United Therapeutics Advances PAH and IPF Data at ESC, ERS

SILVER SPRING, Maryland & RESEARCH TRIANGLE PARK, North Carolina, Aug 28, 2026

Ralinepag Shows Clinical Improvement in PAH

At ESC Congress 2026, United Therapeutics will present late-breaking findings from the Phase 3 ADVANCE OUTCOMES study, including an analysis of ralinepag in a contemporary PAH population. The company reported that the analysis showed clinical improvement among patients with lower-risk PAH, while another analysis found that ralinepag reduced clinical worsening in patients with connective tissue disease-associated PAH. Connective tissue disease can be associated with vascular remodeling and endothelial dysfunction, potentially contributing to more difficult-to-treat PAH. The late-breaking presentation examining connective tissue disease-associated PAH is scheduled for August 29 in Munich, while additional ADVANCE OUTCOMES data examining clinical improvement are scheduled for presentation at the ERS Congress on September 6 in Barcelona. Ralinepag remains an investigational therapy for PAH and has not been approved by the U.S. Food and Drug Administration (FDA). United Therapeutics submitted a New Drug Application (NDA) for ralinepag to the FDA in June 2026, marking a significant regulatory step for the therapy.

Treprostinil Data Highlight IPF and PAH Programs

The company will also present multiple analyses from its TETON clinical program, which evaluates nebulized treprostinil in patients with idiopathic pulmonary fibrosis. According to United Therapeutics, the presentations include analyses showing that inhaled treprostinil improved lung function, demonstrated a consistent benefit in reducing serious clinical worsening events, and produced a dose-dependent magnitude of benefit compared with placebo. A late-breaking analysis using a win-ratio approach will be presented at ERS, alongside additional data examining the effect of inhaled treprostinil dosing and lung-function outcomes. United Therapeutics submitted a supplemental NDA for nebulized treprostinil in IPF to the FDA in June 2026, but the therapy remains investigational for this indication. The company is also presenting interim findings from the ARTISAN study, which evaluates parenteral treprostinil in PAH. The interim analyses include assessments of early and rapid treprostinil titration and its effects on right ventricular ejection fraction, mean pulmonary artery pressure and PAH risk profile.

PHINDER Explores Pulmonary Hypertension Screening

Additional research at ERS will focus on the PHINDER study, described by United Therapeutics as a first-of-its-kind study designed to improve screening for pulmonary hypertension associated with interstitial lung disease (PH-ILD). Preliminary data will examine the limitations of echocardiography for pulmonary hypertension screening in patients with interstitial lung disease. Improved identification of pulmonary hypertension in this population could support more effective evaluation and referral of patients who may have pulmonary vascular complications associated with underlying lung disease. Together, the ESC and ERS presentations demonstrate United Therapeutics’ focus on generating clinical evidence across PAH, IPF and PH-ILD, spanning both established treprostinil-based therapies and investigational programs. The company said the presentations are intended to deepen understanding of treatment approaches and outcomes across patients with serious pulmonary diseases. The combined dataset represents an important clinical-development update for United Therapeutics, particularly as ralinepag and nebulized treprostinil progress through U.S. regulatory pathways. While the presented findings provide additional evidence from ongoing clinical programs, regulatory decisions and potential approvals remain subject to FDA review. The company continues to advance its pulmonary disease portfolio while developing evidence intended to inform treatment strategies for patients with PAH, IPF and PH-ILD.

Source: United Therapeutics press release