Pulmovant announced that Japan’s Ministry of Health, Labour and Welfare has granted orphan drug designation to mosliciguat, a novel, once-daily, inhaled soluble guanylate cyclase activator, currently being studied for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease, which is a progressive and life-threatening condition with significant unmet medical need. Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action designed to deliver targeted pulmonary vasodilation with limited systemic side effects for the treatment of PH-ILD. Mosliciguat is currently being evaluated in the Phase 2 PHocus clinical study, a randomized, double-blind, placebo-controlled, global trial assessing its safety and efficacy in approximately 120 adult patients with PH-ILD. A study-in-progress poster outlining the design of PHocus will be presented at the European Respiratory Society International Congress 2025 on September 28th.
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