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LINAPRAZAN GLURATE

Clinical trials are investigating LINAPRAZAN GLURATE in people with erosive esophagitis caused by gastroesophageal reflux disease (GERD). These studies look at how well it works, how safe it is, and how it compares with lansoprazole in adults with active or healed disease.

Table of contents

Trial overview

Two Phase 3 studies are investigating LINAPRAZAN GLURATE in people with erosive esophagitis due to gastroesophageal reflux disease (GERD).[1][2] Both are interventional trials, which means the researchers give study treatment and then measure the results.[1][2]

The first study is authorised and includes about 500 participants.[1] The second study is completed and included 104 participants.[2]

Study 1: healing of active erosive esophagitis

This randomized, multicenter Phase 3 study is designed to confirm the clinical efficacy of LINAPRAZAN GLURATE compared with lansoprazole in participants with erosive esophagitis due to GERD.[1] Randomized means participants are assigned by chance to different study groups, and multicenter means the study is run at more than one site.[1]

The main goal is to confirm superiority of LINAPRAZAN GLURATE 50 mg twice daily compared with lansoprazole for healing erosive esophagitis after 4 weeks of double-blind treatment.[1] Double-blind means neither the participants nor the study staff know which treatment a person receives during the treatment period.[1]

The primary outcome is healing of erosive esophagitis at Week 4, measured by endoscopy in participants who had LA grade C/D disease at baseline.[1] LA grades C/D describe more severe erosive esophagitis.[1]

Study 2: maintenance of healed erosive esophagitis

This randomized, multicenter Phase 3 trial studies participants with healed erosive esophagitis due to GERD and compares LINAPRAZAN GLURATE with lansoprazole for maintenance treatment.[2] The study also evaluates safety, meaning it looks at how well participants tolerate the treatment during the study period.[2]

The main goal is to confirm non-inferiority of the high-dose LINAPRAZAN GLURATE group compared with lansoprazole for keeping erosive esophagitis healed after 24 weeks.[2] Non-inferiority means the study checks whether LINAPRAZAN GLURATE is not meaningfully worse than the comparison treatment.[2]

The primary outcome is maintained healing of erosive esophagitis after 24 weeks, assessed by central reading of endoscopy.[2]

Who can participate

These studies are for people with erosive esophagitis due to GERD.[1][2] The first trial focuses on participants with active disease, especially those with LA grade C/D at baseline, while the second trial includes participants whose erosive esophagitis has already healed.[1][2]

  • Active disease group: people with erosive esophagitis that still needs healing, including those with more severe LA grade C/D disease at the start of the study.[1]

  • Healed disease group: people whose erosive esophagitis has healed and who are being studied to see whether healing stays in place over time.[2]

Endpoints and assessments

An endpoint is the main result the researchers measure to judge whether the treatment works.[1][2] In these studies, the key endpoint is based on endoscopy findings, which allow doctors to look directly at the esophagus and see whether healing has happened or stayed in place.[1][2]

  • Week 4 healing: the first trial checks whether erosive esophagitis has healed after 4 weeks in people with baseline LA grade C/D disease.[1]

  • 24-week maintenance: the second trial checks whether healing is still present after 24 weeks of treatment.[2]

What the results mean

Together, these trials are testing LINAPRAZAN GLURATE in two important settings: first, to help heal active erosive esophagitis, and second, to keep healed disease from returning.[1][2] The studies compare it with lansoprazole, which helps researchers understand whether LINAPRAZAN GLURATE may offer similar or better results in these patient groups.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-518714-31-00 Phase 3 Erosive esophagitis due to GERD Authorised 500
2025-522750-39-00 Phase 3 Healed erosive esophagitis due to GERD Completed 104

FAQ

  • What is being studied in LINAPRAZAN GLURATE trials? The trials study whether LINAPRAZAN GLURATE can help heal erosive esophagitis and keep it healed in people with GERD. They also compare it with lansoprazole.
  • Who can take part in these trials? The studies include adults with erosive esophagitis due to GERD. One trial focuses on people with active, more severe disease, and the other includes people whose erosive esophagitis has already healed.
  • What phases are the LINAPRAZAN GLURATE trials? Both studies are Phase 3 trials. Phase 3 means they test the treatment in larger groups to confirm benefit and safety.
  • What conditions are these trials targeting? Both trials target erosive esophagitis, which is inflammation and damage in the food pipe, caused by GERD. One trial studies healing, and the other studies maintenance of healing.
  • What outcomes are measured in these studies? One trial measures healing at Week 4 by endoscopy, especially in people with more severe baseline disease. The other measures whether healing is maintained after 24 weeks using central reading of endoscopy.

Ongoing Clinical Trials on LINAPRAZAN GLURATE

  • Comparison of linaprazan glurate versus lansoprazole for healing of erosive esophagitis in adults with gastroesophageal reflux disease

    Recruiting

    3 1 1
    Investigated drugs:
    Bulgaria Czechia Germany Hungary Poland Romania

  • Study of linaprazan glurate and lansoprazole to maintain healing in patients with erosive esophagitis caused by acid reflux disease

    Not recruiting

    3 1 1
    Investigated drugs:
    Bulgaria Czechia Germany Hungary Poland Romania

Glossary

  • Erosive esophagitis (EE): Damage and inflammation in the lining of the esophagus, the tube that carries food from the mouth to the stomach.
  • Gastroesophageal reflux disease (GERD): A long-term condition where stomach contents flow back into the esophagus and can cause symptoms and injury.
  • Healing: In these trials, this means the damaged esophagus has improved on endoscopy.
  • Maintenance of healing: Keeping the esophagus healed over time after it has improved.
  • Endoscopy: A test that uses a thin camera to look inside the esophagus and stomach.
  • Central reading: A review of test results by a central team to help make the assessment more consistent.
  • LA grades C/D: A grading system for erosive esophagitis; C and D are more severe forms.
  • Non-inferiority: A study goal that checks whether one treatment is not worse than another by more than a set amount.
  • Superiority: A study goal that checks whether one treatment works better than another.
  • Phase 3: A later stage of clinical research that usually includes larger numbers of participants.

References

  1. https://clinicaltrials.gov/study/2024-518714-31-00
  2. https://clinicaltrials.gov/study/2025-522750-39-00