United Therapeutics Gets FDA Clearance to Start Phase 2 Trial of Treprostinil Soft Mist Inhaler

07:59 AM EDT, 10/19/2026 (MT Newswires) -- United Therapeutics (UTHR) said Monday the US Food and Drug Administration cleared its phase 2 trial of an investigational soft mist inhaler version of treprostinil in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease. The 16-week double-blind study will track safety and tolerability in about 40 patients, with secondary endpoints covering exercise capacity and a heart failure marker, the company said. If the trial succeeds, a phase 3 registration study is planned for 2028, United Therapeutics said. The product includes a handheld device that delivers treprostinil in a single breath and can be stored at room temperature, the company said.