Butenafine
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
- Butenafine
- Pharmacist Assessment Report
- Butenafine: Squalene epoxidase inhibitor (topical antifungal) → endothrix infectious disease
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Butenafine: Squalene epoxidase inhibitor (topical antifungal) → endothrix infectious disease
One-Sentence Summary
Butenafine is a topical antifungal cream. The TxGNN model predicts it may be useful for endothrix infectious disease, a dermatophyte infection in which the fungus invades the hair shaft. There are currently 0 clinical trials and 0 publications supporting this direction, so the support is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | endothrix infectious disease |
| TxGNN Prediction Score | 0.9902 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (4 of 4) – CDSCO approval status is not included in this data |
| Number of Listed Products | 4 (valid: 4) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Butenafine belongs to the benzylamine class of antifungals, which are generally understood to inhibit squalene epoxidase, an enzyme in fungal ergosterol synthesis. This class description comes from general pharmacological knowledge, not from the compiled data.
Endothrix infections occur when dermatophytes such as Trichophyton tonsurans invade the inside of the hair shaft. These organisms are plausibly susceptible to squalene epoxidase inhibition in vitro, so a mechanistic link is reasonable.
There is an important limitation. Topical butenafine penetrates the hair follicle and hair shaft poorly, and endothrix tinea capitis conventionally requires systemic therapy. The cream formulations marketed in India therefore may not reach the site of infection. The prediction currently rests on the model score alone.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 28571 | Butenaskin Cream | tube of 15 gm Cream | Not recorded |
| 116998 | Kutica Cream | tube of 15 gm Cream | Not recorded |
| 221459 | Tenafin Cream | tube of 10 gm Cream | Not recorded |
| 77405 | Exebute Cream | tube of 15 gm Cream | Not recorded |
All four licences are single-ingredient topical creams and are currently valid.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: No clinical trials or publications address endothrix infection, so the evidence level is L5 (model prediction only). Poor penetration of topical butenafine into the hair shaft further limits the plausibility of benefit as a cream.
To proceed, the following is needed:
- Clinical or in vitro data on butenafine against endothrix dermatophytes, and on hair follicle and hair shaft penetration
- Package insert warnings and contraindications from the India regulator
- Mechanism of action data confirmed from DrugBank
- Assessment of whether a route or formulation other than topical cream would be needed to reach the infection site
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.