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New GERD drug FEXUCLUE shows promise for heartburn relief

NCT ID NCT05660122

Symptom relief Sponsor: Daewoong Pharmaceutical Co. LTD. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed study looked at whether FEXUCLUE (fexuprazan) tablets can improve heartburn and acid reflux symptoms in people with erosive gastroesophageal reflux disease (GERD). Over 2,800 adults took the medication for 4 to 8 weeks and reported their symptom changes. The goal was to see if the drug helps patients feel better day-to-day.

What this could mean

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

Active substance
Fexuprazan Hydrochloride (FEXUCLUE tablet)
What this could lead to
If successful, this could confirm that FEXUCLUE helps relieve heartburn and acid reflux symptoms in people with erosive GERD.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It also only looks at short-term symptom improvement, not long-term healing or prevention.

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.

Participants

2,852 people

The number who actually took part.

Started

Nov 2022

Finished

Aug 2025

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.

Who is studied

This observation research plan assumes the following. 1. level of signification, α=0.05 2. Distance from Mean to Limits = 0.067 3. Standard deviation of the amount of change at the time of two weeks compared to the baseline of the RDQ score = 1.66 As a result of calculating using PASS2020 based on the above assumptions, the number of study subjects required to conduct this study was 2,359. In consideration of the dropout rate of about 20% in the calculated results, we intend to recruit 3,000 study subjects.

Ages

19 to 75 years

Sex

Anyone

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. Adult men and women aged 19 to 75 years of age at the time of registration. 2. A patient with erosive gastroesophageal reflux disease who is scheduled to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization. 3. A person who voluntarily agrees to participate in this observation study and signed the informed consent form. Exclusion Criteria: 1. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet * Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof * Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations * Pregnant and lactating women * Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion 2. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices; 3. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

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

Gastroesophageal reflux disease

Contacts and locations

Locations

  • Samsung Medical Center

    Seoul, South Korea

More trials for these conditions

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