The U.S. Food and Drug Administration has accepted United Therapeutics' new drug application for ralinepag, an investigational oral prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension.
The agency assigned a Prescription Drug User Fee Act target action date of June 24, 2027, according to a company statement. The submission is based on data from the phase 3 ADVANCE OUTCOMES study, which evaluated 687 predominantly pre-treated patients with pulmonary arterial hypertension.
In the trial, ralinepag demonstrated a 55% reduction in the risk of clinical worsening compared with placebo, meeting the primary endpoint. Secondary endpoints included reductions in N-terminal pro-B-type natriuretic peptide levels and improvements in exercise capacity as measured by the six-minute walk distance. Patients also showed a 47% higher likelihood of achieving clinical improvement, with a p-value of 0.015.
Study results were presented at the 2026 annual meeting of the American Thoracic Society and published in The Lancet. Patients who completed the ADVANCE OUTCOMES study were eligible to enroll in the ongoing open-label extension study, ADVANCE EXTENSION.
Pulmonary arterial hypertension is a progressive disease characterized by elevated pressure in the pulmonary arteries, which restricts blood flow in the lungs. The condition affects approximately 500,000 people worldwide, including about 50,000 in the United States. Ralinepag, if approved, would be administered once daily in oral form. The safety profile observed in the study was consistent with known prostacyclin-related adverse events, with no new safety signals identified.
