Buloxibutid Receives Orphan Drug Designation in Japan for the Treatment of Idiopathic Pulmonary Fibrosis

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[{"type":"text","content":"STOCKHOLM, SE / ACCESS Newswire / September 30, 2025 / Vicore Pharma Holding AB (STO:VICO), unlocking the potential of a novel class of drugs, angiotensin II type 2 receptor agonists (ATRAGs), today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Drug designation to buloxibutid for the treatment of idiopathic pulmonary fibrosis (IPF).","length":379,"tagName":"p"},{"type":"text","content":"Buloxibutid is a first-in-class angiotensin II type 2 receptor agonist that activates an upstream mechanism to drive alveolar repair, resolve fibrosis, and promote pulmonary vascular function. In February 2024, Vicore entered into an exclusive licensing agreement with Nippon Shinyaku to develop and commercialize buloxibutid in Japan.","length":335,"tagName":"p"},{"type":"text","content":"The designation is intended to support the development of promising therapies for rare diseases with high unmet need and can provide incentives such as reduced consultation and review fees, and extended market exclusivity upon approval in Japan.","length":245,"tagName":"p"},{"type":"text","content":""This milestone underscores the significant unmet medical need in IPF and reinforces the potential of buloxibutid to offer significant improvement over existing therapies," said Bertil Lindmark , Chief Medical Officer of Vicore. "We look forward to working closely with our partners at Nippon Shinyaku and with the MHLW to support the development of buloxibutid in Japan."","length":392,"tagName":"p"},{"type":"text","content":"Buloxibutid was granted Orphan Drug designation by the European Commission in 2016 and by the United States Food and Drug Administration (FDA) in 2017, as well as Fast Track designation by the FDA in 2025.","length":205,"tagName":"p"},{"type":"text","content":"Buloxibutid is being evaluated in the global Phase 2b ASPIRE trial for the treatment of IPF. More information can be found at www.aspire-ipf.com.","length":145,"tagName":"p"},{"type":"text","content":"For further information, please contact:Megan Richards, VP of IR, Communications, and Portfolio Strategy, tel: +1 978 269-4372, [email protected] Jeppsson, CFO, tel: +46 70 553 14 65, [email protected]","length":234,"tagName":"p"},{"type":"text","content":"About Vicore PharmaVicore Pharma Holding AB i...

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