CYTOSAR-U

Post-LOE

cytarabine

Teva

ANDAINJECTIONINJECTABLE

Approved

Dec 1998

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

CYTOSAR-U (cytarabine) by Teva is (daunorubicin and cytarabine) liposome for injection is a liposomal formulation of daunorubicin and cytarabine at a fixed 1:5 molar ratio. Approved for newly diagnosed therapy-related acute myeloid leukemia (t-aml), aml with myelodysplasia-related changes (aml-mrc) in adults, older and 1 more indications. First approved in 1998.

Drug data last refreshed 20h ago

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 (4)

newly diagnosed therapy-related acute myeloid leukemia (t-AML)

Worked on CYTOSAR-U at Teva? Share your interview experience or compensation data (+7 days Pro)

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.

Clinical Trials (20)

NCT07255872Phase 2/3Not Yet Recruiting

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

NCT07228273Phase 2Recruiting

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

NCT06895473Phase 2Recruiting

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

NCT06533761Phase 1Recruiting

Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

Started Apr 2025

125 enrolled

AML, AdultMDS

NCT06854003Phase 2Recruiting

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