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Luzu (LULICONAZOLE)
Luzu works by inhibiting the growth of fungi by targeting a specific enzyme.
Luzu (Luliconazole) is a small molecule azole antifungal medication originally developed by Medicis and currently owned by Bausch. It is FDA-approved to treat fungal infections of the skin, including tinea corporis, tinea cruris, and tinea pedis. Luzu works by inhibiting the growth of fungi, specifically by targeting the enzyme lanosterol 14α-demethylase. As a patented medication, Luzu is not yet available as a generic. Key safety considerations include potential skin irritation and allergic reactions.
At a glance
| Generic name | LULICONAZOLE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Azole Antifungal [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2013 |
Mechanism of action
Luliconazole Cream, 1% is an azole antifungal [see Microbiology (12.4)].
Approved indications
- Tinea corporis
- Tinea cruris
- Tinea pedis
Common side effects
- Application site reactions
- Contact dermatitis
- Cellulitis
Key clinical trials
- Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor. (PHASE4)
- Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis (PHASE1)
- Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris (PHASE4)
- Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris (PHASE4)
- Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis (PHASE4)
- Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis (PHASE2,PHASE3)
- Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis (PHASE1,PHASE2)
- Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot) (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Luzu CI brief — competitive landscape report
- Luzu updates RSS · CI watch RSS
- Bausch Health portfolio CI