Inhaled Mosliciguat for Pulmonary Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new inhaled treatment called mosliciguat for individuals with pulmonary hypertension linked to interstitial lung disease (ILD). The main goal is to determine if this treatment is safe and effective for those already using inhaled treprostinil. The trial seeks participants with confirmed pulmonary hypertension and a diagnosis of ILD, such as idiopathic interstitial pneumonia or chronic hypersensitivity pneumonitis, who can walk at least 100 meters in a 6-minute walk test. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that inhaled mosliciguat is likely to be safe for humans?
Research has shown that inhaled mosliciguat appears safe for people with pulmonary hypertension, a condition characterized by high blood pressure in the lungs. An earlier study found that mosliciguat was well tolerated by patients, causing no major problems. Most importantly, no serious safety issues emerged after just one dose. Another study supported these findings, indicating that patients handled mosliciguat easily.
While the treatment remains under investigation, these early results are promising. They suggest that mosliciguat could be a safe option for individuals with this condition. However, it is important to note that this information comes from early studies, and further research will provide a clearer understanding.12345Why do researchers think this study treatment might be promising for pulmonary hypertension?
Unlike the standard treatments for pulmonary hypertension, which often involve oral medications or intravenous infusions, mosliciguat is unique because it's inhaled directly into the lungs. This new delivery method allows the treatment to act directly where it's needed, potentially improving effectiveness and reducing side effects. Additionally, mosliciguat targets a specific pathway in the body that helps relax blood vessels, which could lead to better management of the disease. Researchers are excited about mosliciguat because it offers a novel approach that could enhance patient outcomes and improve quality of life.
What evidence suggests that inhaled mosliciguat might be an effective treatment for pulmonary hypertension?
Research has shown that mosliciguat, which participants in this trial will receive, might help treat pulmonary hypertension, a condition characterized by high blood pressure in the lungs. Earlier studies found that mosliciguat lowers resistance in the lung's blood vessels, facilitating blood flow. It also helps open airways. Patients tolerated mosliciguat well, with no serious side effects reported, making it a promising option for managing pulmonary hypertension.13467
Who Is on the Research Team?
Ubaldo Martin, MD
Principal Investigator
Pulmovant, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with pulmonary hypertension (high blood pressure in the lungs) that's linked to interstitial lung disease—a condition where scar tissue forms in the lungs. Participants should already be using inhaled treprostinil, a medication for their condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive inhaled mosliciguat daily for 16 weeks
Extension
Participants continue to receive inhaled mosliciguat beyond 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Inhaled Treprostinil
- Mosliciguat
Trial Overview
The study is testing the safety and effectiveness of a new drug called mosliciguat when used together with an existing treatment, inhaled treprostinil. It's an open-label trial, meaning everyone knows which drugs are being given.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
After Week 16, all participants will continue to receive inhaled mosliciguat through an Extension period
Participants will receive inhaled mosliciguat daily for 16 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pulmovant, Inc.
Lead Sponsor
Citations
Press Release, September 4, 2025
In the Phase 1b ATMOS study of mosliciguat, a single dose of inhaled mosliciguat in PH patients was well tolerated and led to clinically ...
ATMOS, A Proof-of-Concept Trial of Inhaled Mosliciguat ...
Conclusion: Mosliciguat had favorable tolerability and resulted in a sustained, substantial reduction in PVR after a single inhaled dose. This abstract is ...
Inhaled mosliciguat (BAY 1237592): targeting pulmonary ...
Moreover, our data indicate that mosliciguat not only improved circulation but also showed bronchodilatory properties which may be beneficial in ...
NCT06635850 | A Study of Mosliciguat in PH-ILD
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in ...
Pulmovant Announces Publication of Pharmacokinetics ...
Three Phase 1 studies support once-daily inhaled administration of mosliciguat with no evidence of serious systemic side effects.
NCT06635850 | A Study of Mosliciguat in PH-ILD
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in ...
ATMOS, a Proof-of-Concept trial of inhaled mosliciguat in ...
Mosliciguat had favorable tolerability and resulted in a sustained, substantial reduction in PVR after a single inhaled dose.
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