Nystatin
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Nystatin: Disease of orbital region
One-Sentence Summary
Nystatin is a topical polyene antifungal. The TxGNN model ranks disease of orbital region as its top predicted new indication (score 0.9990), but no study directly addresses this disease: the single linked trial tests an unrelated product in retinal disease, and no literature was found. This is a model-only prediction.
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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (1 of 1) – CDSCO approval status is not included in this data |
| Number of Listed Products | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data for nystatin are not available in the data compiled for this report. As a class, polyene antifungals bind ergosterol in fungal cell membranes, forming pores that kill the fungus. That activity is relevant to fungal infection of the skin and mucosa.
No plausible mechanistic link to disease of orbital region was identified. The only associated trial (NCT03178149) tests ASP7317 in geographic atrophy secondary to age-related macular degeneration. It does not involve nystatin and concerns the retina rather than the orbit. The high score is therefore not supported by clinical evidence and should be treated as a computational signal only.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03178149 | Phase 1 | Recruiting | 42 | Dose-escalation safety study of ASP7317 in geographic atrophy secondary to age-related macular degeneration. Does not involve nystatin and does not study orbital disease; the match appears spurious. |
Literature Evidence
Currently no related literature available.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 151372 | Nistin 100000IU Ointment (Jawa Pharmaceuticals Pvt Ltd) | Tube of 3 g ointment | Not stated in the registration record |
One valid single-ingredient licence is on record, and the drug is marketed.
Safety Considerations
- Drug Interactions: 347 potential interactions are recorded, all with an unspecified severity level. Examples include cyclosporine, fluconazole, erythromycin, azithromycin, tramadol, lorazepam, bortezomib, sildenafil, valsartan and ramipril.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on the model score. No study, trial or literature addresses nystatin in disease of orbital region, and the one linked trial is unrelated. There is no mechanistic basis for efficacy in this condition.
To proceed, the following is needed:
- Any direct preclinical or clinical evidence of nystatin in orbital disease
- Mechanism-of-action data and a rationale for the orbital site, including route feasibility (the available product is a topical ointment)
- Package insert warnings and contraindications for the local product
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.