Dexlansoprazole
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Dexlansoprazole: proton pump inhibitor → gastroduodenitis
One-Sentence Summary
Dexlansoprazole is an acid-suppressing drug (proton pump inhibitor) that is currently marketed in Canada. The TxGNN model predicts it may be effective for gastroduodenitis, but this rests on a prediction score alone, with 0 clinical trials and 0 publications currently supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | gastroduodenitis |
| TxGNN Prediction Score | 0.9998 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 4 of 4) |
| Number of DINs | 4 (marketed: 4) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available. Dexlansoprazole belongs to the proton pump inhibitor class, which reduces stomach acid production.
Gastroduodenitis is inflammation of the stomach and duodenal lining. Because acid can aggravate mucosal inflammation, suppressing acid may relieve symptoms of acid-related inflammation. This is a plausible but unconfirmed link: no clinical trials or publications were found that study this disease directly, so the prediction is not yet backed by actual evidence.
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02354969 | DEXILANT | Not recorded | Not recorded |
| 02354950 | DEXILANT | Not recorded | Not recorded |
| 02529025 | APO-DEXLANSOPRAZOLE | Not recorded | Not recorded |
| 02528991 | APO-DEXLANSOPRAZOLE | Not recorded | Not recorded |
All four single-ingredient licences are currently valid.
Safety Considerations
- Drug Interactions: 100 interactions were found in the data compiled for this report. Examples:
- Major: acalabrutinib, atazanavir
- Moderate: furosemide, hydrochlorothiazide, amphotericin B, amikacin, gefitinib, bosutinib, fosamprenavir, foscarnet, fostamatinib, bumetanide, ampicillin, amphetamine
- Minor: acetylsalicylic acid, axitinib, brivaracetam, cyanocobalamin
Please refer to the package insert for other safety information, including warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high (0.9998), but there are no clinical trials or publications that study gastroduodenitis directly, so the evidence level is L5. Acid suppression offers a plausible mechanism, but it has not been tested for this condition.
To proceed, the following is needed:
- Clinical or literature evidence that directly studies dexlansoprazole in gastroduodenitis
- Detailed mechanism of action data
- Package insert warnings and contraindications from Health Canada
- Review of the major interactions (acalabrutinib, atazanavir) for the intended patient population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.