Roivant Sciences (ROIV) said Thursday that Japan's Ministry of Health, Labor and Welfare has granted orphan drug designation for mosliciguat, a potential treatment for pulmonary hypertension associated with interstitial lung disease.
The designation is intended to provide key regulatory and development incentives, including priority consultation, reduced regulatory fees, and up to 10 years of market exclusivity.
The company said mosliciguat is currently being evaluated in a phase 2 clinical study of approximately 120 adult patients.