Doxorubicin hydrochloride, Caelyx pegylated liposomal(doxorubicin)

Doxil, Myocet, Pegylated (doxorubicin) is a small molecule pharmaceutical. Doxorubicin was first approved as Doxorubicin hydrochloride on 1982-01-01. It is used to treat breast neoplasms, gastrointestinal neoplasms, hodgkin disease, lung neoplasms, and myeloid leukemia acute amongst others in the USA. It has been approved in Europe to treat breast neoplasms, kaposi sarcoma, multiple myeloma, and ovarian neoplasms. It is known to target DNA topoisomerase 2-alpha and sorcin.

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
neoplasms	D009369
digestive system diseases	D004066
respiratory tract diseases	D012140
urogenital diseases	D000091642
cardiovascular diseases	D002318
hemic and lymphatic diseases	D006425
hereditary congenital and neonatal diseases and abnormalities	D009358
skin and connective tissue diseases	D017437
endocrine system diseases	D004700

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Trade Name

FDA

EMA

Doxil (generic drugs available since 1989-03-17, discontinued: Adriamycin, Rubex)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Doxorubicin hydrochloride

Tradename	Company	Number	Date	Products
DOXIL (LIPOSOMAL)	Baxter	N-050718 RX	1995-11-17	2 products, RLD
DOXORUBICIN HYDROCHLORIDE	Mylan	N-050629 RX	1987-12-23	3 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
adriamycin	ANDA	2022-12-20
doxil	New Drug Application	2019-08-12
doxorubicin hydrochloride	ANDA	2021-01-31

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
breast neoplasms	EFO_0003869	D001943	C50
gastrointestinal neoplasms	—	D005770	C26.9
hodgkin disease	—	D006689	C81
lung neoplasms	—	D008175	C34.90
myeloid leukemia acute	—	D015470	C92.0
neuroblastoma	EFO_0000621	D009447	—
osteosarcoma	—	D012516	—
ovarian neoplasms	EFO_0003893	D010051	C56
precursor cell lymphoblastic leukemia-lymphoma	—	D054198	C91.0
soft tissue neoplasms	—	D012983	—

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Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01D: Cytotoxic antibiotics and related substances

— L01DB: Anthracyclines and related substances

— L01DB01: Doxorubicin

HCPCS

Code	Description
J9000	Injection, doxorubicin hydrochloride, 10 mg
Q2049	Injection, doxorubicin hydrochloride, liposomal, imported lipodox, 10 mg
Q2050	Injection, doxorubicin hydrochloride, liposomal, not otherwise specified, 10 mg

Clinical

Clinical Trials

1708 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 neoplasms	D001943	EFO_0003869	C50	57	209	82	9	32	357
Sarcoma	D012509			45	81	31	1	8	148
Ovarian neoplasms	D010051	EFO_0003893	C56	51	60	34	1	6	136
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	23	37	27	9	2	90
Large b-cell lymphoma diffuse	D016403		C83.3	27	48	20	1	2	80
Liver neoplasms	D008113	EFO_1001513	C22.0	11	27	16	1	9	60
Multiple myeloma	D009101		C90.0	13	39	10	2	1	54
Non-hodgkin lymphoma	D008228		C85.9	15	29	8	2	2	49
Follicular lymphoma	D008224		C82	9	12	3	1	—	17
Mantle-cell lymphoma	D020522		C83.1	2	11	4	1	—	16

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223		C85.9	25	103	48	—	11	172
Neoplasms	D009369		C80	62	20	7	—	3	83
Hodgkin disease	D006689		C81	7	38	20	—	2	62
Fallopian tube neoplasms	D005185			27	23	13	—	1	54
Leukemia	D007938		C95	6	25	20	—	2	48
Triple negative breast neoplasms	D064726			10	32	7	—	—	46
Neuroblastoma	D009447	EFO_0000621		10	20	13	—	2	45
Prostatic neoplasms	D011471		C61	8	15	4	—	—	24
Endometrial neoplasms	D016889	EFO_0004230		2	12	11	—	—	24
Ovarian epithelial carcinoma	D000077216			12	10	3	—	2	23

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Stomach neoplasms	D013274	EFO_0003897	C16	4	5	—	—	2	11
Male breast neoplasms	D018567			4	7	—	—	2	10
Pancreatic neoplasms	D010190	EFO_0003860	C25	5	5	—	—	1	9
Neoplasm metastasis	D009362	EFO_0009708		3	6	—	—	1	9
Myeloid leukemia acute	D015470		C92.0	4	4	—	—	—	8
Invasive hydatidiform mole	D002820		D39.2	—	8	—	—	—	8
Myelodysplastic syndromes	D009190		D46	4	2	—	—	—	6
Head and neck neoplasms	D006258			4	4	—	—	—	6
Adult t-cell leukemia-lymphoma	D015459		C91.5	3	3	—	—	—	5
Biphenotypic leukemia acute	D015456		C95.0	1	4	—	—	—	5

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cystadenocarcinoma	D003536			3	—	—	—	—	3
Appendiceal neoplasms	D001063	EFO_0003880	C18.1	2	—	—	—	1	3
Myelodysplastic-myeloproliferative diseases	D054437			2	—	—	—	—	2
Castration-resistant prostatic neoplasms	D064129			1	—	—	—	—	1
Primary myelofibrosis	D055728		D47.4	1	—	—	—	—	1
Myelomonocytic leukemia chronic	D015477		C93.1	1	—	—	—	—	1
Anemia	D000740	EFO_0004272	D64.9	1	—	—	—	—	1
Leukemia myeloid chronic atypical bcr-abl negative	D054438		C92.2	1	—	—	—	—	1
Thrombocytosis	D013922		D75.83	1	—	—	—	—	1
Hypersensitivity	D006967	EFO_0003785	T78.40	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Fatigue	D005221	HP_0012378	R53.83	—	—	—	—	1	1
Nausea	D009325	HP_0002018	R11.0	—	—	—	—	1	1
Ataxia telangiectasia	D001260	Orphanet_100	G11.3	—	—	—	—	1	1
Therapeutic equivalency	D013810			—	—	—	—	1	1
Takotsubo cardiomyopathy	D054549	EFO_1002000	I51.81	—	—	—	—	1	1
Liver transplantation	D016031	EFO_0010682		—	—	—	—	1	1
Adjuvant chemotherapy	D017024			—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	DOXORUBICIN
INN	doxorubicin
Description	Doxorubicin is a deoxy hexoside, an anthracycline, an anthracycline antibiotic, an aminoglycoside, a member of tetracenequinones, a member of p-quinones, a primary alpha-hydroxy ketone and a tertiary alpha-hydroxy ketone. It has a role as an Escherichia coli metabolite. It is a conjugate base of a doxorubicin(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(=O)CO)C[C@@H]3O[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1

Identifiers

PDB	5MRA
CAS-ID	23214-92-8
RxCUI	3639
ChEMBL ID	CHEMBL53463
ChEBI ID	28748
PubChem CID	31703
DrugBank	DB00997
UNII ID	80168379AG (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

TOP2A

SRI

Organism

Homo sapiens

Gene name

TOP2A

Gene synonyms

TOP2

NCBI Gene ID

7153

Protein name

DNA topoisomerase 2-alpha

Protein synonyms

DNA gyrase, DNA topoisomerase (ATP-hydrolyzing), DNA topoisomerase II, 170 kD, DNA topoisomerase II, alpha isozyme, topoisomerase (DNA) II alpha 170kDa

Uniprot ID

Q9UQP9

Mouse ortholog

Top2a (21973)

DNA topoisomerase 2-alpha (Q01320)

Variants

Clinical Variant

No data

Financial

No data

Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Safety

Black-box Warning

Black-box warning for: Adriamycin, Doxil, Doxorubicin hydrochloride

Adverse Events

Top Adverse Reactions

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6,930 adverse events reported

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Real-time Data on

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