Darbepoetin alfa - PharmaKB

Aranesp(darbepoetin alfa)

Aranesp (darbepoetin alfa) is a protein pharmaceutical. Darbepoetin alfa was first approved as Aranesp on 2001-06-08. It is used to treat anemia in the USA. It has been approved in Europe to treat anemia, chronic kidney failure, and neoplasms.

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Clinical

Drug

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
urogenital diseases	D000091642
hemic and lymphatic diseases	D006425
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Aranesp (discontinued: Aranesp)

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Darbepoetin alpha

Tradename	Proper name	Company	Number	Date	Products
Aranesp	darbepoetin alpha	Amgen	N-103951 RX		14 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
aranesp	Biologic Licensing Application	2024-05-21

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
anemia	HP_0001903	D000740	D64.9

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

B: Blood and blood forming organ drugs

— B03: Antianemic preparations

— B03X: Other antianemic preparations in atc

— B03XA: Other antianemic preparations in atc

— B03XA02: Darbepoetin alfa

HCPCS

Code	Description
J0881	Injection, darbepoetin alfa, 1 microgram (non-esrd use)
J0882	Injection, darbepoetin alfa, 1 microgram (for esrd on dialysis)

Clinical

Clinical Trials

231 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Anemia	D000740	HP_0001903	D64.9	8	38	71	14	20	148
Kidney diseases	D007674	EFO_0003086	N08	3	10	45	12	12	82
Chronic renal insufficiency	D051436	—	N18	3	10	45	9	11	78
Neoplasms	D009369	—	C80	1	14	12	2	3	31
Chronic kidney failure	D007676	EFO_0003884	N18.9	—	2	8	4	5	19
Renal insufficiency	D051437	HP_0000083	N19	—	4	6	5	4	19
Hyperparathyroidism	D006961	EFO_0008506	E21.3	—	—	—	2	—	2
Secondary hyperparathyroidism	D006962	EFO_1001173	—	—	—	—	2	—	2
Colorectal neoplasms	D015179	—	—	—	—	—	1	1	2
Drug therapy	D004358	—	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myelodysplastic syndromes	D009190	—	D46	2	10	4	—	—	13
Preleukemia	D011289	—	—	2	10	4	—	—	13
Syndrome	D013577	—	—	2	8	3	—	—	10
Lung neoplasms	D008175	HP_0100526	C34.90	—	3	3	—	1	7
Lymphoma	D008223	—	C85.9	—	4	3	—	—	7
Breast neoplasms	D001943	EFO_0003869	C50	—	4	1	—	2	7
Leukemia	D007938	—	C95	—	3	3	—	—	6
Heart failure	D006333	HP_0001635	I50	1	3	2	—	1	6
Diabetes mellitus	D003920	HP_0000819	E08-E13	—	1	2	—	2	5
Multiple myeloma	D009101	—	C90.0	—	3	2	—	—	5

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Brain diseases	D001927	HP_0001298	G93.40	1	3	—	—	—	3
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	1	—	—	1	2
Stroke	D020521	EFO_0000712	I63.9	—	2	—	—	—	2
Brain ischemia	D002545	EFO_0003883	I67.82	1	2	—	—	—	2
Brain hypoxia-ischemia	D020925	EFO_1000846	P91.6	1	2	—	—	—	2
Premature birth	D047928	EFO_0003917	O60	—	1	—	—	1	2
Diabetic nephropathies	D003928	EFO_0000401	—	—	1	—	—	1	2
Iron-deficiency anemia	D018798	HP_0001891	D50	—	1	—	—	1	2
Iron deficiencies	D000090463	—	—	—	1	—	—	1	2
Hypertension	D006973	EFO_0000537	I10	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	4	—	—	—	—	4
Reticulocyte count	D017701	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Renal cell carcinoma	D002292	EFO_0000376	—	—	—	—	—	1	1
Ovarian neoplasms	D010051	EFO_0003893	C56	—	—	—	—	1	1
Endometrial neoplasms	D016889	EFO_0004230	—	—	—	—	—	1	1
Stomach neoplasms	D013274	EFO_0003897	C16	—	—	—	—	1	1
Esophageal neoplasms	D004938	—	C15	—	—	—	—	1	1
Urinary bladder neoplasms	D001749	—	C67	—	—	—	—	1	1
Kidney neoplasms	D007680	EFO_0003865	C64	—	—	—	—	1	1
Cardiomyopathies	D009202	EFO_0000318	I42	—	—	—	—	1	1
Diabetic retinopathy	D003930	EFO_0003770	—	—	—	—	—	1	1
Continuous ambulatory peritoneal dialysis	D010531	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Darbepoetin alfa
INN	darbepoetin alfa
Description	Erythropoietin precursor (Epoetin)
Classification	Protein
Drug class	erythropoietins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—