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Naftin (NAFTIFINE)
Naftin works by inhibiting the synthesis of ergosterol in fungal cell membranes.
Naftifine, marketed by Legacy Pharma, is an antifungal treatment primarily indicated for interdigital tinea pedis, with a key composition patent expiring in 2028. Its mechanism of action, which inhibits ergosterol synthesis in fungal cell membranes, provides a targeted approach to treating fungal infections. The primary risk is the competitive landscape, including off-patent drugs like selenium sulfide and ciclopirox, which are widely available as generics.
At a glance
| Generic name | NAFTIFINE |
|---|---|
| Sponsor | Legacy Pharma |
| Drug class | Allylamine Antifungal |
| Target | Sigma non-opioid intracellular receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1988 |
Mechanism of action
Naftifine hydrochloride gel is topical antifungal drug [see Clinical Pharmacology (12.4)].
Approved indications
- Interdigital tinea pedis
Common side effects
- application site reactions
Key clinical trials
- Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis (PHASE1)
- Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis (PHASE1)
- BE Study of Naftifine HCL (PHASE3)
- Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis (PHASE1)
- Pediatric Subjects With Tinea Corporis (PHASE4)
- An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis (PHASE4)
- Safety and Efficacy of NAFT900 in Children With Tinea Capitis (PHASE2)
- Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis (PHASE4)
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 |