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Acova

(argatroban)

ApprovedSmall molecule

Jazz Pharmaceuticals

Argatroban is used to prevent blood clots in patients who are allergic to heparin (a common blood thinner) or who have a condition where heparin causes dangerous immune reactions. It helps keep blood from clotting abnormally during medical procedures.[2] Acova is currently approved and in use across 7 indications[4].[1]

Acova is one of 176 small molecule programs targeting Thrombotic Disease. It is currently in Approved.

7

Indications

23

Total Trials

0

Active Trials

175

Competitors

9

FDA Applications

NDA/BLA/ANDA regulatory filings

2

Patents

Pipeline

Status by Indication[4][1]

Indication

Thrombotic DiseaseActive, not recruiting

Recurrent ThrombophlebitisActive, not recruiting

Hemorrhagic DiseaseApproved

Coronary Artery DiseaseApproved

Safety and EfficacyCompleted

Ischemic StrokeCompleted

COVID-19Terminated

Thrombotic DiseaseApproved

Active, not recruiting

Recurrent ThrombophlebitisApproved

Active, not recruiting

Hemorrhagic DiseaseApproved

Approved

Coronary Artery DiseaseApproved

Approved

Safety and EfficacyPreclinical

Completed

Ischemic StrokeApproved

Completed

COVID-19Approved

Terminated

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Acova

Jazz Pharmaceuticals

Tricor

Achromycin V

WWyeth-Lederle Vaccines

Statin

Bristol-Myers Squibb

Calcium

Blood Taken

HHospices Civils de Lyon

Other Tkis

Disease-Modifying Anti-Rheumatic Drugs

Immunosuppressive

Chiesi Farmaceutici S.p.A.

Stools

VVersailles Hospital

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Thrombocytopenia3 trials

Retrospective Registry of Patients With Acute Heparin-induced Thrombocytopenia Type II

Completed· GSK logo

GSK··NCT01304238·195 enrolled

Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 2·NCT00861692·20 enrolled

Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia

Completed·MMinistry of Health, Labour and Welfare, Japan·Phase 3·NCT00198588·8 enrolled

Stroke3 trials

Safety and Feasibility of Argatroban, Tissue Plasminogen Activator and Intra-arterial Therapy in Stroke

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02448069·10 enrolled

Multi-arm Optimization of Stroke Thrombolysis

Completed·WWashington University School of Medicine·Phase 3·NCT03735979·514 enrolled

Argatroban Stroke Treatment - A Pilot Safety Study

Completed·TThe University of Texas Health Science Center, Houston·Phase 1/2·NCT00268762·65 enrolled

Occlusion2 trials

Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting

Completed·JJinling Hospital, China·Phase 4·NCT01163604·114 enrolled

Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting

Completed·XXinfeng Liu·Phase 4·NCT01980316·114 enrolled

Critically Ill Patients2 trials

Argatroban Versus Lepirudin in Critically Ill Patients

Terminated·HHeinrich-Heine University, Duesseldorf·Phase 4·NCT00798525·70 enrolled

Argatroban in Critically Ill Patients With Heparin Resistance

Completed·MMedical University Innsbruck·Phase 2·NCT01734252·44 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO

Completed·—·N/A·NCT04925167·20 enrolled

Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban

Terminated·AAspen Global Incorporated·Phase 3·NCT03809481·7 enrolled

10 more indications

Ischemic stroke2 trials

Efficacy Argatroban in Ischemic Stroke With Early Deterioration (EASE)

Completed·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04275180·628 enrolled

Argatroban Plus R-tPA for Acute Ischemic Stroke

Completed·GGeneral Hospital of Shenyang Military Region·Phase 4·NCT03740958·808 enrolled

Percutaneous Coronary Intervention (PCI)1 trial

Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 2·NCT00508924·140 enrolled

Infusion1 trial

Safety of Argatroban Infusion in Conduction Disturbances

Completed·TTanabe Pharma GmbH·Phase 4·NCT05740371·50 enrolled

Anticoagulant1 trial

Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

Completed·MMedical University of Vienna·Phase 2/3·NCT05226442·40 enrolled

Pediatric Patients1 trial

Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin

Completed·EEncysive Pharmaceuticals·Phase 4·NCT00039858·24 enrolled

Anticoagulation1 trial

Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

Completed·UUniversity Hospital Ostrava··NCT06038682·100 enrolled

End-Stage Renal Disease1 trial

Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis

Completed·TTexas Biotechnology Corporation·Phase 4·NCT00035178·12 enrolled

Prophylaxis1 trial

Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Completed·HHuazhong University of Science and Technology·Phase 3·NCT02935530·315 enrolled

COVID-191 trial

Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)

Terminated·WWeill Medical College of Cornell University·Phase 4·NCT04406389·14 enrolled

Unspecified1 trial

A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects

Completed·VVeralox Therapeutics·Phase 1·NCT05325346·12 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 30, 2000

ARGATROBAN

NDA NDA020883

May 9, 2011

ARGATROBAN IN SODIUM CHLORIDE

NDA NDA022485

May 9, 2011

ARGATROBAN IN DEXTROSE

NDA NDA201743

Jun 29, 2011

ARGATROBAN IN SODIUM CHLORIDE

NDA NDA022434

Dec 15, 2014

ARGATROBAN IN 0.9% SODIUM CHLORIDE

NDA NDA206769

Mar 23, 2015

ARGATROBAN

NDA NDA201811

Sep 30, 2016

ARGATROBAN

NDA NDA203049

Nov 27, 2018

ARGATROBAN IN SODIUM CHLORIDE

NDA NDA209552

Jun 7, 2021

ARGATROBAN IN SODIUM CHLORIDE

NDA NDA212035

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for argatroban. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Acova drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — argatroban compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for argatroban. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212035). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Acova. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thrombin Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Sep 26, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7687516Sep 26, 2027

7589106Sep 26, 2027

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