Trial reportClinical and experimental nephrology2020
Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout.
Trial report in Clinical and experimental nephrology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03006445 (Official Title), which is not on this map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)
Who cites it
19 citing papers in PubMed, 42 citations in OpenAlex.
- Efficacy and Safety of Dotinurad Versus Febuxostat for the Treatment of Gout: A Randomized, Multicenter, Double-Blind, Phase 3 Trial in China.Arthritis & rheumatology (Hoboken, N.J.) · 2025Trial
- Changes in urinary albumin levels with dotinurad oral administration in hyperuricemic patients with microalbuminuria: a post hoc analysis.Clinical and experimental nephrology · 2025Trial
- Real-World Effectiveness and Safety of Dotinurad in Chinese Patients with Gout: A Comparative Analysis.Drugs - real world outcomes · 2026Article
- Safety profiles of two XOD and two URAT1 inhibitors in hyperuricemic patients: a real-world pharmacovigilance analysis based on the FAERS and JADER databases.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Efficacy and Safety of Dotinurad in Patients with Advanced Chronic Kidney Disease.Internal medicine (Tokyo, Japan) · 2026Observational
- URAT1 inhibition in hyperuricemia and gout: from transporter biology to clinical precision therapy.Frontiers in immunology · 2026Review
- A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults.Clinical drug investigation · 2025Article
- Dotinurad Treatment for Patients With Hyperuricemia Complicating CKD.Kidney international reports · 2025Article
- Molecular mechanisms of urate transport by the native human URAT1 and its inhibition by anti-gout drugs.Cell discovery · 2025Article
- Drug-Induced Hypouricemia.Drug safety · 2025Review
- Switching from febuxostat to dotinurad, a novel selective urate reabsorption inhibitor, may substantially reduce serum urate levels, through URAT1 inhibition, potentially without adversely affecting ABCG2 function: findings from the SWITCH SURI study.Frontiers in endocrinology · 2025Article
- Article
- Pipeline Therapies for Gout.Current rheumatology reports · 2024Review
- Emerging Urate-Lowering Drugs and Pharmacologic Treatment Strategies for Gout: A Narrative Review.Drugs · 2023Review
- Clinical effects of a selective urate reabsorption inhibitor dotinurad in patients with hyperuricemia and treated hypertension: a multicenter, prospective, exploratory study (DIANA).European journal of medical research · 2023Article
- Genetic Basis of the Epidemiological Features and Clinical Significance of Renal Hypouricemia.Biomedicines · 2022Review
- Efficacy and safety of switching from febuxostat to dotinurad, a novel selective urate reabsorption inhibitor, in hyperuricemic patients with type 2 diabetic kidney disease: Protocol for a single-arm, open-label, prospective, exploratory study.Frontiers in endocrinology · 2022Article
- Comparative study of a novel selective urate reabsorption inhibitor "dotinurad" among patient groups with different stages of renal dysfunction.Clinical and experimental nephrology · 2021Article
- Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDotinurad is a novel selective urate reabsorption inhibitor (SURI) which reduces serum uric acid levels by selectively inhibiting urate transporter 1 (URAT1). This study was intended to verify the efficacy and safety of dotinurad following treatment for 34 or 58 weeks in hyperuricemic patients with or without gout.
methodsThis long-term study had an open-label design with dose escalation. The dose of dotinurad started at 0.5 mg/day and was increased progressively to 2 mg/day. If the serum uric acid level of patients did not reach ≤ 6 mg/dL at week 14, the dose was increased to 4 mg/day. The primary endpoint was the percent change in serum uric acid level from the baseline to each visit.
resultsAt a dose of 2 mg, serum uric acid levels at week 34 and 58 were reduced from the baseline by 46.73% and 47.17%, respectively; at 4 mg, the respective values were 54.92% and 57.35%. At week 34 and 58, the percentages of patients achieving a serum uric acid levels ≤ 6.0 mg/dL with 2-mg dose were 89.11% and 91.30%, respectively; with 4 mg, the respective rates were 97.50% and 100.00%. In addition, the incidences of adverse events and adverse drug reactions were 65.2% and 21.8%, respectively.
conclusionDotinurad at doses of 2-4-mg sufficiently reduced serum uric acid levels in hyperuricemic patients with or without gout, and its efficacy and safety were verified for long-term administration. ClinicalTrials.gov Identifier: NCT03006445.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.