Terbinafine

Generic Name: Terbinafine

Brand Names: Lamisil, Silka Cream

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₅N

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

Clinical Trials

Antifungal Drugs in Treatment of Onychomycosis

Phase 3

Conditions: Antifungal Drugs in Onychomycosis

Interventions: Drug: Terbinafine

First Posted Date: 2017-05-31

Last Posted Date: 2017-05-31

Lead Sponsor: Assiut University

Target Recruit Count: 60

Registration Number: NCT03171584

Three-Arm Trial of Novel Treatment for Tinea Pedis

Phase 2

Completed

Conditions: Tinea Pedis

Interventions: Drug: Experimental Drug SESC 01
Drug: Placebo
Drug: Terbinafine Hydrochloride

First Posted Date: 2017-05-02

Last Posted Date: 2017-10-06

Lead Sponsor: South End Skin Care

Target Recruit Count: 90

Registration Number: NCT03135912

Locations: 🇺🇸
Kuchnir Dermatology & Dermatologic Surgery, Milford, Massachusetts, United States

Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis

Phase 2

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: Placebo
Drug: Metronidazole
Drug: Doxycycline
Drug: Terbinafine

First Posted Date: 2015-11-17

Last Posted Date: 2021-02-10

Lead Sponsor: Hamilton Health Sciences Corporation

Target Recruit Count: 75

Registration Number: NCT02606032

Locations: 🇨🇦
Hamilton Health Sciences / McMaster University, Hamilton, Ontario, Canada

Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population

Phase 3

Completed

Conditions: Onychomycosis

Interventions: Drug: P-3058

First Posted Date: 2015-09-11

Last Posted Date: 2018-03-08

Lead Sponsor: Polichem S.A.

Target Recruit Count: 20

Registration Number: NCT02547701

Locations: 🇮🇹
Polichem Investigative site, One Investigational Site, Italy
🇪🇸
Polichem Investigative Site, One Investigational Site, Spain

Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis

Phase 4

Completed

Conditions: Onychomycosis

Interventions: Drug: Terbinafine
Device: Resin Lacquer
Drug: Amorolfine

First Posted Date: 2013-05-10

Last Posted Date: 2015-11-30

Lead Sponsor: Helsinki University Central Hospital

Target Recruit Count: 129

Registration Number: NCT01851590

Locations: 🇫🇮
Vääksyn Lääkärikeskus, Vääksy, Finland

Bioequivalence Study for Terbinafine 250 mg

Phase 1

Completed

Conditions: Mycoses

Interventions: Drug: Terbinafine 250 mg

First Posted Date: 2013-01-21

Last Posted Date: 2017-06-22

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 30

Registration Number: NCT01772212

Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail

Phase 2

Completed

Conditions: Onychomycosis

Interventions: Drug: Terbinafine HCl

First Posted Date: 2011-12-02

Last Posted Date: 2012-10-19

Lead Sponsor: Nitric BioTherapeutics, Inc

Target Recruit Count: 25

Registration Number: NCT01484145

Locations: 🇺🇸
Cetero Research, San Antonio, Texas, United States

Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

Phase 3

Completed

Conditions: Tinea Pedis

Interventions: Drug: Terbinafine
Drug: Terbinafine Placebo

First Posted Date: 2011-09-13

Last Posted Date: 2013-12-27

Lead Sponsor: Novartis

Target Recruit Count: 290

Registration Number: NCT01433107

Locations: 🇨🇳
The Second Affiliated Hospital of Sun Yat-sen University Guangzhou, Guangdong, China
🇨🇳
Chinese Academy of Medical Sciences, Jiangsu, China
🇨🇳
Beijing University Hospital N°3, Beijing, China

and more 3 locations