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Experimental (fludarabine)
Experimental (fludarabine) is a Purine analog antimetabolite Small molecule drug developed by French Innovative Leukemia Organisation. It is currently in Phase 3 development for Chronic lymphocytic leukemia (CLL), Acute leukemia, Lymphoma. Also known as: Arm B.
Fludarabine is a purine analog that inhibits ribonucleotide reductase and DNA polymerase, leading to DNA strand breaks and apoptosis in rapidly dividing cells.
Fludarabine is a purine analog that inhibits ribonucleotide reductase and DNA polymerase, leading to DNA strand breaks and apoptosis in rapidly dividing cells. Used for Chronic lymphocytic leukemia (CLL), Acute leukemia, Lymphoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Experimental (fludarabine) |
|---|---|
| Also known as | Arm B |
| Sponsor | French Innovative Leukemia Organisation |
| 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 and incorporated into DNA, causing chain termination and inhibition of DNA synthesis. It is particularly effective against lymphoid malignancies because lymphocytes have high levels of deoxycytidine kinase, the enzyme required for its activation, making them more sensitive to the drug's cytotoxic effects than other cell types.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Acute leukemia
- Lymphoma
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Infection
- Nausea and vomiting
- Diarrhea
- Fever
- 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)
- A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
- RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy (PHASE2, PHASE3)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers (PHASE1, PHASE2)
- 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)
- Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma (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:
- Experimental (fludarabine) CI brief — competitive landscape report
- Experimental (fludarabine) updates RSS · CI watch RSS
- French Innovative Leukemia Organisation portfolio CI
Frequently asked questions about Experimental (fludarabine)
What is Experimental (fludarabine)?
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Who makes Experimental (fludarabine)?
Is Experimental (fludarabine) also known as anything else?
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Related
- Drug class: All Purine analog antimetabolite drugs
- Target: All drugs targeting Ribonucleotide reductase, DNA polymerase
- Manufacturer: French Innovative Leukemia Organisation — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocytic leukemia (CLL)
- Indication: Drugs for Acute leukemia
- Indication: Drugs for Lymphoma
- Also known as: Arm B
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing