Inhaled Treprostinil Improves FVC in IPF Phase 3 Trial: Steven D. Nathan, MD

The phase 3 TETON-2 (NCT05255991) clinical trial assessed inhaled treprostinil for idiopathic pulmonary fibrosis (IPF) and found that it significantly improved forced vital capacity (FVC) when compared with placebo.¹

The double-blind trial included 539 patients who underwent randomization of at least 1 dose of treprostinil or a placebo. Of the 224 patients in the treprostinil group that completed the trial, the median change in FVC at 52 weeks was –49.9 mL (95% CI, –79.2 to –19.5) and –136.4 mL (95% CI, –172.5 to –104.0) in the placebo group.

Treprostinil’s efficacy proved promising and perhaps might just be one step closer to being submitted for FDA approval, said Steven D. Nathan, MD, lead study author and medical director of the Advanced Lung Disease Program and Lung Transplant Program at Inova Fairfax Hospital, in an interview with The American Journal of Managed Care^®.

“I don't want to preempt, but I think it should become available as another treatment for IPF, which will give us our 4th antifibrotic to treat these patients,” he said. “And I think having choice is great for providers and especially for patients, and I think it will have a firm place in current treatment management of patients with IPF.”

The most commonly reported adverse event was cough, reported in 48.3% of patients in the treprostinil group and 24.1% of patients in the placebo group. Discontinuation occurred in 33.6% of patients in the tresprostinil group and 24.7% in the placebo group, with about half citing adverse events as the reason.

“My personal belief is that once this is available in clinical practice and is approved for IPF, the attrition will, in all likelihood, hopefully not be the same because patients now have a drug that they know they're getting, and they know that it works,” Nathan said. “I think the motivation to continue with it will be much greater than it was perhaps in the clinical trial.”

Reference

1. Nathan SD, Smith P, Deng C, et al. Inhaled treprostinil for idiopathic pulmonary fibrosis. N Engl J Med. 2026. doi:10.1056/NEJMoa2512911