Nystatin
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Nystatin: Disease of orbital region
One-Sentence Summary
Nystatin is a polyene antifungal medicine marketed in Canada in oral and topical products. The TxGNN model predicts it may be effective for disease of orbital region, but the data compiled for this report contain no clinical trials and no publications that study this condition with nystatin. The prediction rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Disease of orbital region |
| TxGNN Prediction Score | 0.9990 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 10 of 11; cancelled: 1) |
| Number of DINs | 11 (marketed: 10) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the compiled data. Nystatin belongs to the polyene antifungal class. Polyenes bind ergosterol in fungal cell membranes, which disrupts the membrane and kills the fungus.
No plausible mechanistic link between this antifungal action and orbital disease was identified. Orbital disease covers many non-fungal conditions, such as inflammatory, vascular and neoplastic problems. Nystatin has no recognised effect on these. The high score (0.9990) is a model output only and is not backed by any study of nystatin in the orbit.
Clinical Trial Evidence
One trial was linked to this prediction. It is not relevant evidence.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03178149 | Phase 1 | Recruiting | 42 | Tests ASP7317, a cell-based therapy, for geographic atrophy in age-related macular degeneration. It does not involve nystatin and does not address orbital disease. |
Literature Evidence
Currently no related literature available.
Canada Market Information
Nystatin products are marketed in Canada. Of the 11 licences on record, 10 are valid and 1 is cancelled. The records contain no indication text or dosage form.
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 00792667 | PMS-NYSTATIN SUSPENSION 100000 UNIT/ML | Not listed | Not listed |
| 02194201 | TEVA-NYSTATIN | Not listed | Not listed |
| 02433443 | JAMP-NYSTATIN ORAL SUSPENSION USP | Not listed | Not listed |
| 00716871 | NYADERM | Not listed | Not listed |
| 02022818 | THERADERM CREAM | Not listed | Not listed |
Safety Considerations
- Drug Interactions: 100 potential interactions were identified in the interaction database, but their severity levels are unclassified. Examples include cyclosporine, fluconazole, erythromycin, azithromycin, tramadol, lorazepam and bortezomib. These need review before any new use is considered.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no supporting clinical trials or publications and no plausible mechanism. The only linked trial is unrelated to nystatin. The evidence level is L5, so the model score alone does not justify moving forward.
To proceed, the following is needed:
- A defined mechanistic hypothesis for how an antifungal would act on a specific orbital condition
- Published or registered studies that directly examine nystatin in orbital disease
- Package insert warnings and contraindications for the Canadian products
- Severity classification of the listed drug interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.