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 used for fungal nail infections (onychomycosis). The TxGNN model predicts it may be effective for drug-induced osteoporosis, but there are currently no registered clinical trials and no publications supporting this prediction, and no plausible mechanistic link has been identified.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Fungal nail infection (onychomycosis), based on the known clinical use of the product. The approved indication text was not available in the data compiled for this report. |
| Predicted New Indication | Drug-induced osteoporosis |
| TxGNN Prediction Score | 1.0000 |
| 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 in the data compiled for this report. Based on known pharmacology, amorolfine is a topical morpholine antifungal. It inhibits ergosterol biosynthesis in fungi (delta-14 reductase and delta-7,8 isomerase), which explains its efficacy in onychomycosis.
There is no clear mechanistic link between this action and bone metabolism. Systemic exposure after topical nail application is minimal, so no plausible pathway to osteoporosis has been identified. The very high score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
The same applies to the other nine predicted indications (for example disease of retroperitoneum, lumbar spinal stenosis, abdominal ectopic pregnancy and sacrum chordoma). All are Level L5 (model prediction only), with no mechanistic rationale, and are recommended as Hold.
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 4010C | Loceryl | Nail treatment kit containing nail lacquer 50 mg (base) per mL (5%), 5 mL, 60 isopropyl alcohol cleaning pads, 10 spatulas and 30 nail files | Not stated in the data compiled for this report (clinically used topically for onychomycosis) |
Safety Considerations
- Drug Interactions: One pharmacology-based entry was recorded, namely an interaction with the Nav1.7 sodium channel (SCN9A) target. No clinically graded drug-drug interactions were identified, and the clinical significance of this entry is unclear.
For warnings and contraindications, please refer to the TGA-approved Product Information (PI). Because amorolfine is applied topically to the nail, systemic safety for a bone indication has not been assessed.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone (Level L5). There are no clinical trials or publications, no plausible mechanism linking a topical antifungal with minimal systemic absorption to bone metabolism, and the formulation is a nail lacquer, which is not suited to a systemic bone indication.
To proceed, the following is needed:
- Mechanistic evidence for any effect of amorolfine on bone metabolism (including the detailed MOA)
- Evidence of relevant systemic exposure, or a suitable formulation and route of administration
- Preclinical data supporting activity in drug-induced osteoporosis
- Warnings and contraindications from the TGA-approved Product Information (PI)
- The approved indication text for the ARTG entry
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.