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

Anastrozole, Arimidex (discontinued: Anastrozole)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Anastrozole

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

Labels

FDA

EMA

Brand Name	Status	Last Update
anastrozole	ANDA	2025-09-01
arimidex	New Drug Application	2025-07-08
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

466 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	27	166	103	16	81	382
Neoplasms	D009369	—	C80	7	7	6	1	4	23
Triple negative breast neoplasms	D064726	—	—	1	13	5	2	—	21
Male breast neoplasms	D018567	—	—	1	8	7	1	3	20
Neoplasm metastasis	D009362	EFO_0009708	—	2	3	6	1	2	12
Recurrence	D012008	—	—	—	4	2	1	1	8
Hypogonadism	D007006	—	E23.0	1	4	—	2	1	8
Obesity	D009765	EFO_0001073	E66.9	—	—	1	2	4	7
Postmenopause	D017698	—	—	—	3	—	1	2	6
Invasive hydatidiform mole	D002820	—	D39.2	2	1	2	1	—	6

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	4	8	2	—	—	13
Intraductal carcinoma noninfiltrating	D002285	—	D05.1	1	4	2	—	1	8
Breast diseases	D001941	—	N60-N65	2	4	2	—	1	7
Carcinoma in situ	D002278	—	D09.9	1	3	3	—	—	7
Ductal carcinoma	D044584	—	—	1	2	1	—	—	4
Osteoporosis	D010024	EFO_0003882	M81.0	—	2	2	—	—	4
Metabolic syndrome	D024821	EFO_0000195	E88.810	1	1	1	—	1	4
Neoadjuvant therapy	D020360	—	—	—	2	2	—	—	4
Disease progression	D018450	—	—	—	1	1	—	1	3
Neoplasms by site	D009371	—	—	1	1	2	—	—	3

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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	—	M25.5	—	1	—	—	7	8
Endometrial neoplasms	D016889	EFO_0004230	—	4	5	—	—	—	7
Ovarian neoplasms	D010051	EFO_0003893	C56	3	4	—	—	—	6
Insulin resistance	D007333	EFO_0002614	E88.819	2	1	—	—	2	5
Hypertension	D006973	EFO_0000537	I10	1	2	—	—	1	4
Syndrome	D013577	—	—	1	1	—	—	2	4
Non-small-cell lung carcinoma	D002289	—	—	1	1	—	—	—	2
Lung neoplasms	D008175	—	C34.90	1	1	—	—	—	2
Ovarian epithelial carcinoma	D000077216	—	—	—	2	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Malnutrition	D044342	EFO_0008572	E40-E46	3	—	—	—	1	4
Breast density	D000071060	—	—	2	—	—	—	—	2
Aging	D000375	GO_0007568	R41.81	1	—	—	—	1	2
Kallmann syndrome	D017436	Orphanet_478	E23.0	1	—	—	—	—	1
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1
Prostatic neoplasms	D011471	—	C61	1	—	—	—	—	1
Pancreatic neoplasms	D010190	EFO_0003860	C25	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
Vaginitis	D014627	EFO_0005757	N76	—	—	—	—	1	1
Atrophic vaginitis	D059268	EFO_1001271	—	—	—	—	—	1	1
Pregnancy rate	D018873	—	—	—	—	—	—	1	1
Overweight	D050177	—	E66.3	—	—	—	—	1	1
Prader-willi syndrome	D011218	Orphanet_739	Q87.11	—	—	—	—	1	1
Silver-russell syndrome	D056730	Orphanet_813	Q87.19	—	—	—	—	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

€