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Argatroban (ARGATROBAN)
Argatroban works by directly inhibiting the activity of thrombin, a key enzyme in the blood clotting process.
At a glance
| Generic name | ARGATROBAN |
|---|---|
| Sponsor | Hikma Pharm Co Ltd |
| Drug class | Anti-coagulant [EPC] |
| Target | Prothrombin |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
Argatroban is direct thrombin inhibitor that reversibly binds to the thrombin active site. Argatroban does not require the co-factor antithrombin III for antithrombotic activity. Argatroban exerts its anticoagulant effects by inhibiting thrombin-catalyzed or -induced reactions, including fibrin formation; activation of coagulation factors V, VIII, and XIII; activation of protein C; and platelet aggregation. Argatroban inhibits thrombin with an inhibition constant (Ki) of 0.04 uM. At therapeutic concentrations, argatroban has little or no effect on related serine proteases (trypsin, factor Xa, plasmin, and kallikrein). Argatroban is capable of inhibiting the action of both free and clot-associated thrombin.
Approved indications
- Percutaneous coronary intervention
- Thrombosis Prevention in Heparin-Induced Thrombocytopenia
- Thrombosis in Heparin Induced Thrombocytopenia
Common side effects
- Myocardial infarction
- Angina pectoris
- Coronary thrombosis
- Myocardial ischemia
- Intracranial hemorrhage
- Multisystem hemorrhage and DIC
- Limb and BKA stump
- Overall bleeding
- Gastrointestinal
- Genitourinary and hematuria
- Decrease in hemoglobin and hematocrit
- Groin
Drug interactions
- rivaroxaban
Key clinical trials
- Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO (PHASE2)
- Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI) (PHASE2)
- Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II (PHASE2)
- Safety of Argatroban Infusion in Conduction Disturbances (PHASE4)
- HEPARINS: INTERFERENCE IN ARGATROBAN MEASUREMENT
- Multi-arm Optimization of Stroke Thrombolysis (PHASE3)
- Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support (PHASE4)
- Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO (PHASE2,PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 7687516 | 2027-09-26 | Formulation |
| 7589106 | 2027-09-26 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Argatroban CI brief — competitive landscape report
- Argatroban updates RSS · CI watch RSS
- Hikma Pharm Co Ltd portfolio CI