Active Ingredient History
Azacitidine (Vidaza; Pharmion), an inhibitor of DNA methylation, was approved by the US FDA for the treatment of myelodysplastic syndromes in May 2004. It is the first drug to be approved by the FDA for treating this rare family of bone-marrow disorders, and has been given orphan-drug status. It is also a pioneering example of an agent that targets 'epigenetic' gene silencing, a mechanism that is exploited by cancer cells to inhibit the expression of genes that counteract the malignant phenotype. VIDAZA is used for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Azacitidine is a pyrimidine nucleoside analog of cytidine. It is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. As azacitidine is a ribonucleoside, it incorporates into RNA to a larger extent than into DNA. The incorporation into RNA leads to the dissemble of polyribosomes, defective methylation and acceptor function of transfer RNA, and inhibition of the production of protein. Its incorporation into DNA leads to a covalent binding with DNA methyltransferases, which prevents DNA synthesis and subsequent cytotoxicity. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to azacitidine. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Acute Kidney Injury (Phase 1/Phase 2)
Adult (Phase 2)
Aged (Phase 2)
Anemia, Refractory (Phase 3)
Autoimmune Diseases (Phase 2)
beta-Thalassemia (Phase 2)
Bile Duct Neoplasms (Phase 1/Phase 2)
Biomarkers (Phase 1/Phase 2)
Bone Marrow Cells (Phase 2)
Brain Neoplasms (Early Phase 1)
Breast Neoplasms (Phase 2)
Breast Neoplasms, Male (Phase 2)
Carcinoma, Non-Small-Cell Lung (Phase 2)
Carcinoma, Ovarian Epithelial (Phase 2)
Carcinoma, Pancreatic Ductal (Phase 1)
Carcinoma, Renal Cell (Phase 1/Phase 2)
Carcinoma, Squamous Cell (Phase 1)
Carcinoma, Transitional Cell (Phase 1)
Cholangiocarcinoma (Phase 1/Phase 2)
Chondrosarcoma (Phase 1/Phase 2)
Cognitive Aging (Phase 2/Phase 3)
Colonic Neoplasms (Phase 2)
Colorectal Neoplasms (Phase 2)
Crohn Disease (Phase 3)
Drug Therapy (Phase 3)
Enteropathy-Associated T-Cell Lymphoma (Phase 2)
Ependymoma (Phase 1)
Epigenetic Repression (Phase 2)
Esophageal Neoplasms (Phase 1)
Fallopian Tube Neoplasms (Phase 1)
Fibroblasts (Phase 1)
Fusion Proteins, bcr-abl (Phase 2)
Gastrointestinal Neoplasms (Phase 1/Phase 2)
GATA2 Deficiency (Phase 3)
Glioblastoma (Phase 1/Phase 2)
Glioma (Phase 2)
Graft vs Host Disease (Phase 1/Phase 2)
Head and Neck Neoplasms (Phase 1/Phase 2)
Hematologic Neoplasms (Phase 2)
Hematopoietic Stem Cell Transplantation (Phase 2)
Hepatic Insufficiency (Phase 1)
Hodgkin Disease (Phase 2/Phase 3)
Intestinal Neoplasms (Phase 2)
Isocitrate Dehydrogenase (Phase 3)
Kidney Transplantation (Phase 4)
Leukemia (Phase 3)
Leukemia, Biphenotypic, Acute (Phase 2)
Leukemia, Eosinophilic, Acute (Phase 1/Phase 2)
Leukemia, Erythroblastic, Acute (Phase 2)
Leukemia, Hairy Cell (Phase 1)
Leukemia, Large Granular Lymphocytic (Phase 1/Phase 2)
Leukemia, Lymphocytic, Chronic, B-Cell (Phase 2/Phase 3)
Leukemia, Lymphoid (Phase 1)
Leukemia-Lymphoma, Adult T-Cell (Phase 1)
Leukemia, Megakaryoblastic, Acute (Phase 1/Phase 2)
Leukemia, Monocytic, Acute (Phase 2)
Leukemia, Myelogenous, Chronic, BCR-ABL Positive (Phase 2/Phase 3)
Leukemia, Myeloid (Phase 3)
Leukemia, Myeloid, Acute (Phase 4)
Leukemia, Myelomonocytic, Acute (Phase 2)
Leukemia, Myelomonocytic, Juvenile (Phase 2)
Leukemia, Neutrophilic, Chronic (Phase 1/Phase 2)
Leukemia, Prolymphocytic (Phase 1)
Leukemia, Promyelocytic, Acute (Phase 1)
Liposarcoma (Phase 1)
Liver Diseases (Phase 1)
Lung Neoplasms (Phase 2)
Lymphoma (Phase 2/Phase 3)
Lymphoma, B-Cell (Phase 2/Phase 3)
Lymphoma, B-Cell, Marginal Zone (Phase 2/Phase 3)
Lymphoma, Extranodal NK-T-Cell (Phase 1)
Lymphoma, Follicular (Phase 2/Phase 3)
Lymphoma, Large B-Cell, Diffuse (Phase 3)
Lymphoma, Large-Cell, Anaplastic (Phase 1)
Lymphoma, Large-Cell, Immunoblastic (Phase 2/Phase 3)
Lymphoma, Mantle-Cell (Phase 1)
Lymphoma, Non-Hodgkin (Phase 2)
Lymphoma, T-Cell (Phase 3)
Lymphoma, T-Cell, Cutaneous (Phase 1)
Lymphoma, T-Cell, Peripheral (Phase 2)
Mastocytosis (Phase 1/Phase 2)
Melanoma (Phase 2)
Mesothelioma (Phase 1)
Multiple Myeloma (Phase 2)
Mutation (Phase 2)
Myeloproliferative Disorders (Phase 2)
Nasopharyngeal Carcinoma (Phase 1)
Nasopharyngeal Neoplasms (Phase 2)
Neoplasm Metastasis (Phase 1/Phase 2)
Neoplasm, Residual (Phase 2)
Neoplasms ()
Neoplasms, Germ Cell and Embryonal (Phase 1/Phase 2)
Neurofibromatosis 1 (Phase 1/Phase 2)
Osteosarcoma (Phase 1/Phase 2)
Ovarian Neoplasms (Phase 2)
Pain (Phase 1/Phase 2)
Pancreatic Neoplasms (Phase 2)
Patient Preference (Phase 3)
Peritoneal Neoplasms (Phase 1)
Philadelphia Chromosome (Phase 2)
Plasmacytoma (Phase 2)
Polycythemia Vera (Phase 2)
Primary Myelofibrosis (Phase 2)
Prostatic Neoplasms (Phase 2)
Renal Insufficiency (Phase 1)
Risk Factors (Phase 2)
Salvage Therapy (Phase 2)
Sarcoma (Phase 1/Phase 2)
Sarcoma, Myeloid (Phase 1)
Sezary Syndrome (Phase 1)
Small Cell Lung Carcinoma (Phase 1)
Squamous Cell Carcinoma of Head and Neck (Phase 2)
Stem Cell Transplantation (Phase 2)
Thrombocythemia, Essential (Phase 1/Phase 2)
Thrombocytopenia (Phase 3)
Thyroid Neoplasms (Phase 1)
Transplantation (Phase 1)
Tuberculosis, Pulmonary (Phase 2)
Tumor Suppressor Protein p53 (Phase 2)
Tumor Virus Infections (Phase 1)
Urinary Bladder Neoplasms (Phase 1)
Urination Disorders (Phase 1)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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