Indications of Bosentan

Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1), specifically including:

For adult patients, to improve exercise capacity and reduce the risk of clinical disease progression. In the studies supporting its efficacy, the enrolled patients were mainly those with symptoms of WHO Functional Class Ⅱ-Ⅳ. The etiologies of the disease included idiopathic or heritable PAH (accounting for 60%), PAH associated with connective tissue diseases (accounting for 21%), and PAH associated with congenital heart disease with left-to-right shunts (accounting for 18%).

For pediatric patients aged 3 years and older with idiopathic or congenital PAH, to improve pulmonary vascular resistance (PVR) — an improvement in this parameter is expected to further enhance the patient’s exercise capacity.

FDA，2025.07