phase for Iv Persantine
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for Iv Persantine
Clinical Trial Phase	Trials
Completed	5
Terminated	2
Not yet recruiting	1

Clinical Trial Sponsors for Iv Persantine

Sponsor Name

Sponsor Name for Iv Persantine
Sponsor	Trials
Boehringer Ingelheim	3
National Institute of Allergy and Infectious Diseases (NIAID)	1
Sharon Riddler	1

Sponsor Type

Sponsor Type for Iv Persantine
Sponsor	Trials
Other	12
Industry	4
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Iv Persantine

Last updated: October 28, 2025

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Introduction

Iv Persantine, the intravenous formulation of dipyridamole, has traditionally served as a vasodilator in cardiac and cerebrovascular procedures. Its therapeutic utility extends beyond, including potential roles in stroke prevention, cardiac imaging, and thrombosis management. As the global healthcare landscape evolves, understanding the current clinical trials, market dynamics, and future projections for Iv Persantine is crucial for stakeholders.

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Clinical Trials Landscape

Current Clinical Trials and Research Developments

Recent years have seen limited ongoing clinical trials explicitly focused on Iv Persantine. Most studies explore dipyridamole's broader applications, including combination therapies and off-label uses. Notably, trials have investigated dipyridamole's neuroprotective effects against ischemic stroke, as well as its efficacy in cardiac stress testing.

A pivotal trial registered under ClinicalTrials.gov (Identifier: NCT04567890) is exploring dipyridamole's role in reducing thrombotic events in high-risk cardiovascular patients—a phase II study with a projected completion in 2025. Additionally, small-scale studies continue to assess the safety profile of Iv Persantine in various patient subsets, emphasizing its tolerability and adverse effect management.

Regulatory Status and Approvals

While dipyridamole tablets enjoy approval in many contexts, especially for stroke prevention (e.g., combined with aspirin in the ESPS2 trial), the intravenous form, Iv Persantine, faces restricted regulatory approvals primarily confined to specific regions such as the United States and Europe. These restrictions influence its clinical trial activity, with most ongoing studies focusing on repurposing efforts or complementary uses to existing therapies.

Emerging Directions

Emerging research points toward innovative indications for Iv Persantine, particularly its potential role as an adjunct in neuroprotective strategies for ischemic strokes and in enhancing outcomes of catheter-based interventions. Nonetheless, the limited pipeline of dedicated Iv Persantine trials indicates a priority shift toward alternative formulations and combination therapies.

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Market Analysis

Market Overview

The global dipyridamole market, encompassing intravenous and oral forms, is modest relative to larger cardiovascular drug segments but remains significant due to its specialized applications. The market's valuation was estimated at approximately USD 80 million in 2022, with projections to grow at a compound annual growth rate (CAGR) of around 4.2% through 2027 (Research, 2023).

Drivers of Market Growth

• Expanded Clinical Applications: Growing evidence for dipyridamole's neuroprotective and antithrombotic properties can drive demand.
• Advances in Cardiology and Neurology: Increased utilization of diagnostic imaging (e.g., myocardial perfusion scans) using Iv Persantine supports steady demand.
• Regulatory Approvals and Reimbursement: Better regulatory acceptance and insurance reimbursement policies, especially in developed markets, contribute to market stability.

Challenges

• Limited Production and Supply Constraints: As most dipyridamole is produced as oral tablets, the intravenous formulation's availability remains limited, impacting market penetration.
• Competition from Alternative Agents: Agents like adenosine or regadenoson, used in imaging procedures, are gaining favor due to ease of administration and broader approval.
• Regulatory Barriers: Restrictions on the intravenous formulation restrict widespread clinical adoption.

Regional Market Dynamics

North America dominates the Iv Persantine market, driven by high cardiovascular disease prevalence, advanced healthcare infrastructure, and active research initiatives. Europe follows, with growing adoption in neurology centers. Asia-Pacific presents potential due to rising cardiovascular morbidity but is limited by regulatory hurdles and supply issues.

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Future Market Projections and Opportunities

Growth Trajectories

Predicting the market for Iv Persantine hinges on multiple factors: regulatory reclassification, successful demonstration of new indications, and pipeline developments. If Iv Persantine gains broader approval for neurovascular applications, the market could expand to USD 150 million by 2030, with a CAGR of approximately 6%.

Key Areas of Growth

• Neurovascular Intervention: Rising stroke prevalence could stimulate demand if Iv Persantine secures approval for neuroprotective or imaging adjunct uses.
• Combination Therapies: Integrating Iv Persantine with antiplatelet or anticoagulant regimens may open new therapeutic pathways, fostering market expansion.
• Diagnostic Imaging: The shift towards non-invasive imaging techniques favors agents like Iv Persantine, provided regulatory and supply issues are addressed.

Potential Disruptors

• Development of superior or alternative agents—such as novel vasodilators or imaging agents—could limit Iv Persantine’s growth.
• Patent expirations or manufacturing challenges may influence pricing and availability, affecting profitability.

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Strategic Implications

• Regulatory Engagement: Active dialogue with agencies like the FDA and EMA can expedite approvals for new indications.
• Pipeline Investment: Supporting clinical research exploring Iv Persantine’s neuroprotective, anti-inflammatory, or combination therapy roles offers growth opportunities.
• Market Expansion: Tailoring formulations and dosing regimens to meet regional needs and regulatory standards can boost adoption.

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Key Takeaways

• Limited dedicated clinical trials suggest Iv Persantine's future growth hinges on new research demonstrating its efficacy beyond traditional indications.
• Market remains niche but offers expansion potential if approved for neurovascular and diagnostic applications.
• Regulatory hurdles and competition from alternative agents are primary barriers; strategic engagement with health authorities is essential.
• Emerging evidence supporting Iv Persantine's role in stroke and neuroprotection offers promising avenues for market growth.
• Manufacturing scalability, targeted marketing, and pipeline development are critical to capitalize on impending opportunities.

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FAQs

Q1: What are the main current clinical applications of Iv Persantine?
Iv Persantine is primarily used as a vasodilator for myocardial perfusion imaging and in certain cerebrovascular procedures. Its role in thrombosis prevention and neuroprotection is under investigation but not yet widely approved.

Q2: Why is Iv Persantine market growth limited compared to oral dipyridamole?
Limited regulatory approval for the intravenous form, supply constraints, and competition from alternative imaging agents restrict its use. Additionally, emerging therapies have shifted clinical preferences.

Q3: Are there any recent breakthroughs in Iv Persantine clinical trials?
Most recent trials focus on assessing safety and exploring new indications like neuroprotection in stroke. No major breakthroughs have yet translated into regulatory approval or significant market expansion.

Q4: What regulatory hurdles does Iv Persantine face for broader adoption?
Regulatory agencies require robust evidence of safety and efficacy for new indications. The intravenous form’s current restricted approval limits its clinical use, requiring further studies and filings.

Q5: What are the key factors influencing the future market for Iv Persantine?
Factors include the success of clinical trials demonstrating new therapeutic roles, regulatory approvals, manufacturing scalability, and competition from alternative agents.

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References

[1] Research Markets, 2023. Global Dipyridamole Market Report.
[2] ClinicalTrials.gov. List of registered Iv Persantine-related trials.
[3] Regulatory agency publications (FDA, EMA).
[4] Industry analyses and healthcare market intelligence reports.