Table 1.

Clinical trials of dotinurad

References	Clinical trails gov ID	Study objectives	Subjects or patients	Dotinurad dose (day)	Dosing period
[23]	NCT02344862	Dose response, optimal dose and safety (phase 2a)	Hyperuricemia	0.25 → 0.5 → 1,2,4 mg placebo	8 weeks
[24]	NCT02416167	Dose response, optimal dose and safety (phase 2b)	Hyperuricemia	0.25 → 0.5 → 0.5,1,2,4 mg placebo	12 weeks
[25]	NCT03006445	Long-term efficacy and safety	Hyperuricemia	0.5 → 1→2 mg 0.5 → 1→2 → 4 mg	34 or 58 weeks
[26]	NCT02344875	PK, PD, and safety in elder subjects	Elderly	1 mg	Single dose
[27]	NCT02347046	PK, PD, and safety in patients with CKD	CKD Healthy	1 mg	Single dose
[28]	NCT03306667	PK, PD, and safety in patients with liver damage	Liver disease Healthy	4 mg	Single dose
[30]	NCT03100318	Non-inferiority test to benzbromarone and evaluation of safety	Hyperuricemia	0.5 → 1→2 mg benzbromarone 25 → 50 → 50 mg	14 weeks
[31]	NCT03372200	Non-inferiority test to febuxostat and evaluation of safety	Hyperuricemia	0.5 → 1→2 mg febuxostat 10 → 20 → 40 mg	14 weeks
[32]	NCT03350386	PK and safety of oxaprozin in combination (Drug interaction)	Healthy	4 mg → oxaprozin 600 mg → 4 mg + oxaprozin 600 mg	Single dose 6 days
[33]	NCT02837198	PD, PK, and safety in patient groups classified into G1 and G2	G1: overproduction type, G2: underexcretion type	1 mg → 1 mg + topiroxostat 80 mg	7 days
[34]	NCT03375632	PD and safety in patient groups classified into G1 and G2	G1 and G2	0.5 → 1→2 → 4 mg	14 weeks

PK Pharmacokinetics, PD Pharmacodynamics, UA Uric acid, CKD Chronic kidney disease