United Therapeutics said on Monday it has completed enrollment in its phase 3 trial assessing inhaled treprostinil for the treatment of idiopathic pulmonary fibrosis (IPF).
The study, titled INCREASE-IPF, is evaluating the efficacy and safety of the drug in patients with the chronic, progressive lung disease. The company expects to report topline data from the trial in mid-2025, subject to regulatory review timelines.
Treprostinil is a prostacyclin analog already approved under the brand name Tyvaso for pulmonary arterial hypertension. United Therapeutics is testing the inhaled formulation in a new indication, aiming to expand its therapeutic reach in respiratory diseases.
The trial’s completion marks a key milestone for the company’s pipeline, which has faced scrutiny in recent quarters amid patent expirations and competitive pressures in its core markets. United Therapeutics did not disclose the number of patients enrolled or additional trial details in its statement.
Shares of United Therapeutics were indicated 0.8% higher at $92.10 in premarket trading on Monday, following the announcement. The company’s market capitalization stands at approximately $5.1 billion as of the latest close.
Idiopathic pulmonary fibrosis is a rare, debilitating condition with limited treatment options, creating a potential high-value opportunity for effective therapies. Analysts have highlighted the unmet medical need in IPF, where current standard-of-care drugs slow but do not halt disease progression.
United Therapeutics plans to use the trial data to support regulatory submissions, though no specific timelines for filings were provided.
