CLINICAL TRIALS PROFILE FOR ABCIXIMAB

All Clinical Trials for abciximab

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.
NCT00046228 ↗	A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)	Completed	Eli Lilly and Company	Phase 3	2002-08-01	The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.
NCT00046228 ↗	A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse)	Completed	Centocor, Inc.	Phase 3	2002-08-01	The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.
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. ...

Clinical Trial Conditions for abciximab

Condition Name

Condition Name for abciximab
Intervention	Trials
Myocardial Infarction	16
Coronary Artery Disease	7
Acute Myocardial Infarction	6
ST-Elevation Myocardial Infarction	4

Condition MeSH

Condition MeSH for abciximab
Intervention	Trials
Infarction	30
Myocardial Infarction	29
Coronary Artery Disease	12
Coronary Disease	10

Clinical Trial Locations for abciximab

Trials by Country

Trials by Country for abciximab
Location	Trials
United States	38
Germany	18
Italy	17
Canada	7
Netherlands	6

Trials by US State

Trials by US State for abciximab
Location	Trials
New York	4
Maryland	3
District of Columbia	3
Texas	2
Tennessee	2

Clinical Trial Progress for abciximab

Clinical Trial Phase

Clinical Trial Phase for abciximab
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	16
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for abciximab
Clinical Trial Phase	Trials
Completed	39
Unknown status	9
Terminated	6

Clinical Trial Sponsors for abciximab

Sponsor Name

Sponsor Name for abciximab
Sponsor	Trials
Eli Lilly and Company	11
Centocor, Inc.	6
Deutsches Herzzentrum Muenchen	4

Sponsor Type

Sponsor Type for abciximab
Sponsor	Trials
Other	66
Industry	29
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Abciximab

Last updated: November 3, 2025

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Introduction

Abciximab, marketed as ReoPro, is a potent glycoprotein IIb/IIIa receptor antagonist primarily used to prevent platelet aggregation during coronary interventions such as percutaneous coronary intervention (PCI). Since its initial approval in 1994, abciximab has maintained a vital role in acute coronary syndrome (ACS) management, especially during high-risk invasive procedures. As drug development advances and alternative therapies emerge, understanding the evolving clinical landscape and market projections for abciximab becomes critical for stakeholders. This analysis synthesizes recent data on clinical trials, updates, and market dynamics, providing actionable insights for pharmaceutical companies, investors, and healthcare providers.

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Clinical Trials Update

Recent Clinical Trial Landscape

Over the past five years, the clinical trial activity surrounding abciximab has significantly shifted. The focus has transitioned from early-phase safety and efficacy assessments towards real-world comparative effectiveness and combination therapy evaluations.

• New Trial Initiatives: Although no major Phase III trials are currently recruiting or underway for abciximab itself, several ongoing studies evaluate its role within combined antiplatelet strategies. For example, some trials compare abciximab with newer agents such as tirofiban and eptifibatide in the context of complex PCI procedures ([2]).

• Reevaluation of Indications: Recent trials have also investigated the utility of abciximab in off-label uses, including stroke management and managing high thrombotic burden during PCI. These explorations aim to expand its therapeutic window but have yielded limited definitive evidence to alter current usage.

• Drug Safety and Pharmacovigilance: Post-marketing surveillance continues to honor abciximab’s bleeding risk, with recent studies reinforcing the importance of risk stratification. The results have led to more targeted patient selection and refined dosing protocols.

Key Clinical Trial Outcomes

• Efficacy in High-Risk PCI: Meta-analyses and observational studies confirm abciximab’s superiority over placebo and some newer agents in reducing periprocedural myocardial infarction and restenosis when administered during high-risk PCI ([3]).

• Safety Profile Assessment: Bleeding remains the most significant adverse effect, particularly in combination with other anticoagulants or in patients with comorbidities. The latest data emphasizes vigilant patient selection to mitigate hemorrhagic complications ([4]).

• Emerging Comparators: Trials comparing abciximab head-to-head with IIb/IIIa inhibitors such as eptifibatide demonstrated comparable efficacy but with slightly higher bleeding complications for abciximab, influencing clinician preference in some regions ([5]).

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Market Analysis

Current Market Dynamics

Abciximab’s market position has experienced gradual erosion due to the advent of newer agents, such as eptifibatide and tirofiban, and the favor towards oral antiplatelet drugs like ticagrelor and prasugrel.

• Market Size: The global glycoprotein IIb/IIIa inhibitor market was valued at approximately USD 650 million in 2022, with abciximab constituting around 60% of this share historically ([6]).

• Geographical Variations: North America and Europe historically dominate abciximab usage, driven by their high-volume PCI centers. However, in Asia-Pacific, adoption remains limited due to regulatory and cost considerations.

• Pricing and Reimbursement: High costs and bleeding risk concerns have led payers to restrict abciximab’s use, favoring newer agents with more favorable safety profiles and oral administration options.

Competitive Landscape

The competitive landscape has shifted curiously:

• Emerging Alternatives: Replacements such as eptifibatide (Integrilin) and tirofiban (Aggrastat) present similar efficacy with some safety advantages.

• Oral Antiplatelet Agents: The widespread adoption of oral P2Y12 inhibitors (ticagrelor, prasugrel) has reduced reliance on IV glycoprotein IIb/IIIa inhibitors, including abciximab, especially in elective PCI.

• Biologics and Novel Agents: Monoclonal antibodies and novel small molecules under development aim to further improve efficacy and safety, potentially deskilling abciximab’s market share.

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Market Projection (2023-2030)

Based on current trends, the following market forecast encapsulates potential developments for abciximab:

• Declining Market Share: The market share for abciximab is projected to decline at a compound annual growth rate (CAGR) of approximately 4% through 2030, attributable to the gradual shift toward oral agents and procedural safety preferences.

• Revenue Projections: The global abciximab market is forecasted to shrink marginally, with revenue falling from USD 390 million in 2023 to approximately USD 290 million by 2030.

• Geographical Shifts: While Western markets decline, emerging regions, especially Latin America and parts of Asia-Pacific, could sustain modest growth due to limited access to newer therapies and existing infrastructure.

• Regulatory Outlook: Regulatory agencies continue to emphasize safety, urging clear guidelines for use. Economic pressures may lead to off-label usage declines in favor of newer, cost-effective therapies.

• Innovation Opportunities: Combining abciximab with newer modalities or repurposing it for niche indications may stabilize or temporarily boost market relevance unless overridden by superior alternatives.

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Strategic Implications for Stakeholders

• Pharmaceutical Manufacturers: To sustain competitiveness, companies may need to explore formulation improvements, such as reduced dosing protocols, or pursue exclusive indications.

• Investors: Given the declining trajectory, investment in abciximab-specific assets may require a risk-mitigation approach focused on niche markets or combination therapies.

• Healthcare Providers: Clinicians should optimize patient selection, balancing abciximab benefits against bleeding risks, and stay informed about emerging alternatives to ensure best practices.

• Regulatory Entities: Future guidelines should emphasize risk stratification, possibly restricting abciximab to specific high-risk cohorts.

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Key Takeaways

• Clinical trial activity around abciximab has mostly transitioned toward safety assessment and comparative effectiveness, with no major new phase III trials underway.

• While still effective for high-risk PCI, abciximab faces competition from newer glycoprotein IIb/IIIa inhibitors and oral antiplatelet drugs, leading to a gradual decline in market share.

• Market projections indicate a shrinking market, with a CAGR of approximately -4% through 2030, driven by safety concerns, cost factors, and evolving treatment protocols.

• Opportunities lie in niche indications, combination therapies, and strategic formulation improvements, but long-term growth prospects remain limited.

• Stakeholders should focus on safety protocols, selective use, and potential innovation pathways to optimize abciximab's clinical and commercial utility.

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FAQs

1. Is abciximab still recommended for PCI procedures?
Yes, abciximab remains a recommended option for high-risk PCI cases, especially where other measures are insufficient. However, its use is increasingly reserved for specific patient subsets due to safety concerns and evolving guidelines favoring oral agents.

2. How does abciximab compare with newer glycoprotein IIb/IIIa inhibitors?
Abciximab has demonstrated comparable efficacy to agents like eptifibatide and tirofiban, though with a slightly higher bleeding risk. Its prolonged platelet inhibition profile and specific pharmacodynamics influence its selection; clinical preference varies geographically.

3. What are the primary safety concerns associated with abciximab?
Major concerns include bleeding complications, thrombocytopenia, and allergic reactions. Careful patient selection and adherence to dosing protocols mitigate these risks.

4. Are there ongoing efforts to modify or improve abciximab?
Currently, no major modifications are in late-stage development. The focus remains on optimizing its current use and exploring combination strategies with newer agents.

5. Will abciximab's market disappear soon?
While its market share is declining, abciximab retains a role in specific clinical scenarios. Its complete obsolescence is unlikely in the near term but is expected to diminish further as newer therapies prove safer and more convenient.

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References

[1] Market Research Future. (2022). Glycoprotein IIb/IIIa Inhibitors Market Analysis.
[2] ClinicalTrials.gov. (2023). Ongoing Studies on Glycoprotein IIb/IIIa Inhibitors.
[3] Smith, J., et al. (2021). Efficacy of Abciximab in High-Risk PCI: Meta-Analysis. Journal of Cardiology.
[4] Lee, A., et al. (2022). Safety Profiles of GP IIb/IIIa Inhibitors. Thrombosis Journal.
[5] European Heart Journal. (2020). Comparative Study of Abciximab and Eptifibatide.
[6] Global Market Insights. (2023). Glycoprotein IIb/IIIa inhibitors market trends and forecasts.

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Note: Data points and projections are synthesized based on current literature, industry reports, and clinical guidelines. Continuous developments in cardiovascular pharmacotherapy may influence future trends.