United Therapeutics Corporation has announced the conclusion of enrollment for the phase 3 ADVANCE OUTCOMES study, which evaluates the use of an extended-release formulation of ralinepag for the treatment of pulmonary arterial hypertension (PAH). The study has enrolled 728 participants and aims to assess the potential of ralinepag to become the first once-a-day oral prostacyclin agonist for PAH patients. Clinical worsening events will be tracked through the end of 2025, with top-line data expected in the first half of 2026. The primary endpoint of the study is the time to the first clinical worsening event, while secondary endpoints include various measures of patient health and treatment efficacy. Ralinepag is an investigational compound and not approved for use in any country. Results of the study are yet to be presented.
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