Dotinurad is a selective urate reabsorption inhibitor (SURI) and a small-molecule active pharmaceutical ingredient used in pharmaceutical products for the management of hyperuricemia associated with gout. It selectively targets urate transporter 1 (URAT1), a transporter involved in renal uric-acid reabsorption.
Dotinurad has the chemical formula C₁₄H₉Cl₂NO₄S, molecular weight 358.20 g/mol, and CAS Number 1285572-51-1. Its chemical identity is also recognized under the synonym FYU-981.
Dotinurad is a selective URAT1 inhibitor belonging to the uricosuric class of medicines. By inhibiting URAT1 in the renal proximal tubules, Dotinurad reduces the reabsorption of uric acid and promotes its urinary excretion.
Dotinurad was approved in Japan in 2018 and is used for gout and hyperuricemia. Japanese regulatory information identifies Urece tablets containing Dotinurad in 0.5 mg, 1 mg and 2 mg strengths.
Dotinurad selectively inhibits urate transporter 1 (URAT1/SLC22A12). URAT1 is responsible for reabsorbing uric acid from the renal tubular lumen. Inhibition of this transporter decreases uric-acid reabsorption and increases urinary uric-acid excretion, helping reduce serum uric-acid concentrations.
Dotinurad is used in pharmaceutical formulations for:
Japanese regulatory information lists the approved indication as gout and hyperuricemia.
Dotinurad is a synthetic organic small-molecule API. It is generally supplied as a solid material and is associated with oral pharmaceutical formulations. The Japanese Accepted Names database identifies Dotinurad with the chemical name (3,5-Dichloro-4-hydroxyphenyl)(1,1-dioxo-1,2-dihydro-3H-1λ⁶-1,3-benzothiazol-3-yl)methanone.
Dotinurad is reported as a white to off-white solid/powder. Public chemical references report a melting point around 188–191°C and describe it as sparingly soluble in DMSO and slightly soluble in chloroform under specified conditions.
Dotinurad API intended for pharmaceutical manufacturing should be produced and tested according to applicable GMP requirements and the manufacturer's approved quality specification. Quality testing may include identity, assay, related substances, residual solvents, water content, elemental impurities and other applicable quality attributes.
For commercial API supply, the batch-specific Certificate of Analysis (CoA) should be used to confirm the actual analytical results and release status.
Dotinurad is an important API for pharmaceutical development and manufacturing in the gout and hyperuricemia therapeutic area. Pharmaceutical manufacturers and formulation developers can evaluate Dotinurad API based on chemical identity, purity, analytical documentation, regulatory requirements and applicable quality standards.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |