Dotinurad provides comparable efficacy to febuxostat while maintaining a favorable tolerability and safety profile in hyperuricemic patients.
A non-inferiority study has confirmed that dotinurad, a novel selective urate reabsorption inhibitor, delivers uric-acid–lowering effects comparable to febuxostat, a widely prescribed treatment for hyperuricemia and gout.
Dotinurad functions by selectively inhibiting URAT1 (urate transporter 1), which plays a key role in uric acid reabsorption in the kidneys. This mechanism makes it a promising next-generation treatment option for elevated uric acid levels. Hence, this study compared dotinurad versus febuxostat for hyperuricemia. This investigation was a multicenter, double-blind, randomized, active-controlled trial involving 203 Japanese patients diagnosed with hyperuricemia, with or without gout.
Participants were assigned to either the dotinurad group or febuxostat group. Treatment began at 0.5 mg/day of dotinurad or 10 mg/day of febuxostat. Both medications were gradually titrated to their final doses—2 mg/day dotinurad and 40 mg/day febuxostat—over a 14-week period. The key outcome was the percentage decrease in the levels of serum uric acid from baseline to the final evaluation. As found, both medications remarkably reduced uric acid levels (Table 1):

The calculated treatment difference was −2.17%. The confidence interval remained above the non-inferiority threshold of −10%, confirming that dotinurad was non-inferior to febuxostat. Both treatment arms showed similar safety profiles. Adverse events and drug reactions were consistent with expectations. No clinically concerning safety signals were reported. The study confirms that dotinurad is non-inferior to febuxostat in reducing serum uric acid levels in hyperuricemia, with or without gout. Its favorable safety profile and targeted mechanism of action support its usage as a viable option within evidence-based gout and uric acid management strategies.
Clinical and Experimental Nephrology
A non-inferiority study of the novel selective urate reabsorption inhibitor dotinurad versus febuxostat in hyperuricemic patients with or without gout
Tatsuo Hosoya et al.
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