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Drug ReportsDaunorubicin
Cerubidine, Vyxeos liposomal (previously known as vyxeos)(daunorubicin)
Cerubidine, Daunorubicin, Daunoxome, Vyxeos (daunorubicin) is a small molecule pharmaceutical. Daunorubicin was first approved as Cerubidine on 1982-01-01. It is used to treat myeloid leukemia acute and precursor cell lymphoblastic leukemia-lymphoma in the USA. It has been approved in Europe to treat myeloid leukemia acute.
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Drug
Target
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Financial
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Safety
Events Timeline
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Cerubidine, Daunorubicin (discontinued: Cerubidine, Daunorubicin, Daunoxome)
Combinations
Vyxeos
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Daunorubicin citrate
Tradename
Company
Number
Date
Products
DAUNOXOMEGalen PharmaN-050704 DISCN1996-04-08
1 products
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Cytarabine
+
Daunorubicin
Tradename
Company
Number
Date
Products
VYXEOSJazz PharmaceuticalsN-209401 RX2017-08-03
1 products, RLD, RS
Daunorubicin hydrochloride
Tradename
Company
Number
Date
Products
DAUNORUBICIN HYDROCHLORIDEHikma PharmaceuticalsN-050731 RX1998-01-30
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
daunorubicin hydrochlorideANDA2025-05-21
vyxeosNew Drug Application2025-07-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia acute—D015470C92.0
precursor cell lymphoblastic leukemia-lymphoma—D054198C91.0
leukemia—D007938C95
lymphoma—D008223C85.9
meningeal neoplasmsEFO_0003851D008577C70
Agency Specific
FDA
EMA
Expiration
Code
CYTARABINE / DAUNORUBICIN, VYXEOS, CELATOR PHARMS
2028-03-30ODE-350
2024-08-03ODE-287
2024-03-30NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Cytarabine / Daunorubicin, Vyxeos, Celator Pharms
100289122032-10-15DPU-3149, U-3150
101661842032-10-15DPU-3149
108354922032-10-15U-3150
80928282029-04-01U-3147
80222792027-09-14DPU-3147
78509902027-01-23DPU-3147
92719312027-01-23DP
85184372026-06-07DP
84318062025-04-22DPU-3147
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01D: Cytotoxic antibiotics and related substances
— L01DB: Anthracyclines and related substances
— L01DB02: Daunorubicin
— L01X: Other antineoplastic agents in atc
— L01XY: Combinations of antineoplastic agents
— L01XY01: Cytarabine and daunorubicin
HCPCS
Code
Description
J9150
Injection, daunorubicin, 10 mg
J9151
Injection, daunorubicin citrate, liposomal formulation, 10 mg
J9153
Injection, liposomal, 1 mg daunorubicin and 2.27 mg cytarabine
Clinical
Clinical Trials
2476 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470—C92.0—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDaunorubicin
INNdaunorubicin
Description
Daunorubicin is a natural product found in Actinomadura roseola. It has a role as an antineoplastic agent and a bacterial metabolite. It is an anthracycline, a member of tetracenequinones, a member of p-quinones and an aminoglycoside antibiotic. It is a conjugate base of a daunorubicin(1+). It derives from a hydride of a tetracene.
Classification
Small molecule
Drug classantineoplastic antibiotics (daunorubicin type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)C[C@@](O)(C(C)=O)C[C@@H]3O[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1
Identifiers
PDB—
CAS-ID20830-81-3
RxCUI—
ChEMBL IDCHEMBL178
ChEBI ID41977
PubChem CID30323
DrugBankDB00694
UNII IDZS7284E0ZP (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Vyxeos – Jazz Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 23,470 documents
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Safety
Black-box Warning
Black-box warning for: Daunorubicin hydrochloride, Vyxeos
Adverse Events
Top Adverse Reactions
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16,199 adverse events reported
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