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

Last updated: June 30, 2026

Abciximab Clinical Trials Update, Market Analysis, and Sales Projection (2025-2035)

What is the current clinical-trials landscape for abciximab?

Trial status snapshot (last active periods)

Abciximab is a chimeric monoclonal antibody (anti-GPIIb/IIIa) used in acute coronary intervention settings (historically PCI/urgent angioplasty), but it is not a modern “pipeline” drug. The clinical-trials footprint is dominated by legacy mechanistic studies, registry-type comparative datasets, and post-approval safety/real-world evaluations, with limited new interventional trials in recent years.

Practical takeaway: the observable clinical activity is mostly evidence consolidation rather than late-stage development.

What trial endpoints typically drove abciximab approvals and use

Key endpoints historically used in abciximab studies include:

• TIMI flow restoration and angiographic measures
• MI and ischemic event reductions
• Major adverse cardiac events (MACE) composite endpoints
• Bleeding and thrombocytopenia safety endpoints

How guideline shifts changed trial demand

Over time, the interventional cardiology standard of care moved toward:

• More routine use of P2Y12 inhibitors and refined anticoagulation strategies
• Reduced reliance on glycoprotein IIb/IIIa blockade except in selected high-risk or procedural contexts
  This evolution reduced the sponsor incentive to run large new confirmatory trials for abciximab specifically.

Where is abciximab marketed and who drives demand?

Commercial structure: generics and payer-driven buying

Abciximab availability is typically through:

• Branded originator history
• Follow-on products, with pricing and formulary access driven by hospital procurement and competitive tender cycles

Indication demand is procedure-driven

Demand correlates with:

• Volume of PCI procedures in acute coronary syndrome and related settings
• Length and intensity of antithrombotic regimens in cath lab protocols
• Use restrictions based on bleeding risk and local practice patterns

What is the market size for abciximab and how is it changing?

Directional market dynamics (2025 view)

Abciximab demand is structurally constrained by two forces:

1. Established procedural alternatives that reduce IIb/IIIa inhibitor utilization.
2. Mature, older biologic with limited new RCT-driven adoption growth.

Net effect: market growth is typically low to flat, with volatility tied to hospital formularies and PCI volumes.

Competitive substitution landscape

Therapy alternatives that compete for the same procedural anticoagulation/thrombosis treatment time window include:

• Other IIb/IIIa inhibitors (eptifibatide, tirofiban) in jurisdictions where used
• Intensified oral antiplatelet strategies as baseline PCI background therapy

What sales projection range is reasonable for abciximab through 2035?

No specific, citable market share or revenue figure for abciximab can be produced from the provided information. Under a strict patent-and-clinical lens, the best defensible forward projection is scenario-based on procedure volume and utilization share, but a numeric forecast without source-backed inputs would be fabricated.

Therefore, an evidence-backed numeric projection is not deliverable here.

What patents protect abciximab’s products, and how do they affect market duration?

Core commercial constraint: older biologic IP has largely matured

Abciximab is an established biologic. For mature biologics, most remaining value is driven by:

• Formulation and manufacturing process IP (if any active filings exist in certain jurisdictions)
• Labeling and clinical-use territories
• Exclusivity that is generally not comparable to new-origin small molecules

Practical implication for market forecast

Even if minor formulation or process patents remain in niche jurisdictions, the commercial trajectory is usually dominated by clinical positioning and substitution, not by long residual exclusivity.

How do FDA regulatory factors affect abciximab availability and use?

FDA status and labeling control

Abciximab’s competitive position depends on:

• Current labeled indications and contraindication language
• Safety monitoring requirements (notably bleeding risk and thrombocytopenia monitoring practices)
• Institutional protocol adoption

Real-world adoption is more predictive than headline FDA milestones

For mature IV biologics, purchase decisions hinge on cath lab workflow compatibility, dosing protocols, storage logistics, and procurement pricing.

What generic entry risks exist for abciximab?

Biologic pathway reality

Abciximab is a monoclonal antibody and is subject to biosimilar and interchangeability frameworks rather than classic ANDA generic pathways.

Practical entry constraints

Even where biosimilar pathways exist, entry depends on:

• Demonstrating biosimilarity in analytic and functional assays
• Clinical PK/PD comparability and immunogenicity monitoring
• Regulatory acceptance of switching/interchangeability where relevant
• Commercial readiness and contracting with hospital networks

What is the litigation and exclusivity posture that affects abciximab market?

No litigation dataset is provided here that can be reliably cited with dates, case numbers, or settlement outcomes specific to abciximab. A litigation-driven market forecast would require those facts to avoid fabrication.

Result: litigation impact cannot be stated.

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Key Takeaways

• Abciximab clinical activity is dominated by legacy evidence and observational consolidation rather than new large-scale interventional programs.
• Market demand is procedure-driven (PCI utilization) and constrained by broader adoption of alternative antiplatelet and anticoagulation strategies.
• A numeric market size and sales projection through 2035 cannot be produced without source-backed market figures and utilization assumptions.
• Patent and regulatory effects for a mature biologic are typically secondary to real-world protocol preference and substitution patterns.

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FAQs

1. Is abciximab still recommended for PCI in acute coronary syndromes?
2. How does abciximab compare with eptifibatide and tirofiban for bleeding risk in practice?
3. What endpoints matter most when evaluating abciximab trials in modern evidence reviews?
4. How do hospital formulary decisions typically affect IIb/IIIa inhibitor adoption?
5. Do biosimilar developments materially change abciximab competitive dynamics?

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References (APA)

1. No sources were provided in the prompt, and no external, citable dataset is available within the constraints of this response.