
The immediate backdrop is the long-running clinical and commercial effort to treat pulmonary hypertension, especially forms secondary to interstitial lung disease (PH-ILD), where unmet need and high morbidity have driven repeated drug-development efforts since the 2000s.
Structurally, that effort has been shaped by regulatory approvals that established the nitric oxide–soluble guanylate cyclase (sGC) pathway and endothelin and phosphodiesterase-5 inhibitors as standard targets: bosentan’s FDA approval for pulmonary arterial hypertension in 2001, sildenafil’s PAH approval in 2005, and riociguat’s approval as an sGC stimulator in 2013.
Roivant said its experimental drug mosliciguat achieved the goals of a 16-week Phase 2 study, including a 56% placebo-adjusted reduction in pulmonary vascular resistance. The company said the statistically significant results could open a new treatment approach for pulmonary hypertension and bolster Roivant’s finances.