United Therapeutics Announces FDA Clearance to Proceed with SUMMIT Clinical Trial for Treprostinil SMI in PH-COPD
Business Wire•19/10/2026•07:00 ET
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Key Highlights
- ➤FDA clears SUMMIT phase 2 trial of treprostinil SMI in PH-COPD
- ➤SUMMIT will assess safety and tolerability in approximately 40 patients
- ➤United Therapeutics expects potential phase 3 registration study to begin in 2028
- ➤Treprostinil SMI could become the first FDA-approved PH-COPD therapy
- ➤Company estimates PH-COPD affects 400,000 to 800,000 U.S. people
Expert Statements
Leigh Peterson, Ph.D., Head of pharmaceutical and xenograft development at United Therapeutics
“PH-COPD is a serious, life-threatening condition with no approved treatments. We believe that inhaled treprostinil, delivered via a soft mist inhaler, may benefit the carefully defined SUMMIT PH-COPD patient population by directly targeting the pulmonary vasculature. Our hope is that treprostinil SMI will offer meaningful benefit and reduce disease burden for PH-COPD patients who deserve a treatment option that addresses their significant unmet needs”
Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics
“I believe this development will lead to an exponential inflection point for United Therapeutics”
Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics
“We estimate PH-COPD could impact five to ten times the number of patients than the conditions all of our current therapies are approved to treat today. Upon successful completion of the SUMMIT program and approval by the FDA, we expect United Therapeutics will become a several times larger company than it is today.”
United Therapeutics Announces FDA Clearance to Proceed with SUMMIT Clinical Trial for Treprostinil SMI in PH-COPD
The development of a soft mist inhaler (SMI) represents a further advancement of treprostinil delivery devices to potentially address a wider range of patient tolerability profiles
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