Dotinurad is under clinical development by Fortress Biotech and currently in Phase I for Chronic Kidney Disease (Chronic Renal Failure). According to GlobalData, Phase I drugs for Chronic Kidney Disease (Chronic Renal Failure) have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Dotinurad’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Dotinurad overview

Dotinurad (Urece) acts as urate re-absorption agent. It is formulated as tablets for oral route of administration. Urece is indicated for the treatment of gout and hyperuricemia.

Dotinurad (FYU-981) is under development for the treatment of gout and chronic kidney disease. It is administered through oral route as tablet.

Fortress Biotech overview

Fortress Biotech, formerly Coronado Biosciences, identifies, acquires, develops, and commercializes marketed pharmaceuticals and development-stage pharmaceutical product candidates. The company provides business, scientific, regulatory, and legal support for advancing the products or product candidates of its partner firms. It is a marketing partner for various branded drugs indicated for the treatment of radiation dermatitis, severe acne, athlete’s foot, inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, and other skin infections. Fortress Biotech is headquartered in New York, the US.

For a complete picture of Dotinurad’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.