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Fludarabine Injection
Fludarabine is a purine analog that inhibits ribonucleotide reductase and DNA polymerase, leading to disruption of DNA synthesis and cell death in rapidly dividing cells.
Fludarabine is a purine analog that inhibits ribonucleotide reductase and DNA polymerase, leading to disruption of DNA synthesis and cell death in rapidly dividing cells. Used for Chronic lymphocytic leukemia (CLL), Non-Hodgkin's lymphoma, Acute leukemias.
At a glance
| Generic name | Fludarabine Injection |
|---|---|
| Also known as | Fludara |
| Sponsor | University of California, San Francisco |
| Drug class | Purine analog antimetabolite |
| Target | Ribonucleotide reductase, DNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fludarabine is a fluorinated nucleoside analog that is phosphorylated intracellularly to its active form, fludarabine triphosphate. This active metabolite inhibits both ribonucleotide reductase and DNA polymerase, preventing DNA synthesis and repair. The drug is particularly effective against lymphoid malignancies because lymphocytes have high levels of deoxycytidine kinase, the enzyme responsible for its activation.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin's lymphoma
- Acute leukemias
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Infection
- Nausea and vomiting
- Fever
- Fatigue
- Neurotoxicity
- Tumor lysis syndrome
Key clinical trials
- Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL (PHASE1, PHASE2)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- KRAS-Specific Autologous TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors (PHASE1)
- Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases (PHASE1)
- Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia (PHASE1)
- Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fludarabine Injection CI brief — competitive landscape report
- Fludarabine Injection updates RSS · CI watch RSS
- University of California, San Francisco portfolio CI