Sertaconazole
Ertaczo (sertaconazole) is a small molecule pharmaceutical. Sertaconazole was first approved as Ertaczo on 2003-12-10. It is used to treat mycoses and tinea pedis in the USA.
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Commercial
Trade Name
FDA
EMA
Ertaczo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sertaconazole nitrate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ERTACZO | Bausch Health Companies | N-021385 RX | 2003-12-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
ertaczo | New Drug Application | 2020-12-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
mycoses | — | D009181 | B35-B49 |
tinea pedis | EFO_0007512 | D014008 | B35.3 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AC: Imidazole and triazole derivatives, topical antifungals
— D01AC14: Sertaconazole
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AF: Imidazole derivatives, gyncological antiinfectives
— G01AF19: Sertaconazole
HCPCS
No data
Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | 1 | — | 1 | 1 | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Infertility | D007246 | EFO_0000545 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cognitive dysfunction | D060825 | G31.84 | 1 | 1 | — | — | — | 2 | |
Aging | D000375 | GO_0007568 | R41.81 | — | 2 | — | — | — | 2 |
Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | — | — | 1 |
Abdominal obesity | D056128 | HP_0001956 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | SERTACONAZOLE |
INN | sertaconazole |
Description | 1-{2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl}imidazole is a member of the class of imidazoles that carries a 2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl group at position 1. It is a dichlorobenzene, an ether, a member of imidazoles and a member of 1-benzothiophenes. |
Classification | Small molecule |
Drug class | systemic antifungals (miconazole type) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Clc1ccc(C(Cn2ccnc2)OCc2csc3c(Cl)cccc23)c(Cl)c1 |
Identifiers
PDB | — |
CAS-ID | 1330261-47-6 |
RxCUI | — |
ChEMBL ID | CHEMBL1201196 |
ChEBI ID | 83682 |
PubChem CID | 65863 |
DrugBank | DB01153 |
UNII ID | 72W71I16EG (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 391 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13 adverse events reported
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