TheraRadar
Data updated: May 26, 2026

ARGATROBAN IN DEXTROSE (argatroban)

Trial Activity: Mature
Cardiovascular Approved 2011-05-09
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Tanabe Pharma Corporation conducting 1 trials (7%)
18 indications explored (Broad Platform)
→ heparin-induced thrombocytopenia (2 trials)
→ stroke (2 trials)
→ cvd (2 trials)
1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Discontinued
First Approved
2011-05-09
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Novartis
Active Ingredient: ARGATROBAN

ARGATROBAN IN DEXTROSE Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2011 to 2018
Jun 2018 SUPPL
Label · Labeling
FDA Letter Label
May 2016 SUPPL
Label · Labeling
FDA Letter Label
May 2011 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What ARGATROBAN IN DEXTROSE Treats

1 FDA approvals

Originally approved for its first indication in 2011 .

  • Other (1)
📋

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

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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 DEXTROSE FDA Label Details

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Data Sources

FDA Approval: NDA201743 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment