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pantoprazole

✓ Approved

Nanodaru · ATP4A · Small Molecule

What is pantoprazole?

pantoprazole 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

pantoprazole 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

pantoprazole is developed for 4 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Gastrointestinal disordersDuodenal ulcer✓ Approved
Gastrointestinal disordersGastric ulcer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Gastrinoma✓ Approved
Gastrointestinal disordersGastrooesophageal reflux disease✓ Approved

Related Research Articles

PubMedGastroenterology research2026-09-13

Safety and Efficacy of Fixed-Dose Pantoprazole and Sustained Release Levosulpiride for Short-Term Management of Gastroesophageal Reflux Disease.

Garje Yogesh Y, Kamat Vijay V, Biswas Kalidas K, Murugesh M M et al.

Gastroesophageal reflux disease (GERD) and dyspepsia are highly prevalent in India. Pantoprazole suppresses gastric acid secretion by inhibiting H+, K+-ATPase enzyme, yet patients experience inadequate symptom control with proton pump inhibitor (PPI) monotherapy. Levosulpiride, a selective dopamine D2 receptor antagonist, enhances gastrointestinal motility and visceral sensitivity, offering additional symptomatic relief. The aim of the study was to evaluate the safety and efficacy of a fixed-dose combination (FDC) of pantoprazole sodium 40 mg and levosulpiride sustained-release 75 mg for short-term therapy of GERD in patients unresponsive to PPI monotherapy. This phase IV, open-label, single-arm study was conducted at 11 sites across India. Of 540 screened patients, 509 were enrolled and received FDC once daily for 4 weeks. Safety was evaluated through adverse events (AEs) and serious AEs (SAEs). Efficacy was assessed using the Frequency Scale for the Symptoms of GERD (FSSG), Likert Scale, Clinical Global Impression of Improvement (CGI-I), Clinical Global Impression of Severity (CGI-S), and Modified Simpson Angus Scale (MSAS). Of 509 patients, 492 completed the study. Seventy-nine AEs were documented in 69 patients, all mild-to-moderate and no SAEs were reported. The FDC demonstrated significant reduction in GERD symptom severity, with a mean (standard deviation) change from baseline of -16.99 (8.76) (P < 0.0001) on FSSG Scale at visit 4. Additionally, reductions were observed in acid reflux symptoms with a mean (SD) change from baseline of -9.15 (5.25) and dyspeptic symptoms -7.8 (4.05); both changes were statistically significant (P < 0.0001). The Likert Scale also demonstrated a significant reduction in symptom severity indicated by a mean (standard deviation) change from baseline of -1.26 (1.00) (P < 0.0001). At visit 4, CGI-I scores classified 196 patients as "very much improved", while CGI-S indicated "normal" status in 173 patients. The absence of significant movement disorders, assessed by MSAS at visit 4, further supports the favorable safety profile of FDC in management of GERD. The FDC of pantoprazole and levosulpiride is well tolerated and effective for the short-term treatment of GERD in patients unresponsive to PPI therapy. Symptom reductions and favorable global assessments indicate therapeutic benefit of therapy in refractory GERD population.

PMID 42730423
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PubMedFrontiers in microbiology2026-09-08

Beyond acid suppression: the multifaceted role of proton pump inhibitors in Helicobacter pylori eradication.

Sroczyńska Paulina P, Krzyżek Paweł P

Gastric acid is essential for digestion, host defense, and maintenance of gastrointestinal homeostasis; however, its excessive or inappropriate secretion contributes to the development and progression of several acid-related disorders. Proton pump inhibitors (PPIs) have remained the cornerstone of acid-suppressive therapies for more than four decades owing to their potent blockade of gastric H+/K+-ATPases. This review provides a comprehensive overview of the pharmacological properties, clinical applications, and current limitations of the most widely used PPIs, including omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, and rabeprazole. Particular emphasis is placed on their role in the management of Helicobacter pylori infection, a strong risk factor for the development of severe gastric diseases and one of the most clinically important indications for PPI-based antibiotic therapy. Beyond elevating intragastric pH to enhance antibiotic stability and efficacy, accumulating evidence indicates that PPIs exert direct antibacterial activity against H. pylori and may act synergistically with selected antibiotics. The review also discusses emerging evidence for interindividual variability in PPI metabolism, drug-drug interactions, and concerns regarding long-term adverse effects of the current treatments. Finally, it highlights potassium-competitive acid blockers (P-CABs), a newer class of acid-suppressive agents that provide sustained acid inhibition and represent a promising alternative to PPI-based regimens for H. pylori eradication.

PMID 42708030
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PubMedPediatric emergency care2026-09-07

Effect of Intravenous Pantoprazole on Clinical Outcomes in Pediatric Acute Gastroenteritis: A Placebo-Controlled RCT.

Malekiantaghi Armen A, Babajani Nastaran N, Saeedian Behrad B, Eftekhari Kambiz K

Acute gastroenteritis (AGE) is a common cause of pediatric emergency visits, and vomiting often complicates oral rehydration. Despite lack of evidence, proton pump inhibitors (PPIs) are sometimes used empirically for persistent vomiting. We evaluated the effect of intravenous pantoprazole on clinical outcomes in children with AGE and persistent vomiting after ondansetron. This double-blind, placebo-controlled randomized trial was conducted at Bahrami Children's Hospital, Tehran, Iran Children aged 4 months to 18 years with AGE and persistent vomiting despite ondansetron were randomized to receive intravenous pantoprazole (2 mg/kg/d) or placebo. Primary outcomes were vomiting frequency, time to oral tolerance, and length of hospital stay. Analyses used the Mann-Whitney U test, the Fisher exact test, and the ordinal logistic regression. Of 100 children [51 pantoprazole, 49 placebo; median age 14 months (IQR: 11 to 24), 67% male], there were no significant differences between groups in post-treatment vomiting episodes (P=0.64), time to oral tolerance at 6 hours (71% vs. 79%, P=0.37) or 12 hours (86% vs. 86%, P=0.78). However, hospital length of stay was significantly longer in the pantoprazole group [median 2 days (IQR: 1 to 3) vs. 1 day (IQR: 1 to 2), P=0.01]. Ordinal logistic regression showed that the placebo group had 80% lower odds of prolonged hospitalization (adjusted OR=0.2, 95% CI: 0.09-0.43). Subgroup analyses revealed that this difference was more pronounced in children under 2 years, regardless of reflux history, and in formula-fed children (P=0.01 for each). Intravenous pantoprazole does not reduce vomiting or improve oral tolerance in children with acute gastroenteritis. Furthermore, it is associated with longer hospital stays. Empirical PPI use in this setting is not supported by current evidence.

PMID 42703070
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PubMedCardiovascular toxicology2026-09-06

QT Prolongation, Ventricular Arrhythmia, and Cardiac Arrest Signals During Ceftriaxone Co-therapy with Individual Proton Pump Inhibitors: A Multidatabase Study.

Chen Yechao Y, Gu Qiaoling Q, Zhao Mingnuo M, Zhao Aijin A et al.

The concomitant use of ceftriaxone and proton pump inhibitors (PPIs) is common in hospital practice. However, it is unclear whether individual PPIs differ in their effects on QT interval prolongation, ventricular arrhythmia, or cardiac arrest, collectively termed as QVC events. We conducted a two-stage, real-world study. First, we screened the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction (CVAR) database with standard disproportionality measures (reporting odds ratio and proportional reporting ratio) and six drug-drug interaction (DDI) algorithms to identify combination signals that exceeded component signals. Second, we validated signal-positive combinations in the Medical Information Mart for Intensive Care IV (MIMIC-IV) intensive care unit (ICU) electronic health record (EHR) cohort by assembling adult inpatients with overlapping ceftriaxone-PPI exposures. The primary outcome was 28-day QVC events. Multivariable Cox proportional hazards models were the main analysis and complemented by propensity score matching, inverse probability of treatment weighting, and Fine-Gray competing-risk models. To address external generalisability, an additional validation was performed using ECG-ViEW II, an Asian electrocardiogram-linked real-world database. The combination of ceftriaxone and lansoprazole was significantly associated with QVC events, revealing notable DDIs (e.g., in FAERS, Ω025 = 0.54). To validate these findings, a cohort of 5,594 patients receiving ceftriaxone combined with PPIs from the MIMIC-IV database was analyzed using Cox proportional hazards models. The analyses corroborated the initial findings (lansoprazole vs. other PPIs, multivariate HR = 1.30; 95% CI: 1.10-1.54), with the risk associated with the three PPI combinations ranked as lansoprazole > pantoprazole > omeprazole. ECG-ViEW II provided supportive Asian external validation, showing a higher QVC risk for ceftriaxone plus lansoprazole than for ceftriaxone plus other PPIs. Evidence from two national pharmacovigilance systems and an ICU EHR cohort indicated that PPI choice modified cardiac safety during ceftriaxone therapy. Lansoprazole co-use confers a higher risk of QVC, whereas omeprazole appears relatively safer. Therefore, prospective confirmation is warranted.

PMID 42701947
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PubMedFrontiers in pharmacology2026-09-03

Differential fracture risk among proton pump inhibitors in older adults: evidence network and pharmacovigilance validation.

Piao Hui-Ling HL, Wu Zeng-Hao ZH, Zhou Ling-Yun LY, Lai Chang-Hong CH et al.

Proton pump inhibitors (PPIs) are the first-line therapy for acid-related disorders, with particularly high rates of chronic use in adults aged ≥65 years. Nearly all existing studies treat PPIs as a uniform drug class, overlooking potential heterogeneity in fracture risk across individual agents. This study aimed to evaluate the relative fracture risk of individual PPIs in elderly adults, using a complementary dual-method approach of network meta-analysis (NMA) and disproportionality analysis. First, we performed a NMA to compare the relative risk of any-site fracture associated with individual PPIs. Second, we performed a complementary disproportionality analysis using data from the US FDA Adverse Event Reporting System (FAERS) database, with additional analysis of osteoporosis/osteopenia events defined by the Standardised Medical Dictionary for Regulatory Activities (MedDRA) Standardised Query (SMQ). The NMA included 9 eligible studies, enrolling a total of 257,445 participants. Compared with non-PPI users, omeprazole (OR 1.51, 95%CI 1.36-1.67), rabeprazole (OR 1.47, 95%CI 1.22-1.78), pantoprazole (OR 1.44, 95%CI 1.28-1.62), and lansoprazole (OR 1.32, 95%CI 1.14-1.53) were associated with a significantly increased risk of any-site fracture. In contrast, esomeprazole showed no significant association with overall fracture risk (OR 1.16, 95%CI 0.97-1.38). Pairwise comparisons from the NMA showed that esomeprazole had a lower relative fracture risk compared with other individual PPIs. In the FAERS analysis, we identified 16,908 PPI-related fracture adverse events. Consistent with NMA findings, omeprazole exhibited a significant fracture risk signal (ROR 1.25, 95%CI 1.03-1.51), while esomeprazole showed no significant signal for overall fracture (ROR 0.89, 95%CI 0.66-1.20). However, esomeprazole presented a strong positive risk signal in the narrow-scope MedDRA SMQ analysis for Osteoporosis/Osteopenia (ROR 2.44, 95%CI 1.41-4.20). Long-term PPI use is associated with increased fracture risk in elderly adults, with significant heterogeneity in bone safety profiles across individual PPI agents. Although esomeprazole was not significantly associated with fracture risk in NMA or FAERS fracture analyses, it showed a strong narrow-scope osteoporosis/osteopenia SMQ signal. This discordance indicates that absence of a fracture signal should not imply skeletal safety. These findings provide evidence-based guidance for individualized PPI prescribing in elderly patients, with careful benefit-risk assessment for those requiring extended-duration PPI regimens.

PMID 42688114
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PubMedBMJ open2026-08-31

Proton pump inhibitors in invasively ventilated patients with SARS-CoV-2: a substudy of the re-evaluating the inhibition of stress erosions trial.

Dennis Brittany B, Heels-Ansdell Diane D, Ibrahim Quazi Q, Basmaji John J et al.

Observational studies suggest that acid suppression may worsen outcomes among patients infected with SARS-CoV-2. The objectives of this embedded substudy of a randomised controlled trial evaluating pantoprazole in mechanically ventilated patients were to (1) describe the clinical characteristics of critically ill patients with SARS-CoV-2, (2) compare clinical outcomes with a propensity-matched non-infected cohort and (3) assess whether pantoprazole's treatment effects differed by SARS-CoV-2 infection status. A pre-planned substudy of the re-evaluating the inhibition of stress erosions (REVISE) trial, including a propensity-matched analysis of infected and non-infected patients comparing the effect of pantoprazole between patients with and without SARS-CoV-2. 68 intensive care units (ICUs) in eight countries. From July 2019 to October 2023, 4821 eligible participants were enrolled in REVISE whether or not they had SARS-CoV-2 infection. Participants enrolled in REVISE with SARS-CoV-2 infection had additional data collection, including biomarkers, venous thromboembolism, SARS-CoV-2 therapies and tracheostomy timing. The primary outcomes were clinically important upper gastrointestinal bleeding and 90-day mortality. Secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, patient-important upper GI bleeding, renal replacement therapy, ICU and hospital mortality and duration of mechanical ventilation, ICU and hospital stay. Of the eligible trial cohort, 11.9% (540/4550) had SARS-CoV-2; 532 patients had additional SARS-CoV-2-specific data collection. Of these 532 patients, 87.8% received COVID-19-directed treatments-(dexamethasone 75.2%), 11.7% developed pulmonary embolism and 9.2% developed deep-vein thrombosis. After propensity matching, SARS-CoV-2 infection was not associated with clinically important upper gastrointestinal bleeding (adjusted HR 0.78, 95% CI 0.40 to 1.50) but was associated with significantly higher ICU, hospital and 90-day mortality, as well as longer duration of ventilation and ICU and hospital length of stay. The effect of pantoprazole on clinically important upper GI bleeding and 90-day mortality was consistent regardless of SARS-CoV-2 status. SARS-CoV-2 infection was associated with higher mortality and longer duration of mechanical ventilation, ICU and hospital stays, without an increased risk of clinically important upper gastrointestinal bleeding. Pantoprazole reduced clinically important upper gastrointestinal bleeding without adversely affecting other outcomes. REVISE trial (NCT03374800), SARS-CoV-2 cohort study (NCT05715567).

PMID 42674788
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