NCT07333183

A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD

An Open-Label, Phase 2 Study Evaluating the Safety of Mosliciguat in Combination With Inhaled Treprostinil in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Pulmovant, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.

Detailed description

This study is an open-label study with an extension. The study consists of 2 periods: an open label treatment period (16 weeks) and an extension (beyond 16 weeks). Participants will receive mosliciguat in the 16-week treatment period. All participants who complete the 16-week treatment period may continue to participate in the extension period where all participants will receive mosliciguat.

Conditions

• Pulmonary Hypertension
• Interstitial Lung Disease (ILD)
• Lung Diseases
• Vascular Diseases
• Cardiovascular Diseases
• Fibrosis

Interventions

Type	Name	Description
DRUG	inhaled mosliciguat	Dose level 1, 2, or 3 for inhalation
DEVICE	Dry Powder Inhaler	Dry powder inhaler for mosliciguat delivery

Timeline

• Start date: 2025-12-23
• Primary completion: 2026-12-01
• Completion: 2028-01-01
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study