United Therapeutics Corporation Announces ADVANCE OUTCOMES Study of Ralinepag Presented at ATS 2026
The long-term, pivotal, phase 3 ADVANCE OUTCOMES study met its primary endpoint, with ralinepag achieving a statistically significant 55% reduction in risk of clinical worsening in predominantly pre-treated patients with pulmonary arterial hypertension (PAH)
Ralinepag achieved statistical significance for important secondary endpoints, reducing levels of N-terminal pro-B-type natriuretic peptide, a critical biomarker for heart failure, and improving exercise capacity
Investigational ralinepag combines potent receptor binding affinity with continuous exposure to deliver long-term, durable efficacy, and disease-mitigating outcomes, and is expected to become the first and only once-daily oral prostacyclin receptor agonist upon FDA approval
United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that full results of its ADVANCE OUTCOMES study are being presented todayduring the Breaking News: 2026 Clinical Trial Results in Pulmonary Medicine session at the annual meeting of the American Thoracic Society (ATS) International Conference in Orlando. Ralinepag has not been approved for use in any indication by the U.S. Food and Drug Administration (FDA)and remains investigational for PAH.
