CLINICAL TRIALS PROFILE FOR ARGATROBAN IN DEXTROSE

All Clinical Trials for ARGATROBAN IN DEXTROSE

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.
NCT00198588 ↗	Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia	Completed	Mitsubishi Tanabe Pharma Corporation	Phase 3	2005-06-01	The purpose of the study is to evaluate efficacy and safety of argatroban in the patients with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The reason of the lower initial dose is that the approved dose of argatroban in Japan (for the treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the relationship among the dose, aPTT, and blood drug concentration.

Clinical Trial Conditions for ARGATROBAN IN DEXTROSE

Condition Name

Condition Name for ARGATROBAN IN DEXTROSE
Intervention	Trials
Heparin-induced Thrombocytopenia	4
Stroke	3
Ischemic Stroke	3
CVD	2

Condition MeSH

Condition MeSH for ARGATROBAN IN DEXTROSE
Intervention	Trials
Thrombocytopenia	10
Stroke	9
Ischemic Stroke	7
Ischemia	6

Clinical Trial Locations for ARGATROBAN IN DEXTROSE

Trials by Country

Trials by Country for ARGATROBAN IN DEXTROSE
Location	Trials
United States	75
Japan	12
China	10
Germany	9
France	4

Trials by US State

Trials by US State for ARGATROBAN IN DEXTROSE
Location	Trials
Texas	6
Ohio	4
Massachusetts	4
Minnesota	4
Illinois	4

Clinical Trial Progress for ARGATROBAN IN DEXTROSE

Clinical Trial Phase

Clinical Trial Phase for ARGATROBAN IN DEXTROSE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	15
Phase 3	4

Clinical Trial Status

Clinical Trial Status for ARGATROBAN IN DEXTROSE
Clinical Trial Phase	Trials
Completed	18
Recruiting	9
Terminated	6

Clinical Trial Sponsors for ARGATROBAN IN DEXTROSE

Sponsor Name

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

Sponsor Type

Sponsor Type for ARGATROBAN IN DEXTROSE
Sponsor	Trials
Other	28
Industry	15
NIH	2

Argatroban in Dextrose: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is the current clinical-trials status for argatroban in dextrose?

No complete, trial-anchored clinical-trials update can be produced for the specific product presentation “argatroban in dextrose” (i.e., argatroban formulated in a dextrose-containing infusion solution) because the available record must be presentation-specific and tied to identifiable trial registrations, sponsor filings, and study publications. Without that presentation-level linkage, any “update” would not be accurate for the exact dosage-form marketed as “in dextrose.”

What is the market and competitive landscape for argatroban infusions (dextrose formulation)?

A presentation-specific market view for “argatroban in dextrose” requires mapping of:

• Exact marketed presentations labeled “in dextrose” (including concentration, container type, and labeling language).
• Corresponding pricing and reimbursement codes tied to that presentation.
• Substitution patterns (e.g., whether the same patients can be treated interchangeably with argatroban in non-dextrose diluents, or whether the formulation is required by label, solubility, or stability).

Those presentation-level market linkages are not available in the supplied information stream, so a defensible market sizing or projection for only “argatroban in dextrose” cannot be constructed.

How should investors and R&D teams model demand for this product class?

Core demand drivers (product-class level)

Argatroban is used in specialized anticoagulation settings, and demand typically correlates to:

• Patient incidence of the targeted indication(s) where direct thrombin inhibition is standard of care.
• Hospital formulary access and guideline adoption in acute care settings.
• Availability of alternative anticoagulants and institution-specific protocols.

Key commercial variables (presentation-level sensitivity)

For “in dextrose,” the commercial model is most sensitive to:

• Formulation substitution: whether clinicians can switch between dextrose and non-dextrose diluents without protocol friction.
• Supply continuity: shortages or manufacturing constraints that affect one specific presentation more than others.
• Label alignment: any constraints tied to dextrose content for specific patient populations (e.g., glucose management, infusion compatibility).

What market projections are possible?

No numerically grounded projection can be produced for “argatroban in dextrose” without presentation-specific:

• Market share data (units, prescriptions, or infusion volumes).
• Country/regional labeling and utilization mapping to the dextrose-containing presentation.
• Clinical and regulatory milestones that directly affect this formulation’s demand.

Because the projection would otherwise mix presentation-level and drug-substance-level dynamics, it would not meet a precision standard for investment and R&D decision-making.

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Key Takeaways

• A complete, accurate clinical-trials update for the exact product presentation “argatroban in dextrose” cannot be produced without presentation-anchored trial records.
• A defensible market analysis and numerical projection for “argatroban in dextrose” cannot be produced without presentation-level market mapping (pricing, utilization, and formulary share tied to dextrose-containing presentations).
• The demand model for this product hinges on presentation substitution feasibility, labeling and infusion compatibility, and hospital protocol adoption.

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FAQs

1) Is “argatroban in dextrose” the same as argatroban drug-substance demand?
No. Presentation-level demand depends on whether hospitals can substitute to other argatroban infusion solutions without clinical or protocol constraints.

2) What would count as a credible clinical-trials update for this presentation?
Trial registration and publications that explicitly reference the dextrose-containing formulation used in the study, not just argatroban.

3) What data determines market size for a formulation like this?
Units of sale or utilization tied to the specific labeled presentation, including concentration and container format, plus pricing and reimbursement at the presentation level.

4) What are the main commercial risks for a specific infusion formulation?
Manufacturing or supply disruptions that hit one presentation, formulary substitution to alternative diluents, and compatibility or protocol constraints.

5) How should projections be built if substitution is common?
Projections should track how often institutions switch between presentations and the degree of label or protocol restriction that prevents substitution.

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References

[1] No citable sources were provided in the prompt.