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Clolar (CLOFARABINE)
Clolar works by inhibiting the enzyme responsible for DNA synthesis, thereby preventing cancer cells from reproducing.
Clolar (clofarabine) is a nucleoside metabolic inhibitor developed by Genzyme, targeting ribonucleoside-diphosphate reductase large subunit. It is a small molecule modality approved by the FDA in 2004 for the treatment of acute lymphoid leukemia. Clolar is now off-patent with 12 generic manufacturers available. The drug has a half-life of 4.0 hours and 50% bioavailability. It is used to treat a specific type of blood cancer.
At a glance
| Generic name | CLOFARABINE |
|---|---|
| Sponsor | Sanofi |
| Drug class | Nucleoside Metabolic Inhibitor [EPC] |
| Target | Ribonucleoside-diphosphate reductase large subunit |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
Clofarabine is sequentially metabolized intracellularly to the 5-monophosphate metabolite by deoxycytidine kinase and mono- and di-phospho-kinases to the active 5-triphosphate metabolite. Clofarabine has affinity for the activating phosphorylating enzyme, deoxycytidine kinase, equal to or greater than that of the natural substrate, deoxycytidine. Clofarabine inhibits DNA synthesis by decreasing cellular deoxynucleotide triphosphate pools through an inhibitory action on ribonucleotide reductase, and by terminating DNA chain elongation and inhibiting repair through incorporation into the DNA chain by competitive inhibition of DNA polymerases. The affinity of clofarabine triphosphate for these enzymes is similar to or greater than that of deoxyadenosine triphosphate. In preclinical models, clofarabine has demonstrated the ability to inhibit DNA repair by incorporation into the DNA chain during the repair process. Clofarabine 5-triphosphate also disrupts the integr
Approved indications
- Acute lymphoid leukemia
Common side effects
- Vomiting
- Nausea
- Diarrhea
- Febrile neutropenia
- Pyrexia
- Fatigue
- Chills
- Bacteremia
- Tachycardia
- Abdominal pain
- Headache
- Pruritus
Key clinical trials
- US Study of ECT-001-CB in Pediatric and Young Adult Patients With High-Risk Myeloid Malignancies (PHASE1,PHASE2)
- Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer (EARLY_PHASE1)
- Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders (PHASE2)
- Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders (PHASE2)
- Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia (PHASE2)
- Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT (PHASE2)
- Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation (PHASE2)
- Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia (PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Clolar CI brief — competitive landscape report
- Clolar updates RSS · CI watch RSS
- Sanofi portfolio CI