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Dabigatran etexilate

Generic Name
Dabigatran etexilate
Brand Names
Pradaxa
Drug Type
Small Molecule
Chemical Formula
C34H41N7O5
CAS Number
211915-06-9
Unique Ingredient Identifier
2E18WX195X

Overview

Dabigatran etexilate is an oral prodrug that is hydrolyzed to the competitive and reversible direct thrombin inhibitor dabigatran. Dabigatran etexilate may be used to decrease the risk of venous thromboembolic events in patients in whom anticoagulation therapy is indicated. In contrast to warfarin, because its anticoagulant effects are predictable, lab monitoring is not necessary. Dabigatran etexilate was approved by the FDA in 2010.

Background

Dabigatran etexilate is an oral prodrug that is hydrolyzed to the competitive and reversible direct thrombin inhibitor dabigatran. Dabigatran etexilate may be used to decrease the risk of venous thromboembolic events in patients in whom anticoagulation therapy is indicated. In contrast to warfarin, because its anticoagulant effects are predictable, lab monitoring is not necessary. Dabigatran etexilate was approved by the FDA in 2010.

Indication

Dabigatran etexilate is available in both oral pellet and capsule form. Dabigatran etexilate pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients between three months and 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days. They are also indicated in the same age group to reduce the risk of recurrence of VTE in patients who have been previously treated. In capsule form, dabigatran etexilate is indicated in adults to reduce the risk of stroke and systemic embolism associated with non-valvular atrial fibrillation and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days. It is also indicated in adults to reduce the risk of recurrence of DVT and PE in patients who have been previously treated and for the prophylaxis of DVT and PE in patients who have undergone hip replacement surgery. Lastly, it is indicated in pediatric patients between eight and 18 years of age for the treatment of venous thromboembolic events (VTE) in patients who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE in patients who have been previously treated. Dabigatran etexilate is also approved by the EMA to prevent VTE in adult patients. For pediatric patients, Dabigatran etexilate is used to treat TVE and prevent recurrent TVE for patients from birth to less than 18 years of age.

Associated Conditions

  • Deep Vein Thrombosis
  • Deep vein thrombosis recurrent
  • Pulmonary Embolism
  • Recurrent Pulmonary Embolism (Disorder)
  • Recurrent Venous Thromboembolism
  • Stroke
  • Systemic Embolism
  • Venous Thromboembolism

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2011/06/23
Phase 1
Completed
2011/03/01
Phase 1
Completed
2011/02/07
Phase 1
Completed
2010/11/16
Phase 1
Completed
2010/10/21
Phase 2
Completed
2010/08/19
Phase 4
Completed
2010/06/03
Phase 2
Completed
2010/03/10
Phase 2
Completed
2009/02/16
Phase 2
Completed
2008/05/20
Phase 3
Completed

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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