United Therapeutics Announces FDA Clearance to Proceed with SUMMIT Clinical Trial for Treprostinil SMI in PH-COPD
United Therapeutics received FDA clearance to proceed with the SUMMIT Phase 2 trial of treprostinil SMI (soft mist inhaler) in pulmonary hypertension associated with COPD. The 16-week, double-blind study will enroll approximately 40 patients, with secondary endpoints on exercise capacity and NT-proBNP; a Phase 3 registration study is planned for 2028 if results are successful. Management frames PH-COPD — estimated at 400,000-800,000 U.S.
Key figures
- Drug Name
- Treprostinil SMI
- Phase Of Trial
- Phase 2
- Trial name
- SUMMIT
- Trial enrollment
- 40
- Phase3 start year
- 2028
- Trial duration weeks
- 16
- Ph copd us patients low
- 400000
- Ph copd us patients high
- 800000
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