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Zytiga(abiraterone)
Akeega, Yonsa, Zytiga (abiraterone) is a small molecule pharmaceutical. Abiraterone was first approved as Zytiga on 2011-04-28. It is used to treat castration-resistant prostatic neoplasms in the USA. It has been approved in Europe to treat castration-resistant prostatic neoplasms and prostatic neoplasms. The pharmaceutical is active against steroid 17-alpha-hydroxylase/17,20 lyase.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Yonsa, Zytiga (generic drugs available since 2018-10-31)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Abiraterone acetate
Tradename
Company
Number
Date
Products
ZYTIGAJohnson & JohnsonN-202379 RX2011-04-28
2 products, RLD
YONSAsparcN-210308 RX2018-05-22
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
abiraterone acetateANDA2023-06-14
yonsaExport only2022-11-03
zytigaNew Drug Application2020-10-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
castration-resistant prostatic neoplasms—D064129—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Abiraterone Acetate, Yonsa, Sun Pharm
102929902034-05-20U-2535
98891442034-03-17DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02B: Hormone antagonists and related agents
— L02BX: Other hormone antagonists and related agents in atc
— L02BX03: Abiraterone
HCPCS
No data
Clinical
Clinical Trials
268 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 neoplasmsD011471C613911123312172
Castration-resistant prostatic neoplasmsD0641292138133670
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD0002302161——19
Breast neoplasmsD001943EFO_0003869C50441——7
Neoplasm metastasisD009362EFO_0009708—13——3
Urogenital neoplasmsD014565EFO_0003863D07——1—12
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8054———7
Non-small-cell lung carcinomaD00228942———5
Neoadjuvant therapyD020360—3———3
Congenital adrenal hyperplasiaD000312E25.011———2
Bone neoplasmsD001859EFO_0003820D16—1———1
Adrenocortical carcinomaD018268—1———1
Pituitary acth hypersecretionD047748EFO_1001110E24.0—1———1
ProstatectomyD011468—1———1
Urologic neoplasmsD014571C64-C68—1———1
Urinary bladder neoplasmsD001749C67—1———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—9————9
Colorectal neoplasmsD0151792————2
Triple negative breast neoplasmsD0647262————2
PharmacokineticsD0105992————2
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Hematologic neoplasmsD0193371————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Non-hodgkin lymphomaD008228C85.91————1
Primary myelofibrosisD055728D47.41————1
Show 13 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pharmacogenomic testingD000071185————11
Male genital diseasesD005832EFO_0009555N50.9————11
Male genital neoplasmsD005834————11
SyndromeD013577————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameABIRATERONE
INNabiraterone
Description
Abiraterone acetate is a sterol ester obtained by formal condensation of the 3-hydroxy group of abiraterone with the carboxy group of acetic acid. A prodrug that is converted in vivo into abiraterone. Used for treatment of metastatic castrate-resistant prostate cancer. It has a role as a prodrug, an antineoplastic agent and an EC 1.14.99.9 (steroid 17alpha-monooxygenase) inhibitor. It is a sterol ester and a member of pyridines. It is functionally related to an abiraterone.
Classification
Small molecule
Drug classantiandrogens
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@]12CC[C@H]3[C@@H](CC=C4C[C@@H](O)CC[C@@]43C)[C@@H]1CC=C2c1cccnc1
Identifiers
PDB—
CAS-ID154229-18-2
RxCUI1100071
ChEMBL IDCHEMBL254328
ChEBI ID68642
PubChem CID9821849
DrugBankDBSALT001173
UNII IDG819A456D0 (ChemIDplus, GSRS)
Target
Agency Approved
CYP17A1
CYP17A1
Organism
Homo sapiens
Gene name
CYP17A1
Gene synonyms
CYP17, S17AH
NCBI Gene ID
1586
Protein name
steroid 17-alpha-hydroxylase/17,20 lyase
Protein synonyms
17-alpha-hydroxyprogesterone aldolase, CYPXVII, Cytochrome P450 17A1, cytochrome p450 XVIIA1, cytochrome P450, family 17, subfamily A, polypeptide 1, cytochrome P450, subfamily XVII (steroid 17-alpha-hydroxylase), adrenal hyperplasia, Cytochrome P450-C17, Cytochrome P450c17, Steroid 17-alpha-monooxygenase
Uniprot ID
Q5TZV7
Mouse ortholog
Cyp17a1 (13074)
steroid 17-alpha-hydroxylase/17,20 lyase (P27786)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zytiga - Johnson & Johnson
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,582 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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17,962 adverse events reported
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