Esomeprazole
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Esomeprazole: Duodenal obstruction
One-Sentence Summary
Esomeprazole is a proton pump inhibitor originally used for acid-related conditions such as peptic ulcer disease, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. However, there are 0 clinical trials and only 1 general review article for this specific indication, so the prediction rests mainly on the model score.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Duodenal obstruction |
| TxGNN Prediction Score | 0.9945 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Esomeprazole suppresses gastric acid secretion by irreversibly inhibiting the H+/K+ ATPase (proton pump) in gastric parietal cells. Detailed mechanism data were not included in the data compiled for this report, so this description reflects the well-established class pharmacology of proton pump inhibitors.
Duodenogastric reflux and the drug’s original indications are both upper gastrointestinal disorders. The link is plausible but not direct. The main injurious agents in bile reflux are bile and pancreatic secretions, not acid. Acid suppression may therefore relieve symptoms or mucosal injury only indirectly.
It is not disease-specific evidence. The score should be read as a hypothesis, not as confirmation of efficacy.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 18679668 | 2008 | Review | Eur J Clin Pharmacol | General update on proton pump inhibitor use and pharmacokinetics. It covers peptic ulcer, H. pylori infection, GERD, NSAID-related lesions, and Zollinger-Ellison syndrome, but does not address duodenogastric reflux directly. |
India Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 80975 | Esomo 40mg Injection | Vial of 1 injection | Ambreyo Lifesciences |
| 78836 | Esmoden 40 Tablet | Strip of 10 tablets | Welgenic Pharma |
| 79460 | Esoloc 40mg Tablet | Strip of 10 tablets | Meritus Life Care Pvt Ltd |
| 83656 | Esvelo 40mg Tablet | Strip of 10 tablets | Shreeyam Healthcare |
| 74291 | Esmoleaf 40 Tablet | Strip of 10 tablets | Fujin Kami Pharmaceutico |
All 20 registrations are valid single-ingredient products, available as oral tablets and injectable vials. Only the first 5 are listed here, and approved-indication text was not available for them.
Safety Considerations
- Contraindications / disease associations (from a knowledge graph, not label text): liver failure, osteoporosis, postmenopausal osteoporosis, bone fracture, chronic atrophic gastritis.
- Drug Interactions: 168 known interactions were identified. Examples from the compiled list:
- Major: acalabrutinib, atazanavir.
- Moderate: hydrochlorothiazide, amphotericin B, amikacin, amphetamine, fenofibrate, apalutamide, armodafinil, atorvastatin, bendamustine, bosutinib, bumetanide.
- Minor: acetylsalicylic acid, axitinib, bortezomib, brivaracetam, cyanocobalamin.
Please refer to the package insert for label warnings and full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a high model score and one general review that does not address this condition. There are no clinical trials. Because bile reflux is not acid-driven, esomeprazole’s mechanism offers only an indirect rationale.
Note that the same dataset shows far stronger support for a different predicted indication, duodenal ulcer. That indication has 30 registered trials, including multiple completed Phase 3 studies, and RCT literature on esomeprazole-based therapy. Duodenal ulcer is closely related to esomeprazole’s existing peptic ulcer indication, so it is better viewed as confirmation of an existing use than as true repurposing.
To proceed, the following is needed:
- Disease-specific clinical or observational studies of esomeprazole in duodenogastric (bile) reflux.
- Comparison against bile-targeted approaches, to show a benefit beyond acid suppression.
- Package insert warnings and contraindications for the Indian-marketed products.
- Detailed mechanism of action data.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.