Evidence map›Paper›PMID 40183130›Full record

Trial reportAlimentary pharmacology & therapeutics2025

Clinical Trial: Dose-Finding Study of Linaprazan Glurate, A Novel Potassium-Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis.

Prateek Sharma, Michael Vaezi, Peter Unge, Kjell Andersson, Kajsa Larsson, Ivan Popadiyn, Maria Rosenholm, Andras Rosztóczy, Elham Yektaei, David Armstrong

Registry-linked trialAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05055128 (A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05055128 phase2completednot on this map

A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease (GERD) Los Angeles Grade C or D, and Patients With at Least Partial Symptom Response But Endoscopically Still Unhealed After 8 Weeks History of Standard Treatment Healing Course With Proton-pump Inhibitor (PPI), to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole, and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole

TypeinterventionalSponsorCinclus Pharma Holding ABRan2021 to 2022Enrolled248ConditionsErosive EsophagitisArmsX842, X842 Dummy, Lansoprazole, Lansoprazole Dummy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Prateek SharmaDepartment of Gastroenterology, University of Kansas School of Medicine, Leawood, Kansas, USA.ORCID https://orcid.org/0000-0001-5646-8727
Michael VaeziVanderbilt University, Nashville, Tennessee, USA.
Peter UngeCinclus Pharma Holding AB, Stockholm, Sweden.
Kjell AnderssonCinclus Pharma Holding AB, Stockholm, Sweden.
Kajsa LarssonCinclus Pharma Holding AB, Stockholm, Sweden.
Ivan PopadiynHera Clinics, Sofia, Bulgaria.
Maria RosenholmCinclus Pharma Holding AB, Stockholm, Sweden.
Andras RosztóczyDepartment of Medicine, University of Szeged, Szeged, Hungary.
Elham YektaeiCinclus Pharma Holding AB, Stockholm, Sweden.
David ArmstrongMcMaster University, Hamilton, Ontario, Canada.ORCID https://orcid.org/0000-0003-2487-1479

Funding

Cinclus Pharma AB
6 · The paper itself

Abstract

backgroundLinaprazan glurate, a potassium-competitive acid blocker, is in development for the treatment of erosive oesophagitis and other acid-related diseases.

aimTo evaluate the 4-week healing rate and safety of four linaprazan glurate dosing regimens in patients with erosive oesophagitis.

methodsThis double-blind, dose-finding study compared linaprazan glurate to lansoprazole. We included patients with endoscopically confirmed erosive oesophagitis (validated by a central review board) if they had Los Angeles (LA) grade C/D or LA grade A/B with partial response to at least 8 weeks of proton pump inhibitor therapy. Patients were randomised to 4 weeks of linaprazan glurate (25, 50, 75 or 100 mg twice daily) or lansoprazole (30 mg once daily), followed by 4 weeks of open-label lansoprazole.

resultsOf 248 patients randomised, central review confirmed erosive oesophagitis in 182 at screening endoscopy. Across all doses, linaprazan glurate achieved a 4-week healing rate of 71.1% in intention-to-treat (ITT) analysis and 80.9% in per protocol (PP) analysis. In comparison, lansoprazole achieved healing rates of 60.6% (ITT) and 59.1% (PPS). The best performing linaprazan glurate dosing group outperformed lansoprazole by 28% in patients with LA grade A/B with partial PPI response and by more than 50% in patients with LA grade C/D.

conclusionsLinaprazan glurate demonstrated high 4-week healing rates compared to lansoprazole, with a good safety profile, supporting its further development.

trial registrationClinicalTrials.gov: NCT05055128; EudraCT: 2020-003319-91.

Indexed as

EsophagitisLansoprazoleProton Pump InhibitorsPyrrolidinesSulfonamidesAdultAgedDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedPyrrolesTreatment Outcome1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineLansoprazoleProton Pump InhibitorsPyrrolesPyrrolidinesSulfonamides4‐week healing rateserosive oesophagitisGERDLA grade C/Dlinaprazan glurateP‐CAB

Identifiers

PMID40183130
PMCPMC12013784

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.