NCT07481981

A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)

A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 344 (estimated)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Treprostinil Palmitil Inhalation Powder	Oral inhalation using a capsule-based dry powder inhaler device.
DRUG	Placebo	Oral inhalation using a capsule-based dry powder inhaler device.

Timeline

• Start date: 2026-04-17
• Primary completion: 2028-12-28
• Completion: 2029-01-28
• First posted: 2026-03-19
• Last updated: 2026-03-19

Regulatory

• FDA-regulated drug study