Mesalazine
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
- Mesalazine
- Pharmacist Assessment Report
- Mesalazine: Congenital hypotrichosis with juvenile macular dystrophy
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Mesalazine: Congenital hypotrichosis with juvenile macular dystrophy
One-Sentence Summary
Mesalazine (5-aminosalicylic acid) was originally used to treat ulcerative colitis and other inflammatory bowel conditions. The TxGNN model predicts it may be effective for congenital hypotrichosis with juvenile macular dystrophy, but there are currently 0 clinical trials and 0 publications supporting this prediction, so the evidence rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Congenital hypotrichosis with juvenile macular dystrophy |
| TxGNN Prediction Score | 0.9965 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, mesalazine is an aminosalicylate anti-inflammatory agent, its efficacy in ulcerative colitis is established, but a mechanistic link to the predicted indication has not been identified.
Congenital hypotrichosis with juvenile macular dystrophy is an ultra-rare hereditary disorder caused by CDH3 mutation. No inflammatory pathway that mesalazine could plausibly modulate has been identified. The high score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
Other predictions in the ranked list were also reviewed. Rheumatoid arthritis (indirect evidence via sulfasalazine, which is metabolised to mesalazine) and osteoarthritis (a loose anti-inflammatory rationale) have somewhat more plausible rationales. Both are still at the “Hold” stage and do not alter the decision for the lead prediction.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 10254Q | Pentasa | Sachet containing prolonged release granules, 4 g per sachet | Not available in the data compiled for this report |
Safety Considerations
- Contraindications flagged in the knowledge graph (these are graph-derived associations, not product label text): kidney disease, pyoureter, liver disease, gallbladder disease, neutropenia, agranulocytosis, anaemia, macrocytic anaemia, pyloric stenosis, lipoid nephrosis and interstitial nephritis.
- Drug Interactions: 100 interactions were identified. Those listed include:
- Major: cidofovir; human botulinum neurotoxin A/B immune globulin.
- Moderate (examples): NSAIDs (ketorolac, ibuprofen, celecoxib, bromfenac), azathioprine, aminoglycosides (amikacin), amphotericin B formulations, acyclovir, cisplatin, bacitracin, capreomycin, and sulfonylureas (acetohexamide, chlorpropamide).
- Many of these relate to additive nephrotoxicity, so renal function monitoring is relevant.
For full safety information, including warnings, please refer to the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a model score. There are no clinical trials or publications, and no plausible mechanistic link to this ultra-rare genetic disorder. The evidence level is L5.
To proceed, the following is needed:
- Mechanistic data showing that mesalazine can act on CDH3-related pathology
- Preclinical evidence (for example, in vitro or animal models) in the predicted condition
- Mechanism of action data for mesalazine
- Approved indication text and PI warnings and contraindications for the Australian product
- Consideration of better-supported candidates from the ranked list, such as rheumatoid arthritis or osteoarthritis, which still lack direct mesalazine evidence
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.