Anastrozole - PharmaKB

Anastrozole

Anastrozole, Arimidex (anastrozole) is a small molecule pharmaceutical. Anastrozole was first approved as Arimidex on 1995-12-27. It is used to treat breast neoplasms in the USA. The pharmaceutical is active against aromatase.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Arimidex (generic drugs available since 2010-06-28)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Anastrozole

Tradename	Company	Number	Date	Products
ARIMIDEX	ANI PHARMS	N-020541 RX	1995-12-27	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
anastrozole	ANDA	2024-01-24
arimidex	New Drug Application	2022-12-16
lactulose	ANDA	2012-05-01

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
breast neoplasms	EFO_0003869	D001943	C50

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L02: Endocrine therapy antineoplastic and immunomodulating agents

— L02B: Hormone antagonists and related agents

— L02BG: Aromatase inhibitors

— L02BG03: Anastrozole

HCPCS

Code	Description
S0170	Anastrozole, oral, 1 mg

Clinical

Clinical Trials

432 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	21	135	77	14	63	303
Triple negative breast neoplasms	D064726	—	—	—	10	5	1	—	16
Male breast neoplasms	D018567	—	—	1	7	3	1	2	14
Obesity	D009765	EFO_0001073	E66.9	—	—	1	2	4	7
Hypogonadism	D007006	HP_0000044	E23.0	1	3	—	2	1	7
Invasive hydatidiform mole	D002820	—	D39.2	2	1	2	1	—	6
Endometriosis	D004715	EFO_0001065	N80	1	1	—	2	—	4
Neoplasm metastasis	D009362	EFO_0009708	—	—	—	—	1	—	1
Dysmenorrhea	D004412	HP_0100607	N94.6	—	—	—	1	—	1
Cerebrovascular disorders	D002561	EFO_0003763	I60-I69	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	6	5	1	—	2	13
Osteoporosis	D010024	HP_0000939	M81.0	—	2	2	—	—	4
Ductal carcinoma breast	D018270	—	—	—	—	2	—	—	2
Bone density	D015519	EFO_0003923	M85	—	—	1	—	1	2
Gynecomastia	D006177	HP_0000771	N62	—	1	1	—	—	2
Progression-free survival	D000077982	—	—	—	—	1	—	—	1
Oligospermia	D009845	—	N46.1	—	—	1	—	—	1
Hypopituitarism	D007018	EFO_0001380	E23.0	—	1	1	—	—	1
Klinefelter syndrome	D007713	EFO_1001006	Q98.0	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	8	1	—	—	1	10
Arthralgia	D018771	HP_0002829	M25.5	—	1	—	—	6	7
Endometrial neoplasms	D016889	EFO_0004230	—	3	4	—	—	—	6
Ovarian neoplasms	D010051	EFO_0003893	C56	2	2	—	—	—	4
Breast diseases	D001941	—	N60-N65	1	3	—	—	—	3
Metabolic syndrome	D024821	EFO_0000195	E88.810	1	1	—	—	1	3
Non-small-cell lung carcinoma	D002289	—	—	1	1	—	—	—	2
Pulmonary arterial hypertension	D000081029	—	—	—	2	—	—	—	2
Depression	D003863	—	F33.9	—	1	—	—	1	2
Intraductal carcinoma noninfiltrating	D002285	—	D05.1	—	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast density	D000071060	—	—	2	—	—	—	—	2
Hypertension	D006973	EFO_0000537	I10	1	—	—	—	1	2
Aging	D000375	GO_0007568	R41.81	1	—	—	—	1	2
Kallmann syndrome	D017436	Orphanet_478	E23.0	1	—	—	—	—	1
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pain	D010146	EFO_0003843	R52	—	—	—	—	2	2
Postmenopause	D017698	—	—	—	—	—	—	2	2
Atrophic vaginitis	D059268	EFO_1001271	—	—	—	—	—	1	1
Pregnancy rate	D018873	—	—	—	—	—	—	1	1
Prader-willi syndrome	D011218	Orphanet_739	Q87.11	—	—	—	—	1	1
Silver-russell syndrome	D056730	Orphanet_813	Q87.19	—	—	—	—	1	1
Insulin resistance	D007333	HP_0000855	E88.819	—	—	—	—	1	1
Vitamin d deficiency	D014808	EFO_0003762	E55	—	—	—	—	1	1
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	1	1
Nutrition disorders	D009748	EFO_0001069	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Anastrozole
INN	anastrozole
Description	Anastrozole is a 1,2,4-triazole compound having a 3,5-bis(2-cyano-2-propyl)benzyl group at the 1-position. It has a role as an antineoplastic agent and an EC 1.14.14.14 (aromatase) inhibitor. It is a member of triazoles and a nitrile.
Classification	Small molecule
Drug class	aromatase inhibitors (imidazole/triazole derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)(C#N)c1cc(Cn2cncn2)cc(C(C)(C)C#N)c1

Identifiers

PDB	—
CAS-ID	120511-73-1
RxCUI	—
ChEMBL ID	CHEMBL1399
ChEBI ID	2704
PubChem CID	2187
DrugBank	DB01217
UNII ID	2Z07MYW1AZ (ChemIDplus, GSRS)

Target

Agency Approved

CYP19A1

Organism

Homo sapiens

Gene name

CYP19A1

Gene synonyms

ARO1, CYAR, CYP19

NCBI Gene ID

1588

Protein name

aromatase

Protein synonyms

CYPXIX, Cytochrome P-450AROM, Cytochrome P450 19A1, cytochrome P450, family 19, subfamily A, polypeptide 1, cytochrome P450, subfamily XIX (aromatization of androgens), Estrogen synthase, estrogen synthetase, flavoprotein-linked monooxygenase, microsomal monooxygenase

Uniprot ID

Q8IYJ7

Mouse ortholog

Cyp19a1 (13075)

aromatase (P28649)

Alternate

No data

Variants

No data

Financial

Revenue by drug

€