Indications of Macitentan

Macitentan is an endothelin receptor antagonist indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH, WHO Group 1) to reduce the risk of disease progression and hospitalization due to PAH.

Its efficacy was confirmed in a long-term study involving PAH patients mainly with WHO functional class II-III symptoms, with a mean treatment duration of approximately 2 years. The patient population included those with idiopathic and heritable PAH (57%), PAH associated with connective tissue diseases (31%), and PAH associated with congenital heart disease and repaired shunts (8%).

FDA，2025.04