Daunorubicin - PharmaKB

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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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
hemic and lymphatic diseases	D006425
immune system diseases	D007154

Trade Name

FDA

EMA

Cerubidine, Daunorubicin (discontinued: Cerubidine, Daunorubicin, Daunoxome)

Combinations

Vyxeos

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Daunorubicin citrate

Tradename	Company	Number	Date	Products
DAUNOXOME	Galen Pharma	N-050704 DISCN	1996-04-08	1 products

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Daunorubicin hydrochloride

Tradename	Company	Number	Date	Products
DAUNORUBICIN HYDROCHLORIDE	Hikma Pharmaceuticals	N-050731 RX	1998-01-30	1 products, RLD, RS

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Cytarabine

Daunorubicin

Tradename	Company	Number	Date	Products
VYXEOS	Celator Pharmaceuticals	N-209401 RX	2017-08-03	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
daunorubicin hydrochloride	ANDA	2024-12-25
vyxeos	New Drug Application	2022-09-27

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
myeloid leukemia acute	—	D015470	C92.0
precursor cell lymphoblastic leukemia-lymphoma	—	D054198	—
leukemia	—	D007938	C95
lymphoma	—	D008223	C85.9
meningeal neoplasms	EFO_0003851	D008577	C70

Agency Specific

FDA

EMA

Expiration	Code
CYTARABINE / DAUNORUBICIN, VYXEOS, CELATOR PHARMS
2028-03-30	ODE-350
2024-08-03	ODE-287
2024-03-30	NPP

Patent Expiration

Patent	Expires	Flag	FDA Information
Cytarabine / Daunorubicin, Vyxeos, Celator Pharms
10028912	2032-10-15	DP	U-3149, U-3150
10166184	2032-10-15	DP	U-3149
10835492	2032-10-15		U-3150
8092828	2029-04-01		U-3147
8022279	2027-09-14	DP	U-3147
7850990	2027-01-23	DP	U-3147
9271931	2027-01-23	DP
8518437	2026-06-07	DP
8431806	2025-04-22	DP	U-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

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477 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Leukemia	D007938	—	C95	89	157	112	19	23	358
Myeloid leukemia acute	D015470	—	C92.0	78	112	70	4	17	247
Myeloid leukemia	D007951	—	C92	71	98	62	3	12	215
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	13	59	47	14	14	139
Lymphoid leukemia	D007945	—	C91	9	50	37	12	10	111
Lymphoma	D008223	—	C85.9	9	27	14	2	1	49
Philadelphia chromosome	D010677	—	—	2	11	3	2	—	16
Promyelocytic leukemia acute	D015473	—	C92.4	—	5	3	3	1	12

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myelodysplastic syndromes	D009190	—	D46	15	26	18	—	3	56
Preleukemia	D011289	—	—	11	16	17	—	2	41
Syndrome	D013577	—	—	8	11	13	—	2	31
Non-hodgkin lymphoma	D008228	—	C85.9	4	12	9	—	1	26
Neoplasms	D009369	—	C80	8	9	4	—	2	21
Recurrence	D012008	—	—	7	5	2	—	1	13
Carcinoma	D002277	—	C80.0	6	5	2	—	—	12
Myeloproliferative disorders	D009196	—	D47.1	3	6	4	—	—	12
Neoplasm metastasis	D009362	EFO_0009708	—	3	3	5	—	1	11
Sarcoma	D012509	—	—	4	3	5	—	—	10

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Large b-cell lymphoma diffuse	D016403	—	C83.3	6	3	—	—	—	7
B-cell lymphoma	D016393	—	—	5	4	—	—	—	7
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	3	5	—	—	—	6
Hodgkin disease	D006689	—	C81	2	4	—	—	—	6
Blast crisis	D001752	—	—	1	3	—	—	—	4
Urinary bladder neoplasms	D001749	—	C67	—	3	—	—	—	3
Biphenotypic leukemia acute	D015456	—	C95.0	2	1	—	—	1	3
Residual neoplasm	D018365	—	—	—	2	—	—	1	3
Transitional cell carcinoma	D002295	—	—	—	2	—	—	—	2
Primary myelofibrosis	D055728	—	D47.4	2	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hematologic neoplasms	D019337	—	—	5	—	—	—	—	5
Ovarian neoplasms	D010051	EFO_0003893	C56	3	—	—	—	—	3
Lung neoplasms	D008175	HP_0100526	C34.90	2	—	—	—	—	2
Fallopian tube neoplasms	D005185	—	—	2	—	—	—	—	2
Burkitt lymphoma	D002051	—	C83.7	2	—	—	—	—	2
Stomach neoplasms	D013274	EFO_0003897	C16	2	—	—	—	—	2
Ovarian epithelial carcinoma	D000077216	—	—	2	—	—	—	—	2
Prostatic neoplasms	D011471	—	C61	1	—	—	—	—	1
Castration-resistant prostatic neoplasms	D064129	—	—	1	—	—	—	—	1
Pancreatic neoplasms	D010190	EFO_0003860	C25	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ataxia	D001259	—	R27.0	—	—	—	—	1	1
Ataxia telangiectasia	D001260	Orphanet_100	G11.3	—	—	—	—	1	1
Telangiectasis	D013684	—	—	—	—	—	—	1	1
Cerebellar ataxia	D002524	HP_0001251	—	—	—	—	—	1	1
Hiv	D006678	—	—	—	—	—	—	1	1
Cardiomyopathies	D009202	EFO_0000318	I42	—	—	—	—	1	1
Infertility	D007246	HP_0000789	—	—	—	—	—	1	1
Induction chemotherapy	D060828	—	—	—	—	—	—	1	1
Eye abnormalities	D005124	HP_0000478	Q15.9	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Daunorubicin
INN	daunorubicin
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 class	antineoplastic 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