Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Phase 3 Completed 597 enrolled United Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.

Timeline

Start: 2022-10-04
Primary completion: 2025-06-30
Completion: 2025-06-30

Outcome

Met primary endpoint

release “TETON-2 study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis ( IPF ) met its primary efficacy endpoint” unither.com ↗

release “TETON-2 not only met its primary endpoint of change in FVC but also attained statistical significance for time to clinical worsening.” unither.com ↗

Publications

Nathan SD, Smith P, Deng C, De Salvo M, Wuyts W, Pavie-Gallegos J, Song JW, Kramer MR, King CS, Mackintosh JA, Chambers D, Miranda GV, Breytenbach N, Peterson L, Bell H, Flaherty KR, Behr J, Cottin V; TETON-2 Trial Investigators. Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis. N Engl J Med. 2026 Jul 9;395(2):127-137. doi: 10.1056/NEJMoa2512911. Epub 2026 Mar 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Treprostinil	Other / unclassified	6 ug	Inhaled