Amorolfine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Amorolfine: From Fungal Nail Infection to Drug-Induced Osteoporosis
One-Sentence Summary
Amorolfine is a topical morpholine antifungal, marketed in Singapore as a nail lacquer for fungal nail infections (onychomycosis). The TxGNN model predicts it may be effective for drug-induced osteoporosis, but there are currently 0 clinical trials and 0 publications supporting this direction, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Fungal nail infection (onychomycosis) (the Singapore licence records contain no indication text; this is based on the drug's known clinical use) |
| Predicted New Indication | Drug-induced osteoporosis |
| TxGNN Prediction Score | 99.998% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 2 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on general pharmacology, amorolfine is a morpholine antifungal that inhibits fungal sterol delta-14 reductase and delta-7,8 isomerase, which disrupts ergosterol synthesis in the fungal cell membrane.
No established mechanism links this action to bone metabolism. Amorolfine is applied topically to the nail, so systemic exposure is minimal, which further weakens the biological plausibility of an effect on osteoporosis. The high TxGNN score reflects connectivity in the knowledge graph and is not backed by any trial or publication.
The other top-ranked predictions (for example disease of retroperitoneum, lumbar spinal stenosis, sacrum chordoma and urethral disease) show the same pattern. Several are broad anatomical categories or conditions with no pharmacological connection to an antifungal. Their scores are all very close (99.996% to 99.998%), and none has supporting clinical or literature evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN07506P | LOCERYL NAIL LACQUER 5% | Solution | Not stated in licence record (nail lacquer for fungal nail infection) |
| SIN14604P | AMOROLFINE NAIL LACQUER 5% W/V | Solution | Not stated in licence record (nail lacquer for fungal nail infection) |
Both licences are valid single-ingredient products, and no licences have been cancelled.
Safety Considerations
- Drug Interactions: The data compiled for this report show only a pharmacology record, not a clinical drug-drug interaction. It lists the voltage-gated sodium channel Nav1.7 (SCN9A) as a target of amorolfine. No interaction severity level is given.
For warnings and contraindications, please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction of drug-induced osteoporosis is supported only by a graph-based model score. There are no clinical trials or publications, no plausible mechanism, and minimal systemic exposure after topical nail application. Evidence is at the lowest level (L5).
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA website (a blocking gap for safety screening)
- Mechanism of action data confirmed from DrugBank
- A mechanistic or preclinical rationale linking amorolfine to bone metabolism
- An assessment of whether a topical nail formulation can reach the exposure needed for a systemic bone indication, since route compatibility has not been evaluated
- Any trial or literature evidence for the predicted indication; otherwise the prediction should not advance beyond screening
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.