Shanton Pharma Receives Waivers for Pediatric Studies of SAP-001
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SINGAPORE and PRINCETON, N.J., Nov. 11, 2026 /CourierPR/ -- Shanton Pharma, a clinical-stage biotech founded in 2016 by experienced pharma entrepreneurs, has received significant regulatory relief for its lead investigational product, SAP-001, in the form of waivers from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
The EMA has granted a full waiver for pediatric clinical studies of SAP-001 in hyperuricemia and gout, applicable to all pediatric age subsets except those with chronic kidney disease or obesity. This waiver follows a similar exemption granted by the FDA in May, which was based on the extremely low prevalence of gout in children. These regulatory decisions will significantly streamline the clinical development process for SAP-001, reducing both the administrative burden and overall costs associated with pediatric studies.
Bing Li, Ph.D., Chief Executive Officer of Shanton Pharma, expressed satisfaction with the regulatory approvals.
SAP-001 is a once-a-day oral urate-lowering therapy designed to address uncontrolled or refractory gout, a serious condition for which there are considerable unmet medical needs. The drug's urate-lowering properties are based on a unique, First-in-Class mechanism of action, and it has shown Best-in-Class efficacy and safety in gout patients with hyperuricemia refractory to standard of care xanthine oxidase inhibitor therapy, according to a recent Phase 2b study.
Shanton Pharma's commitment to addressing unmet medical needs in patients with hyperuricemia and gout has been recognized through its Fast Track designation from the FDA, based on the promising results from its Phase 2b study. The company is headquartered in Singapore, with research and development activities in the US, China, and Singapore.
The regulatory waivers granted by the EMA and FDA will allow Shanton Pharma to focus on its ongoing clinical development efforts, bringing a potent First-in-Class oral urate-lowering therapy to the market.