Product Description
Apalutamide is used to treat certain types of prostate cancer (cancer in men that begins in the prostate [a male reproductive gland]) and has spread to other parts of the body or that has not spread to other parts of the body but has not been helped by other medical treatments. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a618018.html)
Mechanisms of Action: AR Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Johnson & Johnson
Company Location: Eastern America
Company CEO: Joaquin Duato
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Jordan, Korea, Lebanon, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 47
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Prostate Cancer results on 2024-10-02 for Apalutamide
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Prostate Cancer results on 2024-06-01 for Apalutamide
- Clinical Outcomes Reported - Johnson & Johnson presented P2 Prostate Cancer results on 2024-05-03 for Apalutamide
Highest Development Phases
Phase 3: Adenocarcinoma|Prostate Cancer|Vision Disorders
Phase 2: Neuroendocrine Carcinoma|Oncology Unspecified
Phase 1: Other
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06274047 |
PROSTATE-IQ | P3 |
Recruiting |
Vision Disorders|Prostate Cancer |
2027-06-30 |
15% |
2024-09-28 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT03902951 |
NCI-2019-00337 | P2 |
Active, not recruiting |
Prostate Cancer|Adenocarcinoma|Neuroendocrine Carcinoma |
2026-01-01 |
12% |
2025-01-30 |
|
NCT04325828 |
YATAGARASU | P2 |
Active, not recruiting |
Oncology Unspecified |
2021-06-09 |
12% |
2024-03-28 |
|
NCT04154774 |
CR108714 | P1 |
Completed |
Other |
2025-02-10 |
50% |
2025-03-07 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04267887 |
STUDY00016728 | P2 |
Active, not recruiting |
Prostate Cancer |
2028-01-01 |
12% |
2024-02-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05960578 |
TRAMP | P2 |
Recruiting |
Adenocarcinoma|Prostate Cancer |
2027-03-31 |
12% |
2025-11-04 |
Primary Endpoints|Start Date|Treatments |
NCT06067269 |
HEATWAVE | P2 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2026-12-01 |
12% |
2025-07-16 |
Primary Endpoints|Treatments |
2018-002350-78 |
2018-002350-78 | P3 |
Active, not recruiting |
Prostate Cancer |
2030-03-30 |
2022-03-13 |
Treatments |
|
NCT04513717 |
PREDICT-RT* | P3 |
Active, not recruiting |
Prostate Cancer|Adenocarcinoma |
2033-12-31 |
2025-09-12 |
Primary Endpoints |
|
NCT06496581 |
PEACE6-Poor Responders | P3 |
Recruiting |
Prostate Cancer |
2033-02-01 |
2024-12-21 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT06592924 |
TRIPLE-SWITCH | P3 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2031-03-14 |
2025-06-06 |
Primary Endpoints|Start Date |
|
2023-505852-23-00 |
56021927PCR3015 | P3 |
Active, not recruiting |
Prostate Cancer |
2030-01-28 |
57% |
2025-05-02 |
Treatments |
NCT04557059 |
PRIMORDIUM | P3 |
Active, not recruiting |
Prostate Cancer |
2029-08-27 |
57% |
2024-07-23 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
2022-502254-13-00 |
S67130 | P3 |
Recruiting |
Prostate Cancer |
2029-07-15 |
2025-05-02 |
Treatments |
|
2022-502686-24-00 |
56021927PCR3020 | P3 |
Recruiting |
Prostate Cancer |
2027-08-23 |
25% |
2025-05-02 |
Treatments |
NCT04181203 |
CARLHA-2 | P3 |
Active, not recruiting |
Prostate Cancer |
2028-09-28 |
99% |
2025-07-31 |
Primary Endpoints|Treatments|Trial Status |
2023-509221-47-00 |
ARN-509-003 | P3 |
Active, not recruiting |
Prostate Cancer |
2027-06-01 |
2025-05-02 |
Treatments |
|
2023-508606-26-00 |
56021927PCR3001 | P3 |
Active, not recruiting |
Prostate Cancer |
2026-12-31 |
2025-05-02 |
Treatments |
|
2023-508607-20-00 |
56021927PCR3002 | P3 |
Active, not recruiting |
Prostate Cancer |
2026-12-01 |
2025-05-02 |
Treatments |
|
NCT03903835 |
ProBio | P3 |
Recruiting |
Prostate Cancer |
2026-12-01 |
43% |
2024-01-18 |
Primary Endpoints|Treatments |
NCT04134260 |
NRG-GU008 | P3 |
Recruiting |
Adenocarcinoma|Prostate Cancer |
2026-11-01 |
2025-05-13 |
Primary Endpoints|Start Date|Treatments |
|
NCT05884398 |
LIBERTAS | P3 |
Active, not recruiting |
Prostate Cancer |
2026-10-12 |
25% |
2025-11-11 |
|
NCT07002320 |
ASpiRE | P2 |
Recruiting |
Prostate Cancer |
2029-10-01 |
12% |
2025-06-04 |
Primary Endpoints |
NCT05191680 |
TAPS02 | P2 |
Recruiting |
Prostate Cancer |
2029-10-01 |
12% |
2025-06-21 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04295447 |
ADAM | P2 |
Active, not recruiting |
Prostate Cancer |
2028-11-30 |
77% |
2024-07-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |