Dotinurad is approved in Japan to treat hyperuricemia. Credit: National Cancer Institute on Unsplash.

Urica Therapeutics has reported topline data from the Phase I clinical trial of dotinurad in healthy subjects in the US.

A new urate transporter (URAT1) inhibitor, dotinurad is being developed for treating gout and could be used for ailments linked to hyperuricemia such as chronic kidney disease.

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The placebo-controlled, randomised trial assessed the tolerability, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of varying doses of dotinurad in healthy participants in the region.

According to the trial findings, dotinurad was found to be safe and well tolerated without any severe adverse events reported.

Additionally, no adverse events linked to the drug were seen at 1mg, 2mg and 4mg dose levels, which are currently approved and sold in Japan.

The PK and PD profile in US participants were comparable to those of Japanese counterparts with all doses analysed.

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In 2020, dotinurad (URECE Tablets) received approval in Japan for usage as a once-a-day oral treatment for hyperuricemia irrespective of gout status.

Urica chairman and CEO Jay Kranzler said: “We are encouraged that the data from our Phase I clinical trial in US healthy volunteers show comparable pharmacokinetic, pharmacodynamic and safety profiles between US and Japanese healthy subjects.

“We are initiating a Phase Ib clinical trial in gout patients in the US this summer and expect to begin pivotal clinical trials in 2024.”