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New GERD drug aims to keep esophagus healed, but trial never started

NCT ID NCT07313774

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study was designed to see if a new drug called linaprazan glurate could keep the esophagus healed in people with GERD-related erosive esophagitis, compared to an existing drug (lansoprazole). Participants would have taken daily pills for up to 52 weeks and had regular camera exams of their throat. However, the trial was withdrawn before any participants were enrolled.

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.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 80 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: An individual who has participated in a preceding linaprazan glurate healing trial will be asked to participate in this maintenance trial if the following criteria apply: 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures. 2. The participant has a healed EE as assessed by central review of endoscopic examination either from the last regular visit in a preceding phase 3 healing trial OR from the Run-in Period to the present maintenance trial. 3. The participant is willing and able to comply with all aspects of the protocol (including endoscopies, tablet and capsule swallowing, electronic device \[e-device\] completion, etc.). Exclusion Criteria: An individual who has participated in a preceding linaprazan glurate phase 3 healing trial can be enrolled in this maintenance trial unless they meet any of the following exclusion criteria: 1. EE as graded from the endoscopy during the Run-in Period (only applicable for participants with previous endoscopy \>14 days before the last regular visit in the preceding healing trial). 2. Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett's esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture.\* \*Note: Participants with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate, unless history of dilatation within 3 months of the Run-in Period. 3. Significant noncompliance with protocol-specified procedures or treatment in the preceding healing trial as judged by the Investigator. 4. Adverse event (AE) resulting in premature discontinuation of IP in the preceding healing trial. 5. History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, neurological disease or disorder, or psychiatric diagnosis which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the trial results or the participant's ability to participate in the trial. The following examples are conditions that would exclude the participant from participating: 1. History of myocardial infarction/ acute coronary syndrome within 3 months prior to the M0 visit. 2. History of ventricular arrhythmia or implanted cardioverter defibrillator 3. Symptomatic congestive heart failure (New York Heart Association \[NYHA\] class 3-4) 4. Family history of/ diagnosis of hereditary arrhythmia syndrome

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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.

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