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AboutPricing
Drug ReportsBicalutamide
Bicalutamide
Bicalutamide, Casodex (bicalutamide) is a small molecule pharmaceutical. Bicalutamide was first approved as Casodex on 1995-10-04. It is used to treat prostatic neoplasms in the USA. The pharmaceutical is active against androgen receptor.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Bicalutamide, Casodex (discontinued: Bicalutamide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bicalutamide
Tradename
Company
Number
Date
Products
CASODEXANI PharmaceuticalsN-020498 RX1995-10-04
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
bicalutamideANDA2025-08-19
casodexNew Drug Application2023-12-18
esterified estrogens and methyltestosteroneunapproved drug other2011-03-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02A: Hormones and related agents
— L02AE: Gonadotropin releasing hormone analogues, endocrine therapy drugs
— L02AE51: Leuprorelin and bicalutamide
— L02B: Hormone antagonists and related agents
— L02BB: Anti-androgen hormone antagonists and related agents
— L02BB03: Bicalutamide
HCPCS
No data
Clinical
Clinical Trials
232 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E461————1
Healthy volunteers/patients———1————1
Therapeutic equivalencyD013810——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBicalutamide
INNbicalutamide
Description
N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide is a member of the class of (trifluoromethyl)benzenes that is 4-amino-2-(trifluoromethyl)benzonitrile in which one of the amino hydrogens is substituted by a 3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanoyl group. It is a member of (trifluoromethyl)benzenes, a monocarboxylic acid amide, a member of monofluorobenzenes, a nitrile, a sulfone and a tertiary alcohol.
Classification
Small molecule
Drug classnon-steroid antiandrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(O)(CS(=O)(=O)c1ccc(F)cc1)C(=O)Nc1ccc(C#N)c(C(F)(F)F)c1
Identifiers
PDB—
CAS-ID90357-06-5
RxCUI—
ChEMBL IDCHEMBL409
ChEBI ID—
PubChem CID2375
DrugBankDB01128
UNII IDA0Z3NAU9DP (ChemIDplus, GSRS)
Target
Agency Approved
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
367
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Q9UD95
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Casodex – AstraZeneca
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Estimated US medical usage
Bicalutamide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,377 documents
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Safety
Black-box Warning
Black-box warning for: Esterified estrogens and methyltestosterone
Adverse Events
Top Adverse Reactions
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6,922 adverse events reported
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