Roivant details Phase 2 PHocus data for mosliciguat, unveils ongoing Phase 3 PHrontier trial

Roivant said on September 8, 2026 that its Phase 2 PHocus trial of mosliciguat met its primary endpoint in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The trial showed a placebo-adjusted reduction in pulmonary vascular resistance of 56.3%, with mosliciguat patients improving 51.3% versus a 6.6% worsening on placebo, at Week 16 (p<0.0001).¹

Secondary endpoints were also met. Six-minute walk distance improved by 35.2 meters on a placebo-adjusted basis (20.3 meters for mosliciguat versus a 14.9-meter decline for placebo, p=0.0027), and NT-proBNP, a biomarker of cardiac strain, dropped 357.7 pg/mL on a placebo-adjusted basis (p=0.0002), a 53.2% reduction from baseline at Week 16.¹

In a pre-specified exploratory analysis, the treatment effect appeared to strengthen over time: by Week 24, the placebo-adjusted gain in six-minute walk distance reached 52.7 meters (nominal p<0.0001), while NT-proBNP fell by 487.1 pg/mL, or 75.9% (nominal p<0.0001).¹

On safety, the company said mosliciguat was well tolerated, with adverse events consistent with underlying PH-ILD, and cough occurred less often with mosliciguat than placebo (12.1% versus 18.2%).¹

PHocus (NCT06635850) was a randomized, double-blind, placebo-controlled global trial that enrolled 135 patients across 87 sites in 20 countries.¹ Roivant confirmed its Phase 3 PHrontier study is now underway. PHrontier is a randomized 1:1, double-blind, placebo-controlled global trial designed to enroll approximately 375 patients.¹

The company said as many as 200,000 people across the U.S. and Europe live with PH-ILD, a subset of Group 3 pulmonary hypertension, with limited or no approved treatment options.¹ Results were presented at the European Respiratory Society International Congress 2026 by Professor Marc Humbert, and Roivant hosted an investor call the same day.