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New GERD drug fexuprazan tested against standard treatment in 145 patients

NCT ID NCT07326904

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This study tested whether fexuprazan, a new drug, can relieve heartburn and acid reflux as well as the commonly used esomeprazole. 145 adults with GERD took either fexuprazan or esomeprazole once daily for 4 weeks, with an option to continue for another 4 weeks if symptoms didn't improve. Researchers measured symptom relief using a standard questionnaire and monitored safety.

What this could mean

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

Active substance
fexuprazan
What this could lead to
If fexuprazan works as well as esomeprazole, it could offer another treatment option for people with GERD to ease heartburn and acid reflux.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. It only included 145 adults aged 18-60, so findings may not apply to older people or those with severe GERD.

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

145 people

The number who actually took part.

Started

Aug 2024

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 60 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: * Adults aged 18 to 60 years at the time of providing written informed consent * Male or female participants * History of gastroesophageal reflux disease (GERD) symptoms, including heartburn and/or acid regurgitation * GERD symptoms confirmed by: * GERD-Q score greater than 7, and * Heartburn and/or acid regurgitation occurring on more than 3 days within the last 7 days * Able to understand the study procedures and complete questionnaires and a daily symptom diary * Willing and able to provide written informed consent Exclusion Criteria: Gastrointestinal conditions: * Diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis), primary esophageal motility disorders, or pancreatitis * History of gastric or esophageal surgery affecting acid secretion (except appendectomy, cholecystectomy, or endoscopic polypectomy of benign polyps) * Alarm symptoms suggestive of gastrointestinal malignancy (e.g., severe dysphagia, odynophagia, gastrointestinal bleeding, anemia, unexplained weight loss), unless malignancy was ruled out Medical history * Clinically significant hepatic, renal, endocrine, hematologic, oncologic, or urinary system disease * History of malignancy within the past 5 years (except non-digestive malignancies that were completely treated with no recurrence for ≥5 years) * History of psychosis, substance abuse, or alcohol abuse * Known HIV infection, active hepatitis B, or hepatitis C infection (HCV RNA-positive) Medication and treatment * Use of prohibited concomitant medications within 2 weeks prior to enrollment or need for continuous prohibited medication during the study, including: * Proton pump inhibitors, potassium-competitive acid blockers, H2-receptor antagonists, or other acid-suppressive agents * Certain psychotropic drugs, anticholinergic drugs, antispasmodics, systemic steroids, or mucoprotective agents * Use of another investigational product within 4 weeks prior to study drug administration Laboratory findings * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin ≥2 times the upper limit of normal * Serum creatinine or blood urea nitrogen ≥2 times the upper limit of normal Reproductive status * Pregnant or breastfeeding women * Women of childbearing potential or male participants who were unwilling to use appropriate contraception during the study Other * Known hypersensitivity to the investigational product or comparator drug * Any condition that, in the opinion of the investigator, made the participant unsuitable for study participation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Menteng Mitra Afia Jakarta Hospital

    Jakarta Pusat, DKI Jakarta, 10340, Indonesia

  • RS Islam Jakarta Cempaka Putih

    Jakarta Pusat, DKI Jakarta, 10510, Indonesia

  • RS Universitas Indonesia

    Depok, West Java, 16424, Indonesia

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