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.

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
Inflammation	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
Duke University	2
Texas Children's Hospital	2
Emory University	2

Sponsor Type

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

AMINOCAPROIC Market Analysis and Financial Projection

Last updated: April 28, 2026

Aminocaproic (Aminocaproic Acid): Clinical Trials Update, Market Analysis, and Projection

What is aminocaproic used for, and why does it still attract clinical activity?

Aminocaproic acid (also “aminocaproic,” “ACA”) is an antifibrinolytic used to reduce pathologic bleeding. In practice it is positioned in:

• Surgical bleeding prophylaxis/management (notably cardiac and other major operations)
• Trauma and acute bleeding syndromes
• Bleeding associated with specific hemostatic disorders (program-level indications vary by jurisdiction and product labeling)

From a development perspective, the value proposition in 2025 is not “new biology.” It is access: dosing optimization, delivery improvements (where applicable), and re-anchoring efficacy and safety in contemporary trial designs.

---

What does the clinical trials landscape look like (2020-2026)?

Publicly visible activity for aminocaproic acid continues across registries, but most programs cluster around:

• Bleeding endpoints in defined clinical populations (surgery, trauma, or disease-specific bleeding)
• Pharmacokinetic/pharmacodynamic studies (reinforcing dose selection)
• Trials focused on standard-of-care comparators and bleeding severity scales

Clinical trials update (current state of the evidence base)

• The clinical record for aminocaproic acid is mature in core antifibrinolytic settings.
• Newer trials typically aim to strengthen endpoint choice, improve protocol adherence, and validate safety in the context of modern hemostasis pathways.

Key practical implication for R&D and investment

• Expected regulatory “path” in most jurisdictions for aminocaproic acid tends to rely on clinical endpoint confirmation in a specific use case rather than broad label expansion from scratch.
• The highest probability of near-term label movement typically sits in narrow, well-defined bleeding contexts where antifibrinolytic effect is clinically measurable (blood loss, transfusion need, operative bleeding scores) and safety signals (thrombosis-related outcomes, renal/hepatic tolerability) are trackable.

---

What are the commercial drivers in the aminocaproic market?

Demand drivers

1. Persistent surgical volume growth in geographies with expanding elective cardiac and orthopedic procedures
2. Trauma center utilization (antifibrinolytics remain standard tools in acute bleeding pathways)
3. Hospital formulary consolidation around antifibrinolytics based on cost and availability

Supply and pricing reality

• Aminocaproic acid is widely available as a generic active ingredient.
• Competitive dynamics center on: injectable supply stability, packaging formats, and tender pricing rather than novel IP-heavy differentiation.

Product reality

• For many buyers, the decision is not “who has the best drug,” it is “which supplier can meet hospital procurement rules with consistent supply at the lowest total cost per treated episode.”

---

How big is the aminocaproic addressable market?

A precise global market size requires live market databases and current filings; those figures vary by how analysts define “aminocaproic acid” versus “antifibrinolytics” and which formulations are included.

Actionable market sizing framework (for projection) Use treated-episode logic rather than a single revenue number:

• Define your target geography set (e.g., US + EU5 + Japan/ANZ)
• For each geography, estimate the treated population in:
  • surgical bleeding prophylaxis/management
  • trauma/acute bleeding pathways
  • label-specific bleeding disorders where local uptake exists
• Multiply by average dosing per episode and average net price after tender discounts

What this framework produces in practice

• The market is typically large enough to support steady unit demand but has limited pricing power because generic competition sets net pricing floors.
• Growth rates tend to track procedure volumes and protocol adoption more than drug innovation.

---

Where is growth most likely: US, EU, or other regions?

US

• Stabilized hospital formularies for antifibrinolytics
• Ongoing protocol refinement in bleeding management drives incremental usage
• Generic competition keeps price growth low

EU

• Adoption depends on local guidelines and reimbursement behavior
• Purchases are tender-driven and price-sensitive
• Clinical uptake is strong where guidelines recommend antifibrinolytics for specific surgical or trauma cohorts

APAC and rest of world

• Growth potential often comes from rising surgical volume and expanding trauma care infrastructure
• Procurement constraints and supply chain reliability affect utilization timing

---

What is the likely market projection (2026-2031)?

Because aminocaproic is generic, projections are usually modest in valuation terms. The base case is unit demand growth plus erosion/plateau in net pricing.

Projection model (base-case)

• Unit demand: low-to-mid single-digit CAGR
• Net price: flat-to-low decline CAGR (tender pressure)
• Market revenue: low single-digit CAGR driven by volume

Bull/bear boundaries

• Bull case: faster protocol adoption in trauma and perioperative settings, and improved supply reliability across bidders
• Bear case: procurement shifts to alternative antifibrinolytics where local tendering favors other actives, or tighter formularies that reduce prophylactic use

---

How does IP and exclusivity shape the long-term outlook?

Aminocaproic acid’s IP posture generally relies on:

• Older composition and use coverage that has largely matured
• Limited ability to create broad exclusivity unless a sponsor controls a specific formulation, device-assisted delivery, or a narrowly defined clinical use with its own trial package

This creates a market structure where:

• Revenue growth is not anchored to breakthrough exclusivity
• The competitive set is defined by manufacturing capacity and procurement access

Business implication

• Any investment thesis should focus on: secure supply, tender win capability, and label positioning in a specific clinical niche, not on monolithic “brand-like” growth.

---

What clinical endpoint patterns dominate antifibrinolytic trials for agents like aminocaproic?

Trials commonly center on:

• Total blood loss or calculated operative blood loss
• Transfusion need (rate of allogeneic transfusion)
• Composite bleeding severity scores
• Safety outcomes: thromboembolic events and key tolerability endpoints

In a mature therapeutic class, regulatory value tends to come from:

• Clinically meaningful endpoint selection
• Tight protocolization (dose timing around the bleeding trigger)
• Safety monitoring consistency across arms

---

What risks and constraints matter most for aminocaproic adoption?

Clinical

• Thrombotic risk monitoring (trial and real-world pharmacovigilance)
• Patient selection (co-morbidities and bleeding etiology influence benefit-risk)

Commercial

• Tender pricing pressure from generics
• Supply continuity (manufacturing outages can force short-term substitution and create utilization volatility)

Operational

• Formulary and procurement approvals
• Inventory management in high-volume hospital systems

---

Key Takeaways

• Aminocaproic acid is a mature antifibrinolytic with ongoing clinical activity primarily focused on modern endpoint selection and optimized use in defined bleeding contexts.
• Commercial performance is volume-driven and procurement-sensitive; generic competition keeps pricing power limited.
• A practical 2026-2031 market outlook is low single-digit revenue growth, driven by treated-episode growth with net price largely flat or slightly declining.
• The most investable dynamics are supply reliability, tender execution, and narrow label positioning rather than broad IP-led expansion.

---

FAQs

1) Is aminocaproic acid actively studied in new indications?

Yes. Ongoing trials concentrate on bleeding settings where efficacy can be measured with objective endpoints (blood loss, transfusion need) and safety can be monitored consistently (notably thromboembolic risk).

2) Does aminocaproic have strong pricing power?

Typically no. Generic competition and tender procurement behavior constrain net pricing, making the market more sensitive to unit demand than to price increases.

3) What endpoints do sponsors prioritize for antifibrinolytics?

Common endpoints include blood loss metrics, transfusion rates, bleeding severity scales, and safety outcomes such as thrombotic events.

4) Where are the best commercial opportunities?

Opportunities cluster where hospital uptake is protocol-driven and where procurement favors reliable supply and competitive net pricing.

5) What is a reasonable revenue growth expectation through 2031?

In most practical models for generic antifibrinolytics, revenue growth is low single-digit, reflecting unit demand growth with flat-to-declining net pricing.

---

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. Aminocaproic Acid trials database.
[2] European Medicines Agency. Public assessment and product information resources for antifibrinolytic agents.
[3] World Health Organization. WHO Model List of Essential Medicines (context for antifibrinolytic class use).