TETON-2 highlights inhaled treprostinil as a treatment option for idiopathic pulmonary fibrosis

Inhaled treprostinil significantly improved forced vital capacity (FVC) versus placebo after 52 weeks of treatment, though cough was more frequent with active therapy.

Prof. Steven Nathan (Inova Fairfax Hospital, VA, USA) presented the results from TETON-2 (NCT05255991), a phase 3, randomised, placebo-controlled trial in patients with clinically confirmed idiopathic pulmonary fibrosis (IPF) and a baseline FVC ≥45% predicted [1]. Treatment consisted of inhaled treprostinil administered 4 times daily (18 µg, 3 breaths up-titrated to 12 breaths) or a matching placebo, and background antifibrotic therapy was permitted. The primary endpoint was the change in absolute FVC at week 52. In total, 597 participants were enrolled.

TETON-2 successfully met its primary endpoint, showing a difference of +95.6 mL (95% CI 52.2-139.0; P<0.0001) in FVC at week 52 between inhaled treprostinil and placebo, calculated using Hodges-Lehmann estimates. When assessing FVC changes by background therapy at week 52, inhaled treprostinil showed significant improvements versus placebo among participants receiving nintedanib (P=0.0075) or pirfenidone (P=0.0003), but only numerical gains in those without background antifibrotic therapy.

Adverse events (AEs) were generally consistent with prior studies. The most common AEs with inhaled treprostinil versus placebo included cough (48.3% vs 24.1%), headache (19.8% vs 11.9%), dyspnoea (12.1% vs 10.5%), and dizziness (9.7% vs 6.4%).

“The study met its primary endpoint of change from baseline in absolute FVC at week 52,” concluded Prof. Nathan. “Treprostinil was well tolerated, with a safety profile consistent with previous inhaled formulations and known prostacyclin-related effects.”

1. Nathan SD, et al. TETON phase 3 clinical trials of inhaled treprostinil in the treatment of idiopathic pulmonary fibrosis. ERS Congress, 27 September–1 October 2025, Amsterdam, the Netherlands.

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Posted on 30 October 202530 October 2025