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.

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
Ischemic Stroke	3
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
The University of Texas Health Science Center, Houston	3
GlaxoSmithKline	3
Mitsubishi Tanabe Pharma Corporation	3

Sponsor Type

Sponsor Type for ARGATROBAN IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Other	28
Industry	15
NIH	2

Last updated: May 23, 2026

Argatroban in 0.9% Sodium Chloride Clinical Trials Update and Market Forecast (2026-2035)

Argatroban in 0.9% sodium chloride (0.9% NaCl) is a marketed intravenous (IV) anticoagulant product used for heparin-induced thrombocytopenia (HIT) and related off-label uses. No current, source-citable clinical-trials dataset specific to the exact presentation “argatroban in 0.9% sodium chloride” (as distinct from argatroban injection) is available to compile a complete, accurate update. No source-citable market sizing, unit economics, or pricing dataset specific to this formulation is available to produce a defensible projection.

What clinical trials exist for argatroban injection in 0.9% sodium chloride?

Argatroban is approved as an IV anticoagulant; trials typically report on argatroban injection (not on the diluent presentation) even when IV administration uses 0.9% NaCl as the infusion vehicle.

What indications dominate the argatroban trial pipeline?

• Heparin-induced thrombocytopenia (HIT), including acute HIT with thrombosis (HITT)
• Alternative anticoagulation in HIT when transitioning to or from other therapies (warfarin historically; DOACs in some modern studies where protocol-specific)

What trial endpoints are most common?

• Platelet count recovery and normalization dynamics
• Major thrombotic events and bleeding
• Safety in thrombocytopenic and critically ill subgroups

How often are new trials using the specific diluent “0.9% NaCl”?

Trial protocols generally specify infusion diluent (often 0.9% NaCl) operationally, but published registries and full text often do not stratify results by the diluent presentation. As a result, any “argatroban in 0.9% NaCl” trial update cannot be separated cleanly from argatroban injection updates without a source-citable protocol registry mapping.

Which companies market argatroban injection and how does formulation vary?

Commercial argatroban is sold as an IV drug product; some listings describe the dilution for administration rather than an independently marketed “argatroban in 0.9% sodium chloride” product line.

What dosage forms matter commercially?

• IV concentrate/solution requiring dilution or direct administration per label
• Infusion prepared in 0.9% NaCl in hospital pharmacy workflows

What does this mean for procurement?

Hospitals typically order the commercially packaged argatroban injection and prepare infusion solutions in-house using 0.9% NaCl or other labeled diluents, so “0.9% NaCl” drives administration workflow more than it drives separate market volume unless distributors separate by SKU.

What is the Orange Book status of argatroban for HIT, and does 0.9% NaCl change exclusivity?

Argatroban’s core IP and regulatory exclusivity typically attach to the marketed active drug (argatroban injection), not the infusion diluent. For exclusivity, the relevant questions for market entry are:

• Whether any ANDA-based generics exist (for small-molecule injectables)
• Whether any branded product still carries unexpired data exclusivity or patent protection
• Whether labeling includes the same indicated use and administration conditions

Does “0.9% NaCl” alter patent exclusivity or data exclusivity?

No. Diluent in administration is not a primary determinant of regulatory exclusivity unless a specific composition/patent claim is tied to a novel formulation or packaging. Without source-citable Orange Book listings and corresponding listed patents tied to a formulation claim for this exact presentation, a complete exclusivity assessment cannot be stated.

When does argatroban lose exclusivity, and what drives generic entry risk?

Generic entry risk for IV anticoagulants depends on:

• Listed patents (composition, method-of-use, or manufacturing)
• Status of any Paragraph IV certifications and settlements
• Practical ability to replicate particle size/solution characteristics and meet sterility and stability requirements

What are the typical generic entry pathways for argatroban injection?

• ANDA for small-molecule IV injectables
• 505(b)(2) pathways where bridging studies are needed for labeling or formulation changes

What is the highest barrier to generic launch for HIT anticoagulants?

• Patent landscape around argatroban composition/manufacturing and labeling
• Hospital acceptance and supply-chain readiness (cold chain is not usually the issue for argatroban injection, but sterility and stability profiles matter)

What patent estate protects argatroban, and how strong is it for litigation outcomes?

Patent strength is driven by:

• Number of active patents in the Orange Book
• Remaining life by jurisdiction
• Claim scope around formulation/manufacturing vs broad method-of-use

What patent types tend to matter most

• Composition-of-matter and stabilized solution claims
• Method-of-use claims tied to HIT management
• Manufacturing process and stability-related claims

Which litigation affects argatroban generic entry?

Paragraph IV litigation, if any, typically determines entry timing via:

• Automatic stays
• Settlement-triggered agreed-upon launch dates
• Court outcomes on invalidity and infringement

A litigation-aware assessment requires source-citable docket and settlement details, which cannot be compiled here without dataset access.

How many clinical-trial readouts are expected for argatroban in the next 24 months?

A reliable projection requires a current registry view with pending trial statuses and expected completion dates. No source-citable current-trials registry dataset for “argatroban injection” that isolates “0.9% NaCl” presentation can be produced.

What is the market size for argatroban in IV anticoagulation for HIT, and how is it evolving?

Market sizing for argatroban is generally discussed under:

• “Anticoagulants for thrombosis/HIT management”
• “HIT treatment segment” within hospital-administered anticoagulants

What demand drivers are most material

• Hospital incidence and testing practices for HIT (4Ts scoring and lab confirmation)
• Shift in practice patterns (early recognition and alternative anticoagulants)
• Capacity to manage IV anticoagulants and monitoring workflows

What demand constraints are most material

• Limited addressable population versus broad anticoagulants
• Competition from alternative non-heparin anticoagulants used in HIT settings

A defensible market forecast requires source-citable global and region-specific sales data, unit volumes, and pricing, which are not provided in the current input.

What competitive landscape matters for argatroban HIT therapy?

Key competitive axes:

• Alternative direct thrombin inhibitors (where used clinically)
• Off-label use of other anticoagulants in selected HIT cases
• Adoption and guideline alignment at major hospital systems

How does competitive positioning change purchasing?

For hospital formulary decisions, procurement is driven by:

• Clinical guidelines adoption
• Pharmacy preparation practicality
• Supply reliability and cost

Without source-citable formulary, tender pricing, and competitor sales datasets, a market share and trajectory forecast cannot be made.

Market projection for argatroban infusion prepared in 0.9% sodium chloride: base, upside, downside

A projection requires at minimum:

• Current sales baseline (units and revenue) for argatroban injection
• Growth drivers and headwinds quantified (incidence, share, pricing, competitive entries)
• Regulatory or patent-driven timeline shocks (generic launches, labeling changes)

No source-citable baseline or pipeline shocks are available in the current input, so a three-scenario forecast would not be defensible.

What generic entry risks exist for argatroban injection, and how would they change pricing?

Generic entry typically compresses:

• Branded price and gross margin
• Hospital contract pricing and tender dynamics

What would be the earliest plausible impact window?

• If ANDA approval and launch occur, timing usually follows regulatory approval date plus any exclusivity and litigation-related stays
• Budget impact appears immediately in hospital procurement cycles (often next tender)

A legally precise entry-timing estimate requires Orange Book and litigation facts that are not present in the current input.

Key Takeaways

• “Argatroban in 0.9% sodium chloride” is best treated as an administration presentation of argatroban injection, not a separate market defined solely by the diluent.
• A clinical trials update that isolates “0.9% NaCl” as a distinct presentation cannot be completed with source-citable specificity here.
• A market analysis and projection for the exact presentation likewise cannot be produced without source-citable baseline sales and formulation-specific SKU data.
• Patent, exclusivity, Paragraph IV risk, and litigation outcomes are determined by argatroban injection’s regulatory and patent record, not by the infusion diluent.

FAQs

1. Does argatroban require 0.9% NaCl specifically for IV administration, and can other diluents change market dynamics?
2. Are there current recruiting or active trials for HIT treatment using argatroban injection, and do they report diluent-specific outcomes?
3. How do Orange Book listed patents for argatroban injection map to generic ANDA launch timing?
4. What hospital formulary factors most influence argatroban uptake for HIT versus competing anticoagulants?
5. If a generic launches for argatroban injection, how quickly do tenders and contract pricing shift?

References

No sources were provided in the prompt, and no verifiable external dataset can be cited from within this response.