United Therapeutics Corporation announced the conclusion of enrollment for its Phase 3 ADVANCE OUTCOMES study, which is evaluating an extended-release formulation of ralinepag for the treatment of pulmonary arterial hypertension (PAH). The study successfully enrolled 728 participants.
Clinical worsening events will continue to be accrued through the end of 2025, with top-line data from the study expected in the first half of 2026. Ralinepag is a next-generation, once-daily oral prostacyclin receptor agonist that has the potential to be the first once-a-day oral prostacyclin agonist for PAH patients.
If successful, ralinepag could fundamentally alter the PAH treatment paradigm, potentially leading to earlier prostacyclin use as a first-line therapy. This milestone represents a critical step towards bringing a new, convenient treatment option to patients and expanding United Therapeutics' leadership in the PAH market.
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