Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for gout sufferers: drug dotinurad targets high uric acid

NCT ID NCT07535034

Disease control Sponsor: Crystalys Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests a new drug called dotinurad in 90 adults with gout who cannot take common medications like allopurinol or have not responded to other treatments. The goal is to see if dotinurad can safely lower uric acid levels over 24 weeks. Participants are randomly assigned to receive either the drug or a placebo, and neither they nor their doctors will know which they receive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dotinurad (a drug taken orally to lower uric acid levels)
What this could lead to
If successful, dotinurad could offer a new treatment option for people with gout who cannot tolerate standard medications or for whom other treatments have failed.
What could go wrong
This is an early Phase 2 trial with only 90 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 and has at least 1 of the following: * History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat. * Failed uricase treatment (eg, an sUA level \>6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment). 3. sUA level \>6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit). 4. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding. 5. 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 trial 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. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse. 4. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening. 5. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Gout are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gout

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amarillo Premier Research

    RECRUITING

    Amarillo, Texas, 79124, United States

  • Amicis Research Center

    RECRUITING

    Granada Hills, California, 91344, United States

  • Anchor Medical Research

    RECRUITING

    Miami, Florida, 33176, United States

  • Clinical Research Institute of Michigan

    RECRUITING

    Saint Clair Shores, Michigan, 48081, United States

  • Clinical Research of Central Florida

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Cohen Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • D&H Pompano Research Center, LLC

    RECRUITING

    Margate, Florida, 33063, United States

  • DJL Clinical Research

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • DM Clinical Research

    RECRUITING

    Tomball, Texas, 77375, United States

  • Denver Arthritis Clinic - Lowry

    RECRUITING

    Denver, Colorado, 80230, United States

  • Digestive Health Research of North Texas

    RECRUITING

    Wichita Falls, Texas, 76301, United States

  • Discovery Clinical Trials, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Drug Trials America

    RECRUITING

    Hartsdale, New York, 10530, United States

  • Ellipsis Research Group

    RECRUITING

    Brooklyn, New York, 11215, United States

  • Epic Medical Research

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Great Lakes Clinical Trials

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Health Awareness, Inc.

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Herco Medical and Research Center, Inc

    RECRUITING

    Flagami, Florida, 33126, United States

  • Hometown Urgent Care and Research

    RECRUITING

    Dayton, Ohio, 45424, United States

  • Las Vegas Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89030, United States

  • MD Medical Research

    RECRUITING

    Oxon Hill, Maryland, 20745, United States

  • New Generation of Medical Research

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Oakland Medical Research Center

    RECRUITING

    Troy, Michigan, 48085, United States

  • Omega Research Group

    RECRUITING

    DeBary, Florida, 32713, United States

  • Panax Clinical Research

    RECRUITING

    Miami, Florida, 33014, United States

  • Pioneer Research Solutions

    RECRUITING

    Houston, Texas, 77479, United States

  • Premier Health Research

    RECRUITING

    Sparta, New Jersey, 07871, United States

  • R&H Clinical Research - Westborough Drive

    RECRUITING

    Katy, Texas, 77449, United States

  • Research Group of Lexington, LLC

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Revival Research Institute

    RECRUITING

    Sterling Heights, Michigan, 48313, United States

  • Shelby Clinical Research

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Solace Clinical Research

    RECRUITING

    Tustin, California, 92780, United States

  • Southwest Atlanta Internal Medicine

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Southwest Rheumatology Research

    RECRUITING

    Mesquite, Texas, 75150, United States

  • The Kirklin Clinic of UAB Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Velocity Clinical Research

    RECRUITING

    Norfolk, Nebraska, 68701, United States

  • Velocity Clinical Research (Impact Research Institute)

    RECRUITING

    Waco, Texas, 76710, United States

  • Zenos Clinical Research

    RECRUITING

    Dallas, Texas, 75230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.