Mosliciguat - (PHocus)

September 8, 2026: Roivant (NASDAQ: ROIV) reported positive Phase 2 PHocus results for mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and said the Phase 3 PHrontier trial has been initiated with enrollment underway.

In PHocus (NCT06635850), a randomized, double-blind, placebo-controlled global study in 135 adults, mosliciguat met the primary endpoint at Week 16 with a placebo-adjusted pulmonary vascular resistance reduction of -56.3% (mosliciguat -51.3% vs placebo +6.6%; p<0.0001). Secondary endpoints were also met: placebo-adjusted six-minute walk distance improved by +35.2 meters (+20.3 vs -14.9; p=0.0027) and NT-proBNP fell by -357.7 pg/mL, a -53.2% reduction from baseline (p=0.0002).

In a pre-specified exploratory analysis at Week 24, placebo-adjusted 6MWD improvement increased to +52.7 meters and NT-proBNP reduction to -487.1 pg/mL (-75.9%), both with nominal p<0.0001. Mosliciguat was reported as well tolerated; cough occurred in 12.1% on mosliciguat versus 18.2% on placebo.

Results were presented at the European Respiratory Society International Congress 2026. Phase 3 PHrontier is a randomized, double-blind, placebo-controlled global trial planned to enroll about 375 patients with PH-ILD.