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
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)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
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 | 2026-09-29 |
| arimidex | New Drug Application | 2026-03-02 |
| 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
HCPCS
Code | Description |
|---|---|
| S0170 | Anastrozole, oral, 1 mg |
Clinical
Clinical Trials
493 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 | 30 | 180 | 108 | 16 | 81 | 401 |
| Triple negative breast neoplasms | D064726 | — | — | 3 | 15 | 5 | 2 | — | 24 |
| Neoplasms | D009369 | — | C80 | 7 | 7 | 6 | 1 | 4 | 23 |
| Male breast neoplasms | D018567 | — | — | 1 | 8 | 7 | 1 | 3 | 20 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 4 | 6 | 1 | 2 | 13 |
| Hypogonadism | D007006 | — | E23.0 | 1 | 4 | — | 2 | 2 | 9 |
| 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 |
| Recurrence | D012008 | — | — | — | 2 | 1 | 1 | 1 | 5 |
Show 9 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intraductal carcinoma noninfiltrating | D002285 | — | D05.1 | 1 | 4 | 3 | — | 1 | 9 |
| Carcinoma | D002277 | — | C80.0 | 3 | 5 | 1 | — | — | 8 |
| Breast diseases | D001941 | — | N60-N65 | 2 | 5 | 2 | — | 1 | 8 |
| Carcinoma in situ | D002278 | — | D09.9 | — | 3 | 3 | — | — | 6 |
| Neoadjuvant therapy | D020360 | — | — | — | 3 | 2 | — | — | 5 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 2 | 2 | — | — | 4 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | 1 | 1 | — | 1 | 4 |
| Disease progression | D018450 | — | — | — | 1 | 1 | — | 1 | 3 |
| Ductal carcinoma breast | D018270 | — | — | — | — | 3 | — | — | 3 |
| Neoplasms by site | D009371 | — | — | 1 | 1 | 2 | — | — | 3 |
Show 14 more
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 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | 2 | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | — | — | — | 2 |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | 2 | — | — | — | 2 |
Show 34 more
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 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Fibrosis | D005355 | — | — | 1 | — | — | — | — | 1 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | 1 | — | — | — | — | 1 |
Show 2 more
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 |
| 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 |
| Musculoskeletal pain | D059352 | — | — | — | — | — | — | 1 | 1 |
Show 26 more
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
CYP19A1
Organism
Homo sapiens
Gene name
CYP19A1
Gene synonyms
ARO1, CYAR, CYP19
NCBI Gene ID
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
Mouse ortholog
Cyp19a1 (13075)
aromatase (P28649)
Alternate
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Variants
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Financial
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Arimidex – AstraZeneca
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Anastrozole
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,300 adverse events reported
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