Terbinafine
Lamisil (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.
Download report
Favorite
Novartis Pharmaceuticals
Commercial
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 AT | GSK | N-021958 OTC | 2006-07-24 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| athletes foot | ANDA | 2023-06-19 |
| lamisil | New Drug Application | 2022-10-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic mucocutaneous candidiasis | Orphanet_1334 | D002178 | B37.2 |
| mycoses | — | D009181 | B35-B49 |
| onychomycosis | — | D014009 | B35.1 |
| tinea capitis | — | D014006 | B35.0 |
| tinea pedis | EFO_0007512 | D014008 | B35.3 |
| tinea versicolor | EFO_0007439 | D014010 | B36.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
42 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | — | — | — | 1 |
| Tinea | D014005 | EFO_0007510 | B35.4 | — | 1 | — | — | — | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 5 | — | — | — | — | 5 | ||
| Mycoses | D009181 | B35-B49 | 1 | — | — | — | — | 1 | |
| Fasting | D005215 | EFO_0002756 | 1 | — | — | — | — | 1 | |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | 1 | — | — | — | — | 1 |
| Spondylarthropathies | D025242 | EFO_0000706 | M47 | 1 | — | — | — | — | 1 |
| Spondylitis | D013166 | M46.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | 1 | |
| Nail diseases | D009260 | HP_0001597 | L60 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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 | 37801 |
| ChEMBL ID | CHEMBL822 |
| ChEBI ID | 9448 |
| PubChem CID | 1549008 |
| DrugBank | DB00857 |
| UNII ID | G7RIW8S0XP (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 5,243 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
305 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more