On March 30, 2026, United Therapeutics Corporation (Nasdaq: UTHR) announced the successful results of its pivotal TETON-1 clinical study evaluating the use of nebulized Tyvaso (treprostinil) Inhalation Solution in patients with idiopathic pulmonary fibrosis (IPF). The study met its primary efficacy endpoint, demonstrating a significant improvement in forced vital capacity (FVC) compared to placebo, with a change of 130.1 mL (Hodges-Lehmann estimate, 95% confidence interval, 82.2 to 178.1 mL; p < 0.0001) from baseline to week 52. This result not only highlights the efficacy of Tyvaso but also reinforces the positive outcomes observed in the previous TETON-2 study, indicating a robust treatment effect across various patient subgroups.

The integrated analyses of both TETON-1 and TETON-2 studies showed statistically significant treatment effects across primary and secondary efficacy endpoints, further validating the clinical benefits of nebulized Tyvaso. The treatment was well-tolerated, and no new safety signals were reported, aligning with the known safety profile of Tyvaso from earlier studies.

United Therapeutics plans to submit a supplemental New Drug Application (sNDA) to the FDA by the end of summer 2026, seeking priority review for the inclusion of IPF in the labeled indications for Tyvaso. The company’s CEO, Martine Rothblatt, expressed gratitude to the patients and investigators involved in the trials, emphasizing the potential of these results to significantly impact the management of IPF, a disease with limited treatment options. The findings from the TETON studies will be presented at the upcoming American Thoracic Society Annual Meeting in May 2026, further disseminating this groundbreaking data to the medical community.

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