Dotinurad Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Dotinurad comprises 1 peer-reviewed publications across 1 journals, 1 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including . Most recent publication: A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults., Clin Drug Investig, 2025.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults.
    Liu Y, Chen Q, Sun H, et al. · Clin Drug Investig · 2025

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT05007392GoutPercentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)
At Week 24
Dotinurad73.6 percentage of participants
Febuxostat38.1 percentage of participants

Publications by year

20252025: 1 publications.

2025
1

Publications by journal

Trial-results highlights

In the pivotal trial for gout, NCT05007392, the primary outcome measured the percentage of participants who achieved a serum uric acid (SUA) level of 6.0 mg/dL or less at Week 24.

In the NCT05007392 study, the dotinurad arm reported that 73.6% of participants reached an SUA level of 6.0 mg/dL or less at Week 24. The febuxostat arm in the same study reported that 38.1% of participants achieved an SUA level of 6.0 mg/dL or less at Week 24.

All values presented are sourced from primary registry reporting. Individual papers should be consulted for clinical decisions.

All Dotinurad publications (1)

2025 (1 paper)

  1. A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults.
    Liu Y, Chen Q, Sun H, et al. · Clin Drug Investig · 2025 · Derived

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).