- Design
- Combined analysis of two replicate phase 3, double-blind, placebo-controlled trials
- Population
- 1,191 patients with idiopathic pulmonary fibrosis
- Primary outcome
- Change in forced vital capacity at 52 weeks
- Effect
- FVC change -45.4 vs -161.7 ml; between-group difference 111.8 ml (95% CI 79.7-144.0)
Antifibrotic drugs slow idiopathic pulmonary fibrosis but do not stop it, and new options are scarce. The combined analysis of the replicate phase 3 TETON-1 and TETON-2 trials tested inhaled treprostinil, a prostacyclin analogue, in 1,191 patients with IPF.
It worked on the measure that matters. Forced vital capacity fell by a median of 45.4 ml over 52 weeks with treprostinil against 161.7 ml with placebo, a between-group difference of 111.8 ml favouring treprostinil. Treprostinil was also superior on five of six secondary endpoints, including time to clinical worsening, time to IPF exacerbation, diffusing capacity and quality of life. Deaths were numerically fewer (6.9% vs 9.4%). Cough was the most common adverse effect.
The practical change is that inhaled treprostinil is now a treatment option that slows functional decline and delays worsening in IPF, broadening a thin therapeutic field. It modifies the disease course rather than reversing it, and tolerability, chiefly cough, will shape its use.
- Combined phase 3 analysis of TETON-1 and TETON-2, 1,191 patients with IPF.
- FVC declined 45.4 ml with inhaled treprostinil versus 161.7 ml with placebo over 52 weeks.
- The between-group difference was 111.8 ml (95% CI 79.7-144.0, p<0.0001).
- Treprostinil was superior on five of six secondary endpoints, including time to exacerbation.
- Cough was the most common adverse event; deaths were numerically fewer.
Why it matters
It adds a needed option to a thin IPF treatment field, slowing decline on the endpoint that defines progression.
Don't overread it
It slows decline rather than reversing fibrosis, and the mortality difference was not formally significant; this modifies the disease course, not a cure.
The statistics, in plain English
A 111.8 ml smaller FVC loss over a year, with a confidence interval well clear of zero, is a meaningful slowing for a disease defined by relentless FVC decline. Replicate phase 3 trials pointing the same way make the result robust.
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