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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
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 |
|---|---|---|---|---|
| CASODEX | ANI Pharmaceuticals | N-020498 RX | 1995-10-04 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bicalutamide | New Drug Application | 2025-12-10 |
| casodex | New Drug Application | 2023-12-18 |
| esterified estrogens and methyltestosterone | unapproved drug other | 2011-03-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| prostatic neoplasms | — | D011471 | C61 |
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
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 28 | 75 | 58 | 8 | 25 | 183 |
| Hiv | D006678 | — | O98.7 | — | — | — | 1 | — | 1 |
| Transsexualism | D014189 | — | F64.0 | — | — | — | 1 | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 1 | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 1 | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | 1 | — | 1 |
| Primary dysautonomias | D054969 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 4 | 14 | 4 | — | 4 | 24 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 11 | 1 | — | — | 13 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 3 | 1 | — | — | 4 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | 3 | 1 | — | — | 4 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | 1 | — | — | 3 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | 1 | — | 2 | 3 |
| Recurrence | D012008 | — | — | 1 | — | 2 | — | — | 3 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | 1 | — | — | 2 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 1 | 1 | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 2 | 1 | — | — | 2 |
Show 8 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Castration-resistant prostatic neoplasms | D064129 | — | — | 2 | 2 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 3 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | — | 2 | — | — | 1 | 3 |
| Carcinoma | D002277 | — | C80.0 | 2 | 2 | — | — | — | 3 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | 1 | 2 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | 1 | 1 | — | — | — | 2 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | — | 1 |
| Precocious puberty | D011629 | — | E22.8 | — | 1 | — | — | — | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | 1 | — | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | — | 7 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Hirsutism | D006628 | — | L68.0 | 2 | — | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
Show 20 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Coronary disease | D003327 | — | — | — | — | — | — | 1 | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 1 | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Hypoxia | D000860 | — | R09.02 | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 1 | 1 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 1 | 1 |
| Hyperandrogenism | D017588 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bicalutamide |
| INN | bicalutamide |
| 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 class | non-steroid antiandrogens |
| Image (chem structure or protein) |  |
| 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-ID | 90357-06-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL409 |
| ChEBI ID | — |
| PubChem CID | 2375 |
| DrugBank | DB01128 |
| UNII ID | A0Z3NAU9DP (ChemIDplus, GSRS) |
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Casodex – AstraZeneca
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Bicalutamide
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Trends
PubMed Central
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Additional graphs summarizing 8,561 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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6,970 adverse events reported
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