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RecruitingNCT07333183Updated Sep 2, 2026

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

A Phase 2 interventional study of inhaled mosliciguat and Dry Powder Inhaler in Pulmonary Hypertension, Interstitial Lung Disease (ILD) and Lung Diseases, sponsored by Pulmovant, Inc.. Recruiting at 13 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Pulmovant, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • PH
  • ILD
  • 6 Minute Walk Test
  • mosliciguat
03

In context

Hypertension, Pulmonary

1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.

This study's planned enrollment of 20 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Pulmovant, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants willing and able to provide
  • 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 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

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 , or experimental therapy within 42 days OR 5 half-lives prior to randomization.

Note: Other inclusion and exclusion criteria may apply.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Active Comparator: inhaled mosliciguat

    Participants will receive inhaled mosliciguat daily for 16 weeks

    Drug: inhaled mosliciguat · Device: Dry Powder Inhaler

  • Experimental
    Extension: inhaled mosliciguat

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

    Drug: inhaled mosliciguat · Device: Dry Powder Inhaler

Interventions

  • Dose level 1, 2, or 3 for inhalation

  • DeviceDry Powder Inhaler

    Dry powder inhaler for mosliciguat delivery

06

What researchers measure

Primary outcomes

  1. Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation

    Time frame: Baseline, Week 16

07

Study locations

13 of 13 sites recruiting
  • Clinical Research Site
    Santa Barbara, California 93105, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Torrance, California 90502, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Kissimmee, Florida 34746, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Chicago, Illinois 60611, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Kansas City, Kansas 66160, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Boston, Massachusetts 02115, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Ann Arbor, Michigan 48109, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Detroit, Michigan 48202, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Albuquerque, New Mexico 87131, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Greensboro, North Carolina 27403, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Providence, Rhode Island 02903, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Charleston, South Carolina 29425, United States
    Recruiting
    • Clinical Site · Contact
  • Clinical Research Site
    Houston, Texas 77030, United States
    Recruiting
    • Clinical Site · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.

Of 50 phase 2 interventional studies under Hypertension, Pulmonary, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 71. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2026
First posted
Jan 12, 2026
StartActual
Dec 23, 2025
Primary completionEst.
Dec 2026
CompletionEst.
Jan 2028
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07333183
Lead sponsor
Pulmovant, Inc.
Responsible party
Sponsor
First posted
Jan 12, 2026
Start date
Dec 23, 2025
Primary completion
Dec 2026 (estimated)
Completion
Jan 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Pulmovant
Contact
clinicaltrials@pulmovant.com
+1-919-462-1310
Ubaldo Martin, MD
study director · Pulmovant, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Mosliciguat

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