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New gout drug epaminurad faces off against standard treatment in major trial

NCT ID NCT05815901

Disease control Sponsor: JW Pharmaceutical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a new drug called epaminurad against the standard gout medication febuxostat in 612 adults with gout. The goal was to see if epaminurad could lower uric acid levels more effectively and safely. The study is complete, but results are not yet available.

What this could mean

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

Active substance
Epaminurad (a drug that lowers uric acid)
What this could lead to
If epaminurad works better than febuxostat, it could offer a new treatment option to control gout by lowering uric acid levels.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Epaminurad may not be more effective or safer than existing drugs, and side effects are possible.

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

612 people

The number who actually took part.

Started

Mar 2023

Finished

Apr 2026

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

19 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: * for screening 1. ≥19 to ≤75 years of age at the time of written informed consent 2. Diagnosed record with gout, or ACR/EULAR 2015 score ≥8 3. Able and willing to actively participate in TLC programme 4. Signed ICF for voluntary study participation * for randomization 1. sUA level ≥7.0 mg/dL 2. ACR/EULAR 2015 score ≥8 Exclusion Criteria: 1. Medical history Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient. 2. Concurrent disease or laboratory test abnormality Uncontrolled diabetes mellitus, Uncontrolled hypertension, Uncontrolled dyslipidemia, AST or ALT ≥2×ULN, total bilirubin ≥1.5×ULN, eGFR \<30 mL/min/1.73m\^2, Uncontrolled thyroid dysfunction, HIV, HBV or HCV positive, Drug and alcohol abuse, BMI ≥40 kg/m\^2 3. History of gout flare between 2 weeks before written informed consent and immediately before randomization 4. Any cardiovascular abnormalities that might affect the study 5. Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents 6. Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics 7. Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline 8. Hypersensitivity to the IP (epaminurad or febuxostat) 9. Pregnant or lactating woman.

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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

Contacts and locations

Locations

  • Inha University Hospital

    Incheon, South Korea

More trials for these conditions

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