NDAINTRAVENOUSPOWDERPriority Review
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
4/8 — Partial
Priority Review
VYXEOS ((daunorubicin and cytarabine) liposome) by Jazz Pharmaceuticals is nucleic acid synthesis inhibitors [moa]. First approved in 2017.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYXEOS is a fixed-ratio liposomal combination of daunorubicin and cytarabine approved in 2017 for treatment of acute myeloid leukemia (AML) in newly diagnosed and relapsed/refractory patients. It works by inhibiting nucleic acid synthesis through dual-agent chemotherapy delivered via liposomal formulation to improve drug penetration and reduce systemic toxicity.
Peak6.8 years to LOE
Product is in peak commercial stage with mature market presence; commercial teams are optimizing market penetration rather than executing launch activities.
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
VYxeoS Liposomal Italian Observational Study iN the Real Practice
Started Dec 2023
113 enrolled
Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia With Myelodysplasia-Related ChangesTherapy-Related Acute Myeloid Leukemia
Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms
Started Jan 2023
25 enrolled
Myeloid Neoplasm
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
Started Feb 2022
22 enrolled
Acute Myeloid Leukemia With FLT3/ITD Mutation
Vyxeos® With Clofarabine for Pediatric AML
Started Nov 2020
25 enrolled
Relapsed Pediatric AMLRefractory Pediatric AML
CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome
Started Dec 2018
20 enrolled
Myelodysplastic Syndromes
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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.