NCT05649748

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Treprostinil Palmitil	Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler.
DRUG	Placebo	Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler

Timeline

• Start date: 2023-03-07
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-12-14
• Last updated: 2026-04-14

Locations

45 sites across 15 countries: United States, Argentina, Austria, Belgium, Brazil, Denmark, Germany, Italy, Japan, Malaysia, Mexico, Philippines, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study