25 July 2025 - Shanton Pharma today announced that FDA has designated its Investigational new drug SAP-001 as a fast track product for treatment of hyperuricaemia in adult patients with gout who are refractory to conventional therapy.

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.

Read Shanton Pharma press release