On October 28, 2026, United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) granted clearance under its Investigational New Drug (IND) application to proceed with a clinical trial of Treprostinil-Iloprost soft mist inhaler (SMI) in pulmonary arterial hypertension. If successful this would be the first use-as-needed prostacyclin combination inhaled therapy for pulmonary arterial hypertension. The Phase 1, open-label, single ascending dose study will evaluate safety, tolerability and pharmacokinetics in healthy volunteers. Pending successful outcome, the company anticipates commencing a Phase 2 study in patients with pulmonary arterial hypertension in 2027. It is intended to provide episodic symptom relief for patients needing a bridge between doses of their ongoing prostacyclin therapy due to acute symptom flare-ups.
Read more on the company press release at this link
Summary by Deger Kesimoglu, volunteer for the Alliance for Pulmonary Hypertension