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Dotinurad versus allopurinol for lowering uric acid in gout

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout

Phase 3 Interventional Crystalys Therapeutics · NCT07089875

This trial tests whether dotinurad lowers blood uric acid more than allopurinol in adults with gout.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorCrystalys Therapeutics Industry-sponsored
Locations100 sites (Birmingham, Alabama and 99 other locations)
Trial IDNCT07089875 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares dotinurad and allopurinol in adults with gout and persistent hyperuricemia, with the main outcome being serum uric acid (sUA) level at Week 24. Participants must have had gout for at least one year, at least two flares in the prior 12 months, sUA ≥6.5 mg/dL, and be on a stable allopurinol dose for at least three months before enrollment. Enrolled adults receive either dotinurad or allopurinol and undergo scheduled visits and sUA measurements through Week 24 to compare urate-lowering effects. The trial is conducted at clinical sites in Alabama and Arizona.

Who should consider this trial

Good fit: Adults 18–75 years old with gout for at least one year, at least two gout flares in the past 12 months, sUA ≥6.5 mg/dL, and who have been on a stable allopurinol dose (≥300 mg/day or 200 mg/day for moderate renal impairment) for ≥3 months are ideal candidates.

Not a fit: People whose uric acid is already controlled below 6.5 mg/dL, who have had fewer than two flares in the past year, or who fall outside the 18–75 age range are unlikely to be eligible or to benefit from this comparison.

Why it matters

Potential benefit: If successful, dotinurad could provide a more effective oral option to lower uric acid for people with gout who have continued hyperuricemia.

How similar studies have performed: Earlier phase studies of dotinurad have shown it can lower serum uric acid, but head-to-head phase 3 comparisons against allopurinol have been limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year.
3. Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records).
4. Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment) up to 600 mg/day for at least 3 months prior to Screening and remain on their dosing regimen until Day 1.
5. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
6. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
7. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of study drug.

Exclusion Criteria:

1. History of or presence of kidney stones within 1 year prior to Screening.
2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
3. Hypersensitivity or intolerance to dotinurad or to colchicine and nonsteroidal anti-inflammatory drugs.
4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
5. Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.
6. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.

Where this trial is running

Birmingham, Alabama and 99 other locations

+50 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GoutDotinuradAllopurinolHyperuricemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.