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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Commercial
Therapeutic Areas
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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| antifungal | ANDA | 2023-09-25 |
| antifungal foot | ANDA | 2024-10-10 |
| athletes foot | ANDA | 2024-04-29 |
| ciclopirox 8% / fluconazole 1% / terbinafine hcl 1% | unapproved drug other | 2019-04-24 |
| cvs | ANDA | 2024-04-30 |
| cvs pharmacy | ANDA | 2023-05-25 |
| equate | ANDA | 2019-01-08 |
| fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4% | unapproved drug other | 2019-04-24 |
| good neighbor pharmacy | ANDA | 2020-06-23 |
| goodsense | ANDA | 2015-04-20 |
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Indications
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Onychomycosis | D014009 | — | B35.1 | 4 | 8 | 9 | 1 | 5 | 27 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tinea | D014005 | EFO_0007510 | B35.9 | — | 4 | 4 | — | — | 7 |
| Tinea pedis | D014008 | EFO_0007512 | B35.3 | 1 | 3 | 1 | — | — | 5 |
| Tinea capitis | D014006 | — | B35.0 | 1 | — | 2 | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | 1 | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | 1 | — | 1 | 2 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Dermatomycoses | D003881 | — | — | — | — | 1 | — | — | 1 |
| Tinea cruris | D000084002 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycoses | D009181 | — | B35-B49 | 1 | 1 | — | — | — | 2 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | — | 1 | — | — | — | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | — | 1 |
| Hepatitis b | D006509 | — | — | 1 | 1 | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | — | 1 | — | — | — | — | 1 |
| Onycholysis | D054039 | — | L60.1 | 1 | — | — | — | — | 1 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | 1 | — | — | — | — | 1 |
| Spondylarthropathies | D025242 | EFO_0000706 | M47 | 1 | — | — | — | — | 1 |
| Spondylarthritis | D025241 | — | — | 1 | — | — | — | — | 1 |
| Spondylitis | D013166 | — | M46.9 | 1 | — | — | — | — | 1 |
| Axial spondyloarthritis | D000089183 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Candidiasis | D002177 | — | B37 | — | — | — | — | 1 | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 1 | 1 |
| Nail diseases | D009260 | HP_0001597 | L60 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Terbinafine |
| INN | terbinafine |
| 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) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C/C=C/C#CC(C)(C)C)Cc1cccc2ccccc12 |
Identifiers
| PDB | — |
| CAS-ID | 91161-71-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL822 |
| ChEBI ID | 9448 |
| PubChem CID | 1549008 |
| DrugBank | DB00857 |
| UNII ID | G7RIW8S0XP (ChemIDplus, GSRS) |
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Terbinafine
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Safety
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11,303 adverse events reported
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