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Drug ReportsApalutamide
Erleada(apalutamide)
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
Apalutamide, 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 Application2025-09-09
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
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
161 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 neoplasmsD011471—C61247026226140
HypersensitivityD006967EFO_0003785T78.4013—149
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Castration-resistant prostatic neoplasmsD064129——11102—426
AdenocarcinomaD000230——2165—224
Neoplasm metastasisD009362EFO_0009708—141—38
ProstatectomyD011468———11——2
Directly observed therapyD023801————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80—3——25
CarcinomaD002277—C80.023———5
RecurrenceD012008——12———2
Breast neoplasmsD001943EFO_0003869C5021———2
Neoadjuvant therapyD020360———2———2
Brain neoplasmsD001932EFO_0003833C7111———1
GlioblastomaD005909EFO_0000515—11———1
MelanomaD008545——11———1
Salivary gland neoplasmsD012468EFO_0003826D11—1———1
Disease progressionD018450———1———1
Show 4 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———6————6
Liver diseasesD008107EFO_0001421K70-K772————2
Hepatic insufficiencyD048550——2————2
Ovarian neoplasmsD010051EFO_0003893C562————2
Ovarian epithelial carcinomaD000077216——1————1
Renal cell carcinomaD002292EFO_0000376—1————1
Urologic neoplasmsD014571—C64-C681————1
Colorectal neoplasmsD015179——1————1
Non-small-cell lung carcinomaD002289——1————1
Triple negative breast neoplasmsD064726——1————1
Show 8 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————11
CardiotoxicityD066126EFO_1001482—————11
Bone neoplasmsD001859EFO_0003820D16————11
Bone marrow diseasesD001855——————11
RadiosurgeryD016634——————11
Sleep initiation and maintenance disordersD007319—F51.01————11
FatigueD005221—R53.83————11
DepressionD003863—F33.9————11
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)Loading
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
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Erleada – Johnson & Johnson
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,960 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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9,493 adverse events reported
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