On September 4, 2025, Pulmovant, a Roivant company, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation (ODD) to mosliciguat. This designation is for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), a progressive and life-threatening condition.
The ODD provides significant regulatory and development incentives in Japan, including priority consultation and reduced regulatory fees. It also offers up to 10 years of market exclusivity following potential approval, which is a substantial commercial advantage. This recognition validates the high unmet medical need for PH-ILD patients.
Mosliciguat is a potential first-in-class, once-daily, inhaled soluble guanylate cyclase (sGC) activator designed for targeted pulmonary vasodilation with limited systemic side effects. It is currently being evaluated in the Phase 2 PHocus clinical study, a global trial assessing its safety and efficacy in approximately 120 adult patients with PH-ILD.
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