Overview
Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumour tissues, to regulate androgen biosynthesis. Abiraterone was first approved by the FDA and EMA on April, July, and September 2011, respectively. It is used to treat metastatic castration-resistant prostate cancer and hormone-sensitive high-risk metastatic prostate cancer. As abiraterone has poor oral bioavailability and is susceptible to hydrolysis by esterases, abiraterone acetate was developed as an orally bioavailable prodrug with enhanced stability and absorption.
Indication
Abiraterone is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in combination with methylprednisolone or prednisone. In Europe and Canada, it is also used in patients with mCRPC who are asymptomatic or mildly symptomatic after the failure of androgen deprivation therapy for whom chemotherapy is not yet clinically indicated. In Europe, it is used in patients whose disease has progressed on or after a docetaxel-based chemotherapy regimen. In Canada, it is used in patients who have received prior chemotherapy containing docetaxel after the failure of androgen deprivation therapy. Abiraterone is indicated in combination with prednisone for the treatment of metastatic high-risk castration-sensitive prostate cancer (CSPC). In Europe and Canada, it may also be used in combination with prednisolone and androgen deprivation therapy in newly diagnosed patients. In Canada and the US, abiraterone is also available in a combination product with niraparib, which is indicated with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) mCRPC. In Canada, this combination product is also used with prednisolone and is reserved for patients who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.
Associated Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC)
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/05 | Not Applicable | Not yet recruiting | |||
2025/07/30 | Not Applicable | Recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2025/06/05 | Phase 2 | Recruiting | |||
2025/05/28 | Phase 2 | Recruiting | |||
2025/03/07 | Phase 1 | Recruiting | |||
2025/01/08 | Phase 3 | Recruiting | |||
2024/11/18 | Phase 3 | Recruiting | |||
2024/11/14 | Phase 1 | Recruiting | |||
2024/10/22 | N/A | Recruiting | |||
2024/10/21 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Catalent Pharma Solutions, LLC | 11014-0566 | ORAL | 125 mg in 1 1 | 11/16/2023 | |
| CivicaScript, LLC | 82249-010 | ORAL | 250 mg in 1 1 | 6/27/2022 | |
| CELLTRION USA, INC. | 72606-573 | ORAL | 500 mg in 1 1 | 7/22/2021 | |
| Bryant Ranch Prepack | 72162-2151 | ORAL | 500 mg in 1 1 | 12/8/2023 | |
| AvKARE | 42291-024 | ORAL | 250 mg in 1 1 | 1/9/2024 | |
| Florida Pharmaceutical Products, LLC. | 71921-178 | ORAL | 250 mg in 1 1 | 8/1/2022 | |
| Wockhardt USA LLC. | 64679-021 | ORAL | 250 mg in 1 1 | 11/29/2023 | |
| NorthStar Rx LLC | 16714-963 | ORAL | 250 mg in 1 1 | 12/26/2023 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-882 | ORAL | 500 mg in 1 1 | 5/19/2022 | |
| Major Pharmaceuticals | 0904-6948 | ORAL | 250 mg in 1 1 | 7/13/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/19/2023 | ||
Authorised | 9/5/2011 | ||
Authorised | 6/24/2021 | ||
Authorised | 8/20/2021 | ||
Authorised | 4/26/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TEROPROS FILM COATED TABLET 250MG | SIN16277P | TABLET, FILM COATED | 250.00mg | 7/12/2021 | |
| ABIRATERONE-AFT TABLET 250MG | SIN16853P | TABLET | 250mg | 9/5/2023 | |
| Abiraccord Tablets 250 MG | SIN16018P | TABLET | 250 mg | 9/25/2020 | |
| Zytiga Tablet 250 mg | SIN14146P | TABLET | 250mg | 5/8/2012 | |
| ONCOPROS - ABIRATERONE ACETATE TABLETS USP 250MG | SIN15933P | TABLET | 250.00mg | 4/24/2020 | |
| TEROPROS FILM COATED TABLET 500MG | SIN16278P | TABLET, FILM COATED | 500.00mg | 7/12/2021 | |
| ABIRATERONE-TEVA FC TABLET 500 MG | SIN16987P | TABLET, FILM COATED | 500 mg | 4/18/2024 | |
| ARABITRO ABIRATERONE ACETATE TABLET USP 250 mg | SIN16738P | TABLET | 250 mg | 3/14/2023 | |
| TEROPROS FILM COATED TABLET 1000MG | SIN16279P | TABLET, FILM COATED | 1000.00mg | 7/12/2021 | |
| BIRATO 250 ABIRATERONE ACETATE TABLET USP 250MG | SIN16916P | TABLET | 250mg | 12/18/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ABIRATERONE ACETATE TABLETS USP 250MG | N/A | N/A | N/A | 12/23/2024 | |
| ABIRATERONE SCIGEN TABLETS 500MG | N/A | N/A | N/A | 3/26/2025 | |
| ABIRATERONE SANDOZ TABLETS 500MG | N/A | N/A | N/A | 4/14/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ABIRATERONE SANDOZ abiraterone acetate 250 mg tablet bottle | 350471 | Medicine | A | 7/24/2024 | |
| ZYRON abiraterone acetate 250 mg tablet bottle | 449613 | Medicine | A | 4/30/2025 | |
| JANSSEN ABIRATERONE abiraterone acetate 250 mg tablet bottle | 180340 | Medicine | A | 3/1/2012 | |
| ABIRATERONE-REDDY'S abiraterone acetate 250 mg tablet bottle | 286574 | Medicine | A | 11/4/2024 | |
| ABIRATERONE SANDOZ abiraterone acetate 250 mg tablet blister pack | 344891 | Medicine | A | 7/24/2024 | |
| ABIRATERONE-TEVA abiraterone acetate 250 mg film-coated tablet bottle pack | 393322 | Medicine | A | 9/26/2023 | |
| ABIRATERONE VIATRIS abiraterone acetate 500 mg film-coated tablet bottle | 453790 | Medicine | A | 5/22/2025 | |
| JANSSEN ABIRATERONE abiraterone acetate 500 mg film-coated tablet blister pack | 275368 | Medicine | A | 2/17/2017 | |
| YONSA MPRED abiraterone acetate 125 mg tablet bottle and methylprednisolone 4 mg tablet bottle composite pack | 346890 | Medicine | A | 3/29/2022 | |
| NOVAZET abiraterone acetate 250 mg tablet bottle | 449611 | Medicine | A | 4/30/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MAR-ABIRATERONE | marcan pharmaceuticals inc | 02503999 | Tablet - Oral | 500 MG | 2/3/2021 |
| APO-ABIRATERONE | 02473917 | Tablet - Oral | 250 MG | N/A | |
| PRZ-ABIRATERONE | pharmaris canada inc | 02540452 | Tablet - Oral | 250 MG | N/A |
| ZYTIGA | 02457113 | Tablet - Oral | 500 MG | 9/22/2016 | |
| NAT-ABIRATERONE | natco pharma (canada) inc | 02494132 | Tablet - Oral | 250 MG | 1/18/2021 |
| MAR-ABIRATERONE | marcan pharmaceuticals inc | 02503980 | Tablet - Oral | 250 MG | 2/3/2021 |
| AKEEGA | 02538563 | Tablet - Oral | 500 MG | 8/14/2023 | |
| TEVA-ABIRATERONE | teva canada limited | 02473356 | Tablet - Oral | 250 MG | N/A |
| SANDOZ ABIRATERONE | 02521644 | Tablet - Oral | 500 MG | 3/28/2022 | |
| JAMP ABIRATERONE | 02529629 | Tablet - Oral | 500 MG | 1/30/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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