Cromoglicic Acid
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Cromoglicic acid: mast cell stabilizer → ulcerative proctosigmoiditis
One-Sentence Summary
Cromoglicic acid is a mast cell stabilizer that is currently marketed in Canada as an eye drop and a nasal product. The TxGNN model predicts it may be effective for ulcerative proctosigmoiditis, with a score of 0.9999. No clinical trials or publications were found for this disease, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | ulcerative proctosigmoiditis |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 2 of 2) |
| Number of DINs | 2 (marketed: 2) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Cromoglicic acid is generally known as a mast cell stabilizer. Mast cell activation may contribute to mucosal inflammation in the distal colon in ulcerative colitis, which gives a plausible but unvalidated link to ulcerative proctosigmoiditis.
Oral absorption of the drug is poor (under 1%), so it could in principle act locally in the gut. This is a hypothesis only. No trial or publication was supplied to support it, and the high TxGNN score is a computational prediction rather than evidence of benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02009277 | CROMOLYN EYE DROPS | Not recorded | Not recorded |
| 00500895 | NALCROM | Not recorded | Not recorded |
Both licences are single-ingredient products and both are currently valid.
Safety Considerations
- Drug Interactions: The interaction screen returned 100 records. Only one is rated Moderate: inhaled rapid-acting human insulin. The others shown are of unknown severity, including theophylline, tramadol, lorazepam, valproic acid, erythromycin, fluconazole, metoprolol and valsartan. The clinical significance of these has not been established.
Package insert warnings and contraindications were not available. Please refer to the package insert for further safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a very high model score but no supporting clinical trials or publications for ulcerative proctosigmoiditis, so it stays at evidence level L5. The mast cell rationale is plausible but untested, and the poor oral absorption makes the route and formulation question important.
To proceed, the following is needed:
- A systematic literature search on mast cell stabilizers in ulcerative colitis and proctitis
- Mechanism of action data
- Health Canada package insert warnings and contraindications
- An assessment of whether a rectal or locally acting formulation is feasible
- Preclinical or early clinical data in distal ulcerative colitis
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.