Dexlansoprazole
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Dexlansoprazole: From Erosive Esophagitis and GERD to Active Peptic Ulcer Disease
One-Sentence Summary
Dexlansoprazole is a proton pump inhibitor (the R-enantiomer of lansoprazole) whose marketed indications are erosive esophagitis and non-erosive GERD. The TxGNN model predicts it may be effective for active peptic ulcer disease. The evidence is thin: 20 clinical trials and 4 publications were retrieved, but none is a confirmed dexlansoprazole-specific ulcer efficacy study. Most of the support comes from other proton pump inhibitors, mainly lansoprazole.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Erosive esophagitis and non-erosive GERD (taken from the pipeline’s mechanistic notes; the license records contain no indication text) |
| Predicted New Indication | Active peptic ulcer disease |
| TxGNN Prediction Score | 99.999% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Dexlansoprazole irreversibly inhibits the gastric H+/K+ ATPase (the proton pump). This is the same mechanism that underlies ulcer healing across the PPI class, so the mechanistic link to peptic ulcer is strong.
The original indications (erosive esophagitis, non-erosive GERD) and peptic ulcer are both acid-related upper gastrointestinal diseases. Lansoprazole, the parent racemate, and other PPIs have well-established ulcer efficacy. Dexlansoprazole is not itself marketed for ulcer.
The very high TxGNN score most likely reflects class-level proximity in the knowledge graph rather than dexlansoprazole-specific ulcer data. The supplied data contain no confirmed dexlansoprazole ulcer trial. A detailed mechanism-of-action record is also not available in the source data.
Clinical Trial Evidence
Of the 20 trials retrieved, only three studied dexlansoprazole itself, and all three were in erosive esophagitis or pharmacokinetics. The others test different drugs (often with lansoprazole as comparator) or are unrelated to a PPI.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT05448001 | Phase 3 | Completed | 329 | JP-1366 vs active control in gastric ulcer. Dexlansoprazole involvement is unverified. |
| NCT05813561 | Phase 3 | Completed | 332 | DWP14012 vs esomeprazole in reflux esophagitis. Dexlansoprazole involvement is unverified. |
| NCT04840550 | Phase 3 | Unknown | 390 | Tegoprazan vs lansoprazole 15 mg for preventing NSAID-related ulcers. Lansoprazole is only the comparator. |
| NCT00251719 | Phase 3 | Completed | 2054 | Dexlansoprazole MR (60/90 mg) vs lansoprazole 30 mg in healing erosive esophagitis. Same drug, different disease. |
| NCT00251693 | Phase 3 | Completed | 2038 | Replicate dexlansoprazole MR vs lansoprazole trial in erosive esophagitis. Supports safety, not ulcer efficacy. |
| NCT03675672 | Phase 4 | Recruiting | 154 | Misoprostol plus lansoprazole vs lansoprazole alone for recurrent idiopathic ulcer bleeding. The study drug is lansoprazole. |
| NCT05010954 | Phase 3 | Completed | 400 | LXI-15028 vs lansoprazole 30 mg in duodenal ulcer over up to 6 weeks. Lansoprazole is the comparator. |
| NCT02761512 | Phase 3 | Completed | 306 | CJ-12420 vs lansoprazole 30 mg in gastric ulcer. Lansoprazole is the comparator. |
| NCT04784910 | Phase 3 | Completed | 423 | DWP14012 vs lansoprazole 15 mg for preventing NSAID-induced peptic ulcer. Lansoprazole is the comparator. |
| NCT00942175 | Phase 1 | Completed | 160 | Effect of dexlansoprazole, lansoprazole, omeprazole and esomeprazole on clopidogrel pharmacokinetics. Drug-interaction data only. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38345252 | 2024 | Systematic review / network meta-analysis | Am J Gastroenterol | Compares P-CAB and PPI efficacy and safety for healing severe (LA grade C/D) esophagitis. This is esophagitis, not ulcer. |
| 41809210 | 2026 | Expert consensus | World J Gastrointest Pharmacol Ther | Indian consensus on managing acid-peptic disorders (GERD, peptic ulcer, functional dyspepsia). Warns about prolonged unsupervised acid-suppressant use. |
| 18821474 | 2008 | Review | Curr Opin Investig Drugs | Development overview of dexlansoprazole modified release for reflux esophagitis. |
| 36150104 | 2022 | Preclinical / mechanistic | J Chin Med Assoc | Studies vacuolar ATPase suppression and ER stress by PPIs, including dexlansoprazole, in relation to gastric cancer risk. |
US Market Information
The source data list 20 authorizations. The five main ones are below. Indication text was not supplied for any of them.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA022287 | Dexlansoprazole (A-S Medication Solutions) | Capsule, delayed release | Not provided in source data |
| ANDA202294 | Dexlansoprazole (A-S Medication Solutions) | Capsule, delayed release | Not provided in source data |
| ANDA202294 | Dexlansoprazole (Bryant Ranch Prepack) | Capsule, delayed release | Not provided in source data |
| ANDA202294 | Dexlansoprazole (ENDO USA, Inc.) | Capsule, delayed release | Not provided in source data |
| ANDA202666 | Dexlansoprazole (Upsher-Smith Laboratories, LLC) | Capsule, delayed release | Not provided in source data |
Safety Considerations
Please refer to the package insert for safety information. No drug-interaction records were found in the source data.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanism is credible, but no dexlansoprazole-specific ulcer efficacy trial is confirmed. The only dexlansoprazole ulcer-adjacent trial in the data was withdrawn with 0 participants. The remaining support is class-level evidence from lansoprazole and other PPIs, which does not by itself justify pursuing a new ulcer indication. The lower-ranked predictions (ranks 2–10) are weaker still, and several are likely knowledge-graph artifacts.
To proceed, the following is needed:
- Verify the drug and indication in the truncated-title trials (NCT05448001, NCT05813561, NCT04840550) to see whether dexlansoprazole is involved
- Search for dexlansoprazole-specific ulcer healing or prevention trials, or run one
- Package insert warnings and contraindications, which are currently missing and block safety screening
- Detailed mechanism-of-action data
- Approved-indication text for the US licenses
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.