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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
Sporanox, Tolsura (generic drugs available since 2004-05-28, discontinued: Onmel)
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
SPORANOXJohnson & JohnsonN-020657 RX1997-02-21
1 products, RLD, RS
TOLSURAMayne GroupN-208901 RX2018-12-11
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
itraconazoleANDA2023-05-22
sporanoxNew Drug Application2022-10-20
tolsuraNew Drug Application2020-07-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
aids-related opportunistic infectionsD017088
aspergillosisEFO_0007157D001228B44
blastomycosisEFO_0007174D001759B40
chronic mucocutaneous candidiasisOrphanet_1334D002178B37.2
coccidioidomycosisEFO_0007211D003047B38
cryptococcosisEFO_0007229D003453B45
histoplasmosisEFO_0007310D006660B39
leishmaniasisEFO_0005044D007896B55
mycosesD009181B35-B49
neutropeniaD009503D70
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
87717392023-07-25DP
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
324 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599819
MycosesD009181B35-B4911136
OnychomycosisD014009B35.1211116
Allergic bronchopulmonary aspergillosisD001229EFO_0007140B44.8122125
Cystic fibrosisD003550EFO_0000390E841124
Hematologic neoplasmsD0193371113
NeutropeniaD009503D70123
Invasive fungal infectionsD0000727421112
Fungal lung diseasesD008172EFO_0007278112
Graft vs host diseaseD006086D89.8111
Show 4 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80131115
Hiv infectionsD015658EFO_0000764B20121711
HistoplasmosisD006660EFO_0007310B3932116
Pulmonary aspergillosisD055732EFO_1001834314
Ovarian neoplasmsD010051EFO_0003893C5611113
BlastomycosisD001759EFO_0007174B401112
DermatomycosesD003881112
Invasive hydatidiform moleD002820D39.211
BurnsD002056T30.0111
Second primary neoplasmsD016609111
Show 2 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD00434711111
Non-small-cell lung carcinomaD002289527
Prostatic neoplasmsD011471C61356
Basal cell neoplasmsD0182951113
Esophageal squamous cell carcinomaD00007727733
Myeloid leukemia acuteD015470C92.0212
Covid-19D000086382U07.1112
AspergillosisD001228EFO_0007157B4422
Inflammatory bowel diseasesD015212EFO_0003767112
Cryptococcal meningitisD016919EFO_0007228B45.1112
Show 20 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients131131
Medical sociologyD01296233
Basal cell carcinomaD00228022
Multiple myelomaD009101C90.022
ThrombosisD01392722
Neoplasm metastasisD009362EFO_0009708112
Non-hodgkin lymphomaD008228C85.922
Heart failureD006333EFO_0003144I5022
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.922
CandidiasisD002177B37112
Show 38 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Oral candidiasisD002180EFO_0007406B37.022
DeliriumD003693R41.011
TherapeuticsD01381211
FeverD005334HP_0001945R50.911
Vulvovaginal candidiasisD002181EFO_0007543B37.311
Breast neoplasmsD001943EFO_0003869C5011
InfectionsD007239EFO_000054411
Nail diseasesD009260HP_0001597L6011
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)
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
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 20,941 documents
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Safety
Black-box Warning
Black-box warning for: Itraconazole, Sporanox, Tolsura
Adverse Events
Top Adverse Reactions
Mock data
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12,942 adverse events reported
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