Amorolfine
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Amorolfine: From Onychomycosis to Drug-Induced Osteoporosis
One-Sentence Summary
Amorolfine is a morpholine-class antifungal agent widely used as a topical nail lacquer for the treatment of onychomycosis (fungal nail infections). The TxGNN model predicts it may be effective for Drug-Induced Osteoporosis, however there are currently 0 clinical trials and 0 publications supporting this direction — the prediction is supported by computational modelling only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Onychomycosis (fungal nail infections) — regulatory source unavailable; based on known pharmacological profile |
| Predicted New Indication | Drug-Induced Osteoporosis |
| TxGNN Prediction Score | 99.998% |
| Evidence Level | L5 |
| Singapore Market Status | ✗ Not Marketed |
| Number of Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available from the Evidence Pack. Based on known pharmacological information, Amorolfine belongs to the morpholine class of antifungals and works by inhibiting two key enzymes in the fungal ergosterol biosynthesis pathway (Δ14-reductase and Δ7,8-isomerase), ultimately disrupting fungal cell membrane integrity. Its efficacy in treating onychomycosis has been clinically established, predominantly via topical nail lacquer formulations.
Drug-induced osteoporosis, however, is a metabolic bone disease typically caused by agents such as corticosteroids, aromatase inhibitors, or proton pump inhibitors — all of which interact with the RANK-L/OPG axis, osteoblast/osteoclast homeostasis, or calcium metabolism. There is no known mechanistic intersection between Amorolfine's ergosterol-targeting pathway and mammalian bone remodelling biology.
The Evidence Pack's own mechanistic rationale notes that "no known overlap exists between Amorolfine's antifungal target pathway and bone metabolism pathways relevant to drug-induced osteoporosis, and no supporting literature or trials have been identified." This significantly limits confidence in this prediction's biological plausibility.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
Amorolfine is currently not registered in Singapore. No marketing authorisations were found in the regulatory dataset.
Note: Amorolfine nail lacquer (e.g., Loceryl®) is approved in multiple markets including the EU, Japan, Australia, and South Korea. Its absence from the Singapore register may warrant a separate market access review independent of this repurposing evaluation.
Safety Considerations
Please refer to the package insert for safety information. No warnings, contraindications, or drug interaction data were available in this Evidence Pack.
Conclusion and Next Steps
Decision: Hold
Rationale: There is no clinical trial evidence, no published literature, and no established mechanistic link connecting Amorolfine's antifungal mode of action to the pathophysiology of drug-induced osteoporosis. All 10 TxGNN-predicted indications for this drug returned L5 evidence with a Hold recommendation, indicating that the model's predictions are currently unsupported by any real-world data. Further investment in this repurposing candidate is not justified at this time without additional biological rationale.
To proceed, the following is needed:
- MOA clarification: Confirm whether any sterol-pathway metabolites of Amorolfine have off-target effects on mammalian bone metabolism (e.g., via cholesterol/osteocalcin interactions)
- Preclinical data: Any in vitro or animal studies demonstrating Amorolfine activity in osteoblast/osteoclast systems would be required before elevating evidence to L4
- Singapore regulatory gap: Review feasibility of Singapore market entry for the base indication (onychomycosis) before considering repurposing
- TFDA package insert: Retrieve and parse the approved prescribing information to complete safety profiling (currently Blocking data gap DG001)
- DrugBank MOA query: Retrieve full DrugBank entry to complete mechanism of action documentation (currently High-severity data gap DG002)
- Re-evaluation trigger: If any new preclinical publications emerge linking ergosterol-pathway inhibitors to bone biology, this candidate should be re-queued for evidence collection
⚠️ Disclaimer: This report is for research reference only and does not constitute medical advice. Drug repurposing candidates require clinical validation before any therapeutic application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.