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AboutPricing
Drug ReportsEfinaconazole
Efinaconazole
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.
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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Efinaconazole, Jublia (discontinued: Efinaconazole)
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
JUBLIABausch Health CompaniesN-203567 RX2014-06-06
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
jubliaNew Drug Application2022-03-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
onychomycosis—D014009B35.1
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Efinaconazole, Jublia, Bausch
104786012035-04-25DPU-2721
96623942034-10-02DP
103428752034-10-02DPU-2720
108282932034-10-02U-2720
108642742034-10-02U-2720
116541392034-10-02U-1969
84869782030-10-24DP
93020092030-10-24DP
80394942030-07-08U-281
98616982030-07-08DP
101054442030-07-08DP
95662722028-01-03U-1969
98779552028-01-03U-1969
105126402028-01-03U-1969
108283692028-01-03DP
112135192028-01-03U-2720
118722182028-01-03U-1969
72145062026-02-22U-281
ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AC: Imidazole and triazole derivatives, topical antifungals
— D01AC19: Efinaconazole
HCPCS
No data
Clinical
Clinical Trials
9 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—B35.1—134—8
TineaD014005EFO_0007510B35.9———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEfinaconazole
INNefinaconazole
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 classsystemic antifungals (miconazole type); Fc fusion protein
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C=C1CCN([C@H](C)[C@](O)(Cn2cncn2)c2ccc(F)cc2F)CC1
Identifiers
PDB—
CAS-ID164650-44-6
RxCUI—
ChEMBL IDCHEMBL2103877
ChEBI ID82718
PubChem CID489181
DrugBankDB09040
UNII IDJ82SB7FXWB (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 370 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,155 adverse events reported
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