United Therapeutics Corporation announced the full enrollment of its TETON 1 study, which is evaluating the use of nebulized Tyvaso (treprostinil) inhalation solution for the treatment of idiopathic pulmonary fibrosis (IPF). The study successfully enrolled 598 patients in the United States and Canada.
TETON 1 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 registration study designed to assess the safety and efficacy of nebulized Tyvaso over a 52-week period. Top-line data from this study is anticipated in the first half of 2026.
This milestone follows the completion of enrollment for the TETON 2 study in July 2024, with its top-line data expected in the second half of 2025. Successful results from the TETON program could lead to FDA approval to expand the nebulized Tyvaso label to include IPF, addressing a market with approximately 100,000 U.S. patients.
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