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: None *
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: Oncology Solid Tumor Unspecified | Prostate Cancer | Oncology Unspecified | Oncology Solid Tumor Unspecified | Prostate Cancer | Oncology Unspecified
Known Adverse Events: Hypertension | Spinal Cord Compression | Back Pain | Dizziness | Headache | Low Back Pain | Pain Unspecified | Paresthesia | Insomnia | Arthralgia | Musculoskeletal Pain | Hematuria | Asthenia | Diarrhea | Edema | Constipation
Company: Astellas Pharma
Company Location: NEW YORK NY 10005
Company CEO:
Additonal 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, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 88
Highest Development Phases
Phase 3: Prostate Cancer
Phase 2: Adenocarcinoma|Bone Cancer|Breast Cancer|Male Breast Cancer|Ovarian Cancer|Pancreatic Cancer|Peritoneal Cancer|Small Cell Lung Cancer|Triple Negative Breast Cancer
Phase 1: Healthy Volunteers|Hepatocellular Carcinoma|Soft Tissue Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| PEACE6-Poor Responders | P3 |
Not yet recruiting |
Prostate Cancer |
2033-02-01 |
|
| S65935 | P3 |
Not yet recruiting |
Prostate Cancer |
2032-06-01 |
|
| STAMPEDE | P3 |
Unknown status |
Prostate Cancer |
2030-12-04 |
|
| 2018-002350-78 | P3 |
Active, not recruiting |
Prostate Cancer |
2030-03-30 |