Product Description
Abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has spread to other parts of the body. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.
Mechanisms of Action: CYP17A1 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Company: Johnson & Johnson
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Uruguay, Vietnam
Active Clinical Trial Count: 73
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Prostate Cancer results on 2025-06-03 for Abiraterone
Highest Development Phases
Phase 3: Adenocarcinoma|Colorectal Cancer|Drug Hypersensitivity|Hepatocellular Carcinoma|Neuroendocrine Carcinoma|Neuroendocrine Tumors|Oncology Unspecified|Pancreatic Cancer|Prostate Cancer|Renal Cell Carcinoma|Thyroid Cancer
Phase 2: Hearing Loss, Bilateral|Nose Cancer
Phase 1: Parkinson's Disease
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
ACTRN12618000541202p |
HUM00181946 | P1 |
Not yet recruiting |
Parkinson's Disease |
2019-03-04 |
|||
2023-504466-28-00 |
SENS-501-101 | P2 |
Recruiting |
Hearing Loss, Bilateral |
2030-12-31 |
2025-05-02 |
Treatments |
|
NCT03902951 |
NCI-2019-00337 | P2 |
Active, not recruiting |
Neuroendocrine Carcinoma|Adenocarcinoma|Prostate Cancer |
2027-01-01 |
12% |
2026-02-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06894511 |
PSMAndARPI | P2 |
Active, not recruiting |
Prostate Cancer |
2026-10-15 |
2026-05-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
CTR20243820 |
CTR20243820 | P2 |
Completed |
Prostate Cancer|Nose Cancer |
2026-03-12 |
2026-04-14 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2023-504263-16-00 |
BX44273 | P3 |
Recruiting |
Oncology Unspecified |
2033-03-01 |
32% |
2025-05-02 |
Treatments |
NCT07620574 |
EXEL-LTE-1 | P3 |
Enrolling by invitation |
Pancreatic Cancer|Prostate Cancer|Thyroid Cancer|Neuroendocrine Carcinoma|Colorectal Cancer|Neuroendocrine Tumors|Renal Cell Carcinoma|Hepatocellular Carcinoma |
2030-05-31 |
90% |
2026-08-19 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05288166 |
CYCLONE 3 | P3 |
Active, not recruiting |
Prostate Cancer|Drug Hypersensitivity |
2024-02-15 |
52% |
2025-06-28 |
|
NCT06991556 |
CJSB462C12201 | P2 |
Active, not recruiting |
Prostate Cancer |
2032-02-13 |
68% |
2026-09-01 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT05404139 |
DIRECT | P2 |
Recruiting |
Prostate Cancer |
2031-02-01 |
63% |
2026-07-28 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT06212583 |
KNIGHTS | P2 |
Active, not recruiting |
Prostate Cancer |
2028-12-31 |
12% |
2026-05-07 |
Primary Endpoints|Treatments|Trial Status |
NCT04267887 |
STUDY00016728 | P2 |
Active, not recruiting |
Prostate Cancer |
2028-01-01 |
38% |
2024-02-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06650579 |
REVELUTION-2 | P3 |
Recruiting |
Prostate Cancer |
2029-07-01 |
17% |
2025-05-16 |
Primary Endpoints|Treatments |
2022-501493-19-00 |
CURLu177PSM0001 | P3 |
Active, not recruiting |
Prostate Cancer |
2029-02-02 |
2025-05-02 |
Treatments |
|
NCT06855277 |
AcTFirst | P3 |
Recruiting |
Prostate Cancer |
2028-09-29 |
82% |
2026-02-10 |
|
NCT06496581 |
PEACE6-Poor Responders | P3 |
Recruiting |
Prostate Cancer |
2033-02-01 |
2024-12-21 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
2025-520555-89-00 |
20230239 | P3 |
Not yet recruiting |
Prostate Cancer |
2032-08-30 |
|||
NCT06592924 |
TRIPLE-SWITCH | P3 |
Recruiting |
Adenocarcinoma|Prostate Cancer |
2031-03-14 |
2026-07-15 |
Primary Endpoints|Treatments |
|
NCT06099990 |
SHR6390-305 | P1 |
Not yet recruiting |
Prostate Cancer |
2028-12-01 |
2023-10-26 |
Primary Endpoints|Treatments |
|
2018-002350-78 |
2018-002350-78 | P3 |
Active, not recruiting |
Prostate Cancer |
2030-03-30 |
2022-03-13 |
Treatments |
|
NCT07213674 |
NCT07213674 | P3 |
Recruiting |
Prostate Cancer |
2030-01-07 |
81% |
2026-04-10 |
|
NCT07751133 |
ENHANCE | P3 |
Recruiting |
Prostate Cancer |
2029-08-01 |
2026-09-09 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
2022-502254-13-00 |
S67130 | P3 |
Recruiting |
Prostate Cancer |
2029-07-15 |
2025-05-02 |
Treatments |
|
NCT04175431 |
RG1004972 | P2 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2032-07-01 |
60% |
2026-07-08 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2024-520156-22-00 |
CJSB462C12201 | P2 |
Not yet recruiting |
Prostate Cancer |
2032-05-04 |
68% |