Tyvaso (treprostinil) - (TETON PPF)

August 17, 2026: United Therapeutics (Nasdaq: UTHR) said its Phase 3 TETON-PPF trial of nebulized Tyvaso (treprostinil inhalation solution) in progressive pulmonary fibrosis (PPF) has completed enrollment, with 754 patients enrolled. TETON-PPF is a multinational, randomized, double-blind, placebo-controlled 52-week registration study comparing Tyvaso vs placebo.

Topline data are expected in 2H 2027. The primary endpoint is change in absolute forced vital capacity (FVC) from baseline to week 52. Secondary endpoints include time to first clinical worsening, time to first acute exacerbation of ILD, overall survival at week 52, change in percent predicted FVC, King’s Brief Interstitial Lung Disease questionnaire score, and diffusing capacity of the lungs for carbon monoxide.

If successful, the company plans to use TETON-PPF data to support an FDA supplemental NDA to add PPF to the Tyvaso label; Tyvaso is not approved for PPF and remains investigational for this use.

Separately, United Therapeutics said it is seeking priority review for an sNDA submitted to FDA in June 2026 to add idiopathic pulmonary fibrosis (IPF) to the nebulized Tyvaso label based on TETON-1 and TETON-2 data.