Swedish clinical-stage pharmaceutical company Vicore Pharma Holding AB (STO:VICO) announced on Tuesday that Japan's Ministry of Health, Labor and Welfare has granted Orphan Drug designation to buloxibutid for the treatment of idiopathic pulmonary fibrosis (IPF).
Buloxibutid is a first-in-class angiotensin II type 2 receptor agonist that promotes alveolar repair, resolves fibrosis, and supports pulmonary vascular function.
In February 2024, Vicore entered an exclusive licensing agreement with Nippon Shinyaku to develop and commercialise buloxibutid in Japan. Orphan designation provides incentives such as reduced consultation and review fees and extended market exclusivity upon approval.
Buloxibutid previously received Orphan Drug designation from the European Commission in 2016 and the US FDA in 2017, and Fast Track designation from the FDA in 2025.
The therapy is currently being evaluated in the global Phase 2b ASPIRE trial for IPF.
Alto Neuroscience receives FDA Fast Track designation for ALTO-101
Calico Life Sciences' investigational treatment for ADPKD receives US FDA Fast Track Designation
Hologic receives FDA clearance and CE mark for new gastrointestinal bacterial assays
Celltrion launches AVTOZMA IV in the United States following FDA approval
Vanda Pharmaceuticals agrees collaborative framework to resolve US FDA disputes
Microbot Medical secures first Japanese patent for Liberty robotic system following FDA clearance
Pharming receives FDA priority review for leniolisib in children with APDS
Renalytix submits CE Mark application for kidneyIntelX.dkd in Europe