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# FDA Approves Liquidia’s Pulmonary Hypertension Drug
- URL: https://www.fdaweb.com/fda-approves-liquidias-pulmonary-hypertension-drug/
- Published: 2025-05-23T12:00:00.000Z
- Updated: 2026-09-14T15:12:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159241

FDA has approved Liquidia’s Yutrepia (Treprostinil), a new inhalation powder designed to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Yutrepia is designed to “enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort,” the company says.

Approval was based on data from the Phase 3 INSPIRE trial, which evaluated Yutrepia in patients both new to and previously treated with nebulized treprostinil. The study demonstrated the drug to be safe and well-tolerated across both groups, according to Liquidia.

However, the launch of Yutrepia may face legal hurdles. United Therapeutics has filed a patent infringement lawsuit against Liquidia, seeking to block the commercial release of the drug. Oral arguments on a motion for a temporary restraining order and preliminary injunction were heard 5/20 in federal court, and a ruling is pending. Previously, FDA granted United Therapeutics an additional three-year exclusivity period for Tyvaso DPI (treprostinil), which blocked Liquidia’s Yutrepia from entering the market until today (5/23).