WALTHAM, Massachusetts — September 8, 2026
Pulmovant announced positive topline results from the Phase 2 PHocus study of mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), while also announcing initiation of the global Phase 3 PHrontier study. PHocus met its primary endpoint, demonstrating a statistically significant and clinically meaningful 56.3% placebo-adjusted reduction in pulmonary vascular resistance (PVR) at Week 16 (p<0.0001). Pulmovant described the result as the highest PVR reduction reported in a randomized controlled pulmonary hypertension trial. The study also met its secondary endpoints, including a 35.2-meter placebo-adjusted improvement in six-minute walk distance (6MWD) and a 53.2% placebo-adjusted reduction in NT-proBNP at Week 16. The results are being presented at the European Respiratory Society (ERS) International Congress 2026, providing an important clinical development milestone as Pulmovant transitions mosliciguat into pivotal Phase 3 development.
PHocus Supports Further Development of Once-Daily Inhaled Mosliciguat
The PHocus findings strengthen the clinical rationale for mosliciguat as a potential once-daily inhaled treatment for PH-ILD, with improvements observed across hemodynamic, functional and cardiac biomarker measures. At Week 16, mosliciguat produced a placebo-adjusted 6MWD improvement of 35.2 meters (p=0.0027) and a placebo-adjusted NT-proBNP reduction of 357.7 pg/mL (p=0.0002). Exploratory Week 24 analyses showed that these effects continued to strengthen, with a placebo-adjusted 6MWD improvement of 52.7 meters and NT-proBNP reduction of 75.9%, or 487.1 pg/mL. Mosliciguat was also reported to have a favorable tolerability profile, with most adverse events consistent with the underlying PH-ILD population. Importantly for an inhaled therapy, the incidence of cough was lower with mosliciguat than placebo, at 12.1% versus 18.2%, respectively. The Phase 2 study enrolled 135 patients across 87 sites in 20 countries, establishing a broad international clinical foundation for the next stage of development.
Pulmovant Initiates Global Phase 3 PHrontier Study
Pulmovant has initiated the Phase 3 PHrontier clinical trial, with enrollment now underway in adults with PH-ILD. The randomized, 1:1, double-blind, placebo-controlled global study is designed to evaluate the safety and efficacy of mosliciguat and is currently planned to enroll approximately 375 patients worldwide. The rapid transition from the completed PHocus study into a pivotal program reflects Pulmovant’s strategy to accelerate development of mosliciguat for a patient population with significant unmet medical needs. PH-ILD is classified within Group 3 pulmonary hypertension, which develops in association with underlying lung diseases such as interstitial lung disease. Pulmovant estimates that up to 200,000 patients across the United States and Europe are living with PH-ILD, where treatment options remain limited. The company intends for PHrontier to provide the pivotal evidence required to advance mosliciguat toward potential regulatory approval.
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Mosliciguat Offers Differentiated sGC Activation Strategy
Mosliciguat is a potential first-in-class, once-daily inhaled soluble guanylate cyclase (sGC) activator designed to provide targeted pulmonary vasodilation. The therapy acts on sGC within the nitric oxide/cyclic guanosine monophosphate signaling pathway, with the potential to increase cGMP and influence vasodilation as well as processes associated with inflammation, fibrosis and vascular remodeling. Unlike sGC stimulators, mosliciguat is designed to activate sGC independently of nitric oxide and heme status, potentially providing activity in disease settings where native sGC function is impaired. Pulmovant believes this mechanism could differentiate mosliciguat from existing approaches and support its use as either a single-agent therapy or in combination treatment. With positive Phase 2 data, Phase 3 PHrontier now underway and additional clinical data expected at medical congresses, Pulmovant is accelerating mosliciguat’s development as a potential new treatment option for PH-ILD.
Source: Pulmovant, press release
