According to Pulmovant, the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to Pulmovant’s inhaled dry powder mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company announced in 2024 that it had licensed the dry powder formulation from Bayer and that it had initiated the Phase 2 PHocus study of mosliciguat in PH-ILD patients.
Pulmovant CEO Drew Fromkin commented, “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. 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.”
Read the Pulmovant press release
