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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
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Commercial
Clinical
Drug
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Variants
Financial
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Safety
Events Timeline
5D
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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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 (generic drugs available since 2007-07-02, discontinued: Lamisil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Terbinafine
Tradename
Company
Number
Date
Products
LAMISIL ATKARO HLTHCAREN-021958 OTC2006-07-24
1 products, RLD, RS
Show 1 discontinued
Terbinafine hydrochloride
Tradename
Company
Number
Date
Products
LAMISILKARO HLTHCAREN-020980 OTC1999-03-09
1 products, RLD, RS
LAMISIL ATKARO HLTHCAREN-021124 OTC2000-03-17
2 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
antifungalANDA2023-09-25
antifungal footANDA2019-04-10
athletes footANDA2024-04-29
ciclopirox 8% / fluconazole 1% / terbinafine hcl 1%unapproved drug other2019-04-24
cvsANDA2024-04-30
cvs pharmacyANDA2023-05-25
equateANDA2019-01-08
fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4%unapproved drug other2019-04-24
good neighbor pharmacyANDA2020-06-23
goodsenseANDA2015-04-20
Show 15 more
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
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OnychomycosisD014009—B35.14891527
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TineaD014005EFO_0007510B35.9—44——7
Tinea pedisD014008EFO_0007512B35.3131——5
Tinea capitisD014006—B35.01—2——3
InfectionsD007239EFO_0000544———1—12
Drug-related side effects and adverse reactionsD064420—T88.7——1—12
Communicable diseasesD003141————1——1
DermatomycosesD003881————1——1
Tinea crurisD000084002———11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181—B35-B4911———2
Inflammatory bowel diseasesD015212EFO_0003767—11———2
NeoplasmsD009369—C80—1———1
Ulcerative colitisD003093EFO_0000729K51—1———1
ColitisD003092EFO_0003872K52.9—1———1
UlcerD014456MPATH_579——1———1
RecurrenceD012008———1———1
Crohn diseaseD003424EFO_0000384K50—1———1
Hepatitis bD006509——11———1
Chronic hepatitis bD019694EFO_0004239B18.111———1
Show 3 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
MalnutritionD044342EFO_0008572E40-E461————1
FastingD005215EFO_0002756—1————1
OnycholysisD054039—L60.11————1
Ankylosing spondylitisD013167EFO_0003898M451————1
SpondylarthropathiesD025242EFO_0000706M471————1
SpondylarthritisD025241——1————1
SpondylitisD013166—M46.91————1
Axial spondyloarthritisD000089183——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wounds and injuriesD014947—T14.8————11
Chemical and drug induced liver injuryD056486EFO_0004228—————11
CandidiasisD002177—B37————11
Hiv infectionsD015658EFO_0000764B20————11
Oral candidiasisD002180EFO_0007406B37.0————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Diabetes mellitusD003920HP_0000819E08-E13————11
Nail diseasesD009260HP_0001597L60————11
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—
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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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,228 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,303 adverse events reported
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