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AboutPricing
Drug ReportsAbiraterone
Zytiga(abiraterone)
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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Abiraterone, Yonsa, Zytiga (discontinued: Abiraterone)
Combinations
Akeega
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
YONSASun Pharmaceutical IndustriesN-210308 RX2018-05-22
1 products, RLD, RS
Abiraterone acetate
+
Niraparib tosylate
Tradename
Company
Number
Date
Products
AKEEGAJohnson & JohnsonN-216793 RX2023-08-11
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
abirateroneANDA2025-08-19
abiraterone acetateANDA2025-09-16
abirtegaANDA2025-02-28
akeegaNew Drug Application2024-08-19
yonsaExport only2025-09-22
zytigaNew Drug Application2025-03-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
castration-resistant prostatic neoplasms—D064129—
ovarian neoplasmsEFO_0003893D010051C56
fallopian tube neoplasms—D005185—
peritoneal neoplasms—D010534—
Agency Specific
FDA
EMA
Expiration
Code
ABIRATERONE ACETATE / NIRAPARIB TOSYLATE, AKEEGA, JANSSEN BIOTECH
2026-08-11NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Abiraterone Acetate / Niraparib Tosylate, Akeega, Janssen Biotech
110914592038-03-27DS, DP
116738772038-03-27DS, DP
112073112037-07-28U-2830
88595622031-08-04U-2830
80716232031-03-27DS, DP
84361852029-04-24DS, DP
80715792027-08-12U-2830
81432412027-08-12U-2830
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
454 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C6113269—853
Castration-resistant prostatic neoplasmsD064129——353—111
Breast neoplasmsD001943EFO_0003869C50—21——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0—2———2
AdenocarcinomaD000230———2———2
Neoplasm metastasisD009362EFO_0009708——1———1
PostmenopauseD017698———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———7————7
Hepatic insufficiencyD048550——1————1
Congenital adrenal hyperplasiaD000312—E25.01————1
Adrenogenital syndromeD047808—E25.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80————11
Urogenital neoplasmsD014565EFO_0003863D07————11
Male genital diseasesD005832EFO_0009555N50.9————11
Male genital neoplasmsD005834——————11
Genital diseasesD000091662——————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)Loading
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-ID154229-19-3
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
₣
Zytiga – Johnson & Johnson
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,249 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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37,792 adverse events reported
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