Terbinafine
- Generic Name
- Terbinafine
- Brand Names
- Lamisil, Silka Cream
- Drug Type
- Small Molecule
- Chemical Formula
- C21H25N
- CAS Number
- 91161-71-6
- Unique Ingredient Identifier
- G7RIW8S0XP
- Background
Terbinafine hydrochloride (Lamisil) is a synthetic allylamine antifungal. It is highly lipophilic in nature and tends to accumulate in skin, nails, and fatty tissues. Like other allylamines, terbinafine inhibits ergosterol synthesis by inhibiting the fungal squalene monooxygenase (also called squalene epoxidase), an enzyme that is part of the fungal cell wall synthesis pathway.
Terbinafine hydrochloride was granted FDA approval on 30 December 1992.
- Indication
Terbinafine hydrochloride is indicated to treat fungal skin and nail infections caused by Trichophyton species, Microsporum canis, Epidermophyton floccosum, and Tinea species. Terbinafine hydrochloride also treats yeast infections of the skin caused by Candida species and Malassezia furfur.
- Associated Conditions
- Onychomycosis, Pityriasis versicolor, Sporotrichosis, Tinea Capitis, Tinea Corporis, Tinea Cruris, Tinea Pedis, Cutaneous candidiasis, Severe Tinea Corporis, Severe Tinea Cruris, Severe Tinea Pedis
Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis
- First Posted Date
- 2010-11-23
- Last Posted Date
- 2012-10-25
- Lead Sponsor
- Moberg Pharma AB
- Target Recruit Count
- 250
- Registration Number
- NCT01246518
- Locations
- 🇸🇪
15 Locations, Sweden, Sweden
Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis
- Conditions
- Onychomycosis
- Interventions
- Other: Purified Water
- First Posted Date
- 2010-03-03
- Last Posted Date
- 2012-10-19
- Lead Sponsor
- Nitric BioTherapeutics, Inc
- Target Recruit Count
- 168
- Registration Number
- NCT01080079
- Locations
- 🇺🇸
Temple University Schoool of Podiatric Medicine, Philadelphia, Pennsylvania, United States
🇺🇸International Clinical Research, LLC, Sanford, Florida, United States
🇨🇦Lynderm Research, Inc, Markham, Ontario, Canada
Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo
- Conditions
- Tinea Pedis
- Interventions
- First Posted Date
- 2009-11-16
- Last Posted Date
- 2015-01-27
- Lead Sponsor
- Bayer
- Target Recruit Count
- 220
- Registration Number
- NCT01013909
Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2009-02-02
- Last Posted Date
- 2023-05-30
- Lead Sponsor
- Teva Pharmaceuticals USA
- Target Recruit Count
- 22
- Registration Number
- NCT00833664
- Locations
- 🇺🇸
Novum Pharmaceutical Research Services, Pittsburgh, Pennsylvania, United States
Terbinafine HCl 250 mg Tablet Under Fasting Conditions
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2009-02-02
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- Teva Pharmaceuticals USA
- Target Recruit Count
- 28
- Registration Number
- NCT00833586
- Locations
- 🇺🇸
Novum Pharmaceutical Research Services, Pittsburgh, Pennsylvania, United States
Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis
- Conditions
- Onychomycosis/Onycholysis and Tinea Pedis
- Interventions
- First Posted Date
- 2008-06-05
- Last Posted Date
- 2008-06-05
- Lead Sponsor
- NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
- Target Recruit Count
- 56
- Registration Number
- NCT00691184
- Locations
- 🇺🇸
TKL Research Inc., Paramus, New Jersey, United States
Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2008-04-01
- Last Posted Date
- 2024-04-23
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Target Recruit Count
- 36
- Registration Number
- NCT00647647
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2008-04-01
- Last Posted Date
- 2024-04-23
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Target Recruit Count
- 36
- Registration Number
- NCT00648713
- Locations
- 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States
Bioequivalency Study of Terbinafine Tablets Under Fed Conditions
- Conditions
- Onychomycosis
- First Posted Date
- 2008-01-28
- Last Posted Date
- 2018-01-23
- Lead Sponsor
- Roxane Laboratories
- Target Recruit Count
- 30
- Registration Number
- NCT00602251
- Locations
- 🇺🇸
Gateway Medical Research, Inc., Saint Charles, Missouri, United States
Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions
- Conditions
- Onychomycosis
- First Posted Date
- 2008-01-28
- Last Posted Date
- 2018-01-23
- Lead Sponsor
- Roxane Laboratories
- Target Recruit Count
- 30
- Registration Number
- NCT00602342
- Locations
- 🇺🇸
Gateway Medical Research, Inc., Saint Charles, Missouri, United States
Drug Development Updates
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