United Therapeutics’ Tyvaso Shows Promise in Idiopathic Pulmonary Fibrosis

United Therapeutics’ Tyvaso (treprostinil) has demonstrated encouraging Phase III results in idiopathic pulmonary fibrosis (IPF), showing significant improvement in forced vital capacity (FVC) during the TETON-2 trial (NCT05255991). Patients receiving inhaled Tyvaso achieved a mean FVC increase of 95.6mL, a key indicator of lung function, while also experiencing delayed clinical worsening. After 52 weeks, the therapy improved quality of life, measured by K-BILD, and enhanced diffusion capacity (DLCO).

Although Tyvaso did not meet secondary endpoints of time to acute exacerbation and overall survival, both outcomes trended favorably over placebo. United plans to meet with the FDA by the end of 2025 and awaits results from the nebulised TETON-1 trial, expected in 2026, before submitting for approval. Already approved for pulmonary arterial hypertension and PH-ILD, Tyvaso could significantly expand IPF treatment options, challenging Boehringer’s Ofev and Roche’s Esbriet. If approved, it may reshape the current treatment landscape.

08-09-2025