Dotinurad for Gout

Recruiting at 65 trial locations

Overseen By Clinical Trial Lead

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Crystalys Therapeutics

Must be taking: Allopurinol

Must not be taking: Colchicine, NSAIDs

Disqualifiers: Kidney stones, Malignancy, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 64 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called dotinurad for people with gout, a type of arthritis that causes painful joint flare-ups. Researchers aim to determine if dotinurad can lower uric acid levels in the blood more effectively than allopurinol, a common gout medication. Participants will either continue with allopurinol or switch to different doses of dotinurad for about a year. The trial seeks adults who have had gout for at least a year and have experienced two or more flare-ups in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment option.

Will I have to stop taking my current medications?

The trial requires that participants stay on their current allopurinol medication at a stable dose before and during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that dotinurad is effective and safe for individuals with high uric acid levels, regardless of gout presence. Research indicates it is well tolerated, with no new safety concerns identified. Some studies report that dotinurad has not caused serious side effects or drug-related issues at any dose. This suggests dotinurad is generally safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about dotinurad for treating gout because it offers a fresh approach compared to the standard of care, like allopurinol. Dotinurad stands out due to its novel mechanism of action; it works by selectively inhibiting URAT1, a transporter involved in uric acid reabsorption, which may lead to more effective uric acid reduction. This targeted action could potentially result in fewer side effects and better outcomes for patients. Additionally, dotinurad's dosing flexibility, with maintenance options at 2 mg or 4 mg, allows for tailored treatment to meet individual patient needs.

What evidence suggests that this trial's treatments could be effective for gout?

Research has shown that dotinurad effectively lowers uric acid levels in people with gout by targeting a specific protein in the kidneys that reduces uric acid in the blood. In this trial, participants will receive either dotinurad or allopurinol. Studies have found that dotinurad is as effective as other common treatments, like febuxostat, in controlling uric acid levels. Specifically, one study found that about 55.5% of patients taking dotinurad reached a healthy uric acid level in 12 weeks. This suggests that dotinurad could be a promising option for managing gout symptoms. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with high levels of uric acid in their blood (hyperuricemia) associated with gout. Specific details about who can join or reasons why someone might not be allowed to participate are not provided.

Inclusion Criteria

sUA level ≥6.5 mg/dL at Screening Visit 1 and Screening Visit 2

I have had 2 or more gout attacks in the last year.

I am between 18 and 75 years old.

Exclusion Criteria

Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening

I have not had kidney stones in the past year.

I have not had any cancer in the last 5 years, except for skin cancer that was treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dotinurad or allopurinol for up to 64 weeks

64 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Allopurinol
• Dotinurad

Trial Overview The study aims to compare the effectiveness of a new medication called Dotinurad with Allopurinol, which is commonly used to lower serum uric acid in gout patients. The comparison will be made after 24 weeks of treatment.

How Is the Trial Designed?

Group I: Dotinurad 4 mg Maintenance Experimental Treatment 1 Intervention

Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4), dotinurad 2 mg QD for the next 8 weeks (Weeks 5-12), and dotinurad 4 mg QD thereafter through Week 64.

Group II: Dotinurad 2 mg Maintenance Experimental Treatment 1 Intervention

Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4) and then dotinurad 2 mg QD through Week 64.

Group III: Allopurinol Active Control 1 Intervention

Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 64.

Who Is Running the Clinical Trial?

Crystalys Therapeutics

Lead Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31792640/

Clinical efficacy and safety of dotinurad, a novel selective ... Dotinurad, a novel selective urate reabsorption inhibitor (SURI), reduces serum uric acid levels by selectively inhibiting urate transporter 1 (URAT1)

2. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.43261

Efficacy and Safety of Dotinurad Versus Febuxostat for the ... In phase 3 studies in Japan, dotinurad led to a reduction in serum urate levels in patients with hyperuricemia and gout and was noninferior to ...

3. eisai.com eisai.com/news/2025/news202546.html

“URECE®” (Dotinurad) Launched in China as a treatment ... For the secondary endpoint, the proportion of patients with SUA ≤6.0 mg/dL at 12 weeks was 55.5% in the dotinurad group and 50.5% in the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05007392

NCT05007392 | A Study to Evaluate Efficacy of Dotinurad ... The primary purpose of the study is to confirm the efficacy of dotinurad 4 milligram (mg) to febuxostat 40 mg on the percentage of participants achieving a ...

5. cureus.com cureus.com/articles/56342-efficacy-and-safety-of-dotinurad-in-hyperuricemic-patients-with-or-without-gout-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials

Efficacy and Safety of Dotinurad in Hyperuricemic Patients ... Dotinurad shows significant improvement in serum uric acid levels in hyperuricemic individuals with or without gout. Its urate-lowering effect ...

6. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2022.1042061/full

Efficacy and safety of switching from febuxostat to ... The primary outcome is the achievement rate of serum urate levels of ≤6 mg/dL after 24 weeks of treatment with dotinurad at 0.5 mg to a maximum ...

7. uricatherapeutics.com uricatherapeutics.com/urica-therapeutics-announces-topline-data-from-the-phase-1-clinical-trial-evaluating-dotinurad-in-healthy-volunteers-in-the-united-states/

Urica Therapeutics Announces Topline Data from the ... Dotinurad was shown to be safe and well tolerated with no severe adverse events observed at any dose level. No drug-related adverse events were ...