Friday, July 10, 2026

Drug profile · INN

dabigatran

dabigatran (ARX-DABIGATRAN) is a thrombin inhibitor. Associated with Alphapharm Pty Ltd.

TGA: approved NMPA: clinical trials
Patents linked 1
Pipeline programs 13
News articles 0
Drug details — dabigatran

Quick answer

dabigatran (ARX-DABIGATRAN) is a thrombin inhibitor. Associated with Alphapharm Pty Ltd.

Key facts

INN dabigatran
Brand ARX-DABIGATRAN
Mechanism Thrombin inhibitor
Target Prothrombin

Mechanism of action

Thrombin inhibitor

Primary target: Prothrombin

Approval history

Authority Status Date
TGA approved
NMPA clinical trials

Pipeline programs

  1. DSC/08/2357/32 Phase 3 · ITALFARMACO S.P.A · JAK2V617F-positive high-risk Polycythemia Vera
  2. dabigatran Phase 3 · Yung Shin Pharmaceutical · Atrial Fibrillation
  3. dabigatran dose 1 Phase 3 · Boehringer Ingelheim · Atrial Fibrillation
  4. dabigatran etexilate Phase 3 · Boehringer Ingelheim · Venous Thromboembolism
  5. 1397-0022 Phase 1 · Boehringer Ingelheim · Healthy volunteer trial
  6. 1479-0015 Phase 1 · Boehringer Ingelheim · Pharmacokinetic trial
  7. 22600 Phase 1 · Bayer · Chronic Kidney Disease
  8. BIA-28-6156-113 Phase 1 · BIAL - Portela · Healthy volunteers

Related & competitor drugs

  1. argatroban Thrombin inhibitor
  2. bivalirudin Blood and blood forming organs (B01)
  3. dabigatran etexilate mesylate Thrombin inhibitor
  4. desirudin recombinant Thrombin inhibitor
  5. desirudin Blood and blood forming organs (B01)
  6. lepirudin Blood and blood forming organs (B01)
  1. US 10130618

    Pharmaceutical combinations of dabigatran and proton pump inhibitors

    Expires Mon Nov 15 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is dabigatran?

dabigatran (ARX-DABIGATRAN) is a thrombin inhibitor. Associated with Alphapharm Pty Ltd.

What is the brand name for dabigatran?

ARX-DABIGATRAN is a marketed brand name for dabigatran. Check FDA Drugs@FDA for the current US label holder and prescribing information.