United Therapeutics completed enrollment for its TETON-PPF Phase 3 study. This multinational trial includes 754 patients to evaluate Tyvaso for the treatment of progressive pulmonary fibrosis (PPF).
The 52-week study assesses the safety and efficacy of the inhaled treprostinil solution. Researchers will use the change in forced vital capacity (FVC) as the primary endpoint to measure lung function.
This pivotal trial supports a potential label expansion for Tyvaso. United Therapeutics plans to submit a supplemental New Drug Application to the FDA if the study succeeds. Topline data are anticipated in the second half of 2027.