NDAINJECTIONINJECTABLE, LIPOSOMALPriority Review
Approved
Apr 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
DEPOCYT (cytarabine) by Fresenius Kabi is (daunorubicin and cytarabine) liposome for injection is a liposomal formulation of daunorubicin and cytarabine at a fixed 1:5 molar ratio. First approved in 1999.
Drug data last refreshed 38m ago · AI intelligence enriched 38m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPOCYT is a liposomal formulation combining daunorubicin and cytarabine at a 1:5 molar ratio for treating hematologic malignancies, particularly acute leukemias. The liposomal delivery system allows preferential uptake by leukemia cells in the bone marrow, where both drugs work synergistically—daunorubicin inhibits topoisomerase II and generates DNA-damaging free radicals, while cytarabine inhibits DNA polymerase during S-phase. This combination achieves enhanced cytotoxic activity compared to single agents.
LOE Approaching
With LOE approaching and moderate competitive pressure (30%), the brand team is likely optimizing market position before generic/biosimilar competition intensifies; expect focus on retention and managed decline strategies.
Mechanism of Action
(daunorubicin and cytarabine) liposome for injection is a liposomal formulation of daunorubicin and cytarabine at a fixed 1:5 molar ratio. The 1:5 molar ratio of daunorubicin:cytarabine has been shown to have synergistic effects at killing leukemia cells in vitro and in murine models. Daunorubicin…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Response-adapted Luvometinib With or Without Cytarabine in Langerhans Cell Histiocytosis
Started Jun 2026
30 enrolled
Langerhans Cell Histiocytosis
A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Started Apr 2026
216 enrolled
Acute Myeloid Leukemia
Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia
Started Dec 2025
102 enrolled
Acute Myeloid LeukemiaMyelodysplastic Syndrome
Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome
Started Jun 2025
26 enrolled
Hematopoietic and Lymphatic System Neoplasm
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
Started Apr 2025
125 enrolled
AML, AdultMDS
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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.