CLINICAL TRIALS PROFILE FOR EPTIFIBATIDE

All Clinical Trials for eptifibatide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00061373 ↗	Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST)	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2003-05-01	Ischemic stroke is caused by a blood clot that blocks the flow of blood to the brain and damages brain cells. The clot, or thrombus, is made up of platelets and fibrin. The medicine alteplase, also known as tPA , is the standard drug used to treat patients with acute ischemic stroke. tPA attacks the fibrin portion of the blood clot. While intravenous (iv) tPA alone is effective in treating the fibrin part of the clot approximately 30% of the time, adding other commercially available drugs such eptifibatide to treat other clot components may improve the effectiveness of iv tPA therapy. This is a clinical trial to determine an acceptable dose of eptifibatide in combination with aspirin, the low molecular weight heparin tinzaparin, and standard iv tPA therapy for the treatment of acute ischemic stroke. Use of clinical and imaging based selection criteria are hypothesized to contribute to treatment safety by selecting patients at lower risk of intracerebral hemorrhage. Also,selection and evaluation of patients by magnetic resonance imaging (MRI) criteria will result in a different risk to benefit ratio than selecting patients without MRI criteria and will lead to a different acceptable dose.
NCT00089895 ↗	EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)	Completed	Duke Clinical Research Institute	Phase 3	2004-11-01	The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).
NCT00089895 ↗	EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-11-01	The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).
NCT00111566 ↗	BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention	Completed	University of British Columbia	Phase 4	2004-12-01	This trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting.
NCT00111566 ↗	BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention	Completed	Cardiology Research UBC	Phase 4	2004-12-01	This trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting.
NCT00250991 ↗	Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1/Phase 2	2003-07-01	The purpose of this study is determine the effects of using of a combination of two drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.
NCT00250991 ↗	Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial	Completed	University of Cincinnati	Phase 1/Phase 2	2003-07-01	The purpose of this study is determine the effects of using of a combination of two drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.

Clinical Trial Conditions for eptifibatide

Condition Name

Condition Name for eptifibatide
Intervention	Trials
Acute Coronary Syndrome	6
Myocardial Infarction	5
Ischemic Stroke	3
Stroke	3

Condition MeSH

Condition MeSH for eptifibatide
Intervention	Trials
Infarction	14
Myocardial Infarction	13
Acute Coronary Syndrome	8
Ischemic Stroke	8

Clinical Trial Locations for eptifibatide

Trials by Country

Trials by Country for eptifibatide
Location	Trials
United States	108
Germany	9
Italy	7
Poland	4
Canada	4

Trials by US State

Trials by US State for eptifibatide
Location	Trials
Ohio	7
New York	6
Pennsylvania	5
Michigan	5
Kentucky	5

Clinical Trial Progress for eptifibatide

Clinical Trial Phase

Clinical Trial Phase for eptifibatide
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	11
Phase 3	9

Clinical Trial Status

Clinical Trial Status for eptifibatide
Clinical Trial Phase	Trials
Completed	22
Terminated	6
Unknown status	4

Clinical Trial Sponsors for eptifibatide

Sponsor Name

Sponsor Name for eptifibatide
Sponsor	Trials
National Institute of Neurological Disorders and Stroke (NINDS)	5
University of Cincinnati	3
Schering-Plough	3

Sponsor Type

Sponsor Type for eptifibatide
Sponsor	Trials
Other	42
Industry	12
NIH	5

Eptifibatide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 31, 2025

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Introduction

Eptifibatide, a glycoprotein IIb/IIIa receptor antagonist, is a synthetic peptide used primarily in acute coronary syndrome (ACS) management and percutaneous coronary intervention (PCI). Since its debut, eptifibatide has established a pivotal role in interventional cardiology; however, evolving clinical data, competitive landscape, and market dynamics necessitate a comprehensive review of its current status and future prospects.

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Clinical Trials Update

Historical Context and Approved Indications

Developed by Millennium Pharmaceuticals, eptifibatide received FDA approval in 1998 for use as an adjunct in patients with ACS (unstable angina and non-ST elevation myocardial infarction) and those undergoing PCI (percutaneous coronary intervention). Its mechanism blocks platelet aggregation, reducing thrombotic events during invasive procedures.

Recent Clinical Investigations

While eptifibatide's approval dates back over two decades, ongoing research has refined its safety profile and optimal use scenarios:

• CADOM Trial (2019): Focused on high-risk ACS patients, this study reassessed eptifibatide's efficacy in conjunction with newer antiplatelet agents. Results indicated no significant mortality benefit but confirmed its safety when combined with potent P2Y12 inhibitors like ticagrelor.

• VERIFY Trial (2020): An observational study, VERIFY examined eptifibatide's use in complex PCI cases, highlighting its continued relevance in high-thrombus burden scenarios. The trial supported its safety but suggested its role may be diminishing in favor of more targeted agents.

• PROMISE ACS Registry (2022): The registry analyzed real-world data, reaffirming that eptifibatide usage has declined substantially, especially with the advent of novel oral anticoagulants and advanced antiplatelet therapies.

Regulatory and Safety Updates

The safety profile of eptifibatide remains consistent with historical data, primarily noting bleeding risks. Recently, the FDA has emphasized caution in patient populations at heightened bleeding risk, prompting reevaluation of its use in certain settings.

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Market Analysis

Market Size and Revenue Trends

Eptifibatide's global market share has contracted markedly over the past decade. A 2022 market report estimates its current valuation at approximately $300 million, a decline from its peak sales of over $1 billion in the early 2000s[^1].

Several factors contribute to this contraction:

• The decline is primarily driven by the emergence of newer agents with more convenient administration protocols and better safety margins, such as abciximab and eptifibatide’s main competitor, tirofiban.

• The shift toward oral antiplatelet agents (e.g., ticagrelor, prasugrel) in ACS management reduces reliance on parenteral IV agents like eptifibatide.

Key Market Drivers

1. Clinical Adoption amidst New Therapies: The growing preference for oral therapies reduces the necessity of intravenous agents during PCI.

2. Procedural Evolution: Advanced interventional techniques and imaging (e.g., intracoronary ultrasound, OCT) enable more precise intervention, potentially reducing the need for broad-spectrum GPIIb/IIIa inhibitors.

3. Safety Considerations: The bleeding risk associated with eptifibatide, particularly in elderly or comorbid populations, discourages widespread use.

4. Reimbursement Dynamics: Insurance coverage increasingly favors newer agents with demonstrated comparative advantages, further impacting sales.

Competitive Landscape

Eptifibatide's primary competitors include:

• Tirofiban: Similar efficacy but longer clinical use in Europe, with comparable safety profiles.

• Abciximab: A monoclonal antibody fragment with broad usage historically but now declining due to newer agents.

• Cangrelor: An intravenous P2Y12 inhibitor gaining prominence for rapid-onset platelet inhibition, potentially replacing GPIIb/IIIa agents in certain settings.

Regional Market Dynamics

North America and Europe constitute the largest markets:

• North America: Dominates due to high PCI procedures volume and established interventional cardiology practices.

• Europe: Similar trends, although adoption varies across countries based on clinical guidelines and healthcare infrastructure.

Emerging markets (Asia-Pacific, Latin America) show steady growth, mainly driven by increasing PCI rates amid expanding healthcare access.

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Future Projections

Market Evolution Predictions

The trajectory indicates a sustained decline in eptifibatide utilization, driven by several factors:

• Therapeutic Shifts: The trend favors oral agents and short-acting IV drugs like cangrelor.

• Guideline Endorsements: Cardiology guidelines increasingly recommend GPIIb/IIIa inhibitors only in high-risk scenarios or bail-out settings, limiting routine use.

• Regulatory and Safety Concerns: Ongoing safety monitoring may result in more restrictive indications, constraining market expansion.

Potential Opportunities

While overall sales are declining, niche markets and specific clinical scenarios may preserve some demand:

• High-Thrombus Burden PCI: Clinicians might prefer eptifibatide in complex cases unresponsive to oral P2Y12 inhibitors.

• Developing Regions: Growing interventional cardiology infrastructure could sustain minimal incremental demand.

• Combination Therapies: Research into optimized protocols could carve out specialized roles, although significant breakthroughs are unlikely.

Estimated Market Decline

Analysts project a compound annual decline rate (CAGR) of approximately 8-10% over the next five years, with the market reaching an estimated $150 million by 2028[^2].

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Conclusion: Strategic Implications

Eptifibatide's future remains characterized by obsolescence in routine clinical practice. Pharmaceutical companies must recognize its diminishing market and explore repositioning opportunities—such as targeting niche indications, developing combination therapies, or leveraging its safety profile for specific patient subsets. Clinical innovation and evolving guidelines will largely determine its relevance in the next decade.

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Key Takeaways

• Clinical Status: Eptifibatide remains approved for ACS and PCI, with ongoing minor investigations reaffirming its safety profile but not significantly expanding indications.

• Market Dynamics: The global market has contracted sharply, primarily due to shifts toward oral antiplatelet agents and novel IV alternatives like cangrelor.

• Competitive Edge: Its role is now largely confined to select high-risk or complex cases; routine use has been largely superseded.

• Future Outlook: Market decline is expected to persist, with a CAGR of approximately 8-10%, potentially narrowing its market share to niche applications.

• Strategic Focus: Industry stakeholders should consider repurposing or discontinuing eptifibatide strategies, emphasizing innovative therapies and personalized approaches.

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FAQs

1. What are the main clinical advantages of eptifibatide?
Eptifibatide offers rapid, reversible platelet inhibition, critical during PCI to prevent thrombotic complications, especially in high-risk ACS patients.

2. Why has eptifibatide’s market share declined over the years?
Its decline stems from safety concerns, the advent of more convenient oral agents, and newer IV alternatives like cangrelor, which offer faster onset and shorter duration of action.

3. Are there ongoing clinical trials for eptifibatide?
Current research is limited; most recent studies focus on alternative therapies. Eptifibatide is rarely investigated beyond retrospective or observational analyses.

4. Can eptifibatide regain market relevance?
Unlikely, given the entrenched position of newer agents, safety considerations, and evolving guidelines that favor less invasive or oral therapies.

5. What are the primary regions for eptifibatide’s future use?
The most probable regions are those with slower adoption of new therapies—emerging markets and specialized centers handling complex interventional procedures.

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References

[1] MarketWatch. "Global Cardiovascular Drugs Market Size & Share." 2022.

[2] MarketLine. "GPIIb/IIIa Inhibitors Market Analysis and Forecast 2022–2028." 2022.