WASHINGTON (dpa-AFX) - United Therapeutics Corporation (UTHR) announced that the U.S. FDA has cleared the company to begin clinical testing of Treprostinil-Iloprost SMI, an investigational inhaled combination therapy for pulmonary arterial hypertension.
Pulmonary arterial hypertension (PAH) is a rare, life-threatening condition in which increased pressure in the blood vessels carrying blood from the heart to the lungs makes the heart work harder. Over time, the condition can strain the right side of the heart and lead to heart failure.
Treprostinil-Iloprost SMI combines two prostacyclin analogues, treprostinil and iloprost, which target pathways involved in widening blood vessels. The therapy is being developed as an inhalation spray delivered through a soft mist inhaler for use as needed, rather than on a fixed schedule. It is intended to provide episodic symptom relief when patients experience flare-ups despite their ongoing prostacyclin treatment.
The initial Phase 1, open-label, single-ascending-dose study will evaluate the safety, tolerability, and pharmacokinetics of the therapy in healthy volunteers. Pharmacokinetics refers to how a drug is absorbed, distributed and processed by the body.
If the Phase 1 study is successful, United Therapeutics anticipates starting a Phase 2 study in patients with PAH in 2027. The company is developing the therapy to address situations in which patients may need additional relief between doses of their regular prostacyclin treatment.
If successful, Treprostinil-Iloprost SMI could become the first as-needed combination inhaled therapy developed for PAH. However, the treatment remains investigational and has not been approved for any indication in any country.
UTHR has traded between $409.07 and $609.35 over the past year. The stock closed Tuesday's trading at $591.20, down 0.28%.
Copyright(c) 2026 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2026 AFX News
