ARGATROBAN
Argatroban is an anticoagulant used to prevent or treat blood clots in adult patients who have developed heparin-induced thrombocytopenia (HIT). It also helps patients with or at risk for HIT who are undergoing percutaneous coronary intervention (PCI) by serving as a necessary blood thinner. This medication provides a critical alternative for managing clotting risks in individuals who cannot safely receive heparin.
How ARGATROBAN Works
This drug works by reversibly binding to the active site of thrombin, an enzyme central to the blood clotting process. By blocking thrombin, it prevents the formation of fibrin and stops the activation of various coagulation factors and platelets. It is effective against both free-floating and clot-associated thrombin and does not require a co-factor to exert its effects.
Details
- Status
- None (Tentative Approval)
- First Approved
- 2000-06-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
ARGATROBAN Approval History
What ARGATROBAN Treats
2 indicationsARGATROBAN is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thrombosis
- Heparin-Induced Thrombocytopenia
ARGATROBAN 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.
ARGATROBAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ARGATROBAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ARGATROBAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ARGATROBAN
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 FDA Label Details
Indications & Usage
FDA Label (PDF)ARGATROBAN is indicated for the treatment of Thrombosis; Heparin-Induced Thrombocytopenia.
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ARGATROBAN IN DEXTROSE
Full clinical data, patents, trials, and competitive landscape for argatroban.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.