Isavuconazonium
Cresemba (isavuconazonium) is a small molecule pharmaceutical. Isavuconazonium was first approved as Cresemba on 2015-03-06.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Cresemba
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Isavuconazonium sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CRESEMBA | Astellas Pharma | N-207500 RX | 2015-03-06 | 2 products, RLD, RS |
| CRESEMBA | Astellas Pharma | N-207501 RX | 2015-03-06 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cresemba | New Drug Application | 2023-12-08 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ISAVUCONAZONIUM SULFATE, CRESEMBA, ASTELLAS | |||
| 2027-03-06 | GAIN | ||
| 2025-03-06 | GAIN | ||
| 2022-03-06 | ODE*, ODE-305, ODE-90 | ||
| 2020-03-06 | NCE | ||
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J1833 | Injection, isavuconazonium, 1 mg |
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 |
| Mucormycosis | D009091 | EFO_0007380 | B46.5 | — | 2 | — | 1 | 4 | 7 |
| Zygomycosis | D020096 | — | B46 | — | 2 | — | 1 | 4 | 7 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 1 | 1 | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 2 | 2 | — | — | — | 2 |
| Central nervous system neoplasms | D016543 | — | — | — | 1 | — | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Neutropenia | D009503 | — | D70 | — | 1 | — | — | — | 1 |
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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 | — | — | — | 25 | — | — | — | — | 25 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Renal insufficiency | D051437 | — | 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 | Isavuconazonium |
| INN | isavuconazonium chloride |
| 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 | quaternary ammonium derivatives; quaternary ammonium derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNCC(=O)OCc1cccnc1N(C)C(=O)OC(C)[n+]1cnn(C[C@](O)(c2cc(F)ccc2F)[C@@H](C)c2nc(-c3ccc(C#N)cc3)cs2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 241479-67-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1183349 |
| ChEBI ID | 85978 |
| PubChem CID | 6918485 |
| DrugBank | DB11633 |
| UNII ID | 60UTO373KE (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Cresemba – Pfizer
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 564 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,875 adverse events reported
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