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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
Variants
Financial
Trends
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Events Timeline
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3M
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YTD
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2Y
5Y
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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
Hide discontinued
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
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
2485 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50662981641138536
LymphomaD008223—C85.9902791201017460
LeukemiaD007938—C951052141162421424
Myeloid leukemia acuteD015470—C92.013018790824377
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.034102622116218
Myeloid leukemiaD007951—C926610242511187
SarcomaD012509——499144113180
Non-hodgkin lymphomaD008228—C85.936884336154
Large b-cell lymphoma diffuseD016403—C83.345943424152
Lymphoid leukemiaD007945—C91195832156120
Show 34 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80604314—5109
Ovarian neoplasmsD010051EFO_0003893C56182715—155
RecurrenceD012008——23207—247
NeuroblastomaD009447EFO_0000621—82115—246
Stomach neoplasmsD013274EFO_0003897C1682611—545
Monocytic leukemia acuteD007948——101811—136
Myelomonocytic leukemia acuteD015479—C92.5101810—136
Neoplasm metastasisD009362EFO_0009708—11196—335
Erythroblastic leukemia acuteD004915EFO_1001257C94.081510—131
Ovarian epithelial carcinomaD000077216——11167——30
Show 137 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blast crisisD001752——39———12
Plasmablastic lymphomaD000069293—C83.377———11
Invasive hydatidiform moleD002820—D39.2—8———8
Adult t-cell leukemia-lymphomaD015459—C91.544———7
Aids-related lymphomaD016483EFO_1001365—34———7
Myeloid leukemia chronic-phaseD015466——33———6
Thyroid neoplasmsD013964EFO_0003841—26———6
Head and neck neoplasmsD006258——45———6
Intestinal neoplasmsD007414—C26.024———6
Primary effusion lymphomaD054685—C83.844———5
Show 116 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Appendiceal neoplasmsD001063EFO_0003880C18.12———13
CystadenocarcinomaD003536——2————2
Neoplasms by histologic typeD009370——2————2
Sezary syndromeD012751—C84.11———12
Female genital neoplasmsD005833——2————2
Castration-resistant prostatic neoplasmsD064129——1————1
Leukemia myeloid chronic atypical bcr-abl negativeD054438—C92.21————1
ThrombocytosisD013922—D75.831————1
Skin neoplasmsD012878EFO_0004198C441————1
Cutaneous malignant melanomaD000096142——1————1
Show 10 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CardiomyopathiesD009202EFO_0000318I42————22
Erectile dysfunctionD007172EFO_0004234F52.21————22
Diabetic neuropathiesD003929EFO_1000783—————22
Biliary tract neoplasmsD001661—C24.9————11
FatigueD005221—R53.83————11
AtaxiaD001259—R27.0————11
Ataxia telangiectasiaD001260Orphanet_100G11.3————11
TelangiectasisD013684——————11
Cerebellar ataxiaD002524——————11
Alopecia areataD000506EFO_0004192L63————11
Show 22 more
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 23,705 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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