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Mentax (BUTENAFINE)
Mentax (Butenafine) is a benzylamine antifungal medication originally developed by Mylan and currently owned by Bayer Healthcare LLC. It targets the cytochrome P450 2D6 enzyme and is used to treat various fungal infections such as pityriasis versicolor, tinea corporis, tinea cruris, and tinea pedis. Mentax is a small molecule modality that was FDA-approved in 1996 and is now off-patent with no active Orange Book patents. It is available as a generic medication from a single manufacturer. As an off-patent medication, Mentax is widely available and has a well-established safety profile.
At a glance
| Generic name | BUTENAFINE |
|---|---|
| Sponsor | Bayer |
| Drug class | Benzylamine Antifungal |
| Target | Cytochrome P450 2D6 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Pityriasis versicolor
- Tinea corporis
- Tinea cruris
- Tinea pedis
Common side effects
Key clinical trials
- Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test) (PHASE3)
- Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants (PHASE3)
- Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects (PHASE3)
- Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test) (PHASE3)
- SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS (PHASE2)
- Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis (PHASE1)
- Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis (PHASE1)
- Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis (PHASE1)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mentax CI brief — competitive landscape report
- Mentax updates RSS · CI watch RSS
- Bayer portfolio CI