NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
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. Approved for acute myeloid leukemia, acute lymphoblastic leukemia. First approved in 2004.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLOLAR (clofarabine) is a purine nucleoside analog small molecule that inhibits DNA synthesis and repair while triggering mitochondrial-mediated apoptosis in rapidly proliferating leukemic cells. It is indicated for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The drug works by inhibiting deoxynucleotide triphosphate pools, terminating DNA chain elongation, and disrupting mitochondrial membrane integrity.
LOE Approaching
Product is in declining phase with moderate competitive pressure (30/100); commercial teams should expect stable to modest headcount focused on maintenance and niche indication support.
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 (2)
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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.