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

April 18, 2026 updated by: Pulmovant, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Kissimmee, Florida, United States, 34746
        • Recruiting
        • Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants willing and able to provide informed consent
  • Participants on inhaled treprostinil

  • Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include:

    1. Idiopathic interstitial pneumonia (IIP)
    2. Chronic hypersensitivity pneumonitis
    3. ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) < 70% of predicted
  • Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
  • Ability to perform 6MWD ≥100 meters.

Exclusion Criteria:

  • Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).
  • Exacerbation of underlying lung disease within 28 days prior to randomization.
  • Initiation of pulmonary rehabilitation within 28 days prior to randomization.
  • Receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
  • History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators.
  • Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Comparator: inhaled mosliciguat
Participants will receive inhaled mosliciguat daily for 16 weeks
Drug: inhaled mosliciguat
Dose level 1, 2, or 3 for inhalation
Device: Dry Powder Inhaler
Dry powder inhaler for mosliciguat delivery
Experimental: Extension: inhaled mosliciguat
After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period
Drug: inhaled mosliciguat
Dose level 1, 2, or 3 for inhalation
Device: Dry Powder Inhaler
Dry powder inhaler for mosliciguat delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation
Time Frame: Baseline, Week 16
Baseline, Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmovant, Inc.

Investigators

  • Study Director: Ubaldo Martin, MD, Pulmovant, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVT-2301-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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