Active Ingredient History
Ribociclib, also known as LEE011, is an orally available cyclin-dependent kinase (CDK) inhibitor targeting cyclin D1/CDK4 and cyclin D3/CDK6 cell cycle pathway, with potential antineoplastic activity. CDK4/6 inhibitor LEE011 specifically inhibits CDK4 and 6, thereby inhibiting retinoblastoma (Rb) protein phosphorylation. Inhibition of Rb phosphorylation prevents CDK-mediated G1-S phase transition, thereby arresting the cell cycle in the G1 phase, suppressing DNA synthesis and inhibiting cancer cell growth. Overexpression of CDK4/6, as seen in certain types of cancer, causes cell cycle deregulation. Ribociclib is in phase III clinical trials by Novartis for the treatment of postmenopausal women with advanced breast cancer. Phase II clinical trials are also in development for the treatment of liposarcoma, ovarian cancer, fallopian tube cancer, peritoneum cancer, endometrial cancer, and gastrointestinal cancer. Preregistration for Breast cancer (First-line therapy, Combination therapy, Late-stage disease) in the USA (PO) in November 2016. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
Combination drugs
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Astrocytoma (Phase 2)
Brain Neoplasms (Phase 1)
Breast Neoplasms (Phase 4)
Carcinoma, Hepatocellular (Phase 2)
Carcinoma, Non-Small-Cell Lung (Phase 1/Phase 2)
Carcinosarcoma (Phase 1/Phase 2)
Central Nervous System Neoplasms (Phase 1)
Choroid Plexus Neoplasms (Phase 1)
Colorectal Neoplasms (Phase 1/Phase 2)
Diffuse Intrinsic Pontine Glioma (Phase 2)
Endometrial Neoplasms (Phase 2)
Ependymoma (Phase 1)
Esophageal Neoplasms (Phase 1/Phase 2)
Fallopian Tube Neoplasms (Phase 2)
Fibrosarcoma (Phase 1)
Gastrointestinal Stromal Tumors (Phase 1)
Gene Amplification (Phase 1/Phase 2)
Glioblastoma (Phase 2)
Glioma (Phase 2)
Hamartoma (Phase 2)
Hormones (Phase 2)
Kidney Diseases (Phase 1)
Leiomyosarcoma (Phase 1)
Liposarcoma (Phase 2)
Liver Diseases (Phase 1)
Lung Neoplasms (Phase 2)
Lymphoma (Phase 1/Phase 2)
Medulloblastoma (Phase 1)
Melanoma (Phase 2)
Meningioma (Phase 1)
Mutation (Phase 1)
Neoadjuvant Therapy (Phase 2/Phase 3)
Neoplasm Metastasis (Phase 2)
Neoplasms (Phase 4)
Neoplasms, Germ Cell and Embryonal (Phase 1)
Neoplasms, Neuroepithelial (Phase 1)
Nerve Sheath Neoplasms (Phase 1)
Neuroblastoma (Phase 1/Phase 2)
Neuroectodermal Tumors, Primitive (Phase 1)
Neuroendocrine Tumors (Phase 2)
Oligodendroglioma (Phase 1)
Ovarian Neoplasms (Phase 2)
Pancreatic Neoplasms (Phase 2)
Paraganglioma (Phase 1)
Pinealoma (Phase 1)
Postmenopause (Phase 2)
Primary Myelofibrosis (Phase 1)
Prostatic Neoplasms (Phase 1/Phase 2)
Recurrence (Phase 2)
Rhabdoid Tumor (Phase 1)
Rhabdomyosarcoma (Phase 1)
Sarcoma (Phase 2)
Sarcoma, Synovial (Phase 1)
Squamous Cell Carcinoma of Head and Neck (Phase 1)
Stomach Neoplasms (Phase 2)
Teratoma (Phase 2)
Thymus Neoplasms (Phase 2)
Triple Negative Breast Neoplasms (Phase 1/Phase 2)
Uterine Neoplasms (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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