CLINICAL TRIALS PROFILE FOR ARGATROBAN

All Clinical Trials for Argatroban

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035178 ↗	Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis	Completed	Texas Biotechnology Corporation	Phase 4	2002-05-01	The primary goals of this investigation are to provide guidance on how to dose Argatroban in patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in hemodialysis patients. The secondary goal of the study will be to assess the adequacy of anticoagulation during hemodialysis.
NCT00039858 ↗	Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin	Completed	GlaxoSmithKline	Phase 4	2003-09-01	The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
NCT00039858 ↗	Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin	Completed	Encysive Pharmaceuticals	Phase 4	2003-09-01	The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
NCT00113997 ↗	Safety and Dosing Evaluation of REG1 Anticoagulation System	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	2005-06-01	This 1-week study will test the safety and dosing of an anticoagulation system called REG1 that is designed to improve control of "blood thinning." Patients with heart attack and other conditions require treatment with an anticoagulant (blood thinner) to prevent the formation of blood clots. However, anticoagulation therapy can increase the risk of bleeding. The REG1 system is designed to minimize this risk. One part of the system stops the activity of factor IX (a protein that helps blood clot) while the other part of the system (the antidote) inactivates the drug and stops the thinning process. This study will examine in normal healthy subjects how the REG1 system works in the body and how it leaves the body. Healthy normal volunteers between 12 and 65 years of age who weigh 50-120 kilograms (110-264 pounds) and have no history of bleeding problems or significant bleeding may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Participants must avoid foods that may alter the blood's clotting ability and must not take any medications the week of the study. They undergo the following tests and procedures: Day 1 Subjects are admitted to the NIH Clinical Center for an overnight stay. Two catheters (plastic tubes) are placed in the subject's arm veins, one for drawing blood samples and the other for injecting one of the following: REG1 drug, REG1 antidote, REG1 drug and antidote, or placebo. Two injections of study medication are given, spaced 3 hours apart, each over a 1-minute period. After each injection, blood is collected at specific times to measure levels of the drug or antidote in the body and the blood's ability to clot. Subjects also provide a 24-hour urine collection and stool sample. Day 2 A blood sample is drawn 24 hours after the drug or antidote injection from the previous day. If the blood test result is normal, subjects are discharged home with instructions to follow. They return to the Clinical Center at 36 hours and 48 hours for additional blood samples. Days 3 and 7 A blood sample is collected at the end of day 3 and day 7. Urine and stool samples are also collected.

Clinical Trial Conditions for Argatroban

Condition Name

Condition Name for Argatroban
Intervention	Trials
Heparin-induced Thrombocytopenia	4
Ischemic Stroke	3
Stroke	3
CVD	2

Condition MeSH

Condition MeSH for Argatroban
Intervention	Trials
Thrombocytopenia	10
Stroke	9
Ischemic Stroke	7
Ischemia	6

Clinical Trial Locations for Argatroban

Trials by Country

Trials by Country for Argatroban
Location	Trials
United States	75
Japan	12
China	10
Germany	9
Italy	4

Trials by US State

Trials by US State for Argatroban
Location	Trials
Texas	6
Massachusetts	4
Minnesota	4
Illinois	4
Ohio	4

Clinical Trial Progress for Argatroban

Clinical Trial Phase

Clinical Trial Phase for Argatroban
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Argatroban
Clinical Trial Phase	Trials
Completed	18
Recruiting	8
Terminated	6

Clinical Trial Sponsors for Argatroban

Sponsor Name

Sponsor Name for Argatroban
Sponsor	Trials
GlaxoSmithKline	3
Mitsubishi Tanabe Pharma Corporation	3
The University of Texas Health Science Center, Houston	3

Sponsor Type

Sponsor Type for Argatroban
Sponsor	Trials
Other	27
Industry	15
NIH	2

Argatroban: Clinical Trials, Market Analysis, and Projections

Introduction to Argatroban

Argatroban is a direct thrombin inhibitor used in various clinical settings, including the treatment of heparin-induced thrombocytopenia (HIT), percutaneous coronary intervention (PCI), and cerebral arterial thrombosis. Here, we will delve into recent clinical trials, market analysis, and projections for this critical anticoagulant.

Recent Clinical Trials

Argatroban in Acute Ischemic Stroke

A significant clinical trial, the Argatroban Plus Recombinant Tissue-Type Plasminogen Activator for Acute Ischemic Stroke (ARAIS) study, investigated the efficacy of argatroban combined with alteplase in patients with acute ischemic stroke. This multicenter, open-label, blinded end-point randomized trial involved 808 patients and was conducted at 50 hospitals in China from January 2019 to October 2021.

• Patients were randomly assigned to either the argatroban plus alteplase group or the alteplase alone group within 4.5 hours of symptom onset.
• The argatroban plus alteplase group received a 100-μg/kg intravenous argatroban bolus followed by an infusion of 1.0 μg/kg per minute for 48 hours, in addition to alteplase.
• The results showed that at 90 days, both groups had similar excellent functional outcomes, with 63.8% in the argatroban plus alteplase group and 64.9% in the alteplase alone group achieving this outcome[4].

Argatroban in Early Acute Ischemic Stroke

Another trial explored the use of argatroban in patients with acute ischemic stroke who received early treatment. This randomized clinical trial aimed to determine if argatroban improves neurological function in these patients. The trial found that the treatment groups were well-balanced regarding baseline patient characteristics, and the majority of patients in the argatroban group underwent the complete procedure. However, the trial did not show significant improvements in neurological function with argatroban compared to the control group[1].

Market Analysis

Market Size and Growth

The argatroban market is projected to grow at a compound annual growth rate (CAGR) of 3.5% to 4.09% over the forecast period from 2022 to 2027 or 2029, depending on the source. The market size is estimated to reach approximately $1.65 billion by 2027[3][5].

Market Segmentation

The argatroban market is segmented by indication, end user, and geography.

• Indications: The market is segmented into heparin-induced thrombocytopenia (HIT), percutaneous coronary intervention (PCI), cerebral arterial thrombosis, and other indications. The HIT segment held the largest market share in 2021 due to the increasing application of argatroban in treating HIT[3].
• End Users: The market is segmented into hospital pharmacies, retail pharmacies, and other end users. Hospital pharmacies are a significant segment due to the frequent use of argatroban in hospital settings[2].
• Geography: The market is dominated by North America, but the Asia-Pacific region is expected to grow at the highest CAGR during the forecast period. This growth is driven by the extensive application of argatroban in treating cerebral arterial thrombosis and other thrombotic conditions in this region[2][3].

Key Players

Major players in the global argatroban market include Mitsubishi Tanabe Pharma Corporation, AuroMedics Pharma LLC, Pfizer Inc, Viatris Inc, and Hikma Pharmaceuticals PLC. These companies are driving market dynamics through strategic partnerships, research and development, and expanding their product portfolios[2].

Market Drivers and Restraints

Drivers

• Increased Application in HIT: The extensive use of argatroban in treating heparin-induced thrombocytopenia is a significant driver. Clinical findings support the use of argatroban as a substitute anticoagulant in patients with HIT[3].
• Growing Procedures Requiring Anticoagulation: The rise in procedures such as PCI and the increasing incidence of thromboembolic disorders are driving the demand for argatroban[5].
• Advancements in Formulations and Delivery Systems: Improvements in anticoagulant formulations and delivery systems are enhancing argatroban's efficacy and patient compliance[5].

Restraints

• High Initial Cost: The high cost of argatroban compared to other anticoagulants limits its accessibility in cost-sensitive markets[5].
• Competition from Other Anticoagulants: The presence of other anticoagulants and emerging therapies poses a competitive challenge to the argatroban market[5].
• Stringent Regulatory Requirements: The stringent regulatory approvals and compliance requirements can slow down the innovation and market entry of new argatroban products[5].

Market Opportunities and Challenges

Opportunities

• Expanding Indications: Potential opportunities lie in expanding the indications for argatroban, including new regulatory approvals in different regions and further research into optimizing dosing protocols for specific patient subgroups[5].
• Growing Demand in Emerging Economies: The focus on healthcare improvement in emerging economies presents a significant opportunity for market expansion[5].
• Personalized Medicine and Digital Health Technologies: Research into personalized medicine approaches and the use of digital health technologies for therapeutic drug monitoring could drive future market growth[5].

Challenges

• Limited Availability of Raw Materials: Supply chain disruptions and the limited availability of raw materials can affect argatroban production processes[5].
• Competition and High Costs: The competition from other anticoagulants and the high initial cost of argatroban remain significant challenges[5].

Key Takeaways

• Argatroban is a critical anticoagulant used in various clinical settings, including HIT, PCI, and cerebral arterial thrombosis.
• Recent clinical trials have explored its efficacy in acute ischemic stroke, showing mixed results.
• The market is expected to grow at a CAGR of 3.5% to 4.09% over the forecast period, driven by increasing applications in HIT and PCI.
• North America dominates the market, but the Asia-Pacific region is expected to grow at the highest CAGR.
• Key players are driving market growth through strategic partnerships and research and development.
• High costs and competition from other anticoagulants are significant restraints, while expanding indications and personalized medicine approaches offer future opportunities.

FAQs

What is the current global argatroban market size?

The global argatroban market is projected to register a CAGR of 3.5% to 4.09% during the forecast period, with an estimated market size reaching approximately $1.65 billion by 2027[3][5].

Who are the key players in the global argatroban market?

Major players include Mitsubishi Tanabe Pharma Corporation, AuroMedics Pharma LLC, Pfizer Inc, Viatris Inc, and Hikma Pharmaceuticals PLC[2].

Which region has the largest share in the global argatroban market?

In 2024, North America accounts for the largest market share in the global argatroban market[2].

What are the primary indications for argatroban?

The primary indications include heparin-induced thrombocytopenia (HIT), percutaneous coronary intervention (PCI), and cerebral arterial thrombosis[3].

What are the main drivers of the argatroban market growth?

The main drivers include the increased application in HIT, growing procedures requiring anticoagulation, and advancements in formulations and delivery systems[3][5].

Sources

1. JAMA Network: Argatroban in Patients With Acute Ischemic Stroke With Early...
2. Mordor Intelligence: Argatroban Market Size & Share Analysis - Industry Research Report
3. IndustryARC: Argatroban Market Share, Size and Industry Growth Analysis 2020
4. JAMA Network: Effect of Argatroban Plus Intravenous Alteplase vs...
5. Research and Markets: Argatroban Market Size, Competitors & Forecast to 2030