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Data updated: May 26, 2026

ARGATROBAN IN 0.9% SODIUM CHLORIDE (argatroban)

Cardiovascular Approved 2014-12-15
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2014-12-15
Routes
INTRAVENOUS
Dosage Forms
INJECTABLE

Companies

Teva
Active Ingredient: ARGATROBAN

ARGATROBAN IN 0.9% SODIUM CHLORIDE Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2014 to 2019
Jul 2019 SUPPL
Label · Labeling
FDA Letter Label
Aug 2017 SUPPL
Label · Labeling
FDA Letter Label
May 2016 SUPPL
Label · Labeling
FDA Letter Label

What ARGATROBAN IN 0.9% SODIUM CHLORIDE Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 0.9% SODIUM CHLORIDE FDA Label Details

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Data Sources

FDA Approval: NDA206769 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.