Who is sponsoring NCT07037875?

NCT07037875 is sponsored by Cinclus Pharma Holding AB.

What drugs are being tested in NCT07037875?

Interventions in NCT07037875: Linaprazan glurate 50 mg Twice Daily (BID), Linaprazan Glurate 50 mg Once Daily (QD), Lansoprazole 30 mg Once Daily (QD).

What condition does NCT07037875 study?

NCT07037875 studies GERD (Gastroesophageal Reflux Disease).

Is NCT07037875 still recruiting?

NCT07037875 is currently recruiting now. Last updated 28 May 2026.

Last reviewed 2026-05-28 · How we verify

NCT07037875

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Phase 3, Double-blind, Double-dummy, Active Comparator-controlled Multicenter Study to Evaluate the Efficacy and Safety of 2 Doses of Linaprazan Glurate Compared to Lansoprazole in 4 or 8 Weeks Healing in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) of Los Angeles (LA) Grades A to D

Recruiting now Phase 3 Last updated 28 May 2026

What this trial tests

Phase 3 trial testing Linaprazan glurate 50 mg Twice Daily (BID) in GERD (Gastroesophageal Reflux Disease) in 500 participants. Currently enrolling.

Timeline

11 September 2025

Primary endpoint
1 August 2026

1 September 2026

Quick facts

Lead sponsor	Cinclus Pharma Holding AB
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	500
Start date	11 September 2025
Primary completion	1 August 2026
Estimated completion	1 September 2026
Sites	75 locations across Bulgaria, Czechia, Georgia, Germany, Hungary, Poland, Romania

Drugs / interventions tested

Linaprazan glurate 50 mg Twice Daily (BID) — full drug profile →
Linaprazan Glurate 50 mg Once Daily (QD) — full drug profile →
Lansoprazole 30 mg Once Daily (QD) — full drug profile →

Conditions studied

GERD (Gastroesophageal Reflux Disease) — all drugs for GERD (Gastroesophageal Reflux Disease) →

Sponsor

Cinclus Pharma Holding AB — full company profile →

Who can join

Adults 18 to 80, any sex, with GERD (Gastroesophageal Reflux Disease). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.
Time frame: From enrollment to the end of treatment at 4 weeks.

Sponsor's own description

The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate: * Reduces heartburn symptoms more effectively than lansoprazole * Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate) * Causes any side effects during treatment * Has different effects depending on how much of the drug is in the blood * Works differently depending on participants' genes Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks. The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups (about 167 people in each group): * Linaprazan glurate 50 mg twice a day * Linaprazan glurate 50 mg once a day * Lansoprazole 30 mg once a day Everyone will take 2 tablets and 1 capsule by mouth daily for 8 weeks. Some tablets or capsules will be placebos (look like medicine but contain no active drug). Participants will: * Undergo an endoscopy in the beginning and after 4 weeks of treatment * If healing is not observed, another endoscopy may be done at 8 weeks * During the procedure, doctors will use a thin, flexible tube with a camera to look at the esophagus and take small tissue samples (biopsies) * Have blood and urine tests at clinic visits to check overall health * Receive electrocardiograms (ECGs) to monitor heart function * Complete daily questionnaires on an electronic device about symptoms and experiences

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for GERD (Gastroesophageal Reflux Disease)

Currently open trials in the same condition.

NCT07252180 — Comparing Two Different Methods of Ablation of Inlet Patches (APC vs RFA) · NA · active not recruiting
NCT07125521 — Evaluating Medication Adherence of Patients With Gastroesophageal Reflux Disease With Support of the Smartphone Applicat · NA · recruiting
NCT07121803 — The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility · NA · recruiting
NCT06928350 — Normal Values of Ambulatory 24-hour Oesophageal pH-impedance Monitoring in an Indian Cohort of Participants · recruiting
NCT07252115 — TLSA Versus TBSA Surgical Approach for Hiatal Hernia With Gastroesophageal Reflux Disease · NA · recruiting

Other Cinclus Pharma Holding AB trials

Trials by the same sponsor.

NCT07308041 — A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin · Phase 1 · completed
NCT05742984 — Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects · Phase 1 · completed
NCT05633147 — Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam · Phase 1 · completed
NCT05627518 — Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07037875 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cinclus Pharma Holding AB
Last refreshed: 28 May 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07037875.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing