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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Itraconazole, Sporanox, Tolsura (discontinued: Itraconazole, Onmel, Sporanox)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Itraconazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SPORANOX | Johnson & Johnson | N-020083 RX | 1992-09-11 | 1 products, RLD, RS |
| SPORANOX | Johnson & Johnson | N-020657 RX | 1997-02-21 | 1 products, RLD, RS |
| TOLSURA | Mayne Group | N-208901 RX | 2018-12-11 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ciclopirox 3% / itraconazole 5% / urea 20% | unapproved drug other | 2019-05-20 |
| fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4% | unapproved drug other | 2019-04-24 |
| itraconazole | ANDA | 2024-09-02 |
| itraconazole oral | ANDA | 2023-08-05 |
| sporanox | New Drug Application | 2024-11-04 |
| tolsura | New Drug Application | 2024-08-23 |
Indications
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Agency Specific
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HCPCS
Code | Description |
|---|---|
| J1835 | Injection, itraconazole, 50 mg |
Clinical
Clinical Trials
416 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 24 | 2 | 1 | 1 | 2 | 29 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 6 | 10 | 2 | 2 | 17 |
| Mycoses | D009181 | — | B35-B49 | 2 | 4 | 4 | 5 | 2 | 16 |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | 5 | 2 | 5 | 14 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 2 | 1 | 1 | 8 | 13 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | 3 | 7 | 2 | 2 | 12 |
| Pharmacokinetics | D010599 | — | — | 9 | — | — | 1 | 1 | 11 |
| Communicable diseases | D003141 | — | — | — | — | 3 | 2 | 3 | 8 |
| Onychomycosis | D014009 | — | B35.1 | 3 | 1 | 2 | 1 | 1 | 8 |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | 3 | 3 | 1 | 2 | 7 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Histoplasmosis | D006660 | EFO_0007310 | B39 | 3 | 2 | 2 | — | 1 | 7 |
| Candidiasis | D002177 | — | B37 | 1 | — | 1 | — | 4 | 6 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 2 | 1 | — | 1 | 4 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | 2 | 1 | — | — | 3 |
| Blastomycosis | D001759 | EFO_0007174 | B40 | 1 | 1 | 2 | — | — | 3 |
| Tinea | D014005 | EFO_0007510 | B35.9 | — | 2 | 1 | — | — | 2 |
| Burns | D002056 | — | T30.0 | — | 2 | 2 | — | — | 2 |
| Dermatomycoses | D003881 | — | — | 1 | — | 1 | — | — | 2 |
| Sinusitis | D012852 | EFO_0007486 | J32 | 1 | 1 | 1 | — | — | 2 |
| Febrile neutropenia | D064147 | — | — | — | 1 | 1 | — | — | 2 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 15 | 1 | — | — | — | 15 |
| Non-small-cell lung carcinoma | D002289 | — | — | 9 | 3 | — | — | — | 12 |
| Carcinoma | D002277 | — | C80.0 | 3 | 3 | — | — | 1 | 7 |
| Basal cell carcinoma | D002280 | — | — | 3 | 2 | — | — | 1 | 6 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 3 | 3 | — | — | — | 6 |
| Prostatic neoplasms | D011471 | — | C61 | 3 | 5 | — | — | — | 6 |
| Leukemia | D007938 | — | C95 | 3 | 2 | — | — | — | 4 |
| Syndrome | D013577 | — | — | 1 | 3 | — | — | 1 | 4 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 1 | — | — | 2 | 4 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 3 | — | — | — | 4 |
Show 41 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 170 | — | — | — | — | 170 |
| Lymphoma | D008223 | — | C85.9 | 6 | — | — | — | — | 6 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 2 | — | — | — | 1 | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | — | — | — | — | 3 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 3 | — | — | — | — | 3 |
| Medical sociology | D012962 | — | — | 3 | — | — | — | — | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 3 | — | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | — | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | 2 | — | — | — | — | 2 |
| Thrombosis | D013927 | — | — | 2 | — | — | — | — | 2 |
Show 65 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | — | — | — | 2 | 2 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
| Penicillium chrysogenum | D010408 | NCBITaxon_5076 | — | — | — | — | — | 1 | 1 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | — | — | — | 1 | 1 |
| Therapeutics | D013812 | — | — | — | — | — | — | 1 | 1 |
| Keratitis | D007634 | HP_0000491 | H16 | — | — | — | — | 1 | 1 |
| Lung transplantation | D016040 | — | — | — | — | — | — | 1 | 1 |
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Itraconazole |
| INN | itraconazole |
| 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 class | systemic 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-ID | 84625-61-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL64391 |
| ChEBI ID | — |
| PubChem CID | 55283 |
| DrugBank | DB01167 |
| UNII ID | 304NUG5GF4 (ChemIDplus, GSRS) |
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Itraconazole
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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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10,346 adverse events reported
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