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The excessive purine intaking, increased synthesis and decreased excretion of uric acid are the main causes for hyperuricemia. Uric acid is excreted by kidney (70%), skin (15%) and intestine (15%). Therefore, impaired kidney function directly leads to hyperuricemia. Long-term hyperuricemia would induce a build-up of uric acid crystals under the skin and around the joints, which eventually results in gout.

Drugs for the treatment of hyperuricemia can be divided into three types, xanthine oxidase inhibitor, urate oxidases and URAT1 inhibitors. 40%-60% hyperuricemia patients treated with xanthine oxidase inhibitors alone cannot achieve desirable serum uric acid concentration. Using urate oxidases may result in drug resistance. As a URAT1 inhibitor, benzbromarone may cause fulminant hepatitis, and was banned in Europe and U.S. Another URAT1 inhibitors, lesinurad, was removed from U.S. and Europe in 2019 and 2020 respectively because of the risk of increasing serum creatinine and renal injury. Hence, it is necessary to develop new drugs that are safer and more effective for the treatment of hyperuricemia/gout.

In the early strategy of Hinova's URAT1 development, we evaluated hepatorenal toxicity of compound candidates. While during preclinical toxicology study, anthropoid primates was incorporated for safety evaluation. Furthermore, we decrease the potential side effects by formulation optimizations. At present phase II clinical trial of HP501.