WASHINGTON (dpa-AFX) - United Therapeutics Corp. (UTHR), a public benefit corporation, announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ralinepag to treat pulmonary arterial hypertension or PAH.
The FDA has set a Prescription Drug User Fee Act target action date of June 24, 2027. Ralinepag has not been approved for use in any indication by the FDA and remains investigational for PAH.
Ralinepag has the potential to redefine the PAH treatment landscape as the first and only once-daily oral prostacyclin, if approved by the FDA.
The filing was based on results from the phase 3 ADVANCE OUTCOMES study evaluating the safety and efficacy of ralinepag in patients with PAH.
The study met its primary endpoint, with ralinepag achieving a statistically significant 55% reduction in risk of clinical worsening compared with placebo in predominantly pre-treated patients with PAH. Ralinepag also achieved statistical significance for important secondary endpoints.
Ralinepag is a highly selective and potent prostacyclin (IP) receptor agonist with multiple pathway effects, including vasodilatory, anti-proliferative, and anti-inflammatory effects. Ralinepag combines potent receptor affinity with continuous exposure to deliver long-term, durable efficacy and disease-mitigating outcomes.
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