A Study of Mosliciguat in PH-ILD

Last updated: February 19, 2026
Sponsor: Pulmovant, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Pulmonary Arterial Hypertension

Vascular Diseases

Heart Disease

Treatment

Mosliciguat

Dry Powder Inhaler

Placebo

Clinical Study ID

NCT06635850
RVT-2301-201
  • Ages 18-85
  • All Genders

Study Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants willing and able to provide informed consent

  • Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will beconfirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuseparenchymal 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 vitalcapacity (FVC) < 70% of predicted

  • Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).

  • Ability to perform 6MWD ≥100 meters.

Exclusion

Exclusion Criteria:

  • Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related toleft-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonaryhypertension), 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 atBaseline.

  • History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators oractivators.

  • Receipt of investigational, or experimental therapy within 42 days OR 5 half-livesprior to randomization.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 135
Treatment Group(s): 3
Primary Treatment: Mosliciguat
Phase: 2
Study Start date:
October 29, 2024
Estimated Completion Date:
January 31, 2028

Study Description

This study is a randomized, double-blind, placebo-controlled study with an extension.

The study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks).

Participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period.

All participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat.

Connect with a study center

  • Arizona Pulmonary Specialists

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Arizona Pulmonary Specialists

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90024
    United States

    Site Not Available

  • University of California Davis School of Medicine

    Sacramento, California 95817
    United States

    Site Not Available

  • Harbor-UCLA Medical Center - Torrance

    Torrance, California 90502
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles 5368361, California 5332921 90024
    United States

    Site Not Available

  • University of California Davis School of Medicine

    Sacramento 5389489, California 5332921 95817
    United States

    Site Not Available

  • Harbor-UCLA Medical Center - Torrance

    Torrance 5403022, California 5332921 90502
    United States

    Site Not Available

  • Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC

    Celebration, Florida 34746
    United States

    Site Not Available

  • Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC

    Celebration 4150394, Florida 4155751 34746
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60026
    United States

    Site Not Available

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60026
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Norton Pulmonary Specialists

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Pulmonary Specialists

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Duke University Health System - Duke Clinic

    Durham, North Carolina 27710
    United States

    Site Not Available

  • PulmonIx

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Duke University Health System - Duke Clinic

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • PulmonIx

    Greensboro 4469146, North Carolina 4482348 27403
    United States

    Site Not Available

  • Hoxworth Blood Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Hoxworth Blood Center

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Site Not Available

  • Summit Health

    Bend, Oregon 97701
    United States

    Site Not Available

  • Summit Health

    Bend 5713587, Oregon 5744337 97701
    United States

    Site Not Available

  • Lewis Katz School of Medicine

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Lewis Katz School of Medicine

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • Brown Medicine

    East Providence, Rhode Island 02915
    United States

    Site Not Available

  • Brown Medicine

    East Providence 5221931, Rhode Island 5224323 02915
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Houston Methodist Lung Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Lung Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City, Utah 84132-0001
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City 5780993, Utah 5549030 84132-0001
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.