Sertaconazole
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Sertaconazole: Ectothrix infectious disease
One-Sentence Summary
Sertaconazole is a topical imidazole antifungal that is marketed in India in cream, lotion and tablet forms. The TxGNN model predicts it may be effective for ectothrix infectious disease, with a score of 0.9959. No clinical trials or publications were found for this indication, so the support is a computational prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Ectothrix infectious disease |
| TxGNN Prediction Score | 0.9959 |
| 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?
Sertaconazole is an imidazole antifungal. It is thought to block fungal ergosterol synthesis by inhibiting lanosterol 14-alpha-demethylase. Its benzothiophene ring may also disrupt fungal membranes directly. Detailed mechanism-of-action data are not available in the data compiled for this report, so this description reflects the general behaviour of the drug class.
Ectothrix infection is a dermatophyte infection of the hair, in which fungal spores form around the outside of the hair shaft. It is typically caused by Microsporum or Trichophyton species. Sertaconazole’s activity against dermatophytes makes this link biologically plausible.
There is an important limitation. Hair-shaft infections generally need oral therapy, because topical agents reach the hair follicle poorly. The high score is a computational prediction and does not replace clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
At least 20 licences are recorded, all currently valid, and the list may be partial. Up to five main authorizations are shown below.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 207184 | Sernaz V1 Tablet VT | Strip of 1 Tablet VT | Not recorded |
| 204300 | Sertalin Cream | Tube of 30 gm Cream | Not recorded |
| 202939 | Seriva 2% Lotion | Bottle of 30 ml Lotion | Not recorded |
| 74534 | Episert Cream | Tube of 20 gm Cream | Not recorded |
| 136020 | Mycoclin Lotion | Bottle of 20 ml Lotion | Not recorded |
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on the model score and a plausible antifungal mechanism. No trials or publications address this disease, and topical delivery to the hair follicle is a major concern.
To proceed, the following is needed:
- Clinical or in vitro data on sertaconazole against ectothrix dermatophytes
- Evidence on whether a topical formulation can reach the hair shaft and follicle, or whether an oral route is required
- Detailed mechanism-of-action data
- Package insert warnings and contraindications for a safety review
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.