Recruiting
Phase 2

Mosliciguat with Treprostinil

Sponsor:

Pulmovant, Inc.

Code:

NCT07333183

Conditions

Pulmonary Hypertension

Interstitial Lung Disease (ILD)

Lung Diseases

Vascular Diseases

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

inhaled mosliciguat

Dry Powder Inhaler

Study Details

Brief summary:

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.

Conditions

Pulmonary Hypertension

Interstitial Lung Disease (ILD)

Lung Diseases

Vascular Diseases

Cardiovascular Diseases

Study ID

NCT07333183

Start date

Dec 23, 2025

Status verified date

Apr, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Comparator: inhaled mosliciguat

Participants will receive inhaled mosliciguat daily for 16 weeks

experimental: Extension: inhaled mosliciguat

After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period

Interventions

inhaled mosliciguat

Dose level 1, 2, or 3 for inhalation

Dry Powder Inhaler

Dry powder inhaler for mosliciguat delivery

Primary outcome measure

  • Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation [ Time Frame: Baseline, Week 16 ]

Central Contacts and Locations

Central contacts

Pulmovant

+1-919-462-1310clinicaltrials@pulmovant.com

Locations

Clinical Research Site

Recruiting

Santa Barbara, California, United States, 93105

Clinical Research Site

Recruiting

Torrance, California, United States, 90502

Clinical Research Site

Recruiting

Kissimmee, Florida, United States, 34746

Clinical Research Site

Recruiting

Chicago, Illinois, United States, 60611

Clinical Research Site

Recruiting

Kansas City, Kansas, United States, 66160

Clinical Research Site

Recruiting

Boston, Massachusetts, United States, 02115

Clinical Research Site

Recruiting

Ann Arbor, Michigan, United States, 48109

Clinical Research Site

Recruiting

Detroit, Michigan, United States, 48202

Clinical Research Site

Recruiting

Albuquerque, New Mexico, United States, 87131

Clinical Research Site

Recruiting

Greensboro, North Carolina, United States, 27403

Clinical Research Site

Recruiting

Providence, Rhode Island, United States, 02903

Clinical Research Site

Recruiting

Charleston, South Carolina, United States, 29425

Clinical Research Site

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Pulmovant, Inc.

Last update posted

Sep 2, 2026

Last verified

Apr, 2026

Keywords

  • PH
  • ILD
  • 6 Minute Walk Test
  • mosliciguat

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Pulmovant, Inc. on 2026-09-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.