Product Description
Azacitidine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. (Sourced from: https://medlineplus.gov/druginfo/meds/a607068.html)
Mechanisms of Action: DNA Mtase Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Subcutaneous,Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Anemia | Anemia, Refractory | Anemia, Refractory, with Excess of Blasts | Myelodysplastic Syndrome | Thrombocytopenia | Neutropenia | Chronic Leukemia | Chronic Myelomonocytic Leukemia | Leukemia | Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia
Known Adverse Events: Erythema | Anemia | Ecchymosis | Leukopenia | Thrombocytopenia | Neutropenia | Hypokalemia | Constipation | Diarrhea | Abdominal Pain | Dizziness | Pain Unspecified | Febrile Neutropenia | Arthralgia | Pneumonia | Asthenia
Company: Bristol-Myers Squibb
Company Location: NEW YORK NY 10016
Company CEO: Giovanni Caforio
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 131
Highest Development Phases
Phase 3: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Immunoblastic Lymphadenopathy|Juvenile Myelomonocytic Leukemia,|Leukemia|Lymphoma|Myelodysplastic Syndrome|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Preleukemia|T-Cell Peripheral Lymphoma
Phase 2: Chronic, Atypical, BCR-ABL Negative Myeloid Leukemia|Glioma|Large Granular Lymphocytic Leukemia|Lymphoid Leukemia|Mastocytosis, Systemic|Melanoma|Myelodysplastic-Myeloproliferative Diseases|Myelofibrosis|Myeloproliferative Disorders|Non-Small-Cell Lung Cancer|Osteosarcoma|Other|T-Cell Leukemia
Phase 1: Acute Lymphoid Leukemia|B-Cell Marginal Zone Lymphoma|Biphenotypic Acute Leukemia|Chronic Lymphoid Leukemia|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|Hairy Cell Leukemia|Hepatic Insufficiency|Leukemia, Plasma Cell|Liver Failure|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma|Oncology Unspecified|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Sarcoma, Myeloid|Waldenstrom Macroglobulinemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2071220092 | P3 |
Recruiting |
Myelodysplastic Syndrome |
2032-08-01 |
|
| CA055-026 | P3 |
Unknown Status |
Myelodysplastic Syndrome |
2031-08-04 |
|
| AZURE | P2 |
Recruiting |
Mastocytosis, Systemic |
2029-11-30 |
57% |
| AZURE | P2 |
Recruiting |
Mastocytosis, Systemic |
2029-11-30 |
57% |
| M15-954 | P3 |
Unknown Status |
Myelodysplastic Syndrome |
2029-10-31 |