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
Known Adverse Events: None
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, 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, Vietnam
Active Clinical Trial Count: 77
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|Drug Hypersensitivity|Oncology Unspecified|Prostate Cancer
Phase 2: Hearing Loss, Bilateral|Neuroendocrine Carcinoma|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 |
|---|---|---|---|---|---|---|---|---|
CTR20240341 |
CTR20240341 | P1 |
Completed |
Nose Cancer|Prostate Cancer |
2024-01-23 |
2025-04-29 |
Patient Enrollment|Treatments |
|
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 |
2026-01-01 |
12% |
2025-01-30 |
|
NCT06689163 |
HRS-1167-201-A | P2 |
Recruiting |
Prostate Cancer |
2025-11-30 |
2% |
2025-01-03 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2023-504263-16-00 |
BX44273 | P3 |
Recruiting |
Oncology Unspecified |
2033-03-01 |
40% |
2025-05-02 |
Treatments |
NCT05288166 |
CYCLONE 3 | P3 |
Active, not recruiting |
Drug Hypersensitivity|Prostate Cancer |
2024-02-15 |
17% |
2025-06-28 |
|
NCT06991556 |
CJSB462C12201 | P2 |
Recruiting |
Prostate Cancer |
2032-04-19 |
12% |
2025-10-29 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06212583 |
KNIGHTS | P2 |
Recruiting |
Prostate Cancer |
2028-12-31 |
12% |
2024-04-24 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05361915 |
Maverick Trial | P2 |
Suspended |
Prostate Cancer |
2028-01-01 |
33% |
2024-03-20 |
Primary Endpoints |
NCT04267887 |
STUDY00016728 | P2 |
Active, not recruiting |
Prostate Cancer |
2028-01-01 |
12% |
2024-02-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
jRCT2031220101 |
jRCT2031220101 | P3 |
Active, not recruiting |
Prostate Cancer |
2027-12-31 |
|||
2022-500461-28-06 |
I3Y-MC-JPEG | P3 |
Recruiting |
Prostate Cancer |
2027-10-01 |
17% |
2025-05-02 |
Treatments |
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 |
Prostate Cancer|Adenocarcinoma |
2031-03-14 |
2025-06-06 |
Primary Endpoints|Start Date |
|
2018-002350-78 |
2018-002350-78 | P3 |
Active, not recruiting |
Prostate Cancer |
2030-03-30 |
2022-03-13 |
Treatments |
|
2022-502254-13-00 |
S67130 | P3 |
Recruiting |
Prostate Cancer |
2029-07-15 |
2025-05-02 |
Treatments |
|
NCT06650579 |
REVELUTION-2 | P3 |
Recruiting |
Prostate Cancer |
2029-07-01 |
20% |
2025-05-16 |
Primary Endpoints|Treatments |
2022-501493-19-00 |
CURLu177PSM0001 | P3 |
Active, not recruiting |
Prostate Cancer |
2029-02-02 |
2025-05-02 |
Treatments |
|
NCT06099990 |
SHR6390-305 | P1 |
Not yet recruiting |
Prostate Cancer |
2028-12-01 |
12% |
2023-10-26 |
Primary Endpoints|Treatments |
NCT07213674 |
NCT07213674 | P3 |
Recruiting |
Prostate Cancer |
2028-08-29 |
77% |
2025-10-17 |
|
NCT06855277 |
AcTFirst | P3 |
Recruiting |
Prostate Cancer |
2028-02-29 |
36% |
2025-07-24 |
Primary Endpoints|Start Date |
NCT06120491 |
EvoPAR-PR01 | P3 |
Recruiting |
Prostate Cancer |
2028-01-11 |
39% |
2024-03-09 |
Primary Endpoints|Study Completion Date|Treatments |
2024-520156-22-00 |
CJSB462C12201 | P2 |
Not yet recruiting |
Prostate Cancer |
2032-05-04 |