Shanton Receives Fast Track Designation from US FDA for Refractory Gout Program
SINGAPORE and PRINCETON, N.J., July 25, 2025 /PRNewswire/ — Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced that FDA has designated its Investigational New Drug SAP-001 as a Fast Track product for treatment of hyperuricemia in adult patients with gout who are refractory to conventional therapy.
'We are excited about the Fast Track designation for SAP-001' says Dr. Wenfeng Miao, Shanton's CMO. 'Refractory gout is a serious condition for which there are considerable unmet medical needs, requiring the development of new treatments. We are pleased to tap into the opportunity for faster regulatory reviews provided by this designation to speed up the availability of a much-needed solution for gout patients who do not respond to or cannot tolerate Standard-of-Care treatment with conventional Urate Lowering Therapies.'
FDA's decision to grant the Fast Track designation for SAP-001 was based in part on Shanton's recent efficacy and safety outcomes in a Phase 2b clinical study in which SAP-001 demonstrated the potential to meaningfully improve on currently available Urate Lowering Therapy for refractory gout patients.
About Fast Track
Fast Track is an FDA expedited review program which includes more frequent meetings with FDA, early and ongoing feedback from FDA, rolling review of NDA sections as they become available, and the possibility of priority review and accelerated approval. The purpose is to get important new drugs to patients earlier.
About SAP-001
SAP-001 is Shanton's lead investigational compound for once-a-day oral urate-lowering therapy that targets refractory gout. SAP-001's urate lowering properties are based on a unique, First-in-Class mechanism-of-action and the product has shown Best-in-Class efficacy and safety in gout patients with hyperuricemia refractory to Standard of Care Xanthine Oxidase Inhibitor therapy in a recent Phase 2b study.
About Shanton Pharma
Shanton Pharma is a privately held, clinical-stage biotech founded in 2016 by experienced pharma entrepreneurs, with a research focus on unmet needs associated with hyperuricemia and gout. The company is headquartered in Singapore with research and development activities in the US, China, and Singapore.
To learn more about Shanton Pharma, go to https://shantonpharma.com.
Media Contact
Pieter de RidderVP of Business Developmentmedia@shantonpharma.com
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