Dotinurad Market

The Dotinurad market is projected to grow at a CAGR of 6.1% from 2025 to 2035, driven by the rising global burden of hyperuricemia and gout, as well as an increased focus on developing more selective and safer uricosuric agents. Dotinurad, a novel selective urate reabsorption inhibitor (SURI), targets URAT1 transporters in the kidney to promote uric acid excretion without significantly affecting other renal transporters—an advantage over traditional uricosuric drugs.

Its favorable safety profile, reduced risk of renal burden, and minimal drug interactions position it as a strong therapeutic candidate, particularly for patients who are intolerant to or at risk from xanthine oxidase inhibitors, such as allopurinol or febuxostat. The drug has shown excellent efficacy in lowering serum uric acid levels in both monotherapy and combination regimens, making it a next-generation treatment for chronic hyperuricemia and lifestyle-induced gout, especially in aging populations.

Regionally, Japan is the primary market for Dotinurad, where it was first developed and approved by Fuji Yakuhin Co., Ltd. Japan’s aging population and high prevalence of metabolic syndromes contribute significantly to the domestic demand for safer long-term uric acid-lowering therapies. Clinical adoption in Japan has been swift due to its innovative mechanism and tolerability.

In the Asia-Pacific region beyond Japan, countries like South Korea, Taiwan, and India are beginning to explore Dantrolene for regulatory approval or clinical trials, recognizing its potential in urban populations experiencing a rise in gout and metabolic syndrome. In North America and Europe, although Dotinurad is not yet widely available, interest is growing due to limitations with current urate-lowering drugs and a continued push toward personalized medicine.

If approved in Western markets, Dotinurad could see significant uptake due to the demand for targeted, renal-safe gout therapies. Latin America and the Middle East & Africa currently have minimal exposure, but as generic formulations and clinical awareness increase, these regions may offer long-term growth potential, especially where gout remains underdiagnosed but prevalent. Globally, the promise of Dotinurad lies in its selectivity, tolerability, and potential to redefine second-line treatment in hyperuricemia care.