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esomeprazole

✓ Approved

Nanodaru · ATP4A · Small Molecule

What is esomeprazole?

esomeprazole is a small molecule developed by Nanodaru. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

CompanyNanodaru
Drug ClassSmall Molecule
Molecular TargetATP4A
RouteInjectable (Others), Intravenous (IV)
StatusApproved

Mechanism of Action

Molecular Targets

esomeprazole acts on 1 molecular target:

ATP4AATPase H+/K+ transporting subunit alpha (ATP6A)
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Therapeutic Indications

esomeprazole is developed for 3 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Gastrointestinal disordersDuodenal ulcer✓ Approved
Gastrointestinal disordersGastric ulcer✓ Approved
Gastrointestinal disordersGastrooesophageal reflux disease✓ Approved

Related Research Articles

PubMedClinical pharmacology and therapeutics2026-10-15

Reprocessing Mass Spectra from Therapeutic Drug Monitoring to Unveil Proton Pump Inhibitor Use and Quantify Phenoconversion of Escitalopram Metabolism in CYP2C19-Genotyped Patients.

Hole Kristine K, Wollmann Birgit M BM, Stingl Julia Carolin JC, Molden Espen E

Escitalopram is a frequently prescribed antidepressant drug. CYP2C19 genotype is a major determinant of escitalopram metabolism and treatment outcome. However, real-life studies show a high degree of genotype-phenotype mismatch in escitalopram metabolism. The present study aimed to identify comedication with proton pump inhibitors (PPIs) and quantify phenoconversion of escitalopram metabolism in CYP2C19-genotyped patients by reprocessing high-resolution mass spectra from therapeutic drug monitoring (TDM) analyses. Patients were included from a combined TDM/pharmacogenetics (PGx) laboratory facility in Oslo, Norway. TDM profiles of escitalopram and CYP2C19 genotypes were available in the laboratory database. Reprocessing of high-resolution mass spectra by exact mass and fragment detection identified possible comedication with pantoprazole, esomeprazole/omeprazole or lansoprazole using mzCloud reference library. Patients were grouped as normal metabolizers (NMs), intermediate metabolizers (IMs), poor metabolizers (PMs), rapid metabolizers (RM), or ultrarapid metabolizers (UM). Primary outcome measure was N-desmethylescitalopram-to-escitalopram metabolic ratio (MR; CYP2C19 biomarker) in UMs vs. PMs. 2818 patients were included, constituting 2373 without and 445 (15.8%) with PPIs. Most patients were females (64.2%). Regarding CYP2C19 phenotype distribution, the cohort comprised 39.3% NMs, 29.3% IMs, 2.6% PMs, 24.6% RMs, and 4.2% UMs. Escitalopram MR was 4.5-fold higher in CYP2C19 UMs vs. PMs without PPIs (P < 0.001), while this difference was 2.8-fold in pantoprazole users (P < 0.001), and 1.8-fold in esomeprazole/omeprazole users (P = 0.2). In conclusion, PPIs show significant phenoconversion of CYP2C19-mediated escitalopram metabolism with esomeprazole/omeprazole exhibiting a stronger effect than pantoprazole. The novel method for identification of interacting comedications in TDM samples illustrates the innovative potential of high-resolution mass spectrometry in precision medicine.

PubMedHelicobacter2026-10-13

Management Strategies for Helicobacter pylori-Application of the Stewardship Principles.

Megraud Francis F, Bessède Emilie E, Matysiak-Budnik Tamara T

The management strategies for Helicobacter pylori treatment are still diverse, especially because of the unequal availability of the drugs needed. In addition, the development of resistance to some antibiotics leads to unsatisfactory results. The role of H. pylori in gastric cancer, which allows the possibility of prevention in the general population by eradicating the bacteria, is a stimulus to have well-established regimens. This article presents the antimicrobial stewardship principles that can guarantee appropriate treatment. The optimization of the clarithromycin-based triple therapy includes antimicrobial susceptibility testing for clarithromycin, a higher dose of amoxicillin than in the original regimen, more than twice a day, and a proton pump inhibitor (PPI) like rabeprazole or esomeprazole, all administered for 2 weeks. The other regimen often used, the bismuth quadruple therapy, is optimal with the 3-in-1 capsule and a standard or high dose of PPI. In all cases, an eradication control must be performed after 4 to 6 weeks. The so-called concomitant treatment does not meet stewardship principles. The availability of Potassium-Competitive Acid Blockers (P-CABs) in some countries could allow the use of a dual therapy with only amoxicillin, but it must be confirmed by proper trials in Western countries.

PubMedJournal of gastroenterology and hepatology2026-10-13

14-Day Keverprazan-Amoxicillin Dual Therapy Versus Bismuth-Containing Quadruple Therapy as First-Line Treatment for Helicobacter pylori Eradication: A Prospective, Single-Center, Randomized Controlled Trial.

Yu Yue Y, She Qiang Q, Ding Yan-Bing YB, Zhang Min M et al.

Keverprazan, a novel potassium-competitive acid blocker (P-CAB), provides stronger and more sustained gastric acid suppression than proton pump inhibitors (PPIs). However, direct comparisons between 14-day keverprazan-amoxicillin (KA) dual therapy and 14-day bismuth-containing quadruple therapy (BQT) for Helicobacter pylori (H. pylori) eradication remain limited. This study compared the efficacy and safety of the 14-day KA dual therapy versus BQT as a first-line therapy for H. pylori eradication. This randomized controlled trial (RCT) recruited 316 treatment-naive, H. pylori-infected patients. Participants were randomly assigned to receive either the KA group (keverprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the BQT group (esomeprazole 20 mg twice daily + amoxicillin 1000 mg twice daily + clarithromycin 500 mg twice daily + colloidal bismuth pectin 300 mg twice daily). H. pylori eradication rate was the primary outcome. Adverse events and compliance were considered as secondary outcomes. KA dual therapy was noninferior to BQT in eradication rates across intention-to-treat (ITT) analysis (85.4% vs. 82.9%, noninferiority p = 0.001), modified intention-to-treat (MITT) analysis (92.5% vs. 92.9%, noninferiority p < 0.001), and per-protocol (PP) analysis (93.7% vs. 93.5%, noninferiority p < 0.001). Adverse events were significantly lower in the KA group (19.0%) than in the BQT group (28.5%), p = 0.047. The trial suggested KA dual therapy was a promising first-line therapy, achieving a 93.7% eradication rate in the PP analysis, with favorable safety and similar compliance compared to BQT. Chinese Clinical Trial Registry: ChiCTR2400089303.

PubMedCureus2026-10-11

Proton Pump Inhibitor-Associated Hypomagnesemia: A Case Report Highlighting a Rare Adverse Effect.

Sabillon Hugo H, Fuentes Anna A, Novoa Isabella I, Novoa Jorge J

Proton pump inhibitors (PPIs) are widely prescribed for the management of gastric acid-related diseases, such as gastroesophageal reflux disease (GERD), and are generally well tolerated, with few or mild adverse effects. We present a case of an elderly female patient who developed hypomagnesemia, a rare but serious complication associated with chronic PPI therapy. The patient had been receiving esomeprazole 40 mg daily for approximately 12 months. She developed secondary electrolyte disorders, with hypocalcemia being the most evident. Her clinical manifestations initially included muscle cramps and tremors, which progressed to a seizure and eventually to altered mental status with a positive Trousseau sign. Despite institutional constraints, PPI-associated hypomagnesemia was considered, and the patient improved following electrolyte replacement and discontinuation of esomeprazole. Because fractional excretion of magnesium could not be calculated, the mechanism of magnesium loss could not be definitively established. This report highlights the importance of considering PPI-associated hypomagnesemia, an infrequent but potentially serious adverse effect, in patients receiving prolonged PPI therapy who develop compatible clinical manifestations.

PubMedFrontiers in pharmacology2026-10-08

Comparative hepatic safety between tegoprazan and esomeprazole: a real-world cohort study.

Kim Ji Eun JE, Kim Yuwon Y, Kang Mira M, Kim Kyunga K et al.

Tegoprazan is a newer P-CAB with favorable tolerability, yet data on hepatic safety remain limited. We compared the incidence of laboratory-defined hepatic events between tegoprazan and esomeprazole, a PPI with a well-established safety profile. We conducted a retrospective new-user cohort study at a tertiary hospital in Korea. Adults prescribed tegoprazan or esomeprazole for ≥14 days between March 2019 and December 2024 were included. A laboratory-defined hepatic event was defined as ≥1.5-fold elevation from baseline in ALT, bilirubin, or GGT above the upper limit of normal within 120 days. Propensity score matching was applied, and risks were compared using Cox models. After matching, 2,970 tegoprazan and 4,634 esomeprazole users were analyzed. Tegoprazan was associated with fewer laboratory-defined hepatic events (adjusted HR 0.73, 95% CI 0.56-0.95). The association was consistent in sensitivity analyses and was also observed in patients with baseline ALT below the upper limit of normal (aHR 0.70, 95% CI 0.53-0.93). Follow-up ALT elevations >100 U/L were less frequent with tegoprazan than esomeprazole (0.8% vs. 2.0%, p = 0.007). Tegoprazan was associated with fewer laboratory-defined hepatic events than esomeprazole in this dataset. These findings are hypothesis-generating and require confirmation using standardized monitoring and adjudicated outcomes.

PubMedDigestive diseases (Basel, Switzerland)2026-10-07

IS PYLERA® STILL EFFECTIVE AND SAFE IN PATIENTS INFECTED BY HELICOBACTER PYLORI? A SIX-YEARS, MULTICENTRE, REAL LIFE STUDY.

Di Mario Francesco F, Franceschi Marilisa M, Elisei Walter W, Crafa Pellegrino P et al.

More than ten years after its introduction into clinical practice, we aimed to assess the current real-life effectiveness and safety of bismuth-containing quadruple therapy in patients infected with H. pylori. Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients received Pylera® 3 capsules four times daily plus omeprazole 20 mg or esomeprazole 40 mg bid for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of treatment). We assessed effectiveness and safety in these patients. One thousand and eighteen consecutive patients were included in the study, 648 (63.7%) treated as first-line and 370 (36.3%) treated after failure of at least one previous eradication course. The vast majority of patients were fully compliant, except 18 (1.8%) subjects, who discontinued treatment due to severe adverse events. H. pylori eradication was achieved in 959/1,000 (95.9%, CI 94.7-97.1%) patients, higher in naïve than in previously treated patients (97.3%, CI 96.1-98.6%, vs 93.3%, CI 90.8-95.9%; p=0.002). Overall, the eradication rate remains significantly high during the observational period. In particular, it was 100% in 2020, 97.8% (CI 95.7-99.9%) in 2021, 100% in 2022, 98.8% (CI 97.3-100%) in 2023, 89.1% (CI 84.6-93.6%) in 2024, and 97.8% (CI 95.5-100%) in 2025: the failures, although minimal, were more present in 2024 (P<0.001). Finally, the eradication rate remained constant from 2020 to 2025. Pylera® remains an effective and safe therapeutic option for curing H. pylori infection in both naïve and previously treated patients.

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