Isavuconazole
Cresemba (isavuconazole) is a small molecule pharmaceutical. Isavuconazole was first approved as Cresemba on 2015-10-15. It is used to treat aspergillosis and mucormycosis in the USA. It has been approved in Europe to treat aspergillosis.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
Trade Name
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cresemba | New Drug Application | 2023-12-08 |
Indications
FDA
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Agency Specific
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Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycoses | D009181 | — | B35-B49 | — | — | 4 | 1 | 3 | 8 |
| Invasive fungal infections | D000072742 | — | — | — | — | 2 | 1 | 2 | 5 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 2 | 4 | — | 4 | 10 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 6 | 1 | — | — | 6 |
| Leukemia | D007938 | — | C95 | 3 | 5 | 1 | — | — | 5 |
| Myeloid leukemia | D007951 | — | C92 | 3 | 5 | 1 | — | — | 5 |
| Invasive pulmonary aspergillosis | D055744 | — | B44.0 | — | 2 | 1 | — | 2 | 5 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | 2 | 3 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | 1 | 1 | — | — | 2 |
| Candidemia | D058387 | EFO_1001282 | — | — | — | 1 | — | — | 1 |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | — | 1 | — | — | 1 |
| Candidiasis | D002177 | — | B37 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucormycosis | D009091 | EFO_0007380 | B46.5 | — | 2 | — | — | 4 | 6 |
| Zygomycosis | D020096 | — | B46 | — | 2 | — | — | 4 | 6 |
| Lymphoma | D008223 | — | C85.9 | 1 | 2 | — | — | — | 3 |
| Central nervous system neoplasms | D016543 | — | — | — | 2 | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 2 | 2 | — | — | — | 2 |
| B-cell lymphoma | D016393 | — | — | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | — | — | — | 1 |
Show 7 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 25 | — | — | — | — | 25 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Bacterial infections | D001424 | — | A49 | — | — | — | — | 1 | 1 |
| Neuroaspergillosis | D020953 | EFO_0007393 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Isavuconazole |
| INN | isavuconazole |
| Description | Isavuconazole is a 1,3-thiazole that is butan-2-ol which is substituted at positions 1, 2, and 3 by 1,2,4-triazol-1-yl, 2,5-difluorophenyl, and 4-(p-cyanophenyl)-1,3-thiazol-2-yl groups, respectively. It is an antifungal drug used for the treatment of invasive aspergillosis and invasive mucormycosis. It has a role as an ergosterol biosynthesis inhibitor, an EC 1.14.13.70 (sterol 14alpha-demethylase) inhibitor and an orphan drug. It is a member of 1,3-thiazoles, a nitrile, a difluorobenzene, a tertiary alcohol, a triazole antifungal drug and a conazole antifungal drug. |
| Classification | Small molecule |
| Drug class | systemic antifungals (miconazole type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H](c1nc(-c2ccc(C#N)cc2)cs1)[C@](O)(Cn1cncn1)c1cc(F)ccc1F |
Identifiers
| PDB | — |
| CAS-ID | 241479-67-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL409153 |
| ChEBI ID | 85979 |
| PubChem CID | 6918485 |
| DrugBank | DB11633 |
| UNII ID | 60UTO373KE (ChemIDplus, GSRS) |
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Cresemba – Pfizer
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Safety
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2,741 adverse events reported
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