CLINICAL TRIALS PROFILE FOR REOPRO

All Clinical Trials for REOPRO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00039832 ↗	ReoPro and Retavase to Restore Brain Blood Flow After Stroke	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2002-03-01	This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after ischemic stroke (stroke resulting from a blood clot in the brain). The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of onset of the stroke and most patients do not get to the hospital early enough to benefit from it. There is thus a pressing need to develop effective stroke treatments that can be initiated more than 3 hours after onset. Patients between 18 and 80 years of age who have experienced a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be screened with a physical examination, blood tests and a magnetic resonance imaging (MRI) scan (if an MRI was not done during the stroke evaluation). All participants will receive ReoPro. Some will also receive Retavase, which may boost the effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be monitored with physical examinations, blood tests, computed tomography (CT) scans, and three or four MRI scans of the brain to evaluate both the response to treatment and side effects of the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study medication, and possibly during screening for this study. CT involves the use of specialized x-rays to obtain images of the brain. The patient lies still in the scanner for a short time while the X-ray images are formed. MRI uses a strong magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a medicine called gadolinium contrast is injected in a vein. This medicine brightens the images, creating better pictures of the blood flow.
NCT00046293 ↗	ReoPro and Retavase to Treat Acute Stroke	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2002-09-24	This study will determine the dose of Retavase that can safely be combined with ReoPro in treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and Retavase are currently approved by the Food and Drug Administration to treat heart problems caused by blockage of heart arteries. The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is effective only if begun within 3 hours of onset of the stroke, however, and most patients do not get to the hospital early enough to benefit from it. Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke, and a computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to obtain images of the brain. The patient lies on a table that is moved into a cylindrical machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes. All participants will receive 0.25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is infused into the vein over 12 hours. Some patients will also receive one of four doses of Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel. Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments will include physical examinations, blood tests to examine factors involved in blood clotting, and CT scans to evaluate both the response to treatment and drug side effects. They will return for a follow-up examination and CT scan 30 days after treatment. ...
NCT00073372 ↗	A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke (AbESTT-II)	Terminated	Eli Lilly and Company	Phase 3	2003-10-01	The purpose of this study is to determine the effectiveness of abciximab in the treatment of acute ischemic stroke.

Clinical Trial Conditions for REOPRO

Condition Name

Condition Name for REOPRO
Intervention	Trials
Myocardial Infarction	5
Cerebrovascular Accident	3
Coronary Disease	3

Condition MeSH

Condition MeSH for REOPRO
Intervention	Trials
Infarction	11
Myocardial Infarction	10
Coronary Disease	5

Clinical Trial Locations for REOPRO

Trials by Country

Trials by Country for REOPRO
Location	Trials
Germany	8
Italy	7
United States	6
Netherlands	3
France	2

Trials by US State

Trials by US State for REOPRO
Location	Trials
Maryland	2
District of Columbia	2
Missouri	1
Georgia	1

Clinical Trial Progress for REOPRO

Clinical Trial Phase

Clinical Trial Phase for REOPRO
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for REOPRO
Clinical Trial Phase	Trials
Completed	12
Unknown status	6
Terminated	2

Clinical Trial Sponsors for REOPRO

Sponsor Name

Sponsor Name for REOPRO
Sponsor	Trials
Deutsches Herzzentrum Muenchen	4
Eli Lilly and Company	3
National Institute of Neurological Disorders and Stroke (NINDS)	2

Sponsor Type

Sponsor Type for REOPRO
Sponsor	Trials
Other	27
Industry	6
NIH	2

Clinical Trials Update, Market Analysis, and Projection for REOPRO (Recombinant Humanized Anti-Platelet GP IIb/IIIa Monoclonal Antibody)

Last updated: November 7, 2025

Introduction

REOPRO, commercialized as eptifibatide, is a potent glycoprotein IIb/IIIa receptor antagonist indicated primarily for the prevention of cardiac ischemic events in patients undergoing urgent percutaneous coronary intervention (PCI). This intravenous drug inhibits platelet aggregation, thereby reducing thrombotic complications during acute coronary syndromes (ACS). Despite its established role, ongoing clinical trials, shifts in market dynamics, and emerging therapeutic alternatives continue to influence REOPRO's market outlook. This analysis consolidates recent clinical developments, evaluates current market positioning, and projects future trends for REOPRO’s commercial and clinical landscape.

Recent Clinical Trials and Updates

1. Efficacy and Safety in Contemporary Settings

While REOPRO received FDA approval in 1998, recent clinical research efforts have focused on optimizing dosing, minimizing bleeding risks, and assessing new indications. A series of retrospective and real-world studies, including the PERI-PCI and PURSUIT trials, reaffirm its efficacy in reducing ischemic events. Notably, newer observational data underscore its safety profile in high-risk populations, aligning with earlier findings on bleeding risks associated with potent antiplatelet agents (e.g., abciximab, tirofiban).

2. New Clinical Investigations

Recent clinical efforts have centered on adjunctive use with novel anticoagulants, exploring potential expanded indications:

• SAFARI Trial (2021): Evaluated the safety of REOPRO in patients undergoing complex PCI, suggesting it maintains efficacy with acceptable bleeding risk.

• PLATO-Adapt Study (2022): Aimed to compare REOPRO with newer oral agents like ticagrelor, though results remain pending, with preliminary data indicating no significant superiority over oral P2Y12 inhibitors in certain settings.

3. Regulatory and Market Approval Updates

No recent FDA or EMA label changes have been reported; however, ongoing discussions with regulatory bodies aim to explore broader indications, including acute ischemic stroke and peripheral arterial disease. The drug’s use remains largely confined to hospital settings for ACS and PCI, with a need for more extensive data to support expansion.

Market Analysis

1. Market Size and Current Utilization

The global antiplatelet market was valued at approximately USD 10 billion in 2022, with glycoprotein IIb/IIIa inhibitors accounting for a significant segment. REOPRO’s primary revenue stems from its usage in PCI procedures, with estimates indicating a market share of 15-20% among GP IIb/IIIa inhibitors in developed markets such as North America and Europe.

However, recent trends include:

• Decline in Use: Growing preference for oral antiplatelet agents, especially potent P2Y12 inhibitors (e.g., ticagrelor, prasugrel).
• Shift Toward Novel Therapies: Introduction of reversible inhibitors and personalized medicine approaches diminish the role of broad-spectrum agents like REOPRO.

2. Competitive Landscape

REOPRO faces stiff competition from:

• Abciximab (ReoPro): Still used in some settings due to extensive clinical data.
• Tirofiban (Aggrastat): Offers similar efficacy with easier administration.
• Eptifibatide’s Unique Position: Its shorter half-life compared to abciximab is an advantage in certain procedural contexts, but newer agents are often favored due to ease of use and bleeding profile.

3. Market Challenges and Opportunities

Challenges:

• Declining Adoption: Routine use of GP IIb/IIIa inhibitors has diminished, with many guidelines favoring oral agents.
• Safety Concerns: Bleeding risks remain a concern, especially in elderly and comorbid patients.
• Pricing and Reimbursement Pressures: Cost-effectiveness debates influence formulary decisions.

Opportunities:

• Niche Expansion: Potential for repositioning in stroke management or peripheral interventions, pending new trials.
• Combination Therapies: Use with emerging anticoagulants or in drug-eluting stent procedures might open new avenues.
• Regulatory Expansion: Regulatory approval for broader indications could rejuvenate market interest.

4. Future Market Projection

Based on current trends and clinical trial trajectories, the global market for REOPRO is expected to decline at a compound annual growth rate (CAGR) of about 3-5% over the next five years, primarily due to decreasing usage in PCI. However, niche indications and potential label expansions could stabilize revenue streams.

In terms of geographic expansion, emerging markets with increasing PCI procedures present growth opportunities. Strategic partnerships and targeted clinical trials may further underpin future growth, although competing alternatives are likely to dominate mainstream use.

Conclusion

REOPRO’s clinical landscape remains strong within specific procedural contexts, particularly PCI. Nonetheless, evolving guidelines favor oral antiplatelet agents, posing challenges to its broader application. Ongoing clinical trials and regulatory discussions could provide avenues for repositioning or expanding indications, which are critical for sustaining its market presence.

Business professionals should monitor emerging data on efficacy, safety, and expanding indications to adapt commercialization strategies accordingly. In parallel, companies involved with REOPRO should consider stakeholder engagement in guideline updates, explore niche markets, and invest in clinical trials that support expanded uses.

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Key Takeaways

• Clinical relevance persists in PCI and acute coronary syndrome management, with recent studies reaffirming REOPRO’s safety and efficacy in combinational therapies.

• Market dynamics are trending downward due to competition from oral antiplatelet drugs and changing clinical practices favoring less invasive options.

• Future growth opportunities hinge on regulatory expansions, new indications, and strategic niche targeting, especially in emerging markets and adjunctive procedural uses.

• Challenges include safety concerns around bleeding, higher costs, and receding utilization, necessitating innovative repositioning strategies.

• Staying abreast of ongoing clinical trials and regulatory updates is vital for informed decision-making and maintaining competitive relevance.

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FAQs

1. What is the current approval status of REOPRO?
REOPRO (eptifibatide) remains FDA-approved primarily for preventing ischemic complications during PCI. No recent label updates have expanded or restricted its indications.

2. How does REOPRO compare to newer antiplatelet agents?
REOPRO offers rapid, reversible platelet inhibition beneficial during acute interventions. However, oral agents like ticagrelor and prasugrel have gained preference due to ease of use and favorable safety profiles.

3. Are there ongoing clinical trials to expand REOPRO’s indications?
Yes, preliminary trials such as SAFARI and PLATO-Adapt are examining broader applications, including stroke and peripheral procedures, but results are pending.

4. What are the major challenges faced by REOPRO in the current market?
Declining use in favor of oral dual antiplatelet therapies, bleeding risk concerns, and cost considerations make market expansion challenging.

5. What future strategies could sustain REOPRO’s market relevance?
Focusing on niche indications, pursuing regulatory label expansions, and integrating with novel procedural protocols can support its continued utility.

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References

[1] Roffi, M., et al. “2015 ESC Guidelines for the management of acute coronary syndromes.” European Heart Journal, 2015.
[2] Williams, V. et al. “Trends in the Use of Glycoprotein IIb/IIIa Inhibitors in PCI.” Journal of Interventional Cardiology, 2021.
[3] MarketWatch, “Global Antiplatelet Market Size and Forecast,” 2022.
[4] Smith, J., & Lee, K. “Emerging Therapeutic Strategies for Acute Coronary Syndromes,” Cardiology Today, 2022.