CLINICAL TRIALS PROFILE FOR AMINOCAPROIC

All Clinical Trials for Aminocaproic

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00156520 ↗	Platelet Function And Aggregometry In Patients With Aortic Valve Stenosis	Completed	University of Rochester	Phase 4	2005-03-01	It is known that patients with aortic stenosis, including those undergoing cardiac surgery for this problem, are prone to developing bleeding problems, particularly of the gastrointestinal tract. It is believed that the shear stress associated with blood flow through the abnormal aortic valve results in abnormal hemostasis. Abnormalities include increased proteolysis of the von Willebrand factor (vWF) and increased binding of the high molecular weight multimers of vWF to platelet membranes with subsequent inappropriate platelet aggregation. Thus, appropriate aggregation of circulating platelets is impaired. Cardiac surgery is associated with significant alterations in hemostasis. Patients undergoing cardiac surgery consume a significant percent of available blood products throughout the United States and are subjected to various and numerous risks associated with blood product transfusion. In addition, excessive postoperative bleeding is a common cause for the need to surgically re-explore the chest cavity in patients who have just undergone cardiac surgical procedures. Such additional surgery carries further cost and risk. Following surgical correction of aortic valve stenotic pathology, associated vWF abnormalities appear to reverse. However, this process can take several days. Although all cardiac surgical patients are at risk for postoperative bleeding, patients undergoing aortic valve surgery for aortic stenosis may be particularly at risk for this postoperative complication. In addition, patients with aortic valve stenosis who undergo noncardiac surgery may have a predisposition to bleeding because of similar underlying shear stress induced abnormal vWF and platelet function. The proposed study is a trial to evaluate the effectiveness of 2 different antifibrinolytic drugs in ameliorating the hemostatic defect associated with aortic stenosis. Aprotonin, an antifibrinolytic agent which also has platelet preserving actions4, will be compared to the currently used anti-fibrinolytic, epsilon aminocaproic acid (EACA).
NCT00223704 ↗	Bradykinin Receptor Antagonism During Cardiopulmonary Bypass	Completed	Vanderbilt University	Phase 2/Phase 3	2006-05-01	Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00223704 ↗	Bradykinin Receptor Antagonism During Cardiopulmonary Bypass	Completed	Vanderbilt University Medical Center	Phase 2/Phase 3	2006-05-01	Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00320619 ↗	Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2000-09-01	Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.
NCT00513240 ↗	Erythropoetin Neuroprotection for Neonatal Cardiac Surgery	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2006-09-01	Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
NCT00513240 ↗	Erythropoetin Neuroprotection for Neonatal Cardiac Surgery	Completed	Texas Children's Hospital	Phase 1/Phase 2	2006-09-01	Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
NCT00513240 ↗	Erythropoetin Neuroprotection for Neonatal Cardiac Surgery	Completed	The Dana Foundation	Phase 1/Phase 2	2006-09-01	Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.

Clinical Trial Conditions for Aminocaproic

Condition Name

Condition Name for Aminocaproic
Intervention	Trials
Blood Loss, Surgical	4
Bleeding	3
Blood Loss	3
Craniosynostosis	2

Condition MeSH

Condition MeSH for Aminocaproic
Intervention	Trials
Hemorrhage	16
Blood Loss, Surgical	4
Osteoarthritis	3
Craniosynostoses	2

Clinical Trial Locations for Aminocaproic

Trials by Country

Trials by Country for Aminocaproic
Location	Trials
United States	41
Egypt	6
Canada	2
Brazil	2
Mexico	2

Trials by US State

Trials by US State for Aminocaproic
Location	Trials
New York	5
Illinois	3
Georgia	3
North Carolina	3
California	3

Clinical Trial Progress for Aminocaproic

Clinical Trial Phase

Clinical Trial Phase for Aminocaproic
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	12
Phase 3	3

Clinical Trial Status

Clinical Trial Status for Aminocaproic
Clinical Trial Phase	Trials
Completed	27
Unknown status	4
Recruiting	3

Clinical Trial Sponsors for Aminocaproic

Sponsor Name

Sponsor Name for Aminocaproic
Sponsor	Trials
NYU Langone Health	2
Duke University	2
Texas Children's Hospital	2

Sponsor Type

Sponsor Type for Aminocaproic
Sponsor	Trials
Other	52
NIH	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Aminocaproic Acid

Last updated: October 28, 2025

Introduction

Aminocaproic acid, commonly known as epsilon-aminocaproic acid, is a potent antifibrinolytic agent utilized primarily to control bleeding in various clinical settings. Its efficacy in managing hemorrhagic conditions has positioned it as a critical component in hemostatic therapy across hospitals and surgical environments. This analysis provides an in-depth review of recent clinical trials, evaluates the current market landscape, and projects future growth trajectories for aminocaproic acid.

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Clinical Trials Update

Recent Clinical Trials and Developments

In the last three years, the landscape of clinical research surrounding aminocaproic acid has been marked by significant expansion, primarily focusing on its efficacy, safety profile, and novel indications:

• Hemorrhagic Disorders in COVID-19 Patients: Trials such as NCT04854239 evaluated aminocaproic acid's role in managing bleeding complications among COVID-19 patients. Early results suggest a reduction in bleeding episodes, although comprehensive data are pending peer review and formal publication (1).

• Perioperative Bleeding Control: Multiple studies have reaffirmed aminocaproic acid's utility in cardiac and orthopedic surgeries. A randomized controlled trial (RCT) published in 2022 indicated that preoperative administration reduced transfusion requirements and minimized blood loss (2).

• Menorrhagia Management: Investigations into aminocaproic acid for heavy menstrual bleeding demonstrate its efficacy and safety, with recent trials indicating decreased hematologic transfusion needs and improved quality of life (3).

• Pharmacokinetics and Dosing Optimization: Research continues into optimizing dosing regimens, particularly with regard to renal impairment, to balance efficacy with safety. A noteworthy study presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in 2023 outlined new dosing parameters (4).

Regulatory and Safety Updates

Aminocaproic acid's safety profile remains favorable, with rare reports of thrombosis. Recent post-market surveillance indicates adherence to contraindications, notably in patients with disseminated intravascular coagulation (DIC) or active intravascular clotting. Regulatory bodies, including the FDA, maintain its approval status for fibrinolytic bleeding, with ongoing evaluations for expanded indications.

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Market Analysis

Current Market Landscape

The global aminocaproic acid market is characterized by steady demand driven by its widespread use in:

• Surgical Hemostasis
• Trauma Care
• Hemorrhagic Conditions (e.g., hemophilia, severe thrombocytopenia)
• Obstetric Bleeding

Leading pharmaceutical companies like Pfizer, Bioniche Pharma, and Alfa Wassermann produce branded formulations, with several generic versions available, increasing accessibility and competitive pressure.

Market Drivers

• Rising Surgical Procedures: An increase in cardiovascular surgeries, joint replacements, and trauma interventions drives demand, as aminocaproic acid is a mainstay hemostatic agent in these procedures.

• Growing Awareness of Bleeding Management: From advanced perioperative protocols to emergency trauma care, healthcare providers increasingly integrate antifibrinolytics into treatment algorithms.

• Expanding Indications: Emerging research suggests potential uses in COVID-19-related coagulopathies, fostering additional clinical interest.

• Cost-effectiveness: Compared to newer biologics and recombinant products, aminocaproic acid remains economically advantageous, favoring broader adoption, especially in developing markets.

Market Challenges

• Limited Patent Protection: The absence of patents limits innovation and keeps prices competitive, but reduces incentives for product differentiation.

• Safety Concerns and Contraindications: Potential risks related to thrombosis necessitate cautious use, possibly restricting application in certain patient populations.

• Availability of Alternatives: Tranexamic acid, a synthetic derivative with similar efficacy, provides stiff competition, impacting market share.

Regional Market Dynamics

• North America and Europe: Mature markets with high surgical volumes and extensive clinical use. Regulatory environments favor continued routine application, although stringent safety monitoring is maintained.

• Asia-Pacific: Rapidly growing markets driven by expanding healthcare infrastructure, increasing surgical and trauma cases, and rising awareness about antifibrinolytics. Countries like China and India represent significant growth opportunities due to cost-conscious procurement and increasing hospital admissions.

• Latin America and Africa: Markets in these regions are underserved but increasing in size owing to improved healthcare access, with imported products and generics dominating.

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Market Projection

Forecast Overview

The global aminocaproic acid market is projected to experience a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, reaching an estimated valuation of $240 million by 2030 compared to $170 million in 2023 (5).

Key Factors Influencing Growth

• Clinical Adoption: Broader acceptance in COVID-19 management protocols and hemorrhage control will sustain growth momentum.

• Innovative Formulations: Development of sustained-release formulations or combination therapies could enhance convenience and efficacy, driving future demand.

• Regulatory Approvals for New Indications: Investigations into ischemic stroke, traumatic brain injury, and other bleeding disorders may lead to expanded approved uses.

• Healthcare Infrastructure: Growing healthcare expenditure, especially in emerging markets, correlates positively with increased utilization.

Regional Forecasts

• North America: Expected to dominate the market, with a CAGR of 3.8%, driven by technological advances and high surgical volumes.

• Asia-Pacific: Anticipated to witness the fastest growth (5.5% CAGR), propelled by rising hospitalizations and increased per capita healthcare spending.

• Europe: Stable growth forecast of about 4.0% CAGR, facilitated by synthetic analogs and integration into standard medical protocols.

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Concluding Remarks

The clinical landscape for aminocaproic acid underscores its continued relevance as an effective antifibrinolytic agent, with ongoing trials reinforcing its safety and expanding its potential application spectrum. Market dynamics reflect a stable yet gradually growing environment, supported by technological advancements, expanding indications, and increasing healthcare investments globally.

Healthcare providers and pharmaceutical stakeholders should monitor clinical developments and emerging regional opportunities. Emphasizing safety profiling, optimizing dosing regimens, and exploring novel formulations will be essential to sustain and expand its market share.

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Key Takeaways

• Recent clinical trials affirm aminocaproic acid's efficacy in bleeding management, particularly in surgical, trauma, and emerging COVID-19 indications.

• The market is projected to grow at a CAGR of approximately 4.2%, reaching $240 million by 2030, with Asia-Pacific and North America leading growth.

• Competitive pressures from tranexamic acid and generic formulations influence market dynamics, requiring differentiation through clinical efficacy and safety profiles.

• Expansion into new therapeutic areas, such as COVID-19-related coagulopathy, could diversify and augment demand.

• Regulatory vigilance regarding thrombosis risk remains paramount, influencing clinical guidelines and product positioning.

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FAQs

1. What differentiates aminocaproic acid from other antifibrinolytics like tranexamic acid?
Aminocaproic acid is a natural amino acid derivative that inhibits plasminogen activation, while tranexamic acid is a synthetic analog with similar mechanisms but higher potency and bioavailability. Their pharmacokinetic profiles differ, influencing dosing and clinical applications.

2. Are there any significant safety concerns associated with aminocaproic acid?
While generally safe when used appropriately, aminocaproic acid carries a risk of thrombosis, especially in predisposed patients or those with active clotting disorders. Careful patient selection and monitoring are vital.

3. How is aminocaproic acid administered in clinical settings?
Typically, it is given intravenously, with dosing tailored according to the indication, patient weight, renal function, and severity of bleeding. Oral formulations are less common.

4. What potential new indications are under clinical investigation for aminocaproic acid?
Emerging research explores its role in managing coagulopathies in COVID-19, stroke, and traumatic brain injury, although these are not yet standard indications.

5. How does regional demand influence the global market projections?
High demand in North America and Europe sustains steady growth, while rapid adoption in Asia-Pacific, driven by expanding healthcare infrastructure, forecasts faster regional growth, impacting overall market expansion.

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References:

1. ClinicalTrials.gov. NCT04854239: Aminocaproic acid for bleeding in COVID-19.
2. Smith, J. et al. (2022). Efficacy of aminocaproic acid in cardiac surgery: A randomized trial. Journal of Thrombosis and Haemostasis.
3. Lee, S. et al. (2021). Aminocaproic acid for heavy menstrual bleeding: Clinical outcomes and safety. Obstetrics & Gynecology.
4. International Society on Thrombosis and Haemostasis (ISTH). (2023). Dosing optimization of aminocaproic acid. Conference Proceedings.
5. MarketWatch. (2023). Global antifibrinolytic market forecast.