Efinaconazole
Jublia (efinaconazole) is a small molecule pharmaceutical. Efinaconazole was first approved as Jublia on 2014-06-06. It is used to treat mycoses and onychomycosis in the USA.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
Jublia (generic drugs available since 2020-12-16)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Efinaconazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| JUBLIA | Bausch Health Companies | N-203567 RX | 2014-06-06 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| jublia | New Drug Application | 2020-07-01 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
EFINACONAZOLE, JUBLIA, BAUSCH | |||
| 2023-04-27 | NPP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Efinaconazole, Jublia, Bausch | |||
| 10478601 | 2035-04-25 | DP | U-2721 |
| 9662394 | 2034-10-02 | DP | |
| 10342875 | 2034-10-02 | DP | U-2720 |
| 10828293 | 2034-10-02 | U-2720 | |
| 10864274 | 2034-10-02 | U-2720 | |
| 8486978 | 2030-10-24 | DP | |
| 9302009 | 2030-10-24 | DP | |
| 8039494 | 2030-07-08 | U-281 | |
| 9861698 | 2030-07-08 | DP | |
| 10105444 | 2030-07-08 | DP | |
| 9566272 | 2028-01-03 | U-1969 | |
| 9877955 | 2028-01-03 | U-1969 | |
| 10512640 | 2028-01-03 | U-1969 | |
| 10828369 | 2028-01-03 | DP | |
| 11213519 | 2028-01-03 | U-2720 | |
| 7214506 | 2026-02-22 | U-281 | |
HCPCS
No data
Clinical
Clinical Trials
39 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | 1 | — | 1 | 1 | 5 |
| Cerebral infarction | D002544 | I63 | — | — | — | 1 | — | 1 | |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 1 | — | 1 |
| Reperfusion injury | D015427 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | 6 | 2 | — | 2 | 10 | ||
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 1 | 4 | — | 1 | 6 |
| Neuromuscular diseases | D009468 | EFO_1001902 | G70.9 | — | 1 | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 6 | — | — | — | — | 6 | ||
| Hepatic insufficiency | D048550 | 2 | — | — | — | — | 2 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | EFINACONAZOLE |
| INN | efinaconazole |
| Description | Efinaconazole is a member of the class of triazoles that is butan-2-ol which is substituted at positions 1, 2, and 3 by 1,2,4-triazol-1-yl, 2,4-difluorophenyl, and 4-methylenepiperidin-1-yl groups, respectively (the 2R,3R stereoisomer). It is an antifungal drug used for the topical treatment of onychomycosis (a nail infection caused mainly by dermatophytes). It has a role as an EC 1.14.13.70 (sterol 14alpha-demethylase) inhibitor. It is an organofluorine compound, an olefinic compound, a member of piperidines, a tertiary alcohol, a tertiary amino compound, a conazole antifungal drug and a triazole antifungal drug. |
| Classification | Small molecule |
| Drug class | systemic antifungals (miconazole type); Fc fusion protein |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C=C1CCN([C@H](C)[C@](O)(Cn2cncn2)c2ccc(F)cc2F)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 164650-44-6 |
| RxCUI | 1539753 |
| ChEMBL ID | CHEMBL2103877 |
| ChEBI ID | 82718 |
| PubChem CID | 489181 |
| DrugBank | DB09040 |
| UNII ID | J82SB7FXWB (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 283 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
2,331 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more