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Erleada(apalutamide)
Erleada (apalutamide) is a small molecule pharmaceutical. Apalutamide was first approved as Erleada on 2018-02-14. 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
Erleada
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Apalutamide
Tradename
Company
Number
Date
Products
ERLEADAJohnson & JohnsonN-210951 RX2018-02-14
2 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
erleadaNew Drug Application2020-11-25
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
APALUTAMIDE, ERLEADA, JANSSEN BIOTECH
2023-02-14NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Apalutamide, Erleada, Janssen Biotech
107025082038-04-30U-3012
RE493532033-09-23U-2381
98840542033-09-23U-2237
100523142033-09-23U-2381, U-2382
108498882033-09-23U-3013
94816632033-06-04DS, DPU-2237, U-2624
84455072030-09-15DS, DPU-2237, U-2624
88026892027-03-27U-2237, U-2624
93881592027-03-27DS, DP
99872612027-03-27DP
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
— L02BB05: Apalutamide
HCPCS
No data
Clinical
Clinical Trials
101 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 neoplasmsD011471C61939151668
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD0002301123——16
Bone neoplasmsD001859EFO_0003820D16——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Castration-resistant prostatic neoplasmsD06412966——113
Neoadjuvant therapyD020360—2———2
NeoplasmsD009369C80—2———2
Salivary gland neoplasmsD012468EFO_0003826D11—1———1
ProstatectomyD011468—1———1
Small cell carcinomaD018288—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—6————6
Hepatic insufficiencyD0485502————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAPALUTAMIDE
INNapalutamide
Description
Apalutamide, sold under the brand name Erleada among others, is a nonsteroidal antiandrogen (NSAA) medication which is used in the treatment of prostate cancer. It is specifically indicated for use in conjunction with castration in the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC). It is taken by mouth.
Classification
Small molecule
Drug classnon-steroid antiandrogens
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CNC(=O)c1ccc(N2C(=S)N(c3cnc(C#N)c(C(F)(F)F)c3)C(=O)C23CCC3)cc1F
Identifiers
PDB—
CAS-ID956104-40-8
RxCUI1999574
ChEMBL IDCHEMBL3183409
ChEBI ID—
PubChem CID24872560
DrugBankDB11901
UNII ID4T36H88UA7 (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
Erleada - Johnson & Johnson
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,615 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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