Dexlansoprazole
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Dexlansoprazole: proton pump inhibitor → gastroduodenitis
One-Sentence Summary
Dexlansoprazole is a proton pump inhibitor, an acid-suppressing drug taken as a modified-release capsule. The TxGNN model predicts it may be effective for gastroduodenitis, but the data compiled for this report contain no clinical trials and no publications for this disease. The prediction is a computational signal only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | gastroduodenitis |
| TxGNN Prediction Score | 0.9998 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (11 of 11) – CDSCO approval status is not included in this data |
| Number of Listed Products | 11 (valid: 11) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Dexlansoprazole belongs to the proton pump inhibitor class, which reduces gastric acid secretion.
Gastroduodenitis is an inflammation of the stomach and duodenal lining. Acid suppression could plausibly ease symptoms of acid-related mucosal inflammation, because less acid reaches the irritated tissue. This is a reasoned hypothesis and has not been tested in any trial or publication supplied here.
The high score of 0.9998 reflects a computational prediction. It should not be read as evidence of clinical benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 59177 | Dexolan Capsule MR | Strip of 10 capsule MR | Not recorded |
| 64032 | Dexsofighter 60 Capsule MR | Strip of 10 capsule MR | Not recorded |
| 58377 | DDR 60 Capsule MR | Strip of 10 capsule MR | Not recorded |
| 58423 | DDR 30 Capsule MR | Strip of 10 capsule MR | Not recorded |
| 58342 | Deltone Capsule MR | Strip of 10 capsule MR | Not recorded |
All 11 licences are currently valid, and none is cancelled. Only the first five are listed here.
Safety Considerations
- Drug Interactions: 118 interactions were found in the interaction query. Examples:
- Major: acalabrutinib, atazanavir
- Moderate: fosamprenavir, foscarnet, fostamatinib, furosemide, gefitinib, hydrochlorothiazide, amphotericin B, amikacin, amphetamine, ampicillin, bosutinib, bumetanide
- Minor: acetylsalicylic acid, axitinib, brivaracetam, cyanocobalamin
Package insert warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for them.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support for gastroduodenitis is a model prediction, with no clinical trials or publications. This places the evidence at L5. A plausible acid-suppression rationale is not enough to move forward.
To proceed, the following is needed:
- Clinical or observational studies that directly address gastroduodenitis
- Detailed mechanism-of-action data
- Package insert warnings and contraindications, to allow a safety review
- A 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.