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
Austria	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
Technische Universität München	2

Sponsor Type

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

REOPRO Market Analysis and Financial Projection

Last updated: February 6, 2026

What is the current status of clinical trials for Reopro?

ReoPro (abciximab) is a monoclonal antibody targeting glycoprotein IIb/IIIa receptors on platelets. It was developed by Eli Lilly and Johnson & Johnson. Its primary indication remains for preventing ischemic events during percutaneous coronary interventions (PCI).

As of 2023, ReoPro has completed the initial clinical trial phases and is approved in multiple markets. However, ongoing research explores additional applications, including acute coronary syndrome (ACS) management and secondary prevention in cardiovascular disease.

Recent updates show that several studies explore lower doses or alternative administration protocols to extend its market potential. No new Phase III trials are currently registered or underway on ClinicalTrials.gov. Most recent activity involves post-market surveillance and subgroup analyses to optimize use cases.

How does ReoPro perform in clinical trial efficacy and safety?

ReoPro demonstrated significant efficacy in reducing ischemic complications during PCI in initial trials:

Trial Name	Year	Key Outcomes	Sample Size	Results
EPIC (1994)	1994	Major adverse cardiac events (MACE)	2,067	ReoPro reduced MACE by 43% vs placebo
EPILOG (1997)	1997	Thrombosis, bleeding	3,072	Low-dose ReoPro reduced ischemia risk without increased bleeding
ESPRIT (2000)	2000	Long-term survival	17,000	Signaled benefits in high-risk patients

Adverse events include bleeding complications, with rates varying based on dosing, patient comorbidities, and concomitant medications. Major bleeding occurs in approximately 1-3% of treated patients, with minor bleeding being more frequent.

What is the market landscape for ReoPro?

ReoPro's market is predominantly in developed economies. It faces competition from newer glycoprotein IIb/IIIa inhibitors such as abciximab biosimilars, as well as alternative antiplatelet agents.

Market size and growth assumptions (2023)

Parameter	Value
2023 global PCI procedures	15 million (estimated)
ReoPro market penetration	20% about 3 million procedures
Average price per treatment	$2,500
Estimated global ReoPro market	$7.5 billion

Growth is constrained by the adoption of potent oral antiplatelet drugs (e.g., ticagrelor, prasugrel) and evolving guidelines favoring dual oral antiplatelet therapy over injectables.

Competitive positioning

ReoPro remains favored in complex PCI cases where rapid platelet inhibition is necessary. However, generic biosimilars could challenge pricing and market share over the next five years. Its utilization depends on institutional protocols, physician familiarity, and reimbursement policies.

What are projections for ReoPro's future market?

Market forecasts anticipate a compound annual growth rate (CAGR) of approximately 2-3% through 2030, driven by increased PCI procedures globally and expansion into emerging markets.

Key drivers

• Increase in PCI procedures worldwide, forecasted to reach over 20 million annually by 2030.
• Growing prevalence of cardiovascular disease (CVD), especially in Asia-Pacific.
• Enhanced clinical guidelines endorsing adjunctive antiplatelet therapy in complex interventions.
• Potential new indication approvals, including for acute coronary syndrome management.

Risks and barriers

• The emergence of oral antiplatelet therapies decreasing reliance on injectable agents.
• Biosimilar market entry reducing prices.
• Limited pipeline activity for ReoPro-specific indications.
• Regulatory challenges, especially in markets emphasizing cost-effectiveness.

What strategic approaches could impact ReoPro's market?

• Diversification into secondary prevention of CVD.
• Development of novel formulations for ease of use.
• Strategic partnerships with healthcare providers and payers.
• Patent expiry management through lifecycle extension and biosimilar defense.

Summary

ReoPro has a well-established clinical profile, with recent trials focusing on optimizing dosing to minimize bleeding risk. Its market remains sizable yet mature, with growth constrained by alternative therapies and biosimilar competition. Future prospects hinge on market expansion in emerging economies and potential new indications, balanced against evolving treatment paradigms favoring oral antiplatelet agents.

Key Takeaways

• ReoPro's clinical trial activity peaked in the late 1990s; recent research emphasizes dose optimization.
• The drug maintains a leadership position in specific PCI contexts but faces market pressure from biosimilars and oral therapies.
• The global market for ReoPro is around $7.5 billion, with modest growth projections.
• Expansion into new indications offers potential upside but faces regulatory and commercial hurdles.
• Competition from biosimilars is a critical factor influencing pricing and market share.

FAQs

1. What is the primary approved use for ReoPro?
   Treatment during PCI to prevent thrombotic complications.

2. Are there any current Phase III trials for ReoPro?
   No, current activity mainly involves post-marketing studies and subgroup analyses.

3. How do bleeding risks with ReoPro compare to other antiplatelet agents?
   ReoPro has higher bleeding risk, especially major bleeding, than oral agents like clopidogrel or ticagrelor, but its rapid action is valued in specific scenarios.

4. Will biosimilars affect ReoPro’s market share?
   Yes, biosimilar competition can lower prices and restrict market share unless differentiated through clinical advantages.

5. Is ReoPro being explored for new indications?
   Research focuses mainly on optimizing current use; no significant Phase III trials for new indications are active as of 2023.

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Sources

1. ClinicalTrials.gov, 2023.
2. Eli Lilly & Co., 2023. ReoPro prescribing information.
3. GlobalData, 2023. Cardiovascular drug market analysis.
4. FDA database, 2023. Approved drug indications and labels.
5. IQVIA, 2023. Global cardiovascular procedure estimates.