According to United Therapeutics, the FDA has accepted the company’s sNDA for Tyvaso treprostinil inhalation solution for the treatment of idiopathic pulmonary fibrosis. The FDA granted orphan drug designation to treprostinil for the treatment of IPF in December 2020. In September 2025, United Therapeutics announced that the Phase 3 TETON-2 trial of nebulized Tyvaso in patients with IPF had met its primary endpoint. In March 2026, the company announced that the TETON-1 trial had also met its primary endpoint.
Tyvaso inhalation solution has been approved by the FDA for the treatment of pulmonary arterial hypertension since July 2009 and for the treatment of pulmonary hypertension with interstitial lung disease (PH-ILD) since 2021. The inhalation solution is also in development for the treatment of progressive pulmonary fibrosis (PPF). The Tyvaso treprostinil DPI was approved for the treatment of PAH and PH-ILD in May 2022.
United Therapeutics Chairperson and CEO Martine Rothblatt commented, “Nebulized Tyvaso combines direct lung delivery with multimodal activity across fibrotic, vascular, and inflammatory pathways that are central to IPF, with the potential to help address a significant unmet need for this life-threatening disease. We’re galvanized by the FDA’s acceptance of the nebulized Tyvaso sNDA for review and believe the strength and rigor of our TETON clinical program support an approvable application for this differentiated multi-pathway treatment for patients managing this life-threatening disease.”
Read the United Therapeutics press release
