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New GERD drug shows promise in major trial

NCT ID NCT07037875

Disease control Sponsor: Cinclus Pharma Holding AB 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Updated 2 times

Summary

This study tests a new medication, linaprazan glurate, to see if it heals esophagus damage from acid reflux better than a standard drug. About 500 adults with erosive esophagitis will take either the new drug or lansoprazole daily for up to 8 weeks. Doctors will use cameras to check healing and track symptoms.

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

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2026

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: 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any study-related assessments/procedures. 2. Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF. 3. The participant is willing and able to comply with all aspects of the protocol (including endoscopies, PK sampling, tablet and capsule swallowing, electronic device \[e-device\] completion, etc.). 4. The participant has endoscopically confirmed EE due to GERD of LA grades A to D during the Screening Period as assessed in Central Review by an Independent Review Committee (IRC). Exclusion Criteria: 1. Ongoing infection with HP or diagnosis and treatment of HP infection within 6 weeks of randomization OR any treatment with antibiotics or bismuth containing drugs within 6 weeks of randomization. 2. 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 study, or influence the study results or the participant's ability to participate in the study. The following examples are conditions that would exclude the patient from participating: 1. History of myocardial infarction/acute coronary syndrome within 3 months prior to Screening. 2. History of ventricular arrhythmia or implanted cardioverter defibrillator. 3. Symptomatic congestive heart failure (New York Heart Association class 3-4). 4. Family history of/diagnosis of hereditary arrhythmia syndrome. 5. History of adult asthma that required intensive treatment in an emergency room. 3. History of malignancy of any organ system (other than completely treated localized basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or in situ cervical carcinoma), within the past 5 years. 4. 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\*; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma. \*Note: Patients 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 Screening. 5. History of any surgical or medical condition which might significantly alter the GERD status or the absorption, distribution, metabolism, or excretion of drugs. The Investigator is to be guided by evidence of any of the following: history of major GI surgery such as gastrectomy, gastroenterostomy, any bariatric surgery, bowel resection, or transjugular intrahepatic portosystemic shunt. Nissen fundoplication is not exclusionary as long as the patient is eligible according to other criteria. 6. Known severe atrophic gastritis as assessed from medical history or upper endoscopy during Screening. 7. Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions. 8. History of treatment course with lansoprazole within 2 months prior to Screening. 9. Current peptic ulcer. 10. Body mass index (BMI) ≤ 18 and ≥ 40 kg/m² at Screening.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease peptic esophagitis

As listed by the trial registrant

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

GERD (gastroesophageal reflux disease)

Contacts and locations

Locations

  • "MEDIS" Medical Center

    Bydgoszcz, 85-229, Poland

  • "Vita Longa" Non-Public Healthcare Facility, Limited Liability Company

    Katowice, 40-748, Poland

  • 20th Diagnostic Consultancy Center

    Sofia, Sofia City Province, 1618, Bulgaria

  • Bekes County Central Hospital Dr. Rethy Pal Member Hospital, 4th Department of Internal Medicine - Gastroenterology - Hepatology

    Békéscsaba, H-5600, Hungary

  • CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

    Bydgoszcz, 85-794, Poland

  • Central Hospital of Northern Pest - Military Hospital, Department of Gastroenterology

    Budapest, H-1062, Hungary

  • Clinexpert Ltd. Budapest

    Budapest, H-1033, Hungary

  • Clinic for Internal Medicine Munich-Sued

    Munich, Bavaria, 81379, Germany

  • Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje"

    Belgrade, 11000, Serbia

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080, Serbia

  • Cluj Napoca County Emergency Clinical Hospital, Internal Medicine III

    Cluj-Napoca, 400006, Romania

  • Colentina Clinical Hospital, Department of Gastroenterology

    Bucharest, 020125, Romania

  • Diagnosis - Consulting Centre 1

    Sliven, Sliven, Bulgaria

  • Diagnostic Consultative Center - Focus-5

    Sofia, Sofia City Province, 1463, Bulgaria

  • Diagnostic and Consulting Center Alexandrovska

    Sofia, Sofia City Province, 1431, Bulgaria

  • Diakonie Hospital

    Mannheim, Baden-Wurttemberg, 68163, Germany

  • EMC Medical Institute Joint Stock Company, CERTUS Private Healthcare Facility Hospital No. 1, CERTUS Private Healthcare Facility Ambulatories

    Poznan, 60-309, Poland

  • ETG Warszawa

    Warsaw, 02-677, Poland

  • ETG Zamosc

    Zamość, 22-400, Poland

  • EUGASTRO GmbH

    Leipzig, Saxony, 04103, Germany

  • Endohope Morava s.r.o.

    Zábřeh, 78901, Czechia

  • Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I

    Székesfehérvár, H-8000, Hungary

  • First Private Hospital Vratsa

    Vratsa, 3000, Bulgaria

  • FutureMeds Krakow

    Krakow, 31-501, Poland

  • FutureMeds Warsaw Center

    Warsaw, 00-215, Poland

  • FutureMeds Wroclaw

    Wroclaw, 53-673, Poland

  • Futuremeds Targowek

    Warsaw, 03-291, Poland

  • G1 Institute

    Budapest, 1036, Hungary

  • Gastromed Sp. z o.o. (LLC)

    Torun, 87-100, Poland

  • Gastromedic s.r.o.

    Pardubice, 53003, Czechia

  • General Hospital Leskovac

    Leskovac, 16000, Serbia

  • General Hospital Uzice

    Užice, 31000, Serbia

  • Heves County Markhot Ferenc Teaching Hospital and Clinic, Department of General and Vascular Surgery

    Eger, H-3300, Hungary

  • Hospital Prachatice a.s.

    Prachatice, 38301, Czechia

  • Hospital of Brothers Hospitallers of Saint John of God In Lodz, Endoscopy Lab

    Lodz, 93-357, Poland

  • Independent Public Healthcare Facility University Hospital in Krakow, NSSU Endoscopy Department

    Krakow, 30-688, Poland

  • Independent Public Healthcare Facility, Norbert Barlicki University Teaching Hospital No. 1 of the Medical University in Lodz, Clinical Department of General Gastroenterology and Oncology

    Lodz, 90-153, Poland

  • Israeli - Georgian Medical Research Clinic Healthycore LLC

    Tbilisi, 0119, Georgia

  • JSC Georgian Clinics

    Kutaisi, 4600, Georgia

  • Janmrtelobis Sakhli LLC

    Tbilisi, 0144, Georgia

  • Javorszky Odon Hospital Vac, Department of Gastroenterology

    Vác, H-2600, Hungary

  • K. Eristavi National Center of Experimental and Clinical Surgery JSC

    Tbilisi, 0159, Georgia

  • Khozrevanidze's Clinic

    Batumi, 6000, Georgia

  • Klara Medical Center

    Częstochowa, 42-202, Poland

  • LEPL The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0178, Georgia

  • LLC Geo Hospitals

    Tbilisi, 0144, Georgia

  • LTD Aversi Clinic

    Marneuli, 3000, Georgia

  • LTD Aversi Clinic

    Tbilisi, 0160, Georgia

  • LTD Health

    Batumi, 6010, Georgia

  • LTD Krol Medical Corporation

    Tbilisi, 0101, Georgia

  • LTD The First Medical Center

    Tbilisi, 0180, Georgia

  • Main Railway Outpatient Clinic Debrecen, Department of Gastroenterology

    Debrecen, H-4025, Hungary

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

    Tbilisi, 0180, Georgia

  • Medical Care Unit Dachau

    Dachau, Bavaria, 85221, Germany

  • Medical Center "Futuremeds"

    Plovdiv, 4000, Bulgaria

  • Medical Center "Orange"

    Sofia, Sofia City Province, 1343, Bulgaria

  • Medical Center Hera

    Sofia, Sofia City Province, 1510, Bulgaria

  • Medical Center Hera

    Kyustendil, 2500, Bulgaria

  • Medical Centre Oporow

    Wroclaw, 52-416, Poland

  • Military Hospital Brno, Internal Department

    Brno, Brno, 615 00, Czechia

  • Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD

    Gorna Oryahovitsa, Gorna Oryahovitsa, 5100, Bulgaria

  • Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD

    Dupnitsa, Dupnitsa, 2600, Bulgaria

  • Multiprofile Hospital for Active Treatment "Sveti Panteleymon"

    Plovdiv, 4000, Bulgaria

  • Multiprofile Hospital for Active Treatment - "Vita"

    Sofia, Sofia City Province, 1407, Bulgaria

  • NZOZ KERmed Medical Centre

    Bydgoszcz, 85-231, Poland

  • NZOZ Specialist Gastrology Centre GASTROMED

    Bialystok, 15-322, Poland

  • New health-CK, Kieltucki and partners g.p.

    Staszów, 28-200, Poland

  • Obuda Healthcare Center Ltd.

    Budapest, H-1036, Hungary

  • Oswiecim Clinical Trial Centre

    Oświęcim, 32-600, Poland

  • PreventaMed s.r.o.

    Olomouc, 779 00, Czechia

  • Saint Wojciech Hospital, Gastroenterology Clinic

    Poznan, 61-144, Poland

  • St. John Paul 2nd Municipal Hospital in Elblag, Department of Internal Diseases

    Elblag, 82-300, Poland

  • SurGal Clinic s.r.o.

    Brno, 602 00, Czechia

  • Synexus Hungary Ltd.

    Budapest, H-1036, Hungary

  • Synexus Polska Sp. z o.o. Branch in Gdansk

    Gdansk, 80-382, Poland

  • Synexus Polska Sp. z o.o. Branch in Katowice

    Katowice, 40-040, Poland

  • Synexus Polska Sp. z o.o. Branch in Poznan

    Poznan, 60-702, Poland

  • TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy

    Cluj-Napoca, 400061, Romania

  • The New Hospitals

    Tbilisi, 0114, Georgia

  • Therapia Nova

    Warsaw, 01-595, Poland

  • University Hospital Brno

    Brno, 625 00, Czechia

  • University Multiprofile Hospital for Active Treatment "Sveta Marina"

    Pleven, 5800, Bulgaria

  • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Gastroenterology

    Sofia, 1431, Bulgaria

  • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"

    Sofia, Sofia City Province, 1527, Bulgaria

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov

    Sofia, Sofia City Province, 1606, Bulgaria

  • University of Szeged, Department of Internal Medicine- Western Site

    Szeged, H-6720, Hungary

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501, Poland

More trials for these conditions

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