Press release
United Therapeutics Corporation Concludes Enrollment of the ADVANCE OUTCOMES Study of Ralinepag for the Treatment of Pulmonary Arterial Hypertension
Ralinepag has the potential to be the first once-a-day oral prostacyclin agonist for patients with pulmonary arterial hypertension ADVANCE OUTCOMES will
About this update from United Therapeutics Corporation
[{"type":"text","content":"\nRalinepag has the potential to be the first once-a-day oral prostacyclin agonist for patients with pulmonary arterial hypertension\n\n\nADVANCE OUTCOMES will continue to accrue clinical worsening events through the end of 2025 and top-line data is expected in the first half of 2026\n\n\n SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--\nUnited Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced the conclusion of enrollment of the phase 3 ADVANCE OUTCOMES study evaluating the use of an extended-release formulation of ralinepag for the treatment of pulmonary arterial hypertension (PAH).\n\n\nThe ADVANCE OUTCOMES study enrolled 728 participants. Clinical worsening events will be accrued through the end of 2025 and top-line data from the study is expected in the first half of 2026.\n\n\n“We are excited for the potential of ralinepag to be the first once-a-day oral prostacyclin agonist, which, if successful, could fundamentally change the PAH treatment paradigm, potentially leading over time to upfront use of oral prostacyclins as a first-line therapy alongside traditional ERA and PDE-5 oral products,” said Derek Solum, Ph. D., Senior Director, Product Development at United Therapeutics and the lead for the ADVANCE OUTCOMES development program. “Our philosophy and mission drive us to relentlessly seek ways to improve patient care and achieve better treatment outcomes. We are grateful for the participants and clinical investigators who have participated in this pivotal study to help us pursue our mission.”\n\n\nA previous phase 2 study of ralinepag in 61 PAH participants met its primary endpoint, showing a 29.8% reduction (p=0.03) in median pulmonary vascular resistance (PVR) after 22 weeks of treatment with ralinepag compared with placebo.\n\n\nAfter completing participation in the phase 2 study, 45 participants entered an open-label extension (OLE) study to assess the safety and tolerability of ralinepag for long-term use in patients with PAH. The OLE study reported that ralinepag continued to have a manageable side effect profile. Moreover, two years after entering the OLE study, the study reported that ralinepag significantly increased six-minute walk distance (6MWD) by a mean of 36.3 meters (p=0.004), and over 85% of study participants remained stable in their functional class fr...