Bleomycin - PharmaKB

Bleomycin

Bleomycin (bleomycin) is a small molecule pharmaceutical. Bleomycin was first approved as Blenoxane on 1982-01-01. It is used to treat choriocarcinoma, hodgkin disease, melanoma, non-hodgkin lymphoma, and sarcoma amongst others in the USA.

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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
urogenital diseases	D000091642
hemic and lymphatic diseases	D006425
skin and connective tissue diseases	D017437
endocrine system diseases	D004700
immune system diseases	D007154

Trade Name

FDA

EMA

Bleomycin (discontinued: Blenoxane, Bleomycin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Bleomycin sulfate

Tradename	Company	Number	Date	Products
BLENOXANE	Bristol Myers Squibb	N-050443 DISCN	1982-01-01	2 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
bleomycin	ANDA	2024-10-10

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
non-hodgkin lymphoma	—	D008228	C85.9
sarcoma	—	D012509	—
hodgkin disease	—	D006689	C81
melanoma	—	D008545	—
squamous cell carcinoma	—	D002294	—
testicular neoplasms	—	D013736	C62
choriocarcinoma	—	D002822	C58
teratocarcinoma	—	D018243	—

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

— L01DC: Other cytotoxic antibiotics in atc

— L01DC01: Bleomycin

HCPCS

Code	Description
J9040	Injection, bleomycin sulfate, 15 units

Clinical

Clinical Trials

221 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	4	39	34	1	4	79
Hodgkin disease	D006689	—	C81	2	36	29	1	9	75
Neoplasms	D009369	—	C80	2	6	9	2	3	21
Kaposi sarcoma	D012514	—	C46	3	2	3	1	2	11
Sarcoma	D012509	—	—	3	2	2	1	2	10
Non-hodgkin lymphoma	D008228	—	C85.9	1	2	3	1	1	8
Head and neck neoplasms	D006258	—	—	1	2	3	1	—	7
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	1	—	2	1	2	6
Congenital abnormalities	D000013	EFO_0003915	Q89.9	—	2	—	1	2	5
Warts	D014860	—	B07	—	1	—	1	2	4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Germ cell and embryonal neoplasms	D009373	—	—	—	8	10	—	4	21
Hiv infections	D015658	EFO_0000764	B20	4	3	5	—	2	14
Testicular neoplasms	D013736	—	C62	—	5	5	—	2	12
Teratoma	D013724	—	D28	—	4	4	—	1	8
Carcinoma	D002277	—	C80.0	—	2	3	—	2	7
Ovarian neoplasms	D010051	EFO_0003893	C56	—	2	4	—	1	7
Large b-cell lymphoma diffuse	D016403	—	C83.3	—	2	3	—	—	5
Squamous cell carcinoma	D002294	—	—	—	2	2	—	—	4
Uterine cervical neoplasms	D002583	—	—	—	—	2	—	1	3
T-cell lymphoma	D016399	—	—	—	1	1	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasm metastasis	D009362	EFO_0009708	—	1	4	—	—	2	6
Recurrence	D012008	—	—	1	3	—	—	1	5
Vulvar neoplasms	D014846	—	C51	—	2	—	—	2	4
Liver neoplasms	D008113	EFO_1001513	C22.0	2	3	—	—	1	4
Breast neoplasms	D001943	EFO_0003869	C50	—	2	—	—	2	4
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	—	3	—	—	—	3
Burkitt lymphoma	D002051	—	C83.7	—	3	—	—	—	3
Lymphatic abnormalities	D044148	—	—	—	1	—	—	2	3
Squamous cell neoplasms	D018307	—	—	—	1	—	—	1	2
Leukemia	D007938	—	C95	—	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	2	—	—	—	2	4
Hemangioma	D006391	—	D18.0	1	—	—	—	3	4
Melanoma	D008545	—	—	1	—	—	—	3	4
Stomach neoplasms	D013274	EFO_0003897	C16	1	—	—	—	1	2
Nervous system neoplasms	D009423	—	—	1	—	—	—	—	1
Brain neoplasms	D001932	EFO_0003833	C71	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Capillary hemangioma	D018324	—	Q82.5	—	—	—	—	2	2
Cardiovascular diseases	D002318	EFO_0000319	I98	—	—	—	—	1	1
Esophageal neoplasms	D004938	—	C15	—	—	—	—	1	1
Esophageal diseases	D004935	EFO_0009544	K22.9	—	—	—	—	1	1
Pterygium	D011625	—	H11.0	—	—	—	—	1	1
Port-wine stain	D019339	—	Q82.5	—	—	—	—	1	1
Cutaneous malignant melanoma	D000096142	—	—	—	—	—	—	1	1
Desmoid tumors	D018222	—	D48.11	—	—	—	—	1	1
Merkel cell carcinoma	D015266	EFO_1001471	C4A	—	—	—	—	1	1
Retroperitoneal neoplasms	D012186	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Bleomycin
INN	bleomycin
Description	Bleomycin A2 is a bleomycin. It has a role as an antineoplastic agent and a metabolite.
Classification	Small molecule
Drug class	antibiotics (Streptomyces strain)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1c(N)nc([C@H](CC(N)=O)NC[C@H](N)C(N)=O)nc1C(=O)N[C@H](C(=O)N[C@H](C)[C@@H](O)[C@H](C)C(=O)N[C@H](C(=O)NCCc1nc(-c2nc(C(=O)NCCC[S+](C)C)cs2)cs1)[C@@H](C)O)[C@@H](O[C@@H]1O[C@@H](CO)[C@@H](O)[C@H](O)[C@@H]1O[C@H]1O[C@H](CO)[C@@H](O)[C@H](OC(N)=O)[C@@H]1O)c1c[nH]cn1