Trial reportClinical and experimental nephrology2020
Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study.
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 NCT02416167 (Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout), which is not on this map. Cited by 18 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.
Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)
Who cites it
18 citing papers in PubMed, 28 citations in OpenAlex.
- Dotinurad: a clinical pharmacokinetic study of a novel, selective urate reabsorption inhibitor in subjects with hepatic impairment.Clinical and experimental nephrology · 2020Trial
- Redefining Uric Acid and Cardiovascular Risk: Vascular Gout and Crystal-Driven Vascular Inflammation in Asymptomatic Hyperuricemia.JACC. Asia · 2026Review
- Exploratory Mediation-Informed Analysis and Dose-Response Analysis of Uric Acid Reduction and Kidney Outcomes in SGLT2 Inhibitor Therapy Compared to Allopurinol.Medical sciences (Basel, Switzerland) · 2026Article
- Effect of dotinurad versus febuxostat on the one-year eGFR slope in CKD patients with hyperuricemia: a retrospective cohort study.BMC nephrology · 2026Article
- Efficacy and Safety of Dotinurad in Patients with Advanced Chronic Kidney Disease.Internal medicine (Tokyo, Japan) · 2026Observational
- Changes in uric acid levels and estimated glomerular filtration rate slope after treatment with dotinurad in patients with hyperuricemia.BMC nephrology · 2026Observational
- From soluble uric acid to sodium urate crystal: immune metabolic inflammation driven by uric acid morphological transformation and mechanism-oriented therapy.Frontiers in immunology · 2026Review
- Enhancing therapeutic strategies and drug development for patients with kidney disease.Expert opinion on drug safety · 2026Review
- A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults.Clinical drug investigation · 2025Article
- Synthetic strategies towards benzothiazole-based compounds of therapeutic potency: experimental, investigational and approved drugs.RSC advances · 2025Review
- Hyperuricemia in Chronic Kidney Disease: Emerging Pathophysiology and a Novel Therapeutic Strategy.International journal of molecular sciences · 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
- Seasonal variations for newly prescribed urate-lowering drugs for asymptomatic hyperuricemia and gout in Japan.Frontiers in pharmacology · 2024Article
- A historical journey of searching for uricosuric drugs.Clinical rheumatology · 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
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDotinurad, a novel selective urate reabsorption inhibitor (SURI), reduces serum uric acid levels by selectively inhibiting urate transporter 1 (URAT1) for the treatment of hyperuricemia with or without gout. We confirmed the serum uric acid lowering effect and safety of dotinurad.
methodsThis was a confirmatory, 12-week, randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose escalation, late phase 2 study. The study arms were dotinurad 0.5, 1, 2, or 4 mg and placebo. The primary endpoint was the percent change in serum uric acid level from the baseline to the final visit. The secondary endpoint was the percentage of patients achieving a serum uric acid level ≤ 6.0 mg/dL at the final visit.
resultsThe study drugs were administered to 200 Japanese hyperuricemic patients with or without gout. The mean percent change in serum uric acid level from the baseline to the final visit in the dotinurad 0.5, 1, 2, and 4 mg groups and the placebo group was 21.81%, 33.77%, 42.66%, 61.09%, and - 2.83%, respectively. The percentage of patients achieving a serum uric acid level ≤ 6.0 mg/dL at the final visit in each group was 23.1%, 65.9%, 74.4%, 100%, and none, respectively. Regarding safety, the incidence of adverse events did not increase with dose escalation in the dotinurad groups. No significant differences were observed in the incidence of gouty arthritis in each group.
conclusionThe serum uric acid lowering effect and safety of dotinurad were confirmed in hyperuricemic patients with or without gout. CLINICALTRIALS. GOV IDENTIFIER: NCT02416167.
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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.