Product Description
Enzalutamide is used to treat prostate cancer that has spread to other parts of the body in men and who have been helped by certain medical and surgical treatments that decrease testosterone levels. It is also used to treat prostate cancer in men who have not been helped by certain medical and surgical treatments that decrease testosterone levels. Enzalutamide 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/a612033.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 | Bosnia | Brazil | Bulgaria | Canada | Chile | 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 | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Astellas Pharma
Company Location: NEW YORK NY 10005
Company CEO:
Additional Commercial Interests: Pfizer
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 77
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Pfizer presented P1 Oncology Solid Tumor Unspecified|Prostate Cancer results on 2025-02-13 for Enzalutamide
- Clinical Outcomes Reported - Pfizer presented P3 Prostate Cancer results on 2024-09-15 for Enzalutamide
Highest Development Phases
Phase 3: Adenocarcinoma|Prostate Cancer
Phase 2: Bone Cancer|Breast Cancer|Small Cell Lung Cancer|Triple Negative Breast Cancer
Phase 1: Follicular Lymphoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| NCI-2020-04495 | P2 |
Recruiting |
Prostate Cancer|Adenocarcinoma|Small Cell Lung Cancer |
2028-05-31 |
12% |
2025-05-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| NCT06099769 | P2 |
Recruiting |
Breast Cancer |
2027-10-01 |
12% |
2023-10-26 |
Primary Endpoints|Treatments |
| EP-001 | P1 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2025-06-01 |
67% |
2024-07-23 |
|
| NCT02750358 | P2 |
Active, not recruiting |
Triple Negative Breast Cancer |
2025-05-01 |
2024-07-23 |
Primary Endpoints |
|
| BONENZA | P2 |
Completed |
Bone Cancer|Prostate Cancer |
2023-04-18 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
| PEACE6-Poor Responders | P3 |
Recruiting |
Prostate Cancer |
2033-02-01 |
2024-12-21 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
| S65935 | P3 |
Recruiting |
Prostate Cancer |
2032-06-01 |
2025-05-02 |
Treatments |
|
| COmbined Suppression of MYC | P2 |
Not yet recruiting |
Prostate Cancer |
2031-06-30 |
12% |
2025-04-11 |
Primary Endpoints |
| TRIPLE-SWITCH | P3 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2031-03-14 |
2025-06-06 |
Primary Endpoints|Start Date |
|
| 2018-002350-78 | P3 |
Active, not recruiting |
Prostate Cancer |
2030-03-30 |
2022-03-13 |
Treatments |
|
| S67130 | P3 |
Recruiting |
Prostate Cancer |
2029-07-15 |
2025-05-02 |
Treatments |
|
| CURLu177PSM0001 | P3 |
Active, not recruiting |
Prostate Cancer |
2029-02-02 |
2025-05-02 |
Treatments |
|
| RENAPCA | P1 |
Recruiting |
Prostate Cancer |
2029-01-01 |
23% |
2025-02-12 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date |
| AcTFirst | P3 |
Not yet recruiting |
Prostate Cancer |
2028-02-29 |
69% |
2025-05-31 |
Primary Completion Date|Primary Endpoints |
| EvoPAR-PR01 | P3 |
Recruiting |
Prostate Cancer |
2028-01-11 |
88% |
2024-03-09 |
Primary Endpoints|Study Completion Date|Treatments |
| C3441052 | P3 |
Active, not recruiting |
Prostate Cancer |
2027-08-07 |
69% |
2025-05-02 |
Treatments |
| UMCC 2023.109 | P2 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2027-07-30 |
12% |
2025-06-06 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
| MCC-21139 | P2 |
Active, not recruiting |
Prostate Cancer |
2027-07-15 |
12% |
2024-07-24 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| NCI-2021-08857 | P2 |
Recruiting |
Prostate Cancer |
2027-04-30 |
15% |
2025-06-07 |
|
| ProBio | P3 |
Recruiting |
Prostate Cancer |
2026-12-01 |
43% |
2024-01-18 |
Primary Endpoints|Treatments |
| C3431004/MDV3100-13 | P3 |
Active, not recruiting |
Prostate Cancer |
2026-10-31 |
2025-05-02 |
Treatments |
|
| JapicCTI-205267 | P3 |
Active |
Prostate Cancer |
2026-09-01 |
|||
| jRCT2080225171 | P3 |
Completed |
Prostate Cancer |
2026-09-01 |
47% |
||
| CAAA802A12101 | P2 |
Recruiting |
Prostate Cancer |
2026-08-01 |
2025-05-02 |
Treatments |
|
| 9785-CL-0123 | P2 |
Recruiting |
Prostate Cancer |
2026-07-31 |
12% |
2023-11-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |