Dotinurad is an oral URAT1 inhibitor approved in Japan with long patent life and has excellent long-term efficacy and safety profiles. Phase 1 trials are currently underway in the U.S., and we plan to launch a Phase 2 trial in 2023.
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 was non-inferior to Febuxostat, which has a black box warning for increased risk of cardiovascular death and was well-tolerated with low safety risk or drug interactions. Over 1,000 Japanese patients have been treated safely with Dotinurad and it is currently in Phase 3 clinical trials in China.