Product Description
for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer (Sourced from: https://www.nejm.org/doi/full/10.1056/nejmoa1813904)
Mechanisms of Action: PI3K Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Croatia | Cyprus | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: Breast Cancer | Oncology Solid Tumor Unspecified | Oncology Unspecified
Known Adverse Events: Alopecia | Stomatitis | Diarrhea
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 42
Highest Development Phases
Phase 3: Breast Cancer|Lymphangioma|Lymphatic Abnormalities|Ovarian Cancer|Triple Negative Breast Cancer
Phase 2: Abnormalities, Multiple|Acute Respiratory Distress Syndrome|Breast Diseases|Endometrial Cancer|Head and Neck Cancer|Hyperglycemia|Megalencephaly|Other|Polymicrogyria|Skin Abnormalities|Skin Diseases, Vascular|Squamous Cell Carcinoma|Telangiectasis|Tic Disorders|Vascular Malformations
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CBYL719P12201 | P3 |
Unknown Status |
Unknown |
2030-10-14 |
|
| CBYL719F12201 | P2 |
Recruiting |
Acute Respiratory Distress Syndrome |
2030-06-07 |
|
| EPIK-P2 | P2 |
Active, not recruiting |
Other |
2030-03-01 |
|
| EPIK-B2 | P3 |
Active, not recruiting |
Breast Cancer |
2030-02-07 |