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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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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| itraconazole | ANDA | 2023-03-23 |
| sporanox | New Drug Application | 2022-10-20 |
| tolsura | New Drug Application | 2020-07-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| aids-related opportunistic infections | — | D017088 | — |
| aspergillosis | EFO_0007157 | D001228 | B44 |
| blastomycosis | EFO_0007174 | D001759 | B40 |
| chronic mucocutaneous candidiasis | Orphanet_1334 | D002178 | B37.2 |
| coccidioidomycosis | EFO_0007211 | D003047 | B38 |
| cryptococcosis | EFO_0007229 | D003453 | B45 |
| histoplasmosis | EFO_0007310 | D006660 | B39 |
| leishmaniasis | EFO_0005044 | D007896 | B55 |
| mycoses | — | D009181 | B35-B49 |
| neutropenia | — | D009503 | D70 |
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Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J1835 | Injection, itraconazole, 50 mg |
Clinical
Clinical Trials
318 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | 8 | — | — | 1 | — | 9 | ||
| Mycoses | D009181 | B35-B49 | 1 | 1 | 1 | 3 | — | 6 | |
| Onychomycosis | D014009 | B35.1 | 2 | 1 | 1 | 1 | 1 | 6 | |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | 2 | 2 | 1 | 2 | 5 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | — | 2 | — | 4 |
| Hematologic neoplasms | D019337 | 1 | — | — | 1 | 1 | 3 | ||
| Neutropenia | D009503 | D70 | — | — | — | 1 | 2 | 3 | |
| Invasive fungal infections | D000072742 | — | 1 | 1 | 1 | — | 2 | ||
| Fungal lung diseases | D008172 | EFO_0007278 | — | 1 | — | 1 | — | 2 | |
| Graft vs host disease | D006086 | D89.81 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 12 | — | 1 | — | 1 | 14 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 2 | 1 | — | 7 | 11 |
| Histoplasmosis | D006660 | EFO_0007310 | B39 | 3 | 2 | 1 | — | 1 | 6 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | 3 | — | 1 | 4 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | 1 | — | 1 | 3 |
| Blastomycosis | D001759 | EFO_0007174 | B40 | 1 | 1 | 1 | — | — | 2 |
| Dermatomycoses | D003881 | 1 | — | 1 | — | — | 2 | ||
| Invasive hydatidiform mole | D002820 | D39.2 | — | — | 1 | — | — | 1 | |
| Burns | D002056 | T30.0 | — | 1 | 1 | — | — | 1 | |
| Second primary neoplasms | D016609 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | 11 | 1 | — | — | — | 11 | ||
| Non-small-cell lung carcinoma | D002289 | 5 | 2 | — | — | — | 7 | ||
| Prostatic neoplasms | D011471 | C61 | 3 | 5 | — | — | — | 6 | |
| Basal cell neoplasms | D018295 | 1 | 1 | — | — | 1 | 3 | ||
| Esophageal squamous cell carcinoma | D000077277 | — | 3 | — | — | — | 3 | ||
| Myeloid leukemia acute | D015470 | C92.0 | 2 | 1 | — | — | — | 2 | |
| Covid-19 | D000086382 | U07.1 | 1 | 1 | — | — | — | 2 | |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 2 | — | — | — | 2 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | 1 | — | — | — | 2 | |
| Cryptococcal meningitis | D016919 | EFO_0007228 | B45.1 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 130 | — | — | — | — | 130 | ||
| Medical sociology | D012962 | 3 | — | — | — | — | 3 | ||
| Basal cell carcinoma | D002280 | 2 | — | — | — | — | 2 | ||
| Multiple myeloma | D009101 | C90.0 | 2 | — | — | — | — | 2 | |
| Thrombosis | D013927 | 2 | — | — | — | — | 2 | ||
| Neoplasm metastasis | D009362 | EFO_0009708 | 1 | — | — | — | 1 | 2 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 2 | — | — | — | — | 2 | |
| Heart failure | D006333 | EFO_0003144 | I50 | 2 | — | — | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | — | — | 2 |
| Candidiasis | D002177 | B37 | 1 | — | — | — | 1 | 2 |
Show 38 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 |
| Delirium | D003693 | R41.0 | — | — | — | — | 1 | 1 | |
| Therapeutics | D013812 | — | — | — | — | 1 | 1 | ||
| Fever | D005334 | HP_0001945 | R50.9 | — | — | — | — | 1 | 1 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | — | — | — | 1 | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | 1 | |
| Nail diseases | D009260 | HP_0001597 | L60 | — | — | — | — | 1 | 1 |
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) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Itraconazole, Sporanox, Tolsura
Adverse Events
Top Adverse Reactions
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12,984 adverse events reported
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