United Therapeutics has completed enrolment for the TETON 2 study, which aims to evaluate Tyvaso (treprostinil) inhalation solution (nebulized Tyvaso) to treat idiopathic pulmonary fibrosis (IPF).
The study, which has enrolled 597 patients, is part of the three-study TETON programme, which aims to evaluate the efficacy and safety of inhaled treprostinil.
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The TETON programme also includes TETON 1 and TETON PPF, focusing on IPF and progressive pulmonary fibrosis (PPF), respectively.
TETON 1 is being conducted in the US and Canada while TETON 2 involves patients from other global regions.
The enrolment for TETON 1 and TETON PPF is still in progress.
The TETON 2 study is a Phase III, multicentre, double-blind, randomised, placebo-controlled trial. Top-line data from the study is anticipated in the second half of 2025.
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By GlobalDataParticipants will be randomly assigned to receive either nebulised Tyvaso or a placebo, starting with three breaths four times daily and titrating to a target of 12 breaths four times daily.
The primary endpoint is the change in forced vital capacity (FVC) from baseline to week 52, with several secondary endpoints including time to clinical worsening and overall survival at week 52.
The TETON programme was initiated based on promising data from the INCREASE study, which showed that nebulised Tyvaso led to significant improvements in forced vital capacity (FVC) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Continued improvements in FVC were observed for at least 64 weeks, according to open-label extension data published in 2023.
United Therapeutics is planning to seek US Food and Drug Administration (FDA) approval for Tyvaso DPI Inhalation Powder for IPF and PPF, following the completion of the TETON studies and any necessary bridging studies.
United Therapeutics product development vice-president Peter Smith said: “Our continued goal with the TETON programme is to demonstrate that inhaled treprostinil can lead to better patient outcomes in this underserved, vulnerable patient population with fibrotic lung disease.”
