SAP-001 is the main investigation of Shanton with a first and better potential in class in uncontrolled gout
SINGAPORE And Princeton, nj,, July 25, 2025 / Prnewswire / – Shanton Pharma, a biotechnology company at a clinical stage developing a new treatment for gout, announced today that the FDA has appointed its new SAP -001 student drug as a rapid product for the treatment of hyperuricemia in adult patients with gout that are refractory to conventional treatment.
“We are delighted with the rapid designation of SAP-001,” explains Dr. WENFENG MiaoCMO of Shanton. “Refractory gout is a serious disease for which there are considerable unsatisfied medical needs, requiring the development of new treatments. We are happy to exploit the possibility of faster regulatory journals provided by this designation to accelerate the availability of an essential solution for Patients to Gout who do not respond or cannot tolerate the treatment of the norm with conventional emergency.” “”
The FDA decision to grant the accelerated designation for SAP-001 was based in part on the recent results of the efficiency and safety of Shanton in a phase 2b Clinical study in which SAP-001 has demonstrated the potential to significantly improve the lowering treatment currently available for refractory patients.
About Fast Track
Fast Track is an accelerated revision program of the FDA which includes more frequent meetings with the FDA, early and continuous comments of the FDA, a rolling review of the NDA sections when they become available, and the possibility of a priority examination and an accelerated approval. The goal is to get a new important drug for patients earlier.
About SAP-001
SAP-001 is the main investigation of Shanton for oral oral therapy once a day which targets refractory gout. The SAP-001 URATE drop properties are based on a single and first-class unique action mechanism and the product has shown the best efficiency and safety in hyperuricemic patients to the treatment standard for xanthine oxidase inhibitor in a recent phase 2b study.
Aketwear shanton
Shanton Pharma is a private biotechnology at a clinical stage founded in 2016 by experienced pharmaceutical entrepreneurs, with research on unmet needs associated with hyperuricemia and gout. The company is based in Singapore with research and development activities in the United States, ChinaAnd Singapore.
To find out more about Shanton Pharma, go to https://shantonpharma.com.
Contact with the media
Ridder Pieter
Vice-president of commercial development
media@shantonpharma.com
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Source Shanton Pharma
