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AboutPricing
Drug ReportsTerbinafine
Terbinafine
Lamisil, Terbinafine (terbinafine) is a small molecule pharmaceutical. Terbinafine was first approved as Lamisil on 1992-12-30. It is used to treat chronic mucocutaneous candidiasis, mycoses, onychomycosis, tinea capitis, and tinea pedis amongst others in the USA.
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Novartis Pharmaceuticals
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
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YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Lamisil, Lamisil at, Terbinafine (discontinued: Lamisil, Terbinafine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Terbinafine hydrochloride
Tradename
Company
Number
Date
Products
LAMISILGSKN-020980 OTC1999-03-09
1 products, RLD, RS
LAMISIL ATGSKN-021124 OTC2000-03-17
2 products, RLD, RS
Show 4 discontinued
Terbinafine
Tradename
Company
Number
Date
Products
LAMISIL ATGSKN-021958 OTC2006-07-24
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
antifungalANDA2025-01-09
antifungal footANDA2024-10-10
athletes footANDA2025-01-17
ciclopirox 8% / fluconazole 1% / terbinafine hcl 1%unapproved drug other2019-04-24
curistANDA2025-02-18
cvsANDA2024-04-30
cvs pharmacyANDA2025-03-17
equateANDA2019-01-08
fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4%unapproved drug other2019-04-24
good neighbor pharmacyANDA2020-06-23
Show 16 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
onychomycosis—D014009B35.1
tinea pedisEFO_0007512D014008B35.3
tinea capitis—D014006B35.0
tinea versicolorEFO_0007439D014010B36.0
chronic mucocutaneous candidiasisOrphanet_1334D002178B37.2
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AE: Other antifungals for topical use in atc
— D01AE15: Terbinafine
— D01B: Antifungals for systemic use
— D01BA: Antifungals for systemic use
— D01BA02: Terbinafine
HCPCS
No data
Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OnychomycosisD014009—B35.1————22
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTerbinafine
INNterbinafine
Description
Terbinafine is a tertiary amine that is N-methyl-1-naphthalenemethylamine in which the amino hydrogen is replaced by a 3-(tertbutylethynyl)allyl group. An antifungal agent administered orally (generally as the hydrochloride salt) for the treatment of skin and nail infections. It has a role as an EC 1.14.13.132 (squalene monooxygenase) inhibitor, a P450 inhibitor and a sterol biosynthesis inhibitor. It is a tertiary amine, an acetylenic compound, a member of naphthalenes, an enyne and an allylamine antifungal drug. It is a conjugate base of a terbinafine(1+).
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C/C=C/C#CC(C)(C)C)Cc1cccc2ccccc12
Identifiers
PDB—
CAS-ID91161-71-6
RxCUI—
ChEMBL IDCHEMBL822
ChEBI ID9448
PubChem CID1549008
DrugBankDB00857
UNII IDG7RIW8S0XP (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Terbinafine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,604 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,924 adverse events reported
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