Pulmonary HypertensionPhase 2NCT07333183
A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
A Phase 2 study testing inhaled mosliciguat and Dry Powder Inhaler in people with Pulmonary Hypertension and Interstitial Lung Disease (ILD), run by Pulmovant, Inc. at 13 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension, Interstitial Lung Disease (ILD), Lung Diseases
- What is being tested?
- inhaled mosliciguat and Dry Powder Inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 13 sitesUnited States
- Study dates
- 23 Dec 2025to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Idiopathic interstitial pneumonia (IIP)
- Chronic hypersensitivity pneumonitis
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Clinical Research Site
Albuquerque, New Mexico, 87131
Clinical Site
- Recruiting
Clinical Research Site
Ann Arbor, Michigan, 48109
Clinical Site
- Recruiting
Clinical Research Site
Boston, Massachusetts, 02115
Clinical Site
- Recruiting
Clinical Research Site
Charleston, South Carolina, 29425
Clinical Site
- Recruiting
Clinical Research Site
Chicago, Illinois, 60611
Clinical Site
- Recruiting
Clinical Research Site
Detroit, Michigan, 48202
Clinical Site
- Recruiting
Clinical Research Site
Greensboro, North Carolina, 27403
Clinical Site
- Recruiting
Clinical Research Site
Houston, Texas, 77030
Clinical Site
- Recruiting
Clinical Research Site
Kansas City, Kansas, 66160
Clinical Site
- Recruiting
Clinical Research Site
Kissimmee, Florida, 34746
Clinical Site
- Recruiting
Clinical Research Site
Providence, Rhode Island, 02903
Clinical Site
- Recruiting
Clinical Research Site
Santa Barbara, California, 93105
Clinical Site
- Recruiting
Clinical Research Site
Torrance, California, 90502
Clinical Site
About this study
Official title: 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.
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.
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease (ILD), Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
- Being tested
- inhaled mosliciguat, Dry Powder Inhaler
- Keywords
- PH, ILD, 6 Minute Walk Test, mosliciguat
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Interstitial, Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled mosliciguatDrug
Dose level 1, 2, or 3 for inhalation
Dry Powder InhalerDevice
Dry powder inhaler for mosliciguat delivery
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: inhaled mosliciguat | Experimental | Participants will receive inhaled mosliciguat daily for 16 weeks Receives: Drug: inhaled mosliciguat; Device: Dry Powder Inhaler |
| Extension: inhaled mosliciguat | Experimental | After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period Receives: Drug: inhaled mosliciguat; Device: Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start23 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmovant, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ubaldo Martin, MD, Study director, Pulmovant, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333183
- Sponsor's protocol ID
- RVT-2301-202
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07333183
- Acronym / sponsor ID
- RVT-2301-202
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease (ILD), Lung Diseases, Vascular Diseases, Cardiovascular Diseases, Fibrosis
- Keywords
- PH, ILD, 6 Minute Walk Test, mosliciguat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pulmovant, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: inhaled mosliciguat | Experimental | Drug: inhaled mosliciguat, Device: Dry Powder InhalerParticipants will receive inhaled mosliciguat daily for 16 weeks |
| Extension: inhaled mosliciguat | Experimental | Drug: inhaled mosliciguat, Device: Dry Powder InhalerAfter Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).
- Ability to perform 6MWD ≥100 meters.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled mosliciguatDose level 1, 2, or 3 for inhalation | Drug | Active Comparator: inhaled mosliciguat, Extension: inhaled mosliciguat |
| Dry Powder InhalerDry powder inhaler for mosliciguat delivery | Device | Active Comparator: inhaled mosliciguat, Extension: inhaled mosliciguat |
Primary outcome
Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation
Time frame: Baseline, Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ubaldo Martin, MD study director
Pulmovant, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inhaled mosliciguat and Dry Powder Inhaler in people with Pulmonary Hypertension and Interstitial Lung Disease (ILD), run by Pulmovant, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pulmovant (+1-919-462-1310, clinicaltrials@pulmovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and nature of participant TEAEs, SAEs, and AEs leading to discontinuation (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.