Luliconazole
| Evidence Level: L3 | Predicted Indications: 7 |
Table of Contents
Luliconazole: From Topical Antifungal Cream to Pityriasis Versicolor
One-Sentence Summary
Luliconazole is an imidazole antifungal, marketed in the US as a topical cream. The TxGNN model predicts it may be effective for pityriasis versicolor, a superficial skin infection caused by Malassezia yeast. Support so far is 1 registered trial that has not yet started recruiting, 1 published comparative randomized trial (2016) without an available abstract, and in vitro activity data.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Pityriasis versicolor |
| TxGNN Prediction Score | 99.13% |
| Evidence Level | L3 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 2 (both under NDA204153) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Luliconazole inhibits sterol 14-α-demethylase (CYP51) in fungal cells, which blocks ergosterol synthesis (PMID 29198426). Laboratory work shows broad activity against dermatophytes, Candida and Malassezia species. Malassezia is the organism that causes pityriasis versicolor. The dedicated mechanism-of-action field in the source data is empty, so this description comes from the literature abstract.
The approved indication text is not included in the data provided. Luliconazole is a topical antifungal for skin infections, and the literature describes it as already used clinically for dermatophyte infections. Pityriasis versicolor is another superficial fungal skin infection, and topical azoles are a standard treatment class for it. The prediction is therefore mechanistically plausible and close to the existing use. Cream is also the right route for a skin infection, and the topical safety profile is established from marketed use.
The clinical evidence for this specific disease is still thin. The main signal is a 2016 comparative trial against ketoconazole, and a Phase 4 head-to-head trial is planned but has no results.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07333170 | Phase 4 | Not yet recruiting | 86 | Randomized comparison of luliconazole 2% cream vs ketoconazole 1% cream in pityriasis versicolor. Planned to start 2026-02 and complete 2026-11. No results yet. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27559523 | 2016 | Comparative RCT (prospective, open-label) | Indian Dermatol Online J | Compares topical ketoconazole and topical luliconazole in pityriasis versicolor at a tertiary hospital in eastern India. No abstract is available, so results are unverified. |
| 29198426 | 2018 | In vitro | J Mycol Med | Luliconazole shows broad antifungal activity, including against Malassezia. It is described as clinically used for pityriasis versicolor. The study itself tested Candida strains. |
| 12636984 | 2003 | In vitro | Int J Antimicrob Agents | NND-502, an early name for luliconazole, was tested against three major Malassezia species and compared with lanoconazole, bifonazole and terbinafine. |
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| NDA204153 | Luzu | Cream | Bausch Health US, LLC |
| NDA204153 | Luliconazole | Cream | Oceanside Pharmaceuticals |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The TxGNN score is high and the mechanism is plausible, but there is no verified human efficacy result for pityriasis versicolor. The only comparative study has no available abstract, and the Phase 4 trial has not started. This stays a research question until results are available.
To proceed, the following is needed:
- Full text and results of the 2016 comparative trial (PMID 27559523), including design and outcomes
- Results of NCT07333170, expected after its planned completion in late 2026
- The package insert (warnings, contraindications and approved indications) to complete the safety screen and confirm how this use relates to the labeled indication
- Confirmed mechanism-of-action data from DrugBank
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.