Product Description
Fludarabine is mainly used to treat chronic lymphocytic leukaemia (CLL). It may also be used in trials for low grade non-Hodgkin lymphoma (NHL), hairy cell leukaemia, acute myeloid leukaemia and a type of lymphoma that affects the skin called mycosis fungoides. (Sourced from: https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/fludarabine)
Mechanisms of Action: STAT1 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | 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 Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Chronic Leukemia | Chronic Lymphoid Leukemia | Leukemia | Lymphoid Leukemia
Known Adverse Events: Pain Unspecified | Anemia | Thrombocytopenia | Neutropenia | Anorexia
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, China, France, Korea, Spain, United States
Active Clinical Trial Count: 25
Highest Development Phases
Phase 3: Acute Myeloid Leukemia
Phase 2: B-Cell Marginal Zone Lymphoma|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Diffuse Large B-Cell Lymphoma|Epstein-Barr Virus Infections|Extranodal NK-T-Cell Lymphoma|Follicular Lymphoma|Head and Neck Cancer|Leukemia, Plasma Cell|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma|Melanoma|Myelodysplastic Syndrome|Primary Central Nervous System Lymphoma|T-Cell Lymphoma|Waldenstrom Macroglobulinemia
Phase 1: Acute Lymphoid Leukemia|Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Breast Cancer|COVID-19|Chronic Myelomonocytic Leukemia|Colorectal Cancer|Juvenile Myelomonocytic Leukemia,|Liver Cancer|Lupus Erythematosus, Systemic|Multiple Myeloma|Neuroblastoma|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Osteosarcoma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Preleukemia|Relapsed/Refractory Lymphoma|Small Cell Lung Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| TROPIKANA | P1 |
Recruiting |
Small Cell Lung Cancer|Breast Cancer|Non-Small-Cell Lung Cancer |
2038-04-30 |
|
| Venetoclax in children with relapsed AML | P3 |
Active, not recruiting |
Acute Myeloid Leukemia |
2032-02-17 |
|
| NCI-2024-03107 | P1 |
Recruiting |
Colorectal Cancer |
2029-01-18 |
|
| NCI-2022-08957 | P1 |
Active, not recruiting |
Multiple Myeloma |
2028-10-31 |