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.

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

Last updated: July 27, 2026

Aminocaproic acid (Aminocaproic) clinical trials update, market analysis, and near-term market projections

Executive summary

Aminocaproic acid (ACA, Aminocaproic) is an established antifibrinolytic used off-patent in multiple settings including perioperative bleeding, trauma-associated hemorrhage, and mucosal bleeding. Public evidence supporting current “clinical trials” and a defensible, sponsor-specific product development pipeline is not available in the provided context, so a company-by-company trial update and trial-to-revenue projection cannot be produced from reliable sources. Commercially, the market is best characterized as low-single-product consolidation with pricing and volume driven by hospital formularies, acute-care protocols, and generic availability rather than new entrant exclusivity.

What is aminocaproic acid used for clinically and where is demand concentrated?

Aminocaproic acid is used to reduce bleeding by inhibiting fibrinolysis (lysine analog). Demand concentrates in acute-care hospital settings where clinicians manage perioperative bleeding and trauma bleeding.

Which clinical indications drive use

Common real-world use categories include:

• Surgical bleeding prophylaxis and treatment in selected specialties (cardiac, ENT, ortho, trauma-linked protocols)
• Trauma-associated hemorrhage pathways
• Mucosal bleeding (institution-dependent protocols)
• Hemorrhage associated with elevated fibrinolysis (case-by-case)

What dosing forms are typically supplied

Market access is largely through:

• Injectable formulations used in inpatient and procedural settings
• Oral formulations for outpatient or continued therapy pathways (varies by geography and brand portfolio)

What clinical trials are ongoing for aminocaproic acid right now?

No sponsor-verified clinical trial dataset is present in the provided context, so an accurate “ongoing trials” update (trial IDs, phases, endpoints, enrollment status, and timelines) cannot be compiled.

How to interpret “clinical trials update” for an off-patent product

For established off-patent drugs like aminocaproic acid, active trials often focus on:

• Comparative effectiveness within perioperative bleeding protocols
• Adjunctive use in trauma or coagulation algorithms
• Dosing optimization and pharmacokinetic/pharmacodynamic (PK/PD) endpoints
• Safety in specific subpopulations (pediatrics, renal impairment, special coagulation disorders)

A sponsor-by-sponsor update requires trial registries and would be unreliable without explicit source inputs.

Where does aminocaproic acid face competitive pressure from generics?

Aminocaproic acid is widely generic in most markets. Competitive pressure is driven by:

• Low switching costs across generic manufacturers in hospitals
• Tighter procurement pricing through group purchasing organizations
• Availability reliability of injectables and concentration-specific SKUs

What matters for hospital procurement

• Total cost per course or per case (unit price is secondary to dosing conversion)
• Formulary status and restricted formulary criteria
• Lead times, shortages, and supply continuity for injectables

What is the market size and who are the main buyers?

No quantitative market sizing inputs are provided. A complete market sizing and buyer breakdown cannot be produced without reliable figures.

Buyer and channel map (high-level)

• Hospital pharmacy and therapeutics committees
• Acute-care procurement platforms and integrated delivery networks
• Distributors supplying injectable and oral formulations to institutional buyers

How do pricing and reimbursement typically evolve for aminocaproic acid?

For generic antifibrinolytics, pricing is influenced by:

• Competitive entry of additional generic manufacturers
• Contract renegotiations in hospital procurement cycles
• Shortage dynamics for injectables (if supply constraints occur)

What drives revenue volatility

• Tender cycles and contract renewals
• Supplier availability and allocation during constrained supply
• Changes in clinical guidelines and care pathways affecting antifibrinolytic uptake

When does aminocaproic acid face major exclusivity or patent-driven supply shifts?

Aminocaproic acid’s active ingredient is generally off-patent; revenue is therefore more sensitive to:

• Product-level patent scope (if any) tied to specific formulations, concentrations, delivery devices, or manufacturing methods
• Periodic changes in FDA labeling, safety communications, or approved product discontinuations

No specific patent or Orange Book status for “Aminocaproic” is present in the provided context, so a time-phased exclusivity schedule cannot be established.

What formulations are protected, and do product-level patents matter for market forecasts?

Without a defined product (brand name, NDA/ANDA holder, dosage strength, and jurisdiction) and without patent list inputs, protected formulation and method-of-manufacture coverage cannot be mapped.

What formulation attributes can create defensible niches

When patent protection exists for established actives, it typically targets:

• Injectable concentration and stabilizer systems
• Lyophilized or reconstitution-stable presentations
• Device-integrated delivery (if present)
• Manufacturing process controls that reduce impurities or improve stability

How does aminocaproic acid compare with tranexamic acid for market share and adoption?

Aminocaproic acid is a lysine analog like tranexamic acid (TXA). Across hospitals, adoption is often influenced by:

• Clinical evidence base for each molecule in specific indications
• Per-dose cost and formulary preferences
• Side-effect profile differences as implemented in protocols

A quantitative comparison requires market share and prescribing/utilization datasets not included here.

What generic entry risks exist for aminocaproic acid, and where are barriers highest?

For off-patent small molecules, barriers are usually:

• Manufacturing quality systems and sterile injectable compliance (for injectables)
• Supply chain robustness
• Stability and bioavailability consistency across concentrations/solicitation specs

Barrier analysis by geography needs regulatory and ANDA approval records that are not provided.

What regulatory status does aminocaproic acid have with FDA and other agencies?

No FDA approval identifiers, label revisions, or ANDA/505(j) details are provided, so an Orange Book-style regulatory status mapping cannot be generated.

What is the near-term market projection for aminocaproic acid (2025–2028)?

A numeric projection cannot be produced without:

• current sales baseline by geography and formulation
• leading market share positions by manufacturer
• utilization trends (procedures performed, guideline adherence)
• pricing trends and tender-cycle dynamics

Non-numeric projection drivers (actionable)

• Inelastic demand in perioperative and acute bleeding protocols supports baseline volume stability.
• Generic competition caps long-run growth on value terms unless contract repricing slows or supply constraints raise temporary pricing.
• Protocol shifts that increase antifibrinolytic use can lift volume; protocol restrictions reduce volume.

Which company product portfolios are most exposed to aminocaproic acid demand changes?

No manufacturer roster or product-level listing is provided. Exposure assessment cannot be completed without mapping major suppliers, share positions, and SKU-level availability.

Key Takeaways

• Aminocaproic acid is an established antifibrinolytic with demand concentrated in acute-care hospital protocols.
• A company-level “clinical trials update” and trial-to-projection bridge cannot be produced from the information provided.
• Near-term market direction is most sensitive to generic procurement pricing, tender cycles, and injectable supply continuity rather than new exclusivity events.
• A defensible market projection requires baseline sales and SKU/geography-specific utilization and pricing inputs that are not included here.

FAQs

1. Is aminocaproic acid the same as Amicar, and how does brand vs generic impact purchasing?
2. What clinical situations most commonly use aminocaproic acid in hospitals today?
3. How do institutions choose between aminocaproic acid and tranexamic acid in perioperative bleeding?
4. What risks affect supply of injectable aminocaproic acid and how do shortages impact procurement?
5. Are there any formulation-specific advantages (stability, concentration, device) that influence tender decisions for aminocaproic acid?

References (APA)

1. No sources were provided in the prompt, and no external source data is available in this environment.