Dabigatran etexilate is a novel, oral reversible direct thrombin inhibitor in the clinical development for the treatment and prevention of thromboembolic diseases. Clinical data indicate that dabigatran etexilate has immediate onset of effect, no need for monitoring, predictable and consistent pharmacokinetics and pharmacodynamics—all features that differentiate it from oral vitamin K antagonists (VKAs). Completed phase III studies demonstrated a comparable efficacy and safety profile to enoxaparin in the prevention of venous thromboembolism (VTE) after orthopedic surgery. Ongoing phase III trials are now evaluating the long-term use of dabigatran etexilate for the treatment and secondary prevention of VTE and for prevention of stroke in patients with atrial fibrillation, as a replacement for VKAs. With an immediate, reliable, and predictable anticoagulant effect without the need for coagulation monitoring and the lack of long-term safety concerns, dabigatran etexilate may be a prospective candidate that offers additional benefit over VKAs and parenteral anticoagulants in these settings.