Argatroban

Overview

Argatroban is a direct, selective thrombin inhibitor. The American College of Cardiologists (ACC) recommend using bivalirudin or argatroban in patients who have had, or at risk for, heparin induced thrombocytopenia (HIT) and are undergoing percutaneous coronary intervention. Argatroban is a non-heparin anticoagulant shown to both normalize platelet count in patients with HIT and prevent the formation of thrombi. Parental anticoagulants must be stopped and a baseline activated partial thromboplastin time must be obtained prior to administering argatroban.

Indication

Argatroban is indicated for prevention and treatment of thrombosis caused by heparin-induced thrombocytopenia (HIT). It is also indicated for use in patients with, or at risk for, HIT who are undergoing percutaneous coronary intervention.

Associated Conditions

Thrombosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure	2023/09/15	NCT06038682	N/A	Completed	University Hospital Ostrava
Safety of Argatroban Infusion in Conduction Disturbances	2023/02/23	NCT05740371	Phase 4	Completed	Mitsubishi Tanabe Pharma GmbH
A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects	2022/04/13	NCT05325346	Phase 1	Completed	Veralox Therapeutics
Safety and Feasibility of Argatroban as Anticoagulant in Adults With ECMO	2022/02/07	NCT05226442	Phase 2	Recruiting	Medical University of Vienna
Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO	2021/06/14	NCT04925167	Not Applicable	Completed	Beijing Chao Yang Hospital
Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)	2020/05/28	NCT04406389	Phase 4	Terminated	Weill Medical College of Cornell University
Efficacy Argatroban in Ischemic Stroke With Early Deterioration (EASE)	2020/02/19	NCT04275180	Phase 4	Completed	Second Affiliated Hospital, School of Medicine, Zhejiang University
Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban	2019/01/18	NCT03809481	Phase 3	Terminated	Aspen Global Incorporated
Argatroban Plus R-tPA for Acute Ischemic Stroke	2018/11/14	NCT03740958	Phase 4	Completed	General Hospital of Shenyang Military Region
Multi-arm Optimization of Stroke Thrombolysis	2018/11/08	NCT03735979	Phase 3	Completed	Washington University School of Medicine

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Argatroban	Fresenius Kabi USA, LLC	65219-429	INTRAVENOUS	50 mg in 50 mL	9/3/2025
Argatroban	Mylan Institutional LLC	67457-212	INTRAVENOUS	250 mg in 2.5 mL	8/29/2017
Argatroban	Hospira, Inc.	0409-1140	INTRAVENOUS	100 mg in 1 mL	9/15/2019
Argatroban	Par Pharmaceutical, Inc.	42023-182	INTRAVENOUS	250 mg in 2.5 mL	2/9/2023
Argatroban	Hikma Pharmaceuticals USA Inc.	0143-9288	INTRAVENOUS	250 mg in 2.5 mL	10/20/2020
Argatroban	Sagent Pharmaceuticals	25021-414	INTRAVENOUS	1 mg in 1 mL	3/3/2021
Argatroban	Hikma Pharmaceuticals USA Inc.	0143-9674	INTRAVENOUS	250 mg in 2.5 mL	11/18/2020
Argatroban	Hikma Pharmaceuticals USA Inc.	0143-9559	INTRAVENOUS	50 mg in 50 mL	11/18/2020
ARGATROBAN	Caplin Steriles Limited	65145-126	INTRAVENOUS	50 mg in 50 mL	2/1/2021
ARGATROBAN	Accord Healthcare Inc.	16729-430	INTRAVENOUS	1 mg in 1 mL	11/7/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ARGATROBAN	Sandoz Canada, Inc.	02548968	Solution - Intravenous	1 MG / ML	1/29/2025
ARGATROBAN	Sandoz Canada, Inc.	02243835	Solution - Intravenous	100 MG / ML	6/13/2002

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ARGANOVA 100 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION	Ethypharm	74548	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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