United Therapeutics Wins FDA Clearance for Treprostinil-Iloprost Phase 1 Trial

10:22 AM EDT, 10/28/2026 (MT Newswires) -- United Therapeutics (UTHR) secured US Food and Drug Administration clearance for its investigational new drug application for Treprostinil-Iloprost SMI, clearing the way for a phase 1 trial of the inhaled combination therapy for pulmonary arterial hypertension. The study will assess the safety, tolerability and pharmacokinetics of the treprostinil-iloprost combination in healthy volunteers, the company said Wednesday in a statement. The inhaled therapy is being developed for as-needed relief of episodic symptoms in patients with PAH and is intended to help address symptom flare-ups between doses of maintenance prostacyclin therapy, the company said. If the phase 1 study is successful, United Therapeutics expects to begin a phase 2 trial in PAH patients in 2027. Price: 586.31, Change: -4.89, Percent Change: -0.83