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terbinafine hydrogen chloride
Terbinafine inhibits fungal squalene epoxidase, blocking ergosterol synthesis and causing fungal cell membrane disruption and death.
Terbinafine inhibits fungal squalene epoxidase, blocking ergosterol synthesis and causing fungal cell membrane disruption and death. Used for Onychomycosis (fungal nail infection), Tinea pedis (athlete's foot), Tinea corporis (ringworm).
At a glance
| Generic name | terbinafine hydrogen chloride |
|---|---|
| Also known as | Lamisil |
| Sponsor | Novartis |
| Drug class | Allylamine antifungal |
| Target | Squalene epoxidase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Dermatology |
| Phase | Phase 3 |
Mechanism of action
Terbinafine is a fungicidal agent that selectively inhibits the enzyme squalene epoxidase in the fungal sterol synthesis pathway. By blocking ergosterol production, an essential component of fungal cell membranes, the drug causes membrane instability and fungal cell death. It is particularly effective against dermatophytes and has broad antifungal activity.
Approved indications
- Onychomycosis (fungal nail infection)
- Tinea pedis (athlete's foot)
- Tinea corporis (ringworm)
- Tinea cruris (jock itch)
Common side effects
- Headache
- Diarrhea
- Rash
- Dyspepsia
- Taste disturbance
- Hepatotoxicity
- Stevens-Johnson syndrome
Key clinical trials
- Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail (PHASE3)
- Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis (PHASE3)
- Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail (PHASE3)
- Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis (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 |
|---|---|
| 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:
- terbinafine hydrogen chloride CI brief — competitive landscape report
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- Novartis portfolio CI