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: *
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: None
Known Adverse Events: None
Company: Sanofi
Company Location: Europe
Company Founding Year: 1973
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Korea, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, United Kingdom, United States
Active Clinical Trial Count: 47
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Histiocytosis|Leukemia
Phase 2: 22q11 Deletion Syndrome|Acute Lymphoid Leukemia|Acute Myeloid Leukemia|B-Cell Marginal Zone Lymphoma|Biphenotypic Acute Leukemia|Carcinoma, Merkel Cell|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Colorectal Cancer|Cutaneous Squamous Cell Carcinoma|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|Hodgkin Lymphoma|Kidney Diseases|Kidney Transplant|Leukemia, Plasma Cell|Liposarcoma, Myxoid|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma|Multiple Myeloma|Myelodysplastic Syndrome|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Non-Small-Cell Lung Cancer|Pancreatic Cancer|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Primary Central Nervous System Lymphoma|Renal Transplant|Schizophrenia|Skin Cancer|Squamous Cell Carcinoma|Stiff-Person Syndrome|Synovial Sarcoma|T-Cell Cutaneous Lymphoma|T-Cell Leukemia|T-Cell Lymphoma|Waldenstrom Macroglobulinemia
Phase 1: Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Adenocarcinoma|Adrenocortical Adenoma|Adrenocortical Carcinoma|Allogeneic Stem Cell Transplant|Breast Cancer|COVID-19|Chronic Myelomonocytic Leukemia|Gaucher Disease|Islet Cell Adenoma|Islet Cell Carcinoma|Juvenile Myelomonocytic Leukemia,|Liver Cancer|Lung Cancer|Lupus Erythematosus, Systemic|Myeloproliferative Disorders|Neuroblastoma|Neuroendocrine Carcinoma|Neuroendocrine Tumors|Oncology Solid Tumor Unspecified|Oropharyngeal Cancer|Osteosarcoma|Papilloma|Paraganglioma|Pheochromocytoma|Preleukemia|Relapsed/Refractory Lymphoma|Sarcoma|Small Cell Lung Cancer|Thyroid Cancer|Triple Negative Breast Cancer|Uveal Melanoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03721068 |
LCCC 1743-ATL | P1 |
Recruiting |
Neuroblastoma|Gaucher Disease|Osteosarcoma |
2030-05-19 |
2% |
2025-09-10 |
Primary Endpoints |
NCT07358260 |
NCT07358260 | P1 |
Not yet recruiting |
Neuroblastoma |
2029-12-31 |
2026-01-23 |
||
NCT06358430 |
NCI-2024-03107 | P1 |
Recruiting |
Colorectal Cancer |
2029-01-18 |
2024-12-13 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT07246304 |
D101-IIT-01 | P1 |
Recruiting |
Small Cell Lung Cancer |
2027-11-30 |
2025-11-25 |
Primary Endpoints|Treatments |
|
NCT05088356 |
IRB-60439 | P1 |
Recruiting |
Acute Myeloid Leukemia|Myeloproliferative Disorders|Myelodysplastic Syndrome|Chronic Myeloid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia |
2027-11-01 |
50% |
2025-12-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06277804 |
LTC004-102 | P1 |
Not yet recruiting |
Oncology Solid Tumor Unspecified |
2027-07-01 |
2% |
2024-02-27 |
Primary Endpoints|Treatments |
NCT06373991 |
EDI-901-SLE01 | P1 |
Not yet recruiting |
Lupus Erythematosus, Systemic |
2027-04-30 |
32% |
2024-07-23 |
|
NCT04119024 |
IRB-77842 | P1 |
Recruiting |
Breast Cancer|Head and Neck Cancer|Lung Cancer|Adrenocortical Carcinoma|Squamous Cell Carcinoma|Islet Cell Adenoma|Thyroid Cancer|Pancreatic Cancer|Pheochromocytoma|Uveal Melanoma|Adenocarcinoma|Cutaneous Squamous Cell Carcinoma|Adrenocortical Adenoma|Paraganglioma|Islet Cell Carcinoma|Neuroendocrine Carcinoma|Neuroendocrine Tumors |
2026-10-01 |
2025-10-23 |
Primary Completion Date|Primary Endpoints|Start Date|Treatments |
|
NCT07105176 |
HS-IT101ST01-â b-02 | P1 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2026-08-30 |
50% |
2025-08-06 |
Primary Endpoints |
NCT05582590 |
NEXI-003-HPV-101 | P1 |
Not yet recruiting |
Oropharyngeal Cancer|Squamous Cell Carcinoma|Papilloma|Head and Neck Cancer |
2026-07-01 |
4% |
2024-01-17 |
|
NCT06247787 |
PEPN2312 | P1 |
Recruiting |
Preleukemia|Acute Myelomonocytic Leukemia|Acute Myeloid Leukemia|Myelodysplastic Syndrome|Acute Monocytic Leukemia|Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,|Chronic Myeloid Leukemia |
2026-06-30 |
50% |
2025-02-07 |
Primary Endpoints|Treatments |
NCT06347068 |
LCCC2128-ATL | P1 |
Recruiting |
Triple Negative Breast Cancer |
2026-05-01 |
50% |
2024-07-26 |
|
NCT05577000 |
NCI-2022-08957 | P1 |
Active, not recruiting |
Multiple Myeloma |
2025-11-30 |
50% |
2026-02-21 |
Primary Endpoints |
NCT06464965 |
NCT06464965 | P1 |
Completed |
Gastrointestinal Cancer|Pancreatic Cancer|Adenocarcinoma |
2025-10-10 |
2026-01-27 |
Primary Completion Date|Primary Endpoints |
|
NCT06532643 |
CD20/CD30-CN-A1 | P1 |
Recruiting |
Relapsed/Refractory Lymphoma |
2025-09-01 |
8% |
2025-08-27 |
Primary Endpoints|Treatments |
NCT07164469 |
NCI-2025-06569 | P2 |
Not yet recruiting |
Lymphoma, B-Cell|Hodgkin Lymphoma |
2031-09-30 |
12% |
2025-09-11 |
Primary Endpoints |
NCT05900401 |
2023P000486 | P2 |
Active, not recruiting |
Kidney Diseases|Kidney Transplant|Renal Transplant |
2028-12-01 |
50% |
2025-06-10 |
Primary Endpoints|Treatments|Trial Status |
NCT07288073 |
NCT07288073 | P2 |
Recruiting |
Squamous Cell Carcinoma|Cutaneous Squamous Cell Carcinoma|Carcinoma, Merkel Cell|Skin Cancer |
2028-09-29 |
12% |
2026-02-14 |
Primary Endpoints|Start Date |
NCT05934448 |
NCT05934448 | P2 |
Recruiting |
T-Cell Lymphoma|Diffuse Large B-Cell Lymphoma|Epstein-Barr Virus Infections |
2027-06-06 |
12% |
2024-01-06 |
|
NCT05589896 |
PRESERVE I | P2 |
Recruiting |
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, B-Cell|Acute Myeloid Leukemia|Acute Lymphoid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|T-Cell Leukemia|Lymphocytic Chronic B-Cell Leukemia|Myelodysplastic Syndrome|T-Cell Cutaneous Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, Non-Hodgkin|Biphenotypic Acute Leukemia |
2026-05-31 |
12% |
2026-02-25 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06588491 |
KYSA-8 | P2 |
Active, not recruiting |
Stiff-Person Syndrome |
2026-04-01 |
2025-12-23 |
||
NCT02859402 |
RRTCLAlloSCT | P2 |
Recruiting |
Extranodal NK-T-Cell Lymphoma|Lymphoma, Non-Hodgkin |
2025-12-01 |
29% |
2022-08-19 |
|
NCT04426669 |
2019LS002 | P2 |
Completed |
Gastrointestinal Cancer|Pancreatic Cancer|Digestive System Cancer|Esophageal Cancer|Colorectal Cancer|Gallbladder Cancer |
2025-05-28 |
12% |
2026-02-24 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2024-512657-24-00 |
ALL SCTped FORUM | P3 |
Not yet recruiting |
Leukemia |
2030-06-01 |
2025-05-02 |
Treatments |
|
2024-512676-36-00 |
042011 | P3 |
Not yet recruiting |
Histiocytosis |
2025-12-30 |
2025-05-02 |
Treatments |