NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
CLOLAR (clofarabine) by Sanofi is 5'-monophosphate metabolite by deoxycytidine kinase and mono- and di-phospho-kinases to the active 5'-triphosphate metabolite. First approved in 2004.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLOLAR (clofarabine) is a purine nucleoside antimetabolite administered intravenously that inhibits DNA synthesis and repair while triggering mitochondrial-mediated apoptosis in rapidly proliferating cancer cells. It is indicated for relapsed or refractory acute leukemias in pediatric patients. The drug works by being phosphorylated to its active 5'-triphosphate form, which competes with natural nucleotides to block DNA polymerases and ribonucleotide reductase, ultimately inducing programmed cell death.
LOE Approaching
As a product approaching loss of exclusivity with moderate competitive pressure (30/100), commercial teams are likely focused on maximizing remaining branded lifecycle value and managing the transition to post-LOE positioning.
Mechanism of Action
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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia
Started Aug 2023
23 enrolled
Acute Myeloid LeukemiaMyelodysplastic Syndrome
Vyxeos® With Clofarabine for Pediatric AML
Started Nov 2020
25 enrolled
Relapsed Pediatric AMLRefractory Pediatric AML
Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders
Started May 2015
25 enrolled
Langerhans Cell Histiocytosis
Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies
Started Aug 2013
16 enrolled
Hodgkin LymphomaNon-Hodgkin LymphomaAcute Leukemia
Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
Started Jun 2012
4 enrolled
Myeldysplastic Syndrome (MDS)Chronic Myelomonocytic LeukemiaBone Marrow Diseases+2 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.