SAP-001, Shanton’s primary investigational compound, shows potential to be a first- and best-in-class treatment for uncontrolled gout.
SINGAPORE and PRINCETON, N.J., July 25, 2025 — Shanton Pharma, a clinical-stage biotechnology firm focused on developing a new gout treatment, announced today that the FDA has granted Fast Track designation to its Investigational New Drug (IND) SAP-001. This designation is for its use in treating hyperuricemia in adult gout patients who have not responded to standard treatments.
Dr. Wenfeng Miao, Shanton’s Chief Medical Officer, stated, “We are enthusiastic about the Fast Track designation for SAP-001. Refractory gout represents a serious condition with significant unmet medical needs, necessitating the creation of novel treatments. We welcome the chance for accelerated regulatory reviews offered by this designation, which will help hasten the delivery of a vital solution for gout patients unable to respond to or tolerate conventional Urate Lowering Therapies.”
The FDA’s decision to award Fast Track designation for SAP-001 was partly influenced by the recent efficacy and safety data from Shanton’s Phase 2b clinical study. In this study, SAP-001 showed the potential to substantially enhance existing Urate Lowering Therapy for patients with refractory gout.
About Fast Track
The Fast Track program is an expedited review process by the FDA that allows for more frequent interactions with the agency, continuous early feedback, a rolling review of New Drug Application (NDA) sections as they are completed, and the potential for both priority review and accelerated approval. Its aim is to accelerate the delivery of critical new medications to patients.
About SAP-001
SAP-001 serves as Shanton’s primary investigational compound, designed as a once-daily oral therapy to lower urate levels for refractory gout. Its urate-lowering capabilities stem from a distinct, first-in-class mechanism of action. The product has demonstrated best-in-class efficacy and safety in a recent Phase 2b study involving gout patients with hyperuricemia who were refractory to standard-of-care Xanthine Oxidase Inhibitor therapy.
About Shanton Pharma
Shanton Pharma, a privately held, clinical-stage biotechnology firm, was established in 2016 by seasoned pharmaceutical entrepreneurs. The company’s research primarily targets unmet medical needs related to hyperuricemia and gout. Headquartered in Singapore, Shanton Pharma also conducts research and development operations in the U.S., China, and Singapore.
For additional information regarding Shanton Pharma, please visit .
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