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.