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Cerubidine, Vyxeos liposomal (previously known as vyxeos)(daunorubicin)
Cerubidine, 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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Combinations
Vyxeos
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cytarabine
+
Daunorubicin
Tradename
Company
Number
Date
Products
VYXEOSCelator PharmaceuticalsN-209401 RX2017-08-03
1 products, RLD, RS
Daunorubicin citrate
Tradename
Company
Number
Date
Products
DAUNOXOMEGalen PharmaN-050704 DISCN1996-04-08
1 products
Hide discontinued
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 hydrochlorideANDA2023-01-01
vyxeosNew Drug Application2021-04-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia acute—D015470C92.0
precursor cell lymphoblastic leukemia-lymphoma—D054198C91.0
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
298 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.048643714133
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.06212312765
Promyelocytic leukemia acuteD015473C92.4—111—3
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95113336—578
Myelodysplastic syndromesD009190D4661613—133
LymphomaD008223C85.9—57——12
Myeloid leukemiaD007951C92267——11
Monocytic leukemia acuteD007948145——9
Myelomonocytic leukemia acuteD015479C92.5145——9
Megakaryoblastic leukemia acuteD007947C94.2125——7
Erythroblastic leukemia acuteD004915EFO_1001257C94.0125——7
Myelomonocytic leukemia chronicD015477C93.1331——6
AnemiaD000740EFO_0004272D64.9132——4
Show 11 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Biphenotypic leukemia acuteD015456C95.011——12
ThrombocytopeniaD013921HP_0001873D69.6—2———2
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034011———1
Non-hodgkin lymphomaD008228C85.9—1———1
Essential thrombocythemiaD013920D47.311———1
Polycythemia veraD011087D4511———1
Primary myelofibrosisD055728D47.411———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD0193372————2
Precursor t-cell lymphoblastic leukemia-lymphomaD0542181————1
Breast neoplasmsD001943EFO_0003869C501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ataxia telangiectasiaD001260Orphanet_100G11.3————11
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)
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
RxCUI3109
ChEMBL IDCHEMBL178
ChEBI ID41977
PubChem CID30323
DrugBankDB00694
UNII IDZS7284E0ZP (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Vyxeos - Jazz Pharmaceuticals
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,925 documents
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Safety
Black-box Warning
Black-box warning for: Vyxeos
Adverse Events
Top Adverse Reactions
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12,785 adverse events reported
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