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Drug ReportsNilutamide
Nilutamide
Nilandron (nilutamide) is a small molecule pharmaceutical. Nilutamide was first approved as Nilandron on 1996-09-19. It is used to treat carcinoma and prostatic neoplasms in the USA. The pharmaceutical is active against androgen receptor.
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FDA approval date
EMA approval date
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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
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Nilandron (generic drugs available since 2016-07-15)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nilutamide
Tradename
Company
Number
Date
Products
NILANDRONConcordia LaboratoriesN-020169 RX1999-04-30
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
carcinoma—D002277C80.0
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
— L02B: Hormone antagonists and related agents
— L02BB: Anti-androgen hormone antagonists and related agents
— L02BB02: Nilutamide
HCPCS
No data
Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C61166—113
AdenocarcinomaD000230———21——2
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNilutamide
INNnilutamide
Description
Nilutamide is an imidazolidinone, a member of (trifluoromethyl)benzenes and a C-nitro compound. It has a role as an antineoplastic agent and an androgen antagonist.
Classification
Small molecule
Drug classnon-steroid antiandrogens
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC1(C)NC(=O)N(c2ccc([N+](=O)[O-])c(C(F)(F)F)c2)C1=O
Identifiers
PDB—
CAS-ID63612-50-0
RxCUI—
ChEMBL IDCHEMBL1274
ChEBI ID7573
PubChem CID4493
DrugBankDB00665
UNII ID51G6I8B902 (ChemIDplus, GSRS)
Target
Agency Approved
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Nilutamide
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,000 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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82 adverse events reported
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