Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor for gout and possibly other hyperuricemic indications including chronic kidney disease and heart failure. It can lower blood uric acid levels by selectively inhibiting URAT1 and uric acid reabsorption in the kidneys. Dotinurad (URECE® tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia. Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials. Its efficacy demonstrated non-inferiority to Febuxostat, which has a black box warning for increased risk of cardiovascular death, and dotinurad was well-tolerated with apparent low safety risk and drug interaction. Over 1,000 Japanese patients have been treated safely with dotinurad in clinical trials. Also, dotinurad is currently in Phase 3 clinical trials in China.