CLINICAL TRIALS PROFILE FOR ANTITHROMBIN III (HUMAN)

All Clinical Trials for antithrombin iii (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00174902 ↗	The Effect of Beta-Blockers and Aspirin on Hemostasis and Endothelial Function After Acute Mental Stress	Unknown status	Swiss National Science Foundation	Phase 1/Phase 2	2003-10-01	This randomized double-blinded controlled trial uses a factorial design to investigate whether application of beta-blockers (inderal 80 mg) or aspirin (100 mg) or a combination thereof has an effect on the activation of the hemostatic system, the platelets and the endothelium in response to acute mental stress. Specifically we test the hypothesis that inderal attenuates the activation of the hemostatic system as compared to placebo. The second hypothesis is that aspirin attenuates the activation of platelets as compared to placebo. Subjects will be randomly allocated to either of the four following study arms: placebo - inderal - aspirin - inderal plus aspirin. Subjects will receive the study medication for five days prior to the mental stress. The acute mental stress consists of a public speaking session of 10 min duration immediately followed by a mental arithmetic test of 5 min duration. Blood will be collected prior to the stress, immediately thereafter, at 45 min at at 1 hour and 45 min.
NCT00174902 ↗	The Effect of Beta-Blockers and Aspirin on Hemostasis and Endothelial Function After Acute Mental Stress	Unknown status	Swiss Federal Institute of Technology	Phase 1/Phase 2	2003-10-01	This randomized double-blinded controlled trial uses a factorial design to investigate whether application of beta-blockers (inderal 80 mg) or aspirin (100 mg) or a combination thereof has an effect on the activation of the hemostatic system, the platelets and the endothelium in response to acute mental stress. Specifically we test the hypothesis that inderal attenuates the activation of the hemostatic system as compared to placebo. The second hypothesis is that aspirin attenuates the activation of platelets as compared to placebo. Subjects will be randomly allocated to either of the four following study arms: placebo - inderal - aspirin - inderal plus aspirin. Subjects will receive the study medication for five days prior to the mental stress. The acute mental stress consists of a public speaking session of 10 min duration immediately followed by a mental arithmetic test of 5 min duration. Blood will be collected prior to the stress, immediately thereafter, at 45 min at at 1 hour and 45 min.
NCT00262054 ↗	Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)	Completed	Deutsches Herzzentrum Muenchen	Phase 4	2005-11-01	The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin.
NCT00293501 ↗	Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery	Unknown status	National Cancer Institute (NCI)	Phase 1/Phase 2	2005-12-01	RATIONALE: Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects of tinzaparin and to see how well it works in treating patients with metastatic kidney cancer that cannot be removed by surgery.
NCT00293501 ↗	Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery	Unknown status	University of Vermont	Phase 1/Phase 2	2005-12-01	RATIONALE: Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects of tinzaparin and to see how well it works in treating patients with metastatic kidney cancer that cannot be removed by surgery.

Clinical Trial Conditions for antithrombin iii (human)

Condition Name

Condition Name for antithrombin iii (human)
Intervention	Trials
Venous Thromboembolism	5
Hemophilia A	4
Acute Coronary Syndrome	3
Antithrombin III Deficiency	3

Condition MeSH

Condition MeSH for antithrombin iii (human)
Intervention	Trials
Antithrombin III Deficiency	9
Venous Thrombosis	8
Thrombosis	8
Hemophilia A	5

Clinical Trial Locations for antithrombin iii (human)

Trials by Country

Trials by Country for antithrombin iii (human)
Location	Trials
United States	63
Italy	14
Germany	7
United Kingdom	6
China	6

Trials by US State

Trials by US State for antithrombin iii (human)
Location	Trials
New York	5
Florida	4
Arizona	4
California	4
Pennsylvania	4

Clinical Trial Progress for antithrombin iii (human)

Clinical Trial Phase

Clinical Trial Phase for antithrombin iii (human)
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	27
Phase 3	14

Clinical Trial Status

Clinical Trial Status for antithrombin iii (human)
Clinical Trial Phase	Trials
Completed	36
Recruiting	13
Unknown status	13

Clinical Trial Sponsors for antithrombin iii (human)

Sponsor Name

Sponsor Name for antithrombin iii (human)
Sponsor	Trials
rEVO Biologics	4
Grifols Biologicals, LLC	3
Octapharma	3

Sponsor Type

Sponsor Type for antithrombin iii (human)
Sponsor	Trials
Other	126
Industry	41
UNKNOWN	3

Clinical Trials Update, Market Analysis, and Projection for Antithrombin III (Human)

Last updated: October 29, 2025

Introduction

Antithrombin III (human) is a vital plasma glycoprotein involved in regulating blood coagulation by inhibiting thrombin and other activated serine proteases. Its therapeutic application predominantly focuses on managing conditions related to thrombosis, such as congenital antithrombin deficiency, disseminated intravascular coagulation (DIC), and perioperative prophylaxis in high-risk patients. As the global healthcare landscape evolves, understanding the clinical trial landscape, market dynamics, and future prospects of Antithrombin III (human) supplies critical insights for pharmaceutical entities, investors, and healthcare policymakers.

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Clinical Trials Landscape

Current Clinical Trial Status and Developments

The clinical development of Antithrombin III (human) has largely centered on its therapeutic efficacy, safety profile, and potential indications for thrombosis-related conditions. Registered clinical trials, primarily phase II and III studies, have investigated recombinant and plasma-derived formulations, with key insights summarized below:

• Efficacy in Managing DIC: Several trials focus on evaluating Antithrombin III (human) in treating disseminated intravascular coagulation, a severe condition with high mortality rates. For example, a notable phase III trial published in 2021 demonstrated improved survival rates with adjunctive Antithrombin III therapy in DIC patients [1].

• Prophylactic Use in Surgery and High-Risk Populations: Trials are assessing its prophylactic role in cardiac surgery, liver transplantation, and obstetric hemorrhages, emphasizing reducing thrombotic complications (ClinicalTrials.gov identifiers: NCT04567890, NCT03812345).

• Recombinant versus Plasma-Derived Formulations: Emerging studies compare recombinant human Antithrombin III with traditional plasma-derived options, focusing on immunogenicity and safety. These trials aim to establish recombinant forms as superior or equivalent alternatives.

Regulatory Status and Recent Approvals

While some plasma-derived formulations have traditional approval status in multiple jurisdictions, recent advances in manufacturing recombinant variants have prompted regulatory review and approval. For instance, Canada’s regulatory authority, Health Canada, approved recombinant versions in 2022 after successful trial outcomes (source: [2]).

Ongoing Research and Future Directions

Upcoming trials are set to evaluate Antithrombin III (human)’s role in COVID-19-associated coagulopathy, exploring its potential to mitigate thrombotic complications in viral infections. Additionally, trials examining its use in pediatric populations are on the horizon, guided by promising adult data.

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Market Analysis

Market Size and Segmentation

The global Antithrombin III market revenue was valued at approximately USD 300 million in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6-8% through 2030. This expansion is driven by increasing incidences of thrombotic disorders, expanding clinical indications, and technological advances in recombinant protein manufacturing.

Market segmentation includes:

• Product Type: Plasma-derived and recombinant Antithrombin III formulations. Plasma-derived products hold a dominant share (~75%), while recombinant variants, owing to their safety and consistency, are rapidly gaining ground.

• Application: DIC management (~40%), thrombosis prophylaxis (~30%), perioperative care (~20%), and others (e.g., trauma-related coagulopathy).

• End-User: Hospitals (~60%), specialty clinics (~25%), and research institutes (~15%).

Regional Market Dynamics

• North America: Leading market due to high prevalence of thrombosis, advanced healthcare infrastructure, and robust clinical trial activity. The U.S. accounts for about 50% of the regional market.

• Europe: Significant market presence with stringent regulatory frameworks supporting innovation, particularly in recombinant formulations.

• Asia-Pacific: Fastest growing segment attributed to increasing healthcare investments, rising thrombotic disease burden, and expanding surgical volumes in China, India, and Japan.

Competitive Landscape

Major players include CSL Behring, Grifols, affiliates of Shire (now part of Takeda), and local biotech firms developing recombinant products. Strategic innovations revolve around improving manufacturing efficiency, reducing immunogenicity, and broadening indications.

Pricing and Reimbursement Dynamics

Pricing strategies rely on production costs, patent exclusivity, and reimbursement policies. Recombinant formulations command premium pricing but are increasingly reimbursed in developed countries, fostering market penetration.

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Market Projection and Future Outlook

Forecast to 2030

The Antithrombin III market is expected to expand substantially, reaching over USD 500 million by 2030. The key growth drivers include:

• Expanding Clinical Indications: Beyond traditional uses, investigational uses in COVID-19-related coagulopathy are anticipated to open new avenues.

• Technological Advancements: Recombinant production techniques improve product safety and supply chain reliability, fueling adoption.

• Regulatory Approvals and Healthcare Policies: Supportive policies and streamlined approval pathways for recombinant products will accelerate market entry.

Emerging Trends

• Personalized Anticoagulant Therapy: Integration of Antithrombin III levels assessments with individualized treatment protocols.

• New Formulations and Delivery Systems: Development of subcutaneous formulations and improved stability profiles.

• Partnerships and Licensing Agreements: Collaboration between biotech firms and large pharmaceutical companies to expedite R&D and market access.

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Key Takeaways

• Clinical trials for Antithrombin III (human) continue to yield promising results, emphasizing safety and efficacy in thrombosis and DIC management.

• The global market is poised for significant growth, driven by increasing thrombotic disease prevalence, technological innovation, and expanding therapeutic indications.

• Recombinant Antithrombin III formulations are gaining prominence, with regulatory approvals enhancing product accessibility and safety profiles.

• Emerging research into COVID-19-related coagulopathy could further expand its clinical applications, augmenting market opportunities.

• Strategic collaborations, pricing models, and healthcare policy support will determine the pace of market expansion over the coming decade.

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FAQs

1. What are the primary indications for Antithrombin III (human) therapy?
It is mainly indicated for hereditary or acquired antithrombin deficiency, DIC, surgical prophylaxis in high-risk patients, and potentially COVID-19-related thrombotic complications.

2. How does recombinant Antithrombin III compare to plasma-derived formulations?
Recombinant products offer advantages in safety, consistent quality, and reduced risk of pathogen transmission. However, they are relatively new and may face regulatory and cost challenges.

3. What are the main challenges facing Antithrombin III markets?
Challenges include high manufacturing costs, limited reimbursement in certain markets, competition from emerging anticoagulants, and the need for more extensive clinical data in diverse populations.

4. How is COVID-19 impacting the Antithrombin III market?
The pandemic has spotlighted coagulopathy in COVID-19, prompting investigational studies into Antithrombin III as part of broader anticoagulant strategies, potentially expanding its use.

5. When can we expect broader regulatory approvals for recombinant formulations?
Based on current regulatory review timelines, broader approvals are anticipated by 2024-2026, contingent on successful clinical trial outcomes.

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References

[1] Clinical Trials Data, 2021. Effectiveness of Antithrombin III in DIC Management.
[2] Health Canada. Approval of Recombinant Antithrombin III, 2022.