Tavaborole
Kerydin (tavaborole) is a small molecule pharmaceutical. Tavaborole was first approved as Kerydin on 2014-07-07. It is used to treat mycoses and onychomycosis in the USA.
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Commercial
Trade Name
FDA
EMA
Kerydin (generic drugs available since 2020-10-13)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tavaborole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| KERYDIN | Anacor Pharmaceuticals | N-204427 RX | 2014-07-07 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kerydin | New Drug Application | 2018-08-13 |
| tavaborole | ANDA | 2019-06-15 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
181 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | 17 | 7 | 17 | 22 | 7 | 69 |
| Urinary retention | D016055 | HP_0000016 | R33 | 5 | 6 | 6 | 7 | 2 | 23 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | 2 | 7 | 6 | 7 | 1 | 21 | |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 2 | 1 | 1 | 7 | — | 10 |
| Ureteral calculi | D014514 | — | — | 2 | 4 | 3 | 9 | ||
| Urolithiasis | D052878 | N20-N23 | — | — | 1 | 1 | 2 | 4 | |
| Ureterolithiasis | D053039 | EFO_1001228 | N20.1 | — | — | 1 | 3 | — | 4 |
| Nephrolithiasis | D053040 | N20.0 | — | — | — | 2 | 1 | 3 | |
| Inguinal hernia | D006552 | HP_0000023 | K40 | 2 | 1 | — | 1 | — | 3 |
| Ureteral obstruction | D014517 | HP_0006000 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 4 | — | 2 | — | — | 6 |
| Kidney calculi | D007669 | EFO_0004253 | N20.0 | — | — | 2 | — | 3 | 5 |
| Prostatic neoplasms | D011471 | C61 | — | 1 | 1 | — | 1 | 3 | |
| Neurogenic urinary bladder | D001750 | HP_0000011 | N31 | — | 2 | 1 | — | — | 2 |
| Urinary catheterization | D014546 | — | — | 1 | — | — | 1 | ||
| Premature ejaculation | D061686 | HP_0012876 | F52.4 | — | — | 1 | — | — | 1 |
| Pelvic organ prolapse | D056887 | EFO_0004710 | — | 1 | 1 | — | — | 1 | |
| Stress urinary incontinence | D014550 | HP_0010992 | — | 1 | 1 | — | — | 1 | |
| Urological manifestations | D020924 | — | — | 1 | — | — | 1 | ||
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatitis | D011472 | EFO_0003830 | N41 | — | 1 | — | — | 1 | 2 |
| Macular edema | D008269 | 1 | 1 | — | — | — | 1 | ||
| Urinary bladder neck obstruction | D001748 | EFO_1000840 | N32.0 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eyelid diseases | D005141 | EFO_0009547 | H02.9 | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 1 | 1 |
| Dysuria | D053159 | EFO_0003901 | R30 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TAVABOROLE |
| INN | tavaborole |
| Description | Tavaborole is a member of the class of benzoxaboroles that is 1,3-dihydro-1-hydroxy-2,1-benzoxaborole substituted at position 5 by a fluoro group. A topical antifungal agent used for the treatment of onychomycosis (fungal infection of the toenails and fingernails). It has a role as an antifungal agent, a protein synthesis inhibitor and an EC 6.1.1.4 (leucine--tRNA ligase) inhibitor. It is an organofluorine compound and a benzoxaborole. |
| Classification | Small molecule |
| Drug class | boroles, boron compounds |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | OB1OCc2cc(F)ccc21 |
Identifiers
| PDB | — |
| CAS-ID | 174671-46-6 |
| RxCUI | 1543173 |
| ChEMBL ID | CHEMBL443052 |
| ChEBI ID | 77942 |
| PubChem CID | 11499245 |
| DrugBank | DB09041 |
| UNII ID | K124A4EUQ3 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 262 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,110 adverse events reported
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