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Drug ReportsItraconazole
Itraconazole
Itraconazole, Sporanox, Tolsura (itraconazole) is a small molecule pharmaceutical. Itraconazole was first approved as Sporanox on 1992-09-11. It is used to treat aids-related opportunistic infections, aspergillosis, blastomycosis, chronic mucocutaneous candidiasis, and coccidioidomycosis amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
stomatognathic diseasesD009057
respiratory tract diseasesD012140
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Itraconazole, Sporanox, Tolsura (discontinued: Itraconazole, Onmel, Sporanox)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Itraconazole
Tradename
Company
Number
Date
Products
SPORANOXJohnson & JohnsonN-020083 RX1992-09-11
1 products, RLD, RS
TOLSURAMayne GroupN-208901 RX2018-12-11
1 products, RLD, RS
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
ciclopirox 3% / itraconazole 5% / urea 20%unapproved drug other2019-05-20
fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4%unapproved drug other2019-04-24
itraconazoleANDA2025-07-16
itraconazole oralANDA2023-08-05
sporanoxNew Drug Application2024-12-30
tolsuraNew Drug Application2025-04-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mycoses—D009181B35-B49
aspergillosisEFO_0007157D001228B44
neutropenia—D009503D70
oral candidiasisEFO_0007406D002180B37.0
vulvovaginal candidiasisEFO_0007543D002181B37.3
aids-related opportunistic infections—D017088—
onychomycosis—D014009B35.1
coccidioidomycosisEFO_0007211D003047B38
cryptococcosisEFO_0007229D003453B45
blastomycosisEFO_0007174D001759B40
Show 6 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Itraconazole, Tolsura, Mayne Pharma
89213742033-06-21DP
92720462033-06-21DP
97136422033-06-21U-2453
104637402033-06-21DPU-2453
108067922033-06-21DP
Itraconazole, Onmel, Sebela Ireland Ltd
84864562028-10-03DPU-1054
ATC Codes
J: Antiinfectives for systemic use
— J02: Antimycotics for systemic use
— J02A: Antimycotics for systemic use
— J02AC: Triazole and tetrazole derivatives
— J02AC02: Itraconazole
HCPCS
Code
Description
J1835
Injection, itraconazole, 50 mg
Clinical
Clinical Trials
459 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeutropeniaD009503—D70—1—1—2
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CoccidioidomycosisD003047EFO_0007211B38—1———1
CoccidiosisD003048EFO_0007212——1———1
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 nameItraconazole
INNitraconazole
Description
Itraconazole is an N-arylpiperazine that is cis-ketoconazole in which the imidazol-1-yl group is replaced by a 1,2,4-triazol-1-yl group and in which the actyl group attached to the piperazine moiety is replaced by a p-[(+-)1-sec-butyl-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl]phenyl group. A potent P-glycoprotein and CYP3A4 inhibitor, it is used as an antifungal drug for the treatment of various fungal infections, including aspergillosis, blastomycosis, candidiasis, chromoblastomycosis, coccidioidomycosis, cryptococcosis, histoplasmosis, and sporotrichosis. It has a role as a P450 inhibitor, an EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor and a Hedgehog signaling pathway inhibitor. It is a member of triazoles, a dioxolane, a N-arylpiperazine, a dichlorobenzene, a cyclic ketal, a conazole antifungal drug, a triazole antifungal drug and an aromatic ether.
Classification
Small molecule
Drug classsystemic antifungals (miconazole type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Identifiers
PDB—
CAS-ID84625-61-6
RxCUI—
ChEMBL IDCHEMBL64391
ChEBI ID—
PubChem CID55283
DrugBankDB01167
UNII ID304NUG5GF4 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Itraconazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 26,931 documents
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Safety
Black-box Warning
Black-box warning for: Itraconazole, Itraconazole oral, Sporanox, Tolsura
Adverse Events
Top Adverse Reactions
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11,043 adverse events reported
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