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A Phase 2B Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of 3 Dosages of SAP-001 in Combination With Standard of Care in Adult Subjects With Gout

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Trial Profile

A Phase 2B Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of 3 Dosages of SAP-001 in Combination With Standard of Care in Adult Subjects With Gout

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Nov 2025

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At a glance

  • Drugs SAP 001 (Primary)
  • Indications Gout; Gouty arthritis
  • Focus Therapeutic Use
  • Acronyms RID-GOUT
  • Sponsors Shanton Pharma

Most Recent Events

  • 27 Oct 2025 According to a Shanton Pharma media release, company announced the successful completion of an End-of-Phase 2 meeting with US FDA. Based on FDA's feedback company is confident to enter into a Multi-Regional Clinical Trial program in the coming months.
  • 25 Jul 2025 According to a Shanton Pharma media release, company 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, decision to grant is based on results from this study.
  • 19 May 2025 According to a Shanton Pharma media release, company will be presenting topline data from this study at the annual EULAR Congress in Barcelona on June 14.

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