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New gout drug aims to beat allopurinol in major trial

NCT ID NCT07089875

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 medicine called dotinurad against the standard drug allopurinol for lowering uric acid in adults with gout. About 500 people who have had at least two gout flares in the past year will take either dotinurad or allopurinol for 24 weeks. The main goal is to see if dotinurad can lower uric acid levels below 6.0 mg/dL more effectively than allopurinol.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

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

Started

Aug 2025

Expected to finish

Nov 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. 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 as documented in the participant's medical history) 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 both 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.

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Conditions

The condition(s) this trial relates to.

gout Hyperuricemia

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

    96 sites in 3 countries. 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

  • Accellacare - Alcobendas

    RECRUITING

    Alcobendas, Madrid, 28100, Spain

  • Acclaim Clinical Research, Inc.

    RECRUITING

    San Diego, California, 92120, United States

  • Alabama Clinical Therapeutics

    WITHDRAWN

    Birmingham, Alabama, 35235, United States

  • Alliance Clinical Lewisville (Epic Clinical Research)

    RECRUITING

    Lewisville, Texas, 75057, United States

  • Altoona Center for Clinical Research

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Amicis Research Center - Balboa

    RECRUITING

    Northridge, California, 91324, United States

  • Anchor Medical Research, LLC

    RECRUITING

    Miami, Florida, 33176, United States

  • Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Arizona Arthritis & Rheumatology Associates (AARA) - Glendale

    RECRUITING

    Glendale, Arizona, 85306, United States

  • Arizona Arthritis & Rheumatology Associates (AARA) - Mesa

    RECRUITING

    Mesa, Arizona, 85110, United States

  • BTC Network - Encompass Clinical Research

    RECRUITING

    Spring Valley, California, 91978, United States

  • Best Quality Research

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Boeson Research - Great Falls

    RECRUITING

    Great Falls, Montana, 59405, United States

  • Bradenton Research Center

    RECRUITING

    Bradenton, Florida, 34205, United States

  • Carteret Medical Group LLC

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Centrum Medyczne Solumed

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-529, Poland

  • Charlottesville Medical Research

    RECRUITING

    Charlottesville, Virginia, 22911, United States

  • Chicago Clinical Research Institute, Inc. (CCRII)

    RECRUITING

    Chicago, Illinois, 60607, United States

  • ClinicMed Daniluk Nowak Spółka Komandytowa

    RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-879, Poland

  • Clinical Research Institute of Michigan - St. Clair Shores

    RECRUITING

    Saint Clair Shores, Michigan, 48081, United States

  • Clinical Research Trials of Florida

    RECRUITING

    Tampa, Florida, 33607, United States

  • Clinical Research of Center Florida

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Clínica Gaias Santiago

    RECRUITING

    Santiago de Compostela, La Coruña, 15706, Spain

  • Clínica NTDE - Nuevas Tecnologías en Diabetes y Endocrinología

    RECRUITING

    Seville, Sevilla, 46010, Spain

  • Coastal Carolina Research Center - Main

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Cohen Medical Centers

    RECRUITING

    Thousand Oaks, California, 91360-3967, United States

  • Complejo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, La Coruña, 15006, Spain

  • Conquest Research - Winter Park

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Curalta Clinical Trials

    RECRUITING

    Oradell, New Jersey, 07649, United States

  • D&H Pompano Research Center

    RECRUITING

    Pompano Beach, Florida, 33064, United States

  • DM Clinical Research - Detroit

    WITHDRAWN

    Southfield, Michigan, 48076, United States

  • DM Clinical Research - Tomball - Multiple Specialties

    RECRUITING

    Tomball, Texas, 77375, United States

  • Del Sol Research Management - Tucson East

    RECRUITING

    Tucson, Arizona, 85715, United States

  • DelRicht Research

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • DelRicht Research - Atlanta

    WITHDRAWN

    Atlanta, Georgia, 30329, United States

  • DelRicht Research - Hendersonville

    WITHDRAWN

    Hendersonville, Tennessee, 37075, United States

  • DelRicht Research - LCMC Health Urgent Care - Lakeview

    RECRUITING

    New Orleans, Louisiana, 70124, United States

  • DelRicht Research - Louisville (Derby City DPC)

    RECRUITING

    Louisville, Kentucky, 40205, United States

  • DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)

    WITHDRAWN

    Rockville, Maryland, 20852, United States

  • DelRicht Research - Prairieville

    RECRUITING

    Prairieville, Louisiana, 70769, United States

  • DelRicht Research - Town and Country

    RECRUITING

    Town and Country, Missouri, 63017, United States

  • DelRicht Research - Tulsa

    WITHDRAWN

    Tulsa, Oklahoma, 74133, United States

  • Delricht Research - Better Life Direct Primary Care

    WITHDRAWN

    Indianapolis, Indiana, 46202, United States

  • Delricht Research - Command Family Medicine

    WITHDRAWN

    Springfield, Missouri, 65807, United States

  • Delricht Research - Concierge And Direct Primary Care

    RECRUITING

    Overland Park, Kansas, 66223, United States

  • Delricht Research - Concierge Medicine Of Cincinnati

    WITHDRAWN

    Mason, Ohio, 45040, 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

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Dream Team Clinical Research

    WITHDRAWN

    Pomona, California, 91767, United States

  • ERG - Endeavor Clinical Trials

    RECRUITING

    San Antonio, Texas, 78240, United States

  • East Bay Rheumatology Medical Group

    RECRUITING

    San Leandro, California, 94578, United States

  • Ellipsis Research Group

    RECRUITING

    Brooklyn, New York, 11215, United States

  • Epic Medical Research - DeSoto

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

    RECRUITING

    Chicago, Illinois, 60640, United States

  • FutureMeds - Krakow

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • FutureMeds - Targówek

    RECRUITING

    Warsaw, Masovian Voivodeship, 03-291, Poland

  • FutureMeds - Wroclaw

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-673, Poland

  • FutureMeds Gdynia

    RECRUITING

    Gdynia, Pomeranian Voivodeship, 81-537, Poland

  • G&L Research

    RECRUITING

    Foley, Alabama, 36535, United States

  • Gateway Clinical Trials

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • Gershon Pain Specialists

    RECRUITING

    Virginia Beach, Virginia, 23454, United States

  • Health Awareness Inc

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Health Concepts

    RECRUITING

    Rapid City, South Dakota, 57702, United States

  • Healthcare Research Network

    WITHDRAWN

    Hazelwood, Missouri, 63042, United States

  • Healthcare Research Network - Tinley Park

    RECRUITING

    Flossmoor, Illinois, 60402, United States

  • Herco Medical and Research Center, Inc

    RECRUITING

    Coral Gables, Florida, 33134, United States

  • Hometown Urgent Care and Research - Dayton

    RECRUITING

    Dayton, Ohio, 45424, United States

  • Hospital Quirónsalud Infanta Luisa

    RECRUITING

    Seville, Sevilla, 41010, Spain

  • Hospital Universitario Infanta Leonor

    RECRUITING

    Madrid, Madrid, 28032, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Infinity Clinical Research

    RECRUITING

    Norco, California, 92860, United States

  • Innova Clinic

    RECRUITING

    Plońsk, Masovian Voivodeship, 09-100, Poland

  • Inter Clinic

    RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-077, Poland

  • Investigators Research Group

    RECRUITING

    Brownsburg, Indiana, 46112, United States

  • Las Vegas Clinical Trials

    RECRUITING

    North Las Vegas, Nevada, 89030, United States

  • Lone Star Arthritis & Rheumatology Associates - Denton

    RECRUITING

    Denton, Texas, 76205, United States

  • MD Medical Research - Oxon Hill

    RECRUITING

    Oxon Hill, Maryland, 20745, United States

  • Med-Progress Ośrodek Nowoczesnego Leczenia

    RECRUITING

    Wejherowo, Pomeranian Voivodeship, 84-200, Poland

  • MedVadis Research

    RECRUITING

    Waltham, Massachusetts, 02451, United States

  • MediSphere Medical Research Center, LLC

    RECRUITING

    Evansville, Indiana, 47714, United States

  • Medicover Integrated Clinical Services- MICS Centrum Medyczne Warszawa Chlodna

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-872, Poland

  • Medvin Clinical Research - Covina

    RECRUITING

    Covina, California, 91722, United States

  • Medvin Clinical Research - Tujunga

    RECRUITING

    Tujunga, California, 91042, United States

  • Michigan Medicine - University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109-5000, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • New Generation of Medical Research

    RECRUITING

    Hialeah, Florida, 32016, United States

  • Oakland Medical Center

    RECRUITING

    Troy, Michigan, 48085, United States

  • Omega Research DeBary

    RECRUITING

    Orlando, Florida, 32808, United States

  • Panax Clinical Research

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Pioneer Research Solutions

    RECRUITING

    Houston, Texas, 77099, United States

  • Premier Health Research

    RECRUITING

    Sparta, New Jersey, 07871, United States

  • Pro Familia - Katowice

    RECRUITING

    Katowice, Silesian Voivodeship, 40-122, Poland

  • Prolato Clinical Research Center

    RECRUITING

    Houston, Texas, 77027, United States

  • Prolato Clinical Research Center

    RECRUITING

    Sochaczew, Masovian Voivodeship, 96-500, Poland

  • R & H Clinical Research - Westborough Drive

    RECRUITING

    Katy, Texas, 77449, United States

  • Revive Research Institute - Sterling Heights

    RECRUITING

    Sterling Heights, Michigan, 48313, United States

  • SKYCRNG - Rophe Adult and Pediatric Medicine

    RECRUITING

    Decatur, Georgia, 30034, United States

  • Shelby Clinical Research, LLC - North Carolina

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Siena Research Network

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • Silmedic sp. z o.o.

    RECRUITING

    Katowice, Silesian Voivodeship, 40-282, Poland

  • Southland Arthritis and Osteoporosis Medical Center, Inc

    RECRUITING

    Menifee, California, 92586, United States

  • Southwest Rheumatology Research

    RECRUITING

    Mesquite, Texas, 75150, United States

  • Suburban Research Associates - West Chester Office

    WITHDRAWN

    West Chester, Pennsylvania, 19380, United States

  • Tandem Clinical Research - Metairie Clinic

    ACTIVE_NOT_RECRUITING

    Metairie, Louisiana, 70006, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Velocity Clinical Research - San Bernardino

    RECRUITING

    San Bernardino, California, 92408, United States

  • West Coast Research

    RECRUITING

    Dublin, California, 94568, United States

  • Zenos Clinical Research

    RECRUITING

    Dallas, Texas, 75230, United States

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