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Treprostinil-Iloprost SMI is an investigational, fixed-dose combination inhaled therapy being developed by United Therapeutics Corporation. It combines two synthetic prostacyclin analogues, treprostinil and iloprost, delivered as an inhalation spray via a soft mist inhaler (SMI). The therapy is designed for pro re nata (as-needed) use to provide episodic symptom relief for patients with pulmonary arterial hypertension (PAH) who experience acute symptom flare-ups between scheduled doses of their maintenance prostacyclin therapy. Both components act as agonists of the prostacyclin (IP) receptor, promoting vasodilation of the pulmonary arterial vasculature. In October 2026, the US FDA cleared the Investigational New Drug (IND) application for a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of the combination in healthy volunteers, with a Phase 2 trial in PAH patients anticipated to begin in 2027.
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