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
No data
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cresemba | New Drug Application | 2019-12-02 |
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 | ||
HCPCS
Code | Description |
|---|---|
| J1833 | Injection, isavuconazonium, 1 mg |
Clinical
Clinical Trials
89 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Iron-deficiency anemia | D018798 | HP_0001891 | D50 | 3 | 5 | 12 | 6 | 8 | 32 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 2 | 8 | 12 | 7 | 3 | 29 |
| Chronic renal insufficiency | D051436 | N18 | — | — | 2 | 6 | 1 | 9 | |
| Iron deficiencies | D000090463 | E61.1 | 1 | 3 | 1 | 3 | — | 8 | |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 2 | 2 | 2 | 1 | 6 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | 3 | — | 4 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | 1 | 1 | — | 3 | |
| Altitude sickness | D000532 | EFO_1000782 | T70.29 | — | — | — | 1 | 1 | 2 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | 2 | — | 2 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | 2 | — | 1 | 3 |
| Neoplasms | D009369 | C80 | — | 1 | 1 | — | — | 2 | |
| Hematologic neoplasms | D019337 | — | 1 | 1 | — | — | 1 | ||
| Leukemia | D007938 | C95 | — | — | 1 | — | — | 1 | |
| Lymphoma | D008223 | C85.9 | — | — | 1 | — | — | 1 | |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | 1 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | — | — | 1 | — | — | 1 | |
| Multiple myeloma | D009101 | C90.0 | — | — | 1 | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | — | 1 | — | — | 1 | |
| Weight loss | D015431 | HP_0001824 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wounds and injuries | D014947 | T14.8 | — | 1 | — | — | 1 | 2 | |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 1 | — | — | 1 | 2 |
| Replacement arthroplasty knee | D019645 | — | 1 | — | — | — | 1 | ||
| Chronic disease | D002908 | — | 1 | — | — | — | 1 | ||
| Ovarian epithelial carcinoma | D000077216 | 1 | 1 | — | — | — | 1 | ||
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | — | 3 | ||
| Therapeutic equivalency | D013810 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | C34.90 | — | — | — | — | 1 | 1 | |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
| Heart disease risk factors | D000082742 | — | — | — | — | 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 | 1720882 |
| ChEMBL ID | CHEMBL1183349 |
| ChEBI ID | 85978 |
| PubChem CID | 6918485 |
| DrugBank | DB11633 |
| UNII ID | HZQ5R80I6Y (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 401 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,397 adverse events reported
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