Dotinurad (Urece) is a selective uricosuric agent indicated for the treatment of gout and hyperuricemia; it was developed by Fuji Yakuhin and approved for use in Japan in 2020. The molecule acts primarily by inhibiting the renal urate transporter URAT1 in the proximal tubule, reducing urate reabsorption and increasing urinary uric acid excretion. It has been formulated for oral administration and has been the subject of further clinical development and regulatory activities; the drug is continuing clinical trials by Fortress Biotech and regulatory evaluation for approval in North Ame + some more technical info. Clinical and nonclinical programs have characterized its pharmacology, selectivity for URAT1 relative to other renal transporters, and safety margins; manufacture and formulation development address stability of the acid functional group and control of oxidative and positional isomer impurities.
Parent: Dotinurad
Parent: Dotinurad
Parent: Dotinurad
Dotinurad API and finished product specifications are developed to meet ICH impurity and safety guidance, with reporting and threshold criteria aligned to ICH Q3A/Q3B; for a drug substance with a typical daily dose in the low gram or subgram range, the commonly applied thresholds are reporting at 0.05 percent, identification at 0.10 percent, and qualification at 0.15 percent. Typical specification practice for Dotinurad includes individual specified related compounds controlled to 0.10 to 0.20 percent depending on toxicology and known degradation pathways, a combined total impurities allocation commonly not to exceed 0.5 to 1.0 percent, and dedicated limits for known route- and process-related impurities such as starting material carryover, des-bromo or dehalogenated analogs, positional isomers, dealkylated or hydrolytic cleavage products, and N-oxide species. Residual solvents and elemental impurities are controlled to ICH Q3C and Q3D limits respectively, and degradation profiles are established by forced-degradation studies to set shelf-life acceptance criteria.
Dotinurad inhibits the renal urate transporter URAT1 in the proximal tubular epithelium, decreasing reabsorption of uric acid from the tubular lumen into the blood and thereby increasing urinary urate excretion and lowering serum urate levels; preclinical and clinical data indicate selectivity for URAT1 with limited inhibition of other renal transporters at therapeutic exposures.
Dotinurad is an oral uricosuric medication marketed as Urece for treatment of gout and hyperuricemia, developed by Fuji Yakuhin and approved in Japan in 2020; it is undergoing additional clinical trials and regulatory evaluation by Fortress Biotech for potential approval in North Ame + some more technical info, and its development program includes characterization of pharmacology, safety, formulation, and impurity controls.
