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Fludarabine mono
Fludarabine mono is a Purine analog antimetabolite Small molecule drug developed by German CLL Study Group. It is currently in Phase 3 development for Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Small lymphocytic lymphoma (SLL).
Fludarabine is a purine analog that inhibits DNA synthesis by blocking ribonucleotide reductase and incorporating into DNA, leading to cell death in rapidly dividing lymphocytes.
Fludarabine is a purine analog that inhibits DNA synthesis by blocking ribonucleotide reductase and incorporating into DNA, leading to cell death in rapidly dividing lymphocytes. Used for Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Small lymphocytic lymphoma (SLL).
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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 | Fludarabine mono |
|---|---|
| Sponsor | German CLL Study Group |
| Drug class | Purine analog antimetabolite |
| Target | Ribonucleotide reductase; DNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fludarabine monophosphate is a fluorinated nucleotide analog that is phosphorylated intracellularly and incorporated into DNA, disrupting DNA synthesis and repair. 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)
- Follicular lymphoma
- Small lymphocytic lymphoma (SLL)
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Infection
- Nausea and vomiting
- Fever
- Fatigue
- Neurotoxicity (peripheral neuropathy, confusion)
- Tumor lysis syndrome
Key clinical trials
- AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (PHASE1, PHASE2)
- Pre-transplant Immunosuppression and Donor Stem Cell Transplant for the Treatment of Severe Hemoglobinopathies (EARLY_PHASE1)
- A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL (PHASE1, PHASE2)
- Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (PHASE2)
- T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Melanoma (PHASE1)
- Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia (PHASE3)
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 mono CI brief — competitive landscape report
- Fludarabine mono updates RSS · CI watch RSS
- German CLL Study Group portfolio CI
Frequently asked questions about Fludarabine mono
What is Fludarabine mono?
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Related
- Drug class: All Purine analog antimetabolite drugs
- Target: All drugs targeting Ribonucleotide reductase; DNA polymerase
- Manufacturer: German CLL Study Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocytic leukemia (CLL)
- Indication: Drugs for Follicular lymphoma
- Indication: Drugs for Small lymphocytic lymphoma (SLL)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing