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 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPOCYT is a liposomal fixed-ratio combination of daunorubicin and cytarabine (1:5 molar ratio) administered by injection for hematologic malignancies, particularly acute leukemias. The liposomal formulation enables selective uptake by leukemia cells in bone marrow, where daunorubicin inhibits topoisomerase II and DNA polymerase while cytarabine acts as an S-phase-specific inhibitor, producing synergistic cytotoxic effects. This targeted delivery approach maximizes drug concentration at the disease site while minimizing systemic exposure.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating a contracting market opportunity and likely streamlined commercial infrastructure.
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)
A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Started Mar 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
BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma
Started Apr 2025
60 enrolled
Mantle Cell LymphomaLymphoma
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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.