CLINICAL TRIALS PROFILE FOR APROTININ

All Clinical Trials for Aprotinin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00131040 ↗	Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass	Completed	British Heart Foundation	N/A	2003-01-01	The purpose of this study was to see if the heart-lung machine involved in cardiac surgery increases the movement of activated white blood cells from the bloodstream into the patient's tissues and also to see if aprotinin usage during surgery reduces this effect.
NCT00131040 ↗	Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass	Completed	Imperial College London	N/A	2003-01-01	The purpose of this study was to see if the heart-lung machine involved in cardiac surgery increases the movement of activated white blood cells from the bloodstream into the patient's tissues and also to see if aprotinin usage during surgery reduces this effect.
NCT00214656 ↗	"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery	Unknown status	Austin Health	Phase 3	2005-06-01	Aims and Hypotheses: This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional therapy in complex cardiac surgery. Major bleeding is still of concern in complex cardiac surgery. It has been shown to be associated with poorer patient outcome and results in the consumption of resources (hospital costs, manpower and blood bank reserves). This study has the potential to provide evidence that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic aspect of complicated cardiac surgery. The objective is to conduct a multi-centre randomised placebo controlled study that has been designed to scientifically evaluate the treatment of post bypass coagulopathy in the association with complex cardiac surgery. The trial design is based on clinical practice that has evolved over 2 years at the Austin Hospital during which 38 patients have received open label administration of rVIIa. There is currently no published RCT in this area and there is no TGA approval for the use of rVIIa for this indication.
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.
NCT00306137 ↗	Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer	Terminated	Bayer	Phase 3	2005-12-01	Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
NCT00306150 ↗	Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy	Terminated	Bayer	Phase 3	2005-12-01	The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.

Clinical Trial Conditions for Aprotinin

Condition Name

Condition Name for Aprotinin
Intervention	Trials
Blood Loss, Surgical	5
Coronary Artery Disease	4
Postoperative Hemorrhage	3
Cardiac Surgery	2

Condition MeSH

Condition MeSH for Aprotinin
Intervention	Trials
Hemorrhage	10
Coronary Artery Disease	5
Postoperative Hemorrhage	5
Blood Loss, Surgical	5

Clinical Trial Locations for Aprotinin

Trials by Country

Trials by Country for Aprotinin
Location	Trials
United States	60
Germany	15
Canada	9
China	8
United Kingdom	4

Trials by US State

Trials by US State for Aprotinin
Location	Trials
Pennsylvania	4
North Carolina	4
Illinois	3
California	3
Texas	3

Clinical Trial Progress for Aprotinin

Clinical Trial Phase

Clinical Trial Phase for Aprotinin
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	9
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Aprotinin
Clinical Trial Phase	Trials
Completed	19
Unknown status	7
Terminated	4

Clinical Trial Sponsors for Aprotinin

Sponsor Name

Sponsor Name for Aprotinin
Sponsor	Trials
Bayer	5
Chinese Academy of Medical Sciences, Fuwai Hospital	3
Soroka University Medical Center	2

Sponsor Type

Sponsor Type for Aprotinin
Sponsor	Trials
Other	33
Industry	7

Aprotinin: Clinical Trials, Market Analysis, and Projections

Overview of Aprotinin

Aprotinin, also known as bovine pancreatic trypsin inhibitor (BPTI), is a protein-based drug that has been used to reduce the risk of bleeding during complex surgical procedures, particularly in heart and liver surgery. It functions by inhibiting serine proteases such as trypsin, chymotrypsin, and plasmin, thereby slowing down fibrinolysis and reducing the need for blood transfusions[4].

Clinical Trials Update

Historical Context and Withdrawal

Aprotinin was widely used until its global withdrawal in May 2008 due to studies indicating an increased risk of complications or death associated with its use. However, it has been made available for restricted research purposes[4].

Current Clinical Trials

Despite its withdrawal, research into aprotinin continues, particularly in exploring its potential in other therapeutic areas. Here are some key points about ongoing and past clinical trials:

• Phase Trials: Aprotinin has been through various phases of clinical trials. As of the latest data, there have been 2 Phase 1 trials, 3 Phase 2 trials, 6 Phase 3 trials, and 1 Phase 4 trial[4].
• New Therapeutic Uses: Recent studies have explored the use of aprotinin in treating respiratory diseases, including influenza and COVID-19. For instance, aprotinin has shown promising results in reducing viral load and clinical symptoms in patients with influenza and COVID-19[1].

Market Analysis

Global Market Size

The global aprotinin market has seen significant growth despite the drug's limited use due to its withdrawal.

• Current Market Size: The global aprotinin market was valued at approximately USD 164.74 million in 2023[2].
• Projected Growth: The market is expected to grow to USD 228.30 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 4.8% during the review period[2].

Market Segmentation

The market is segmented based on type, application, and geographical regions.

• Type: Aprotinin injections and pharmaceutical products are the main segments. Aprotinin from bovine lung is the largest segment, accounting for nearly 80% of the market[2].
• Application: The primary applications are in cardiac surgery and blood loss management. The increasing prevalence of cardiovascular diseases has driven the demand for aprotinin in these areas[3].
• Geographical Regions: India is the largest market, followed by China and North America, which together account for about 35% of the market share[2].

Key Players

The global aprotinin market is dominated by several key players:

• Sigma-Aldrich
• BeiJing Geyuantianrun Biotech
• Cayman Chemical
• Taj Pharmaceuticals Limited

These top four manufacturers hold over 25% of the market share[2].

Market Projections

Growth Drivers

Several factors are driving the growth of the aprotinin market:

• Increasing Demand in Surgical Procedures: The growing need for minimizing blood loss during high-risk surgeries, such as heart and liver surgeries, is a significant driver[3].
• Research into New Therapeutic Uses: Ongoing research into the potential uses of aprotinin in other medical specialties, such as orthopedic surgery and cancer treatment, is expected to expand the market[3].
• Emphasis on Patient Safety: The focus on improving surgical outcomes and patient safety has led to increased adoption of aprotinin in specific procedures[3].

Projected Market Size

By 2031, the global aprotinin market is expected to reach USD 2.3 billion, growing at a CAGR of 7.5% from 2024 to 2031[3].

Regional Growth

The market is expected to grow significantly in regions such as North America, Europe, and Asia-Pacific, driven by the increasing prevalence of cardiovascular diseases and the need for advanced surgical care[3].

Future Trends and Opportunities

Expanding Therapeutic Uses

Research into new therapeutic uses of aprotinin, such as its antiviral properties against influenza and COVID-19, presents significant opportunities for market expansion[1].

Regulatory Environment

Changes in regulatory policies and the potential for reapproval of aprotinin for broader clinical use could significantly impact market growth.

Technological Advancements

Advancements in biotechnology and pharmaceutical manufacturing could improve the production and efficacy of aprotinin, further driving its adoption.

Key Takeaways

• Aprotinin is a serine protease inhibitor used primarily to reduce bleeding during complex surgeries.
• Despite its withdrawal in 2008, ongoing research explores its use in new therapeutic areas.
• The global aprotinin market is projected to grow significantly, driven by increasing demand in surgical procedures and research into new uses.
• Key players dominate the market, with India, China, and North America being major regions.
• The market is expected to reach USD 2.3 billion by 2031, growing at a CAGR of 7.5%.

FAQs

What is the primary use of aprotinin?

Aprotinin is primarily used to reduce the risk of bleeding during complex surgical procedures, such as heart and liver surgery.

Why was aprotinin withdrawn from the market?

Aprotinin was withdrawn from the market in 2008 due to studies indicating an increased risk of complications or death associated with its use.

What are the current clinical trials focusing on for aprotinin?

Current clinical trials are exploring the use of aprotinin in treating respiratory diseases, including influenza and COVID-19.

Which regions dominate the global aprotinin market?

India is the largest market, followed by China and North America, which together account for about 35% of the market share.

What is the projected growth of the global aprotinin market?

The global aprotinin market is expected to reach USD 2.3 billion by 2031, growing at a CAGR of 7.5% from 2024 to 2031.

Sources

1. Ivashchenko, A.; Svistunov, A.; Khorobryh, T.; Loginov, V.; Karapetian, R.; Mishchenko, N.; Poyarkov, S.; Topr, M.; Volgin, M.; Yakubova, E.; et al. "Aprotinin—A new multi-target drug candidate or “magic shotgun” for the therapy of COVID-19." COVID-19-Preprints, 2020.
2. Bonafide Research. "Global Aprotinin Market Growth 2024-2030." Bonafide Research, 2024.
3. Market Research Intellect. "Aprotinin Market Size, Sales Analysis & Opportunity to 2031." Market Research Intellect, December 2024.
4. DrugBank. "Aprotinin: Uses, Interactions, Mechanism of Action | DrugBank Online." DrugBank, [Accessed 2024].