Product Description
Verzenio is given with an aromatase inhibitor as initial endocrine-based therapy if you are postmenopausal or male. If you are a female or male, and the cancer has gotten worse after hormone therapy, then Verzenio is given with fulvestrant. If you are female or male and the cancer has gotten worse after both hormone therapy and chemotherapy, then Verzenio is given by itself. (Sourced from: https://www.verzenio.com/)
Mechanisms of Action: CDK4/6 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Breast Cancer|Oncology Solid Tumor Unspecified *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | 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 | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Breast Cancer | Oncology Solid Tumor Unspecified | Oncology Unspecified
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Anemia | Leukopenia | Thrombocytopenia | Neutropenia | Diarrhea
Company: Eli Lilly
Company Location: INDIANAPOLIS IN 46285
Company CEO: David A. Ricks
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 98
Highest Development Phases
Phase 3: Breast Cancer|Breast Cyst|Drug Hypersensitivity|Liposarcoma|Male Breast Cancer|Non-Small-Cell Lung Cancer|Prostate Cancer
Phase 2: Adenocarcinoma|Adenoid Cystic Carcinoma|Brain Cancer|Brain Diseases|Breast Diseases|Cholangiocarcinoma|Endometrial Cancer|Esophageal Cancer|Glioblastoma|Glioma|Granulosa Cell Tumor|Head and Neck Cancer|Lung Cancer|Meningioma|Neuroblastoma|Neuroendocrine Tumors|Oncology Solid Tumor Unspecified|Ovarian Cancer|Pancreatic Cancer|Peripheral Neuroectodermal Tumors, Primitive|Peritoneal Cancer|Primitive Neuroectodermal Tumors|Sarcoma, Ewing|Serous Cystadenocarcinoma|Transitional Cell Carcinoma|Triple Negative Breast Cancer
Phase 1: Bladder Cancer|Lymphoma|Myelofibrosis|Polycythemia Vera|Renal Cell Carcinoma|Sarcoma|Unilateral Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
CARABELA | P2 |
Active, not recruiting |
Breast Cancer |
2033-05-27 |
|
NCT05940493 | P2 |
Not yet recruiting |
Meningioma |
2031-06-30 |
|
2020-004035-24 | P3 |
Active, not recruiting |
Breast Cancer |
2031-04-26 |
|
I3Y-MC-JPCF | P3 |
Unknown Status |
Breast Cancer |
2028-12-31 |