ARGATROBAN IN SODIUM CHLORIDE (argatroban) · EUGIA PHARMA SPECLTS
Argatroban in Sodium Chloride injection is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). HIT undergoing percutaneous coronary intervention (PCI).
Details
- Status
- Prescription
- First Approved
- 2011-05-09
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION, INJECTABLE
ARGATROBAN IN SODIUM CHLORIDE Approval History
What ARGATROBAN IN SODIUM CHLORIDE Treats
2 indicationsARGATROBAN IN SODIUM CHLORIDE is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thrombosis
- Heparin-Induced Thrombocytopenia
Same approved indications as ARGATROBAN (same active ingredient).
ARGATROBAN IN SODIUM CHLORIDE Target & Pathway
ProTarget
A key enzyme in the blood clotting cascade that converts prothrombin to thrombin. Inhibiting Factor Xa prevents clot formation, reducing risk of stroke in atrial fibrillation and treating/preventing venous thromboembolism.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00861692 results posted | ARG-E07 | Ph 2 | completed | Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II |
| NCT05740371 SAICoDis results posted | ARG-E08 2016-003521-42 | Ph 4 | completed | Safety of Argatroban Infusion in Conduction Disturbances |
| NCT03735979 MOST results posted | 2018-1464 1U01NS100699-01A1 | Ph 3 | completed | Multi-arm Optimization of Stroke Thrombolysis |
| NCT05226442 | Argatroban_ECMO | Ph 2, Ph 3 | completed | Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO |
| NCT04406389 IMPACT results posted | 20-04021936 | Ph 4 | terminated | Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) |
| NCT04275180 EASE | Yan-2019-293 | Ph 4 | completed | Efficacy Argatroban in Ischemic Stroke With Early Deterioration (EASE) |
| NCT05325346 | VLX-1005-002 | Ph 1 | completed | A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects |
| NCT03809481 HITSOVA | ERGCR-18-ORGHIT-001 | Ph 3 | terminated | Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban |
| NCT03740958 | k （2018）45 | Ph 4 | completed | Argatroban Plus R-tPA for Acute Ischemic Stroke |
| NCT02935530 | VTE-01 | Ph 3 | completed | Thromboprophylaxis After Surgery for Gynecologic Malignancy in China |
| NCT01734252 | ArgHeR | Ph 2 | completed | Argatroban in Critically Ill Patients With Heparin Resistance |
| NCT02448069 ARTSS-IA | HSC-MS-15-0327 | Ph 2 | completed | Safety and Feasibility of Argatroban, Tissue Plasminogen Activator and Intra-arterial Therapy in Stroke |
| NCT01163604 APORIAS results posted | JLH | Ph 4 | completed | Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting |
| NCT01980316 | JLH3 | Ph 4 | completed | Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting |
| NCT00798525 ALiCia | 2006-003122-28 | Ph 4 | terminated | Argatroban Versus Lepirudin in Critically Ill Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARGATROBAN IN SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Argatroban in Sodium Chloride injection is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) 1.1 Heparin-Induced Thrombocytopenia Argatroban in Sodium Chloride Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban in Sodium Chloride Injection is indicated as an antic...
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.