Shanton Pharma has received regulatory waivers from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), removing the need for additional pediatric clinical studies of its investigational drug SAP-001 for hyperuricemia and gout.
The company announced on November 11, 2026, that the EMA had agreed to a full pediatric study waiver for SAP-001 across all pediatric age groups for hyperuricemia caused by conditions other than chronic kidney disease or obesity.
The decision follows an earlier agreement with the FDA. In May 2026, Shanton Pharma submitted an initial Pediatric Study Plan to the agency, which exempted SAP-001 from pediatric study requirements. The decision was based on the extremely low occurrence of gout in children.
The two regulatory decisions are expected to reduce the time, cost and administrative work involved in developing SAP-001. They will also allow the company to focus its clinical development efforts on adult patients.
SAP-001 is Shanton Pharma’s lead investigational drug candidate. It is being developed as a once-daily oral treatment to lower uric acid levels in adults with uncontrolled or difficult-to-treat gout.
The drug works through a new mechanism of action and is designed to address patients who do not respond adequately to existing urate-lowering treatments, including xanthine oxidase inhibitors.
According to the company, SAP-001 has shown encouraging results in a recent Phase 2b clinical study involving patients with gout and high uric acid levels who had an inadequate response to standard treatment.
The FDA had previously granted SAP-001 Fast Track designation, recognising its potential to address an important unmet medical need in patients with uncontrolled or refractory gout.
Bing Li, CEO of Shanton Pharma, said the EMA and FDA decisions would reduce regulatory requirements and lower the overall cost of developing the drug.
Robert Terkeltaub, Professor Emeritus of Medicine at the University of California, San Diego, also highlighted the importance of the decisions. He noted that SAP-001 could offer a new treatment option for patients whose gout remains uncontrolled despite currently available oral medications.
Founded in 2016, Shanton Pharma is a privately held clinical-stage biotechnology company headquartered in Singapore, with research and development activities in the United States, China and Singapore.
With both pediatric study waivers in place, the company can streamline the development of SAP-001 as it continues working towards a potential new oral treatment for adults living with difficult-to-control gout.