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Naftifine
Naftin (naftifine) is a small molecule pharmaceutical. Naftifine was first approved as Naftin on 1988-02-29. It is used to treat mycoses and tinea pedis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Naftin (generic drugs available since 2016-01-06)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Naftifine hydrochloride
Tradename
Company
Number
Date
Products
NAFTINSebela PharmaceuticalsN-019356 RX1990-06-18
1 products, RLD, RS
NAFTINSebela PharmaceuticalsN-019599 RX2012-01-13
1 products, RLD, RS
NAFTINSebela PharmaceuticalsN-204286 RX2013-06-27
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
naftifine hydrochlorideANDA2023-02-03
naftinNew Drug Application2020-04-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
tinea pedisEFO_0007512D014008B35.3
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Naftifine Hydrochloride, Naftin, Sebela Ireland Ltd
87783652033-01-31DP
91619142033-01-31U-540
101662052033-01-31DP
101662062033-01-31DP
106953032033-01-31DP
107296672033-01-31DP
ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AE: Other antifungals for topical use in atc
— D01AE22: Naftifine
HCPCS
No data
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteomyelitisD010019EFO_0003102M86—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BacteremiaD016470EFO_0003033R78.81—1———1
Gram-positive bacterial infectionsD016908—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cerebral hemorrhageD0025431————1
Subarachnoid hemorrhageD013345EFO_0000713I601————1
HydrocephalusD006849HP_0000238G911————1
Cerebral ventriculitisD058565G04.901————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNAFTIFINE
INNnaftifine
Description
Naftifine is a tertiary amine in which the nitrogen is substituted by methyl, alpha-naphthylmethyl, and (1E)-cinnamyl groups. It is used (usually as its hydrochloride salt) for the treatment of fungal skin infections. It has a role as an EC 1.14.13.132 (squalene monooxygenase) inhibitor and a sterol biosynthesis inhibitor. It is a member of naphthalenes, a tertiary amine and an allylamine antifungal drug.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN(C/C=C/c1ccccc1)Cc1cccc2ccccc12
Identifiers
PDB—
CAS-ID65472-88-0
RxCUI31476
ChEMBL IDCHEMBL626
ChEBI ID7451
PubChem CID47641
DrugBankDB00735
UNII ID4FB1TON47A (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:
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Additional graphs summarizing 386 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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551 adverse events reported
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