Drug Profile

Dotinurad - Fuji Yakuhin/Mochida Pharmaceutical

Alternative Names: FYU-981; URECE; Urece; Yurisu

Latest Information Update: 03 Nov 2025

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At a glance

Originator Fuji Yakuhin
Developer Crystalys Therapeutics; Eisai Co Ltd; Fuji Yakuhin; Mochida Pharmaceutical
Class Antigouts; Benzothiazoles; Small molecules; Uricosurics
Mechanism of Action SLC22A12 protein inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Highest Development Phases

Marketed Gout; Hyperuricaemia

Most Recent Events

21 Oct 2025 Crystalys Therapeutics plans regulatory submissions and commercialization of Dotinurad for Gout in Europe
01 Oct 2025 Crystalys Therapeutics plans regulatory submissions and commercialization of Dotinurad for Gout in USA
13 Aug 2025 Phase-III clinical trials in Gout in USA (PO) (NCT07089875)

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