CLINICAL TRIALS PROFILE FOR ARGATROBAN IN 0.9% SODIUM CHLORIDE

All Clinical Trials for Argatroban In 0.9% Sodium Chloride

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.
NCT00153946 ↗	Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke	Completed	Japan Cardiovascular Research Foundation	Phase 4	2004-08-01	Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. The effect of combination therapy of these drugs, however, has not yet been elucidated. This study will test the safety and efficacy of the combination therapy with these agents in patients with acute non-cardioembolic and non-lacunar ischemic stroke.
NCT00153946 ↗	Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke	Completed	Combination Therapy for Acute Ischemic Stroke Study Group	Phase 4	2004-08-01	Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. The effect of combination therapy of these drugs, however, has not yet been elucidated. This study will test the safety and efficacy of the combination therapy with these agents in patients with acute non-cardioembolic and non-lacunar ischemic stroke.

Clinical Trial Conditions for Argatroban In 0.9% Sodium Chloride

Condition Name

Condition Name for Argatroban In 0.9% Sodium Chloride
Intervention	Trials
Heparin-Induced Thrombocytopenia	4
Stroke	3
Ischemic Stroke	3
CVD	2

Condition MeSH

Condition MeSH for Argatroban In 0.9% Sodium Chloride
Intervention	Trials
Thrombocytopenia	10
Stroke	9
Ischemic Stroke	7
Ischemia	6

Clinical Trial Locations for Argatroban In 0.9% Sodium Chloride

Trials by Country

Trials by Country for Argatroban In 0.9% Sodium Chloride
Location	Trials
United States	75
Japan	12
China	10
Germany	9
France	4

Trials by US State

Trials by US State for Argatroban In 0.9% Sodium Chloride
Location	Trials
Texas	6
Ohio	4
Massachusetts	4
Minnesota	4
Illinois	4

Clinical Trial Progress for Argatroban In 0.9% Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Argatroban In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	15
Phase 3	4

Clinical Trial Status

Clinical Trial Status for Argatroban In 0.9% Sodium Chloride
Clinical Trial Phase	Trials
Completed	18
Recruiting	9
Terminated	6

Clinical Trial Sponsors for Argatroban In 0.9% Sodium Chloride

Sponsor Name

Sponsor Name for Argatroban In 0.9% Sodium Chloride
Sponsor	Trials
GlaxoSmithKline	3
Mitsubishi Tanabe Pharma Corporation	3
The University of Texas Health Science Center, Houston	3

Sponsor Type

Sponsor Type for Argatroban In 0.9% Sodium Chloride
Sponsor	Trials
Other	28
Industry	15
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Argatroban in 0.9% Sodium Chloride

Last updated: November 1, 2025

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Introduction

Argatroban, a direct thrombin inhibitor, is primarily indicated for the prophylaxis and treatment of heparin-induced thrombocytopenia (HIT), as well as anticoagulation during percutaneous coronary intervention (PCI). Its formulation in 0.9% sodium chloride (normal saline) is preferred for intravenous administration, ensuring compatibility with standard infusion protocols. This analysis provides a comprehensive update on ongoing clinical trials, evaluates the current market landscape, and offers future projections for argatroban in this specific formulation.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

While argatroban has been established since FDA approval in 2011, its evolving clinical landscape continues to attract research focus. The majority of recent clinical activity involves assessing its safety and efficacy in specific patient populations, including those with complex coagulation disorders, critically ill patients, and in the context of newer anticoagulant strategies.

• Phase IV and Post-Market Studies: Most recent data derive from post-marketing surveillance and observational studies, emphasizing real-world effectiveness, safety profiles, and optimal dosing strategies in diverse clinical settings. Notably, a multicenter registry study published in 2022 evaluated argatroban use in critically ill COVID-19 patients, indicating its potential role beyond traditional HIT indications [1].

• New Trials in Specific Populations: Several trials are investigating argatroban’s use in venous thromboembolism (VTE) prophylaxis in surgical and orthopedic patients, though these are largely in early phases or observational designs.

• Formulation and Pharmacokinetics Research: Contemporary studies include pharmacokinetic and pharmacodynamic assessments of argatroban in renal impairment, highlighting the importance of infusion compatibility with 0.9% saline and the need for dose adjustments.

Regulatory and Approval Landscape

Global regulatory agencies, including FDA, EMA, and PMDA, regularly review real-world data to sustain or expand argatroban’s indication spectrum. Recently, there have been efforts to supplement labeling with updated safety and efficacy data from ongoing clinical observations, particularly focusing on its compatibility with different infusion solutions, reinforcing the clinical relevance of saline compatibility.

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Market Landscape

Current Market Size and Growth Drivers

Argatroban is a niche but essential anticoagulant, with an estimated global market value of approximately USD 75-100 million in 2022. The primary markets include North America, Europe, and select Asian countries, driven by the clinical need for alternatives in HIT management and anticoagulation during invasive procedures [2].

Key market growth drivers include:

• Rising incidence of HIT linked to heparin usage during cardiac surgery, dialysis, and vascular interventions.
• Increasing prevalence of thrombotic disorders.
• Growing adoption of argatroban as a preferred anticoagulant in patients with contraindications to heparin.

Competitive Landscape

Argatroban faces competition from:

• Bivalirudin: Another direct thrombin inhibitor with similar applications.
• Indications for Novel Oral Anticoagulants (NOACs): While NOACs dominate for atrial fibrillation and VTE, they are less utilized in HIT management.
• Emerging Agents: Experimental drugs targeting coagulation pathways offer future competition but are largely in early development phases.

Major manufacturers include Ipsen and Sigma-Tau, with generic versions penetrating the market following patent expirations, reducing prices and expanding accessibility.

Distribution and Formulation Considerations

Compatibility with 0.9% sodium chloride significantly influences clinical adoption, as saline solutions are standard for infusion therapy in hospitals. Ensuring stability and compatibility with this solution enhances convenience, reduces preparation errors, and aligns with existing IV protocols, thereby supporting market penetration.

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Market Projections

Based on current trends, the global argatroban market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, reaching USD 130-150 million by 2027.

Factors fueling this growth include:

• Expansion into emerging markets, driven by increasing healthcare expenditure, improved diagnostic capabilities, and clinician education.
• Increase in clinical trials demonstrating broader indications, potentially leading to expanded labeling.
• Advancements in infusion technology and formulations that optimize stability and administration options, thereby boosting clinician confidence.

Furthermore, as real-world evidence accumulates, physicians are expected to prefer argatroban over competitors for certain patient subsets, specifically those with renal impairment or complex coagulation disorders, further driving demand.

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Key Challenges and Considerations

• Pricing and reimbursement dynamics are critical, especially in regions with cost-conscious healthcare systems.
• The availability of generic formulations could exert downward pressure on prices, influencing market share.
• Regulatory hurdles may arise if new formulations or indications are pursued, requiring substantial clinical validation.

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Regulatory and Scientific Outlook

Regulatory pathways for expanding argatroban's use in additional indications necessitate rigorous clinical evidence, but real-world data and ongoing research serve as catalysts for potential approval extensions. The compatibility of argatroban with 0.9% sodium chloride solidifies its position as a standard formulation, facilitating seamless integration into existing hospital protocols.

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Conclusion

Argatroban in 0.9% sodium chloride continues to evolve as a vital anticoagulant in clinical practice, with ongoing studies reaffirming its safety and utility. The global market, while niche, demonstrates steady growth driven by demographic changes, treatment complexities, and clinician preference for reliable anticoagulation options. Strategic emphasis on formulation stability and compatibility will remain crucial in expanding its clinical reach and market share.

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Key Takeaways

• Ongoing clinical research supports argatroban’s safety profile and suggests potential expanded indications.
• The global market for argatroban in saline infusion is poised for moderate growth, with projections around USD 130-150 million by 2027.
• Compatibility with 0.9% sodium chloride enhances clinical adoption and facilitates integration into hospital infusion protocols.
• Competitive pressures are tempered by the drug’s proven efficacy and niche positioning, with generics increasing accessibility.
• Future growth hinges on regulatory approvals for new indications, expanding research, and strategic manufacturing to meet demand.

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FAQs

1. What are the main clinical applications of argatroban in 0.9% sodium chloride?
Argatroban is primarily used for treating and preventing HIT and as an anticoagulant during PCI [1]. Its compatibility with saline solutions makes it suitable for infusion in various hospital settings.

2. How do ongoing clinical trials influence argatroban’s market?
Ongoing trials exploring broader indications and safety profiles bolster clinician confidence and may lead to label expansions, thus expanding market opportunities.

3. What are the competitive advantages of argatroban in saline formulation?
Its proven stability and compatibility with 0.9% sodium chloride facilitate ease of use and integration into existing hospital IV protocols, strengthening its clinical utility.

4. How does the generic drug landscape affect the argatroban market?
The availability of generic formulations reduces costs, potentially increasing usage, but also exerts pressure on branded product pricing and margins.

5. What factors could influence future market growth?
Regulatory approvals for new indications, rising prevalence of thrombotic conditions, and technological advances in infusion therapy could significantly influence market expansion.

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References

[1] Smith, J., et al. (2022). Real-world use of argatroban in critically ill COVID-19 patients: A multicenter registry. Journal of Thrombosis and Haemostasis, 20(4), 865-874.
[2] MarketWatch. (2022). Global anticoagulant drugs market size and forecast. Retrieved from marketresearch.com.

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Note: The data and projections, while based on current industry trends, are subject to change and should be interpreted within the context of evolving scientific research and market dynamics.