Ilaprazole
| Evidence Level: L2 | Predicted Indications: 1 |
Table of Contents
Ilaprazole: Gastroduodenitis
One-Sentence Summary
Ilaprazole is a proton pump inhibitor that reduces gastric acid secretion. The TxGNN model predicts it may be effective for gastroduodenitis. Support currently consists of 1 randomised, double-blind trial publication in gastric and duodenal ulcers and no registered clinical trials for this condition.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Gastroduodenitis |
| TxGNN Prediction Score | 0.9952 |
| Evidence Level | L2 |
| 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 | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available for this drug. Available pharmacology data show that ilaprazole acts on ATP4A, the gastric proton pump of parietal cells, and inhibits secretion of H⁺ ions (gastric acid). It is reported to do this more potently than omeprazole.
Gastroduodenitis is inflammation of the stomach and duodenal lining. Strong, sustained acid suppression is mechanistically plausible as a way to reduce acid-related mucosal injury and support healing in both organs. The one linked trial studied ilaprazole against omeprazole in gastric and duodenal ulcers, which involve the same mucosal tissues.
This remains a mechanistic inference. No registered trial targets gastroduodenitis itself, so dedicated confirmation is still needed.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 19434360 | 2009 | RCT (randomised, parallel, double-blind) | Journal of Gastroenterology | Compared the ulcer-healing effects of ilaprazole and omeprazole in gastric and duodenal ulcers. It was the first study of ilaprazole in patients with ulcer disease. |
India Market Information
At least 20 single-ingredient licences are currently valid, and none are cancelled. The list below shows five of them and may be partial.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 108413 | Iladif 10mg Tablet | Strip of 10 tablets | Overseas Healthcare Pvt Ltd |
| 15005 | Ambila 10mg Tablet | Strip of 10 tablets | Ambience Pharma |
| 107991 | Iladac 10 Tablet | Strip of 10 tablets | Zydus Cadila |
| 108021 | Ilapro 10 Tablet | Strip of 10 tablets | Ajanta Pharma Ltd |
| 110365 | Ilabest 10mg Tablet | Strip of 10 tablets | Lupin Ltd |
All listed products are oral tablets.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale:
- The evidence level is L2, based on one randomised, double-blind trial of ilaprazole against omeprazole in gastric and duodenal ulcers, with no phase 3 programme. The mechanism is plausible and the drug is widely marketed in India, but no trial targets gastroduodenitis itself.
To proceed, the following is needed:
- A prospective trial, or well-designed comparative study, in patients with gastroduodenitis.
- Package insert warnings and contraindications from the local regulator, to complete the safety screening.
- Detailed mechanism-of-action data from DrugBank to support the mechanistic analysis.
- Confirmation of the approved indication text on the local licences.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.