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AboutPricing
Drug ReportsIsavuconazonium
Isavuconazonium
Cresemba (isavuconazonium) is a small molecule pharmaceutical. Isavuconazonium was first approved as Cresemba on 2015-03-06.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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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)
Isavuconazonium sulfate
Tradename
Company
Number
Date
Products
CRESEMBAAstellas PharmaN-207500 RX2015-03-06
2 products, RLD, RS
CRESEMBAAstellas PharmaN-207501 RX2015-03-06
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cresembaNew Drug Application2025-04-25
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
ISAVUCONAZONIUM SULFATE, CRESEMBA, ASTELLAS
2027-03-06GAIN
2025-03-06GAIN
2022-03-06ODE*, ODE-305, ODE-90
2020-03-06NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Isavuconazonium Sulfate, Cresemba, Astellas
102068792027-09-14DP
106032802027-09-14DP
68122382025-10-31DP
ATC Codes
No data
HCPCS
Code
Description
J1833
Injection, isavuconazonium, 1 mg
Clinical
Clinical Trials
63 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181—B35-B49——41510
MucormycosisD009091EFO_0007380B46.5—2—1710
ZygomycosisD020096—B46—2—147
Invasive fungal infectionsD000072742————2136
Invasive hydatidiform moleD002820—D39.2———112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AspergillosisD001228EFO_0007157B44—23—49
Myeloid leukemia acuteD015470—C92.0561——7
Invasive pulmonary aspergillosisD055744—B44.0—21—25
LeukemiaD007938—C95231——4
Myeloid leukemiaD007951—C92231——4
Pulmonary aspergillosisD055732EFO_1001834——11——2
CandidemiaD058387EFO_1001282———1——1
Invasive candidiasisD058365EFO_1001283B37——1——1
Coronavirus infectionsD018352EFO_0007224B34.2——1——1
Sars-cov-2D000086402————1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337——21——14
NeoplasmsD009369—C8021———2
Myelodysplastic syndromesD009190—D4611———2
Central nervous system neoplasmsD016543———1———1
Myeloproliferative disordersD009196—D47.1—1———1
NeutropeniaD009503—D70—1———1
PreleukemiaD011289———1———1
SyndromeD013577———1———1
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.011———1
Biphenotypic leukemia acuteD015456—C95.011———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———25————25
PharmacokineticsD010599——3———14
Renal insufficiencyD051437—N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—————22
Communicable diseasesD003141——————11
Bacterial infectionsD001424—A49————11
NeuroaspergillosisD020953EFO_0007393—————11
Hematologic diseasesD006402EFO_0005803D75.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIsavuconazonium
INNisavuconazonium 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 classquaternary ammonium derivatives; quaternary ammonium derivatives
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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-ID241479-67-4
RxCUI—
ChEMBL IDCHEMBL1183349
ChEBI ID85978
PubChem CID6918485
DrugBankDB11633
UNII ID60UTO373KE (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Cresemba – Pfizer
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 629 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,160 adverse events reported
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