United Therapeutics Announces FDA Clearance to Proceed with Clinical Trial for Treprostinil-Iloprost SMI in Pulmonary Arterial Hypertension
United Therapeutics received FDA clearance under its IND to begin clinical testing of Treprostinil-Iloprost SMI, a first-of-its-kind use-as-needed combination inhaled therapy for pulmonary arterial hypertension. The phase 1 open-label single ascending dose study will assess safety, tolerability, and pharmacokinetics in healthy volunteers, with a phase 2 study in PAH patients anticipated in 2027 if results are positive.
Key figures
- Drug Name
- Treprostinil-Iloprost SMI
- Phase Of Trial
- Phase 1
- Disease
- pulmonary arterial hypertension (PAH)
- Phase2 start
- 2027
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