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Daunorubicin And Cytarabine Liposome · Vyxeos, CPX-351

Antibody-drug conjugate · Cytotoxic · developed by Jazz Pharmaceuticals

Approved FDA

JAZZ Developer

3 Registered trials

What is Daunorubicin And Cytarabine Liposome?

Vyxeos is a liposomal formulation combining daunorubicin and cytarabine in a fixed 1:5 molar ratio. Daunorubicin inhibits topoisomerase II and DNA polymerase while generating DNA-damaging free radicals; cytarabine inhibits DNA polymerase and affects S-phase cells. The liposomes deliver both agents intracellularly to leukemia cells for synergistic cytotoxic effects in acute myeloid leukemia.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Vyxeos, CPX-351, cytarabine/daunorubicin liposomal
Drug type: Antibody-drug conjugate
Mechanism: Cytotoxic
Pathways: DNA replication, DNA repair, topoisomerase II inhibition, free radical generation
Therapy area: Oncology
Developer: Jazz Pharmaceuticals, Inc. (JAZZ)
FDA status: Approved as Vyxeos, NDA209401 · FDA label

✅ FDA-approved uses

Newly diagnosed therapy-related acute myeloid leukemia (t-AML)
AML with myelodysplasia-related changes (AML-MRC)

From the indications section of the FDA label (version of Jan 30, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT04217278	Phase 2/3	Acute Myeloid Leukaemia	Active not recruiting	JAZZ
NCT05656248	Phase 2	Myeloid Neoplasm	Active not recruiting	JAZZ
NCT04269213	Phase 2	Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome	Completed	JAZZ

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Acute Myeloid LeukaemiaHigh-risk Myelodysplastic SyndromeMyeloid NeoplasmAcute Myeloid Leukemia With Myelodysplasia-Related ChangesSecondary Acute Myeloid LeukemiaTherapy-Related Acute Myeloid Leukemia

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Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the JAZZ page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z