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 |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Yonsa, Zytiga (generic drugs available since 2018-10-31)
CombinationsAkeega
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 |
|---|---|---|---|---|
| ZYTIGA | Johnson & Johnson | N-202379 RX | 2011-04-28 | 2 products, RLD |
| YONSA | sparc | N-210308 RX | 2018-05-22 | 1 products, RLD, RS |
Abiraterone acetate
+
Niraparib tosylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AKEEGA | Johnson & Johnson | N-216793 RX | 2023-08-11 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| abiraterone | ANDA | 2023-12-27 |
| abiraterone acetate | ANDA | 2024-01-15 |
| akeega | New Drug Application | 2023-08-22 |
| yonsa | Export only | 2023-11-16 |
| zytiga | New Drug Application | 2021-10-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| castration-resistant prostatic neoplasms | — | D064129 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ABIRATERONE ACETATE / NIRAPARIB TOSYLATE, AKEEGA, JANSSEN BIOTECH | |||
| 2026-08-11 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Abiraterone Acetate / Niraparib Tosylate, Akeega, Janssen Biotech | |||
| 11091459 | 2038-03-27 | DS, DP | |
| 11673877 | 2038-03-27 | DS, DP | |
| 11207311 | 2037-07-28 | U-2830 | |
| 8859562 | 2031-08-04 | U-2830 | |
| 8071623 | 2031-03-27 | DS, DP | |
| 8436185 | 2029-04-24 | DS, DP | |
| 8071579 | 2027-08-12 | U-2830 | |
| 8143241 | 2027-08-12 | U-2830 | |
| Abiraterone Acetate, Yonsa, Sun Pharm | |||
| 10292990 | 2034-05-20 | U-2535 | |
| 9889144 | 2034-03-17 | DP | |
HCPCS
No data
Clinical
Clinical Trials
392 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 neoplasms | D011471 | — | C61 | 55 | 137 | 27 | 4 | 30 | 231 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 33 | 55 | 16 | 4 | 12 | 102 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 2 | 17 | 1 | — | 2 | 22 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 4 | 1 | — | — | 8 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 3 | — | 1 | 4 |
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | — | — | 1 | — | 1 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 6 | 5 | — | — | — | 8 |
| Non-small-cell lung carcinoma | D002289 | — | — | 6 | 3 | — | — | — | 7 |
| Colorectal neoplasms | D015179 | — | — | 5 | 2 | — | — | — | 5 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | 3 | — | — | — | 3 |
| Triple negative breast neoplasms | D064726 | — | — | 3 | 1 | — | — | — | 3 |
| Neoadjuvant therapy | D020360 | — | — | — | 3 | — | — | — | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 1 | — | — | — | 2 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 2 | — | — | — | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 1 | — | — | — | 2 |
| Congenital adrenal hyperplasia | D000312 | — | E25.0 | 1 | 1 | — | — | — | 2 |
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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 | — | — | — | 10 | — | — | — | — | 10 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease resistance | D060467 | — | — | — | — | — | — | 1 | 1 |
| Pharmacogenomic testing | D000071185 | — | — | — | — | — | — | 1 | 1 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | — | 1 | 1 |
| Supraventricular tachycardia | D013617 | HP_0004755 | I47.1 | — | — | — | — | 1 | 1 |
| Male genital diseases | D005832 | EFO_0009555 | N50.9 | — | — | — | — | 1 | 1 |
| Male genital neoplasms | D005834 | — | — | — | — | — | — | 1 | 1 |
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Abiraterone |
| INN | abiraterone |
| 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 class | antiandrogens |
| 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-ID | 154229-19-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL254328 |
| ChEBI ID | 68642 |
| PubChem CID | 9821849 |
| DrugBank | DBSALT001173 |
| UNII ID | G819A456D0 (ChemIDplus, GSRS) |
Target
Agency Approved
CYP17A1
CYP17A1
Organism
Homo sapiens
Gene name
CYP17A1
Gene synonyms
CYP17, S17AH
NCBI Gene ID
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
Mouse ortholog
Cyp17a1 (13074)
steroid 17-alpha-hydroxylase/17,20 lyase (P27786)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Zytiga – Johnson & Johnson
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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27,963 adverse events reported
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