CLINICAL TRIALS PROFILE FOR AMICAR

All Clinical Trials for Amicar

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00617955 ↗	Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates	Completed	State University of New York - Upstate Medical University		2007-09-01	The dept. of Anesthesiology currently has a database of subjects whom had surgery and received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is more harmful than Amicard. In an effort to see what the long term outcomes were for subjects whom had surgery here at Upstate, it was decided to look at long term death rates to see if any differences. A student t-test will be used to determine statistical significance where a p value of
NCT00912119 ↗	Amicar Pharmacokinetics of Children Having Craniofacial Surgery	Completed	Children's Anesthesiology Associates, Ltd.	Phase 1	2009-05-01	Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. The surgery is extensive, often requiring wide scalp dissections and multiple osteotomies and has been associated with significant morbidity. Some of the most severe and commonly seen problems are associated with the rate and extent of blood loss. Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and a lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of fibrinolysis, reduces transfusion requirements in children undergoing procedures on cardiopulmonary bypass (CPB), as well as in older children undergoing spinal surgery for scoliosis (1-6). Before controlled studies to assess efficacy of EACA in a craniofacial surgical population can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal dosing strategy. PK data exist for EACA in children undergoing operations on CPB and hypothermia. The aim of this study is to determine the pharmacokinetics of EACA in infants and children undergoing craniofacial reconstruction procedures.
NCT00912119 ↗	Amicar Pharmacokinetics of Children Having Craniofacial Surgery	Completed	Thomas B. and Jeannette E. Laws McCabe Fund Pilot Award	Phase 1	2009-05-01	Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. The surgery is extensive, often requiring wide scalp dissections and multiple osteotomies and has been associated with significant morbidity. Some of the most severe and commonly seen problems are associated with the rate and extent of blood loss. Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and a lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of fibrinolysis, reduces transfusion requirements in children undergoing procedures on cardiopulmonary bypass (CPB), as well as in older children undergoing spinal surgery for scoliosis (1-6). Before controlled studies to assess efficacy of EACA in a craniofacial surgical population can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal dosing strategy. PK data exist for EACA in children undergoing operations on CPB and hypothermia. The aim of this study is to determine the pharmacokinetics of EACA in infants and children undergoing craniofacial reconstruction procedures.

Clinical Trial Conditions for Amicar

Condition Name

Condition Name for Amicar
Intervention	Trials
Blood Loss	2
Cardiopulmonary Bypass	2
Craniosynostosis	2
Aortic Disease	1

Condition MeSH

Condition MeSH for Amicar
Intervention	Trials
Hemorrhage	2
Osteoarthritis	2
Craniosynostoses	2
Hematologic Neoplasms	1

Clinical Trial Locations for Amicar

Trials by Country

Trials by Country for Amicar
Location	Trials
United States	11
Mexico	1

Trials by US State

Trials by US State for Amicar
Location	Trials
California	2
Pennsylvania	2
Tennessee	2
District of Columbia	1
Georgia	1

Clinical Trial Progress for Amicar

Clinical Trial Phase

Clinical Trial Phase for Amicar
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Amicar
Clinical Trial Phase	Trials
Completed	8
Active, not recruiting	1
Withdrawn	1

Clinical Trial Sponsors for Amicar

Sponsor Name

Sponsor Name for Amicar
Sponsor	Trials
State University of New York - Upstate Medical University	1
Akorn, Inc.	1
Children's Anesthesiology Associates, Ltd.	1

Sponsor Type

Sponsor Type for Amicar
Sponsor	Trials
Other	19

AMICAR (aminocaproic acid) clinical trials update, market analysis, and projection

Last updated: May 23, 2026

Executive summary: AMICAR (aminocaproic acid, Amicar) is an off-patent, generic drug with no meaningful late-stage pipeline ownership tied to the brand in the way investors track for patent-protected small molecules. Current demand is driven by episodic use in hemorrhage indications (notably surgery-associated bleeding and other bleeding disorders) plus stock-level hospital purchasing cycles. Near-term market growth is constrained by mature generic supply, payer normalization, and limited incremental clinical differentiation versus older antifibrinolytics. Absent a new, branded regulatory strategy or major label expansion with clear differentiation, market performance is most sensitive to hospital adoption, seasonal surgical volume, and constrained supply events rather than launches of new formulations or new active ingredients.

What clinical trials exist for AMICAR (aminocaproic acid) in 2024-2026?

Clinical-trial activity for aminocaproic acid is largely characterized by: (1) older randomized or observational studies that informed use in perioperative bleeding and (2) periodic regeneration of evidence via smaller trials in bleeding subpopulations. For the AMICAR brand specifically, most modern clinical research does not track to brand-funded, late-stage pivotal registrational programs.

Key pattern: perioperative and high-bleeding-risk populations

Aminocaproic acid is commonly evaluated in:

• Cardiac surgery and other high-blood-loss procedures
• Trauma and critical bleeding settings
• Hematology-associated bleeding (example: certain bleeding tendencies related to fibrinolysis)

What this means for a clinical trials “update”

• If a new pivotal phase program for AMICAR is ongoing or recruiting at scale, it typically would be reflected in modern registrational pathways or label expansions.
• Aminocaproic acid trials frequently appear as comparative antifibrinolytic studies rather than brand-led drug development.

Result: For market and competitive planning, the clinically actionable signal is not “phase progression for a brand pipeline,” but the consistency of evidence supporting antifibrinolytic use protocols and hospital formularies.

What is AMICAR’s current FDA regulatory status and label scope?

AMICAR is an FDA-approved drug product with an established label for reducing bleeding by antifibrinolytic activity. Regulatory relevance for market projection hinges on label breadth, dosing instructions, and whether newer evidence supports expansion or guideline adoption rather than new marketing approvals.

Label drivers that affect market demand

• Clear perioperative bleeding reduction claims and dosing convenience
• Guideline alignment for antifibrinolytic protocols
• Hospital formulary placement for episodic inpatient use

Generic reality

Because aminocaproic acid is widely available as generics, “FDA status” for forecasting is less about regulatory exclusivity and more about:

• Ongoing manufacturing capacity
• Shortages or recalls that affect short-term unit availability
• Payer and procurement practices that determine which manufacturer’s NDCs hospitals stock

What patents protect AMICAR (aminocaproic acid) and when do they expire?

For AMICAR, patent protection is generally not a primary variable in near-term competition because aminocaproic acid is mature and widely generic. In forecasting, the relevant question is whether any formulation, method-of-use, or manufacturing-process patents exist that are enforceable for specific dosage forms, routes, or combination regimens.

Patent estate framing for an off-patent generic

A practical way investors and litigators evaluate is to separate:

• Active ingredient freedom-to-operate (typically broad for a mature molecule)
• Orange Book-listed patents for any brand/innovator product still listed for specific NDCs
• Formulation patents (solubility, stability, container-closure systems)
• Method-of-use patents (dose regimens, perioperative settings, specific bleeding etiologies)

Result: For market projection, competitive entry is generally settled at the active ingredient level; any residual patent constraints would be narrow and NDC-specific.

What is the Orange Book status of AMICAR?

AMICAR is a brand name for aminocaproic acid. For meaningful exclusivity forecasting, the Orange Book entry must be reviewed for:

• Listed patents per NDC
• Patent expiration dates
• Whether exclusivity is tied to the listed drug application versus separate exclusivities

Result: Forecasting assumptions for AMICAR should treat it as effectively generic at the therapeutic and active-ingredient level, with limited incremental impact from exclusivity unless a specific NDC has still-active listed patents.

How many generic manufacturers compete with AMICAR, and how does that affect pricing?

Because aminocaproic acid is mature, competition typically comes from multiple ANDA manufacturers across IV and oral presentations (depending on which dosage forms are produced and stocked).

Competitive implications for pricing and procurement

• Competitive tendering reduces WAC-to-net pricing spreads.
• Hospitals often switch NDCs based on contract pricing and inventory availability.
• Short supply events can temporarily widen net pricing.

Market elasticity

Use is not price-elastic in a typical sense for inpatient hemorrhage protocols; stock availability and clinician protocol matter more than small price changes.

What commercial metrics define AMICAR demand: usage settings and payer drivers?

AMICAR demand is driven by inpatient episodes with high bleeding risk. Market sizing tends to correlate with:

• Surgical volumes (especially surgeries with high bleeding risk)
• Trauma incidence and ICU throughput
• Guideline adoption of antifibrinolytics in specific surgical and bleeding settings
• Hospital formulary and utilization management

Hospital procurement behavior

For an off-patent drug:

• Formularies emphasize supply reliability and contract price.
• Pharmacy and therapeutics committees update protocols based on safety and comparative effectiveness evidence.
• Switching can happen rapidly when contracts change.

What is the market size and growth outlook for aminocaproic acid (AMICAR) in the US?

Answer for projection framing: Aminocaproic acid is expected to show low-to-moderate growth versus earlier years, primarily tied to:

• Volume growth in surgical/critical care settings
• Population aging and procedure incidence
• Replacement of older antifibrinolytic protocols in certain settings, offset by clinician caution where evidence varies

Growth constraints

• Generic price normalization
• Protocol variability across specialties
• Competitive substitution with other antifibrinolytics

What would change the forecast meaningfully

• A new label expansion or strong guideline shift in a high-volume setting
• A significant supply disruption that changes contracting dynamics
• A durable differentiation strategy via new delivery systems or combination regimens

How does AMICAR (aminocaproic acid) compare with tranexamic acid (TXA) on clinical adoption and market exposure?

Aminocaproic acid competes with tranexamic acid in antifibrinolytic use. Market impact depends on clinician preference, evidence strength in specific indications, and local protocol inertia.

Adoption dynamics

• TXA often benefits from broader contemporary evidence visibility and adoption in multiple bleeding contexts.
• Aminocaproic acid still retains use in specific perioperative or bleeding protocols, including settings where it is historically entrenched.

Forecast implication

• If TXA further consolidates standard-of-care roles in high-volume bleeding indications, aminocaproic acid growth is likely capped.
• If aminocaproic acid retains niche protocols or proves favorable in toxicity or dosing logistics in specific populations, it can maintain stable share.

What patent litigation or Paragraph IV challenges affect AMICAR generics?

For mature off-patent drugs, litigation risk often centers on:

• Narrow formulation/process patents (if any are still listed)
• NDC-specific differences
• Container-closure or stability-related IP

Result: Major brand-level litigation is unlikely to be a dominant driver of AMICAR market performance unless a specific listed patent is still enforced for an NDC.

What generic entry risks exist for AMICAR?

Generic entry risk is typically low in the sense that many competitors already supply the molecule. The actionable risks for market projection are operational:

• Manufacturing capacity constraints
• Quality system findings leading to temporary suspensions
• Sterile manufacturing disruptions for IV products

Where “entry” still matters

• If an innovator maintains exclusive supply of a specific dosage form or presentation, entry risk becomes a supply chain question rather than an exclusivity hurdle.

How do manufacturing and supply constraints affect AMICAR availability and revenue?

For off-patent hospital drugs:

• Revenue and volume often correlate with contract supply continuity.
• Any shortage impacts unit sales, because hospitals continue to use the drug when protocols demand it.

Supply-side indicators to watch

• FDA shortage communications for antifibrinolytics
• Sterile facility operational status
• Contract procurement cycles and distributor allocation

What formulations of AMICAR are used clinically, and do formulation patents matter?

Clinically, aminocaproic acid is used in:

• Intravenous regimens for rapid control in acute bleeding contexts
• Oral regimens in select bleeding disorders depending on protocol

Formulation IP relevance

If formulation patents exist, their commercial effect is typically NDC-specific and short-lived. For forecasting:

• Treat formulation differentiation as less important than protocol adoption and supply continuity unless a specific, still-listed patent blocks a competitor.

How do biosimilar risks apply to AMICAR?

AMICAR is a small-molecule drug (aminocaproic acid), not a biologic. Biosimilar frameworks do not apply.

Timelines: when does AMICAR “lose exclusivity,” and how does that affect projected demand?

Because the active ingredient is mature and broadly generic, “loss of exclusivity” effects are already realized for the molecule. The practical timeline variable now is:

• When any NDC-specific listed patents (if still present) expire
• When manufacturing entrants expand capacity
• When shortages end or resume

Key Takeaways

• AMICAR (aminocaproic acid) is effectively generic; market projection is more supply- and protocol-driven than pipeline-driven.
• Clinical trial updates tend to reinforce established antifibrinolytic roles rather than produce brand-defining late-stage outcomes.
• Market growth is constrained by generic price normalization and substitution versus tranexamic acid in higher-visibility bleeding indications.
• Near-term commercial variability is most sensitive to hospital formularies, surgical/critical care volume, and potential supply disruptions.

FAQs

1. What are the most common aminocaproic acid (AMICAR) dosing and administration settings in hospitals?
2. How does aminocaproic acid usage differ between cardiac surgery, trauma, and hematology bleeding protocols?
3. Do aminocaproic acid shortages in the US impact hospital contracting and net prices?
4. What competitive substitution patterns exist between aminocaproic acid and tranexamic acid by specialty?
5. Are there any formulation or NDC-specific IP barriers that could limit generic supply for AMICAR presentations?

References (APA)

1. FDA. (n.d.). Drugs@FDA: AMICAR (aminocaproic acid). U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. ClinicalTrials.gov. (n.d.). Aminocaproic acid (AMICAR) clinical trials listings. National Library of Medicine.