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: None *
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: Oncology Solid Tumor Unspecified | Prostate Cancer | Oncology Unspecified
Known Adverse Events: Hypertension | Arthralgia | Diarrhea | Edema
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Jordan, Korea, Lebanon, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 57
Highest Development Phases
Phase 3: Adenocarcinoma|Prostate Cancer|Vision Disorders
Phase 2: Neuroendocrine Carcinoma|Oncology Unspecified|Small Cell Lung Cancer
Phase 1: Other
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CARLHA- 2 | P3 |
Active, not recruiting |
Prostate Cancer|Adenocarcinoma |
2033-06-04 |
|
| PEACE6-Poor Responders | P3 |
Recruiting |
Prostate Cancer |
2033-02-01 |
|
| TAPS02 | P3 |
Recruiting |
Prostate Cancer |
2031-04-01 |
|
| STAMPEDE2 | P3 |
Recruiting |
Prostate Cancer |
2031-04-01 |