United Therapeutics Announces FDA Clearance to Proceed with Clinical Trial for Treprostinil-Iloprost SMI in Pulmonary Arterial Hypertension
Business Wire•28/10/2026•07:00 ET
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Key Highlights
- ➤FDA cleared United Therapeutics’ IND for Treprostinil-Iloprost SMI clinical testing
- ➤Phase 1 study will assess safety, tolerability, and pharmacokinetics in healthy volunteers
- ➤Phase 2 PAH patient study anticipated to commence in 2027, pending phase 1 success
- ➤Treprostinil-Iloprost SMI could become the first as-needed combination inhaled PAH therapy
Expert Statements
Ravi Patel, PharmD, Senior Vice President, Global Patient Safety and Strategic Clinical Development, United Therapeutics
“Many people living with PAH experience moments when their symptoms flare despite their maintenance medication, and today they have no therapy designed specifically for those moments. Treprostinil-Iloprost SMI is intended to explore whether an as-needed, combination prostacyclin therapy could help fill that gap. FDA clearance to begin clinical testing is an important first step, and we look forward to advancing this program”
Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer, United Therapeutics
“As a company known for pioneering prostacyclin therapies, Treprostinil-Iloprost SMI represents another important advancement in United Therapeutics’ PAH treatment portfolio. It also reflects continued innovation from our product development platform and our culture of running down the corridors of indifference in pulmonary medicine”
United Therapeutics Announces FDA Clearance to Proceed with Clinical Trial for Treprostinil-Iloprost SMI in Pulmonary Arterial Hypertension
If successful, Treprostinil-Iloprost SMI would be the first use-as-needed combination inhaled therapy to be developed for pulmonary arterial hypertension (PAH)
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