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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
Sources: ClinicalTrials.gov, Nanodaru

Mechanism of Action

Molecular Targets

esomeprazole acts on 1 molecular target:

ATP4AATPase H+/K+ transporting subunit alpha (ATP6A)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

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

PubMedMedicine2026-08-22

Complete remission of Helicobacter pylori-negative gastric MALT lymphoma following eradication therapy: A case report.

Chen Hui H, Tang Jingtong J, Mo Lin L, Wang Xi X et al.

Gastric mucosa-associated lymphoid tissue (MALT) lymphoma is typically associated with Helicobacter pylori infection; however, approximately 10% of cases are H pylori-negative. Management guidelines differ between the European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN) regarding first-line treatment for these patients. Here, we report a case of H pylori-negative gastric MALT lymphoma that achieved complete remission following standard eradication therapy. A woman of Asian ethnicity in her late 50s presented with a 4-month history of intermittent, left-upper-quadrant abdominal pain. The patient had no significant medical or family history of gastric cancer or lymphoma. Upper gastrointestinal endoscopy revealed irregular whitish mucosa with ill-defined borders in the distal gastric body. Biopsies demonstrated dense lymphoid infiltrates positive for CD20, CD79a, CD43, kappa light chain, focal CD23, and CD21, with a Ki-67 index of approximately 8%, consistent with extranodal marginal zone lymphoma (MALT lymphoma). H pylori testing by 13C-urea breath test (DOB 3.5; cutoff < 4.0) and Giemsa staining was negative, although the DOB value was close to the cutoff threshold. Positron emission tomography-computed tomography and endoscopic ultrasound confirmed Lugano stage IE disease confined to the mucosa and submucosa. After multidisciplinary consultation, the patient received a 14-day bismuth-containing quadruple eradication regimen consisting of bismuth potassium citrate (2.4 g) twice daily, esomeprazole (40 mg) twice daily, amoxicillin (1 g) twice daily, and clarithromycin (0.5 g) twice daily. At 2-month follow-up, the patient was asymptomatic. Positron emission tomography-computed tomography showed no abnormalities, and repeat endoscopy with biopsies demonstrated complete histological remission, which persisted at 6-month follow-up. This case adds to the growing evidence that H pylori status alone should not preclude a trial of eradication therapy in patients with localized gastric MALT lymphoma. Potential mechanisms include the role of non-H pylori helicobacters, the direct antitumor effects of antibiotics, and immunomodulation. Larger prospective studies are needed to identify predictors of response in this population.

PMID 42629740
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PubMedArquivos de gastroenterologia2026-08-19

REAL-WORLD EFFECTIVENESS OF HIGH-DOSE DUAL THERAPY VS OPTIMIZED CLARITHROMYCIN TRIPLE THERAPY FOR HELICOBACTER PYLORI: A PROSPECTIVE COHORT STUDY WITH TEST-OF-CURE SENSITIVITY ANALYSES.

Ugarte Lastra Alejandro A, Advincula Solis David E DE, Ramos Mamani Harold H, Cedrón Cheng Hugo Guillermo HG et al.

Helicobacter pylori eradication rates have declined globally due to rising antibiotic resistance, challenging the effectiveness of standard triple therapy. High-dose dual therapy has emerged as a simplified alternative supported by pharmacodynamic rationale. We aimed to compare the real-world effectiveness, adherence, and safety of high-dose dual therapy versus optimized clarithromycin-based triple therapy in routine gastroenterology practice. We conducted a prospective, multicenter observational cohort study in adult patients with confirmed H. pylori infection treated with either high-dose dual therapy (amoxicillin 1 g three times daily plus esomeprazole 40 mg three times daily for 14 days) or optimized clarithromycin-based triple therapy (amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and esomeprazole 40 mg twice daily for 14 days) according to physician decision. Eradication was assessed by carbon-14 urea breath test ≥4 weeks after therapy. Comparative effectiveness was estimated with effect measures, 95% confidence intervals (CI), and predefined sensitivity analyses for incomplete test-of-cure follow-up. Among 218 treated patients, 104 completed post-treatment breath testing. Eradication rates were 80.4% with high-dose dual therapy and 81.3% with triple therapy (absolute difference -0.9%; 95%CI -16.3 to 14.5; P=0.91). Moderate-to-high adherence was observed in 51.5% vs 67.6%, respectively (P=0.19). Adverse events were more frequent with high-dose dual therapy (70.8% vs 58.9%), although the difference was not statistically significant. Mainly gastrointestinal intolerance and taste disturbance. Sensitivity analyses across plausible missing-outcome scenarios showed stable comparative results. In prospective real-world practice, high-dose dual therapy achieved eradication effectiveness comparable to optimized triple therapy, with favorable tolerability. These findings support high-dose dual therapy as a pragmatic and clinically attractive alternative in settings with evolving resistance and adherence constraints.

PMID 42615755
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PubMedPsychiatry research2026-08-15

Drug-associated bipolar disorder: A disproportionality analysis of the FAERS database.

Du Pengqiang P, Chen Xiaoyu X, Zhang Wenjin W, Zhou Yujie Y et al.

Drug-induced bipolar disorder (BD) is easily neglected clinically. We mined the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to screen high BD-risk drugs and assess BD risk warnings in drug labels. Data were extracted from the FAERS database spanning the first quarter of 2004 to the third quarter of 2025. Preferred terms (PTs) related to BD, including 'bipolar disorder', were identified using the Medical Dictionary for Regulatory Activities (MedDRA v27.1). Generic drug names were standardized via the DrugBank database. Sex-stratified and BD subtype-stratified disproportionality analyses were performed. A total of 23,607,454 adverse event reports were analyzed, with 17,620 cases linked to BD. Varenicline (537 cases) was associated with the highest number of BD reports. Based on disproportionality analysis, the top five medications with the highest reporting odds ratios (RORs), proportional reporting ratio (PRR), empirical bayes geometric mean (EBGM) and information component (IC) were pizotifen, tafenoquine, flupenthixol, naltrexone, and pemoline. Among the top 50 medications, 44 (88%) lacked any mention of BD risk in their prescribing information. Time-to-onset analysis revealed that 51% of cases (n = 993) occurred within 0-30 days of drug exposure. Signals differed markedly by sex: varenicline showed higher male risk, while esomeprazole and oxycodone carried mild female-specific risks. Naltrexone strongly associated with BD-I and oxcarbazepine with BD-II, with elevated subtype-specific RORs limited by small subtype samples. Most high BD-signal drugs lack label warnings. Drug-induced BD presents distinct sex and subtype-specific risks, requiring gender- and subtype-personalized clinical monitoring.

PMID 42603523
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PubMedOncology letters2026-08-14

[Retracted] Esomeprazole affects the proliferation, metastasis, apoptosis and chemosensitivity of gastric cancer cells by regulating lncRNA/circRNA-miRNA-mRNA ceRNA networks.

Xu Qian Q, Jia Xiyun X, Wu Qian Q, Shi Lei L et al.

[This retracts the article DOI: 10.3892/ol.2020.12193.].

PMID 42597662
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PubMedJournal of the Formosan Medical Association = Taiwan yi zhi2026-08-13

Comparison of the efficacy of 14-day sequential therapy and 10-day bismuth quadruple therapy in the second line therapy for Helicobacter pylori infection- A multi-center randomized trial.

Yang Tsung-Hua TH, Lee Ji-Yuh JY, Yu Jian-Jyun JJ, Kuo Chia-Chi CC et al.

Whether extending treatment duration and using high-dose esomeprazole can improve the efficacy of sequential therapy as second-line treatment for Helicobacter pylori (H. pylori) infection remains uncertain. We aimed to compare the efficacy and tolerability of optimized 14-day sequential therapy (ST14) and 10-day bismuth quadruple therapy (BQ10), both containing high-dose esomeprazole, as second-line treatment after failure of standard triple therapy. In this multicenter, open-label, randomized trial conducted at six hospitals in Taiwan, adult patients (≥20 years) with confirmed H. pylori infection who failed first-line standard triple therapy were randomly assigned to receive ST14 or BQ10. Both regimens included esomeprazole 40 mg twice daily. The primary outcome was eradication rate assessed by ^13C-urea breath test using intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary outcomes included adverse events, treatment adherence, and short-term changes in metabolic parameters. Antibiotic resistance and 23S ribosomal RNA mutations were assessed in available isolates. gov: NCT03208426. A total of 155 patients were randomized (ST14, n = 76; BQ10, n = 79). Eradication rates were significantly lower with ST14 than with BQ10 in both ITT analysis (60.5% vs. 87.3%, P < 0.0001) and PP analysis (62.2% vs. 98.6%, P < 0.0001). ST14 was associated with fewer adverse events than BQ10 (39.5% vs. 62.0%, P = 0.008), while treatment adherence was high and comparable between groups. The eradication rate of ST14 was 80% in strains harboring 23S ribosomal RNA mutations and 99% in those without mutations (P < 0.0001). No clinically meaningful differences in metabolic parameters were observed at 8 weeks. BQ10 provides superior eradication efficacy compared with ST14 as second-line treatment for H. pylori infection, despite higher rates of adverse events. Sequential therapy with high-dose esomeprazole should not be used empirically as second-line therapy.

PMID 42595603
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PubMedJournal of clinical pharmacology2026-08-12

PBPK Modeling of Esomeprazole to Support Adolescent Pharmacokinetic Extrapolation and Label Extension in Chinese Patients With Gastroesophageal Reflux Disease (GERD).

Jin Yuwen Y, Ding Junjie J, Hua Xiaohan X, Duan Wei W et al.

Esomeprazole, a proton pump inhibitor (PPI), is widely approved for gastroesophageal reflux disease (GERD) in adults and pediatrics globally, but prior to December 2022, its oral tablets (20 and 40 mg) were approved only for adults in China. To address unmet needs in Chinese adolescents aged 12-17 years, physiologically based pharmacokinetic (PBPK) modeling was employed to extrapolate data and support label extension, leveraging similarities in GERD pathophysiology and PK/PD relationships across ages and ethnicities. A PBPK model was developed for esomeprazole to capture the enteric-coated formulation's pharmacokinetics. The model was validated against clinical PK studies in Caucasian, Japanese, and Chinese adults and/or adolescents, demonstrating good predictions of concentration-time profiles and area under the curve (AUC) for CYP2C19-specific genotypes as well as overall populations across these ethnic groups. All predicted-to-observed ratios for AUC fell within 0.5- to 2.0-fold, with 14 out of 18 predictions within the 0.67- to 1.5-fold. This robust validation enabled the model's application to predict PK in Chinese adolescents. PBPK predictions for Chinese adolescents indicated that steady-state AUC for 20- and 40-mg doses was comparable to that in Japanese adolescents and slightly higher than in Caucasian adolescents. By integrating an established PK/PD relationship between AUC and the percentage of time with intragastric pH >4, once-daily doses of 20 or 40 mg were justified, achieving adequate acid suppression with a favorable safety profile. This PBPK-informed extrapolation was accepted by China's National Medical Products Administration (NMPA), enabling GERD indication extension to adolescents.

PMID 42584807
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