JUN 24 2027
United Therapeutics Corporation — ralinepag $UTHR
for pulmonary arterial hypertension (PAH)
Accepted AUG 24 2026.
About
Pulmonary arterial hypertension is a progressive, life-threatening disease in which the arteries carrying blood from the heart to the lungs narrow, forcing the right side of the heart to work harder until it fails. Ralinepag is an oral, once-daily tablet that mimics prostacyclin, a natural hormone that binds to IP receptors and widens blood vessels. Because narrowed arteries are the core problem in this disease, ralinepag may ease the heart's workload and potentially slow worsening for people already on standard PAH therapy.
Pivotal trial
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on ralinepag
- FDA Accepts United Therapeutics' NDA Filing for Ralinepag in PAH - Eastern Progress
- Ralinepag Improves Clinical Outcomes in Contemporary PAH Population - HCPLive
- FDA Accepts United Therapeutics' NDA Filing for Ralinepag in PAH - Yahoo Finance
- United Therapeutics Ralinepag NDA Accepted by FDA With June 2027 Decision Date - Yahoo Finance
- FDA Accepts NDA for Ralinepag in Pulmonary Arterial Hypertension - HCPLive
Sponsor Watch — recent news on United Therapeutics Corporation
- United Therapeutics Corporation Announces Accelerated Share Repurchase Agreement for Remainder of $2.0 Billion Authorization
- United Therapeutics Corporation Announces FDA Acceptance of Supplemental New Drug Application for Nebulized Tyvaso® to Treat Idiopathic Pulmonary Fibrosis
- United Therapeutics Corporation Announces Participation at Upcoming Investor Conferences