Roivant Sciences Ltd. announced on September 8, 2026, that its subsidiary Pulmovant, Inc. has completed a Phase 2 clinical trial evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, named PHocus, met its primary and secondary endpoints, demonstrating clinically meaningful improvements in pulmonary vascular resistance and patient function.
The PHocus trial enrolled 135 patients across 87 sites in 20 countries. At Week 16, the study met its primary endpoint with a placebo-adjusted reduction in pulmonary vascular resistance (PVR) of 56.3% (p<0.0001). This represents the highest percentage reduction in PVR ever reported in a randomized controlled pulmonary hypertension trial. The study also met its secondary endpoints, showing a placebo-adjusted improvement in six-minute walk distance (6MWD) of 35.2 meters (p=0.0027) and a placebo-adjusted reduction in N-terminal pro–B-type natriuretic peptide (NT-proBNP) of 357.7 pg/mL (p=0.0002).
Pre-specified exploratory results from Week 24 indicated continued improvement, with a placebo-adjusted 6MWD increase of 52.7 meters and an NT-proBNP reduction of 487.1 pg/mL. The trial reported that mosliciguat was well tolerated with a favorable safety profile. Notably, the incidence of cough was lower in the mosliciguat group (12.1%) compared to the placebo group (18.2%).
Roivant announced the initiation of a Phase 3 clinical trial, PHrontier, to further evaluate mosliciguat in patients with PH-ILD. The Phase 3 study is designed to enroll approximately 375 patients worldwide. The results were presented at the European Respiratory Society (ERS) International Congress 2026, and Roivant will host a conference call and webcast on September 8, 2026, at 8:00 a.m. ET.
