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Clofarabine, ara-C
Clofarabine, ara-C is a Nucleoside analog and cytosine analog Small molecule drug developed by Hannover Medical School. It is currently in Phase 2 development for Acute lymphoblastic leukemia, Acute myeloid leukemia.
Clofarabine is a nucleoside analog that interferes with DNA synthesis, while ara-C is a cytosine analog that also interferes with DNA synthesis.
Clofarabine is a chemotherapy medication used to treat various types of leukemia and lymphoma, including CD22+ Relapsed/Refractory B-ALL, Acute Myeloid Leukemia, and Acute Lymphoblastic Leukemia. It is often used in combination with other treatments, such as immunotherapy and chemotherapy, as part of clinical trials to evaluate its efficacy in these conditions.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Clofarabine, ara-C |
|---|---|
| Sponsor | Hannover Medical School |
| Drug class | Nucleoside analog and cytosine analog |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Clofarabine and ara-C are both antimetabolites that work by inhibiting DNA polymerase, which is necessary for DNA replication and cell division. This leads to cell death, particularly in rapidly dividing cancer cells.
Approved indications
- Acute lymphoblastic leukemia
- Acute myeloid leukemia
Common side effects
- Nausea
- Vomiting
- Fatigue
- Diarrhea
- Anemia
Key clinical trials
- Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma (PHASE2, PHASE3)
- Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations (PHASE3)
- Vyxeos® With Clofarabine for Pediatric AML (PHASE1)
- The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial) (PHASE2)
- Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia (PHASE3)
- Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL (PHASE2, PHASE3)
- Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia (PHASE2)
- Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) (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:
- Clofarabine, ara-C CI brief — competitive landscape report
- Clofarabine, ara-C updates RSS · CI watch RSS
- Hannover Medical School portfolio CI
Frequently asked questions about Clofarabine, ara-C
What is Clofarabine, ara-C?
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Who makes Clofarabine, ara-C?
What drug class is Clofarabine, ara-C in?
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Related
- Drug class: All Nucleoside analog and cytosine analog drugs
- Manufacturer: Hannover Medical School — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute lymphoblastic leukemia
- Indication: Drugs for Acute myeloid leukemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing