Drug intelligence / Profile preview

ketoconazole + urea

Development stage
Approved
Lead developer
V2 Pharma
Modality
Small Molecules
Administration
Topical
01

Overview

**Ketoconazole + urea** is a combination topical therapy consisting of *ketoconazole*, a broad-spectrum synthetic imidazole antifungal, and *urea*, a keratolytic agent. \n- **Mechanism of Action**: \n - *Ketoconazole* inhibits ergosterol synthesis in fungal cell membranes by blocking lanosterol 14-α-demethylase, leading to impaired cell membrane formation and cell death. \n - *Urea* acts as a keratolytic and hydrating agent, disrupting the hydrogen bonds in the stratum corneum, resulting in reduced skin thickness and increased moisture, as well as enhancing the penetration of other topical agents. Urea can also facilitate nonsurgical avulsion of diseased nails in onychomycosis. \n- **Indications**: Used for the topical treatment of dermatophytic and yeast fungal infections (e.g., tinea pedis, tinea corporis, tinea cruris, tinea versicolor, cutaneous candidiasis, onychomycosis), and as adjunctive therapy in seborrheic dermatitis. The rationale for combining urea and ketoconazole is that urea enhances the penetration and efficacy of ketoconazole in hyperkeratotic or thickened skin or nail conditions[1][2][3][7].\n- **Status**: Not FDA-approved as a combination; available as compounded or specialty products[1][3][7].

Brand names
PODIATROLE
Other names
ketoconazole and ureaketoconazole/ureaketoconazole 2% and urea 20% kitketoconazole 1%/urea 38% creamketoconazole 2%/urea topicalketoconazole 2%/urea/DMSO nail suspension
02

Targets

CYP51A1 (Sterol 14α-demethylase)SRD5A (Steroid 5-alpha-reductase)ALOX12 (Arachidonate 12-lipoxygenase, 12S type)

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