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Xtandi(enzalutamide)
Xtandi (enzalutamide) is a small molecule pharmaceutical. Enzalutamide was first approved as Xtandi on 2012-08-31. It is used to treat prostatic neoplasms in the USA. It has been approved in Europe to treat prostatic neoplasms. The pharmaceutical is active against androgen receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Xtandi (generic drugs available since 2022-04-22)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Enzalutamide
Tradename
Company
Number
Date
Products
XTANDIAstellas PharmaN-203415 RX2012-08-31
1 products, RLD, RS
XTANDIAstellas PharmaN-213674 RX2020-08-04
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xtandiNew Drug Application2021-07-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic neoplasms—D011471C61
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Enzalutamide, Xtandi, Astellas
77095172027-08-13DS, DP
81832742026-08-24U-1281, U-1588, U-2345, U-2708
91269412026-05-15U-1588, U-2345, U-2708
ATC Codes
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02B: Hormone antagonists and related agents
— L02BB: Anti-androgen hormone antagonists and related agents
— L02BB04: Enzalutamide
HCPCS
No data
Clinical
Clinical Trials
264 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C6141942249149
Castration-resistant prostatic neoplasmsD06412928511571094
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C509111——17
AdenocarcinomaD000230482—216
Neoplasm metastasisD009362EFO_0009708—12——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8076———10
Triple negative breast neoplasmsD06472634———5
Pancreatic neoplasmsD010190EFO_0003860C2541———4
Non-small-cell lung carcinomaD00228922———3
Liver neoplasmsD008113EFO_1001513C22.021———3
Covid-19D000086382U07.1—2———2
Ovarian neoplasmsD010051EFO_0003893C5612———2
Urinary bladder neoplasmsD001749C6711———2
Squamous cell carcinoma of head and neckD00007719511———1
LiposarcomaD00808011———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—5————5
Colorectal neoplasmsD0151792————2
Renal cell carcinomaD0022922————2
Drug interactionsD0043472————2
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Hematologic neoplasmsD0193371————1
Non-hodgkin lymphomaD008228C85.91————1
Primary myelofibrosisD055728D47.41————1
Multiple myelomaD009101C90.01————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain diseasesD001927HP_0001298G93.40————11
EpilepsyD004827EFO_0000474G40.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameENZALUTAMIDE
INNenzalutamide
Description
Enzalutamide is a benzamide obtained by formal condensation of the carboxy group of 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl}-2-fluorobenzoic acid with methylamine. Used for the treatment of of metastatic castration-resistant prostate cancer. It has a role as an antineoplastic agent and an androgen antagonist. It is a member of benzamides, an imidazolidinone, a thiocarbonyl compound, a nitrile, a member of (trifluoromethyl)benzenes and a member of monofluorobenzenes.
Classification
Small molecule
Drug classdeuterated compounds; non-steroid antiandrogens
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CNC(=O)c1ccc(N2C(=S)N(c3ccc(C#N)c(C(F)(F)F)c3)C(=O)C2(C)C)cc1F
Identifiers
PDB—
CAS-ID915087-33-1
RxCUI1307298
ChEMBL IDCHEMBL1082407
ChEBI ID68534
PubChem CID15951529
DrugBankDB08899
UNII ID93T0T9GKNU (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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 10,459 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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20,518 adverse events reported
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