Product Description
Decitabine 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). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. (Sourced from: https://medlineplus.gov/druginfo/meds/a608009.html)
Mechanisms of Action: DNA Mtase Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Anemia | Anemia, Refractory | Anemia, Refractory, with Excess of Blasts | Myelodysplastic Syndrome | Chronic Leukemia | Chronic Myelomonocytic Leukemia | Leukemia | Anemia | Anemia, Refractory | Anemia, Refractory, with Excess of Blasts | Myelodysplastic Syndrome | Chronic Leukemia | Chronic Myelomonocytic Leukemia | Leukemia
Known Adverse Events: Anemia | Thrombocytopenia | Neutropenia | Dizziness | Headache | Mucositis | Febrile Neutropenia | Respiratory Tract Infections | Arthralgia | Myalgia | Pneumonia | Dyspnea | Constipation | Diarrhea | Edema
Company: Astex
Company Location: DUBLIN CA 94568
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belgium, Bulgaria, Canada, Finland, France, Germany, Greece, Hungary, India, Italy, Lebanon, Lithuania, Netherlands, New Zealand, Oman, Poland, Romania, Slovakia, South Africa, Spain, Turkey, United Kingdom, United States
Active Clinical Trial Count: 41
Highest Development Phases
Phase 3: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,|Myelodysplastic Syndrome|Preleukemia
Phase 2: Adenocarcinoma|Allogeneic Stem Cell Transplant|Anemia, Sickle Cell|Head and Neck Cancer|Melanoma|Oncology Unspecified|Ovarian Cancer|Pancreatic Cancer|Pancreatic Ductal Carcinoma|T-Cell Peripheral Lymphoma|Triple Negative Breast Cancer
Phase 1: Bone Marrow Diseases|Healthy Volunteers|Mastocytosis, Systemic|Myelofibrosis|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloproliferative Disorders|Oncology Solid Tumor Unspecified|Prostate Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCT04742634 | P2 |
Recruiting |
Myelodysplastic Syndrome |
2033-11-30 |
|
| NCT05983276 | P2 |
Recruiting |
Ovarian Cancer |
2030-08-28 |
|
| NCI-2023-10826 | P1 |
Recruiting |
Acute Myeloid Leukemia |
2028-12-31 |
|
| VICCHEM2163 | P2 |
Recruiting |
Acute Myeloid Leukemia |
2028-03-01 |