Pantoprazole
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Pantoprazole: From Peptic Ulcer Disease to Active Peptic Ulcer Disease
One-Sentence Summary
Pantoprazole is a proton pump inhibitor originally used for peptic ulcer disease, gastroesophageal reflux disease, esophagitis and Zollinger-Ellison syndrome. The TxGNN model predicts it for active peptic ulcer disease, which is essentially an on-label indication rather than true repurposing. Support comes from 1 completed Phase 3 trial specific to this indication (plus several related ulcer trials) and 18 publications in the data compiled for this report.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Peptic ulcer disease, gastroesophageal reflux disease, esophagitis, Zollinger-Ellison syndrome (the Singapore licence records contain no indication text) |
| Predicted New Indication | Active peptic ulcer disease |
| TxGNN Prediction Score | 99.69% |
| Evidence Level | L2 (see note below) |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 14 |
| Recommended Decision | Proceed with Guardrails |
Evidence level note: the compiled data labels this prediction L1. Within the evidence listed for the top prediction, only one completed Phase 3 randomized trial (NCT02084420) appears, which by the rules in this report fits L2. The closely related duodenal ulcer prediction (rank 6) does reach L1, with several Phase 3 trials and double-blind randomized comparisons.
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the compiled data. Based on the literature retrieved, pantoprazole irreversibly inhibits the gastric H+/K+ ATPase (the "proton pump") in parietal cells. This blocks the final step of acid secretion. The drug accumulates in the acidic compartment of the parietal cell and must be acid-activated before it acts, which gives it selectivity.
Peptic ulcers form when acid overwhelms the protective mucosal barrier. Reducing acid lets the ulcer heal. This directly matches pantoprazole's known uses in peptic ulcer disease and reflux disease. The prediction is therefore consistent with existing practice and is not a new therapeutic direction.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02084420 | Phase 3 | Completed | 323 | Randomized, double-blind, active-controlled trial of ilaprazole vs pantoprazole triple therapy for 7 days in H. pylori-positive gastric/duodenal ulcer |
Other pantoprazole ulcer trials were found under related predictions (for example duodenal and gastric ulcer): NCT02551744 (pantoprazole vs famotidine for ulcer recurrence prevention, n=101), NCT00843063 (famotidine vs pantoprazole for aspirin-related ulcers, n=161) and NCT00374101 (PPI doses in bleeding peptic ulcers, Phase 3, n=450).
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38345252 | 2024 | Systematic review / network meta-analysis | Am J Gastroenterol | P-CAB vs PPI for healing severe (grade C/D) esophagitis |
| 38384180 | 2024 | RCT | Gut Liver | Tegoprazan vs active control for endoscopic resection-induced ulcers |
| 19938880 | 2009 | Review | Clin Drug Investig | Pantoprazole irreversibly binds the proton pump; no drug interactions identified in numerous studies |
| 21534455 | 2011 | Review | Med Arh | PPIs in the management of GERD |
| 10450061 | 1999 | Review | Pharmacology | PPIs show similar dose-response relationships at equal milligram doses |
| 10638560 | 2000 | Clinical trial | Am J Gastroenterol | Pantoprazole vs ranitidine in duodenal ulcer, Brazilian multicenter study |
| 15244210 | 2003 | Comparative study | Hepatogastroenterology | Lansoprazole vs pantoprazole in active duodenal ulcer and H. pylori eradication |
| 38652367 | 2024 | Preclinical | Inflammopharmacology | Pantoprazole plus stem cells in experimental gastric ulcer in rats |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN08843P | Controloc Tablet 40 mg | Enteric coated tablet | Not stated in the licence record |
| SIN11170P | Controloc Tablet 20 mg | Enteric coated tablet | Not stated in the licence record |
| SIN11165P | Controloc IV Injection 40 mg/vial | Injection | Not stated in the licence record |
| SIN14775P | Pantoprazole Sandoz Gastro Resistant Tablets 40 mg | Enteric coated tablet | Not stated in the licence record |
| SIN16905P | Pantoprazole-AFT Powder for Injection 40 mg/vial | Lyophilized powder for injection | Not stated in the licence record |
A total of 14 valid single-ingredient licences exist, covering oral enteric-coated or delayed-release tablets (20 mg and 40 mg) and intravenous injection.
Safety Considerations
- Disease associations from the knowledge graph (not label text): osteoporosis, postmenopausal osteoporosis, bone fracture and pernicious anemia are flagged. Bone health and vitamin B12 status deserve attention in long-term use.
- Drug Interactions: 100 interactions were found in total. Major-level interactions in the sample reviewed include acalabrutinib and atazanavir. Moderate interactions include hydrochlorothiazide, atorvastatin, bosutinib, fenofibrate, amphotericin B, amikacin, alpelisib, apalutamide, amphetamine and bumetanide.
Please refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Pantoprazole is already marketed in Singapore with 14 licences, and active peptic ulcer disease is essentially an on-label use. Phase 3 evidence and double-blind comparisons support acid suppression for ulcer healing.
To proceed, the following is needed:
- Package insert warnings and contraindications, including the indication text for each Singapore licence (currently missing)
- Detailed mechanism of action data
- A long-term monitoring plan for bone health and vitamin B12 status
- Review of major interactions (acalabrutinib, atazanavir) before co-prescribing
Other predictions in the data (for reference):
- Duodenal ulcer and gastric ulcer: on-label, L1, Proceed with Guardrails.
- Peptic ulcer perforation, gastrojejunal ulcer and duodenogastric reflux: only indirect or limited evidence, so research questions at most.
- Duodenal obstruction, acne, smouldering systemic mastocytosis and lymphoadenopathic mastocytosis with eosinophilia: model prediction only, with no supporting evidence, so Hold.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.