Nystatin
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Nystatin: Disease of orbital region
One-Sentence Summary
Nystatin is a polyene antifungal that is marketed in Australia as an oral suspension. The TxGNN model predicts it may be effective for disease of orbital region. However, there are 0 directly relevant clinical trials and 0 publications on this condition, so the prediction is not backed by any study evidence.
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 |
| 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?
Detailed mechanism of action data is not available in the data compiled for this report. As a polyene antifungal, nystatin is generally understood to bind ergosterol in fungal cell membranes and disrupt them. This mechanism is relevant to fungal infections.
No plausible mechanistic link between nystatin and disease of orbital region was identified. The condition is a broad category of eye-socket disorders, and the supplied data give no sign that an antifungal acts on it. The only trial linked to this prediction studies a different drug in a retinal disease. The very high score is therefore most likely a modelling artefact and should not be read as clinical support.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT03178149 | Phase 1 | Recruiting | 42 | Safety and tolerability of ASP7317 in geographic atrophy secondary to age-related macular degeneration. It does not involve nystatin and does not address an orbital disease. |
This trial is not evidence for nystatin in the predicted condition.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 10854G | Pharmacy Action Nystatin Oral Drops | Oral suspension, 100,000 units per mL, 24 mL | Not available in the data compiled for this report |
This is a single-ingredient product, and the licence is currently valid.
Safety Considerations
- Drug Interactions: The interaction screen returned 100 potential interacting drugs, with severity not classified in the source. Examples include cyclosporine, fluconazole, erythromycin, azithromycin, bortezomib, tramadol, lorazepam and sildenafil. Each should be checked against the TGA-approved Product Information (PI) before any use.
No key warnings or contraindications were available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no supporting trial or publication for this disease, and the only linked trial concerns a different drug and a retinal condition. No mechanistic rationale is apparent, so the evidence level is L5.
To proceed, the following is needed:
- Clinical or preclinical studies that directly examine nystatin in orbital region disease
- A clearer clinical definition of which orbital conditions are of interest, and whether an antifungal mechanism could plausibly apply
- Detailed mechanism of action data
- Safety information from the TGA-approved PI, including warnings, contraindications and prioritised interaction severity
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.