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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
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
458 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8027511232
Hiv infectionsD015658EFO_0000764B202211915
MycosesD009181B35-B492345114
InfectionsD007239EFO_0000544242512
AspergillosisD001228EFO_0007157B44461212
PharmacokineticsD01059991111
Pulmonary aspergillosisD055732EFO_100183415129
OnychomycosisD014009B35.1312118
Communicable diseasesD0031412237
Allergic bronchopulmonary aspergillosisD001229EFO_0007140B44.8133127
Show 14 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HistoplasmosisD006660EFO_0007310B3932217
CandidiasisD002177B371135
Ovarian neoplasmsD010051EFO_0003893C5622114
Ovarian epithelial carcinomaD0000772162213
TineaD014005EFO_0007510B35.42113
BlastomycosisD001759EFO_0007174B401123
BurnsD002056T30.0222
DermatomycosesD003881112
SinusitisD012852EFO_0007486J321112
Febrile neutropeniaD064147112
Show 13 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD00434716116
Non-small-cell lung carcinomaD00228912615
CarcinomaD002277C80.04418
Basal cell carcinomaD0022803216
LeukemiaD007938C95446
Prostatic neoplasmsD011471C61356
Myeloid leukemia acuteD015470C92.0445
Neoplasm metastasisD009362EFO_00097083215
Acquired immunodeficiency syndromeD000163EFO_0000765B201135
Esophageal neoplasmsD004938C15145
Show 53 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients187187
ObesityD009765EFO_0001073E66.944
Non-hodgkin lymphomaD008228C85.933
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.933
Respiratory syncytial virus infectionsD018357EFO_100141333
Medical sociologyD01296233
Alzheimer diseaseD000544EFO_0000249F0333
LymphomaD008223C85.933
Hepatocellular carcinomaD006528C22.0112
Multiple myelomaD009101C90.022
Show 71 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FeverD005334R50.922
Oral candidiasisD002180EFO_0007406B37.022
Tinea capitisD014006B35.022
Long qt syndromeD008133HP_0001657I45.8111
DeliriumD003693R41.011
Torsades de pointesD016171EFO_0005307I47.2111
Opportunistic infectionsD00989411
Penicillium chrysogenumD010408NCBITaxon_507611
Kidney diseasesD007674EFO_0003086N0811
Immunologic deficiency syndromesD007153D84.911
Show 9 more
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
$
£
No data
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 26,794 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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