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Fludarabine

Alternative Names: fludarabine, fludara, oforta
Latest Update: 2025-01-21
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Fludarabine

Countries in Clinic: Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Korea, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States

Active Clinical Trial Count: 53

Highest Development Phases

Phase 3: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Chronic Lymphoid Leukemia|Histiocytosis|Leukemia|Myelodysplastic Syndrome|Precursor Cell Lymphoblastic Leukemia-Lymphoma

Phase 2: 22q11 Deletion Syndrome|B-Cell Marginal Zone Lymphoma|Biphenotypic Acute Leukemia|Chronic Myeloid Leukemia|Colorectal Cancer|Diffuse Large B-Cell Lymphoma|Digestive System Cancer|Epstein-Barr Virus Infections|Esophageal Cancer|Extranodal NK-T-Cell Lymphoma|Follicular Lymphoma|Gallbladder Cancer|Gastrointestinal Cancer|Head and Neck Cancer|Kidney Diseases|Kidney Transplant|Leukemia, Plasma Cell|Liposarcoma, Myxoid|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma|Melanoma|Non-Small-Cell Lung Cancer|Pancreatic Cancer|Primary Central Nervous System Lymphoma|Renal Transplant|Schizophrenia|Stiff-Person Syndrome|Synovial Sarcoma|T-Cell Lymphoma|Waldenstrom Macroglobulinemia

Phase 1: ANCA Vasculitis|Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Adenocarcinoma|Adrenocortical Carcinoma|Allogeneic Stem Cell Transplant|Breast Cancer|COVID-19|Chronic Myelomonocytic Leukemia|Cutaneous Squamous Cell Carcinoma|Juvenile Myelomonocytic Leukemia,|Liver Cancer|Lung Cancer|Lupus Erythematosus, Cutaneous|Lupus Erythematosus, Systemic|Lupus Vasculitis|Multiple Myeloma|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloproliferative Disorders|Neuroblastoma|Neuroendocrine Carcinoma|Neuroendocrine Tumors|Oncology Solid Tumor Unspecified|Oropharyngeal Cancer|Osteosarcoma|Papilloma|Paraganglioma|Pheochromocytoma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Preleukemia|Prostate Cancer|Relapsed/Refractory Lymphoma|Sarcoma|Scleroderma, General|Skin Cancer|Small Cell Carcinoma|Small Cell Lung Cancer|Squamous Cell Carcinoma|Systemic Vasculitis|Thyroid Cancer|Triple Negative Breast Cancer|Uveal Melanoma

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
TROPIKANA

P1

Recruiting

Breast Cancer|Non-Small-Cell Lung Cancer|Small Cell Lung Cancer

2038-04-30

Venetoclax in children with relapsed AML

P3

Active, not recruiting

Acute Myeloid Leukemia

2032-02-17

ALL SCTped FORUM

P3

Unknown Status

Leukemia

2030-06-01

AIEOP-BFM AML 2020

P3

Unknown Status

Acute Myeloid Leukemia

2029-12-31

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