Luliconazole
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Luliconazole: Endothrix infectious disease
One-Sentence Summary
Luliconazole is a topical azole antifungal used for skin fungal infections. The TxGNN model predicts it may be effective for endothrix infectious disease, but currently there are no clinical trials and no publications supporting this direction, so the evidence rests on the model prediction alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Endothrix infectious disease |
| TxGNN Prediction Score | 0.9910 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available. Luliconazole belongs to the azole class of antifungals, which act against fungal cells, and it is used on the skin as a cream or lotion.
Endothrix infections (for example, those caused by Trichophyton tonsurans) are dermatophyte infections in which the fungus grows inside the hair shaft. Because dermatophytes are generally susceptible to azoles, activity is biologically plausible.
There is an important limitation. Fungus inside the hair shaft may be hard for a topical product to reach, and systemic therapy is usually the standard approach for this type of infection. At this stage the support is a model prediction only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Luliconazole is marketed in India as a single-ingredient product. The data compiled for this report show 20 valid single-ingredient licences and no cancelled ones; the list may be partial. The licence records carry no indication text. Five main authorizations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 127415 | Lucaf 1% Cream (Gary Pharmaceuticals) | Cream, 20 g tube | Not stated |
| Registration No. 123876 | Lucoz Lotion (Ajanta Pharma) | Lotion, 15 ml bottle | Not stated |
| Registration No. 121984 | Ludura Lotion (Cipla) | Lotion, 30 ml bottle | Not stated |
| Registration No. 248083 | Zole 1% Cream (Sun Pharmaceutical) | Cream, 50 g tube | Not stated |
| Registration No. 121555 | Lulimac Cream (Macleods) | Cream, 20 g tube | Not stated |
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high, but there are no clinical trials or publications for endothrix infectious disease, so the evidence level is L5. Limited penetration of a topical product into the hair shaft further weakens the case.
To proceed, the following is needed:
- Laboratory data showing luliconazole activity against endothrix-causing dermatophytes
- Evidence that topical delivery reaches the hair shaft, or an assessment of whether a systemic route would be required
- Mechanism of action data
- Package insert warnings and contraindications for the safety review
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.