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Pulmovant, a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases, and a Roivant (NASDAQ:ROIV) company, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation (ODD) to mosliciguat, a novel, once-daily, inhaled soluble guanylate cyclase (sGC) activator, currently being studied for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), which is a progressive and life-threatening condition with significant unmet medical need.
"Obtaining orphan drug designation for mosliciguat in Japan validates the significant unmet need that exists for people living with PH-ILD, a progressive and life-threatening cardiopulmonary condition with poor prognosis and limited or no treatment options," said Drew Fromkin, Chief Executive Officer of Pulmovant. "We appreciate the MHLW's recognition of this challenge for PH-ILD patients and look forward to continued collaboration with Japanese regulators as we advance mosliciguat through the next stages of clinical development."
ODD designation is based on the recommendation of Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and provides key regulatory and development incentives, including priority consultation, reduced regulatory fees, and up to 10 years of market exclusivity following potential approval. For more information about Japan's ODD, please visit the MHLW website.
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 (NCT06635850), 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 (ERS) International Congress 2025 on September 28th.
Posted In: ROIV
