Letrozole
Femara, Letrozole (letrozole) is a small molecule pharmaceutical. Letrozole was first approved as Femara on 1997-07-25. 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
Femara, Letrozole (discontinued: Letrozole)
CombinationsKisqali femara co-pack
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| femara | New Drug Application | 2024-12-16 |
| kisqali femara co-pack | New Drug Application | 2025-02-25 |
| letrozole | ANDA | 2025-05-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LETROZOLE / RIBOCICLIB SUCCINATE, KISQALI FEMARA CO-PACK (COPACKAGED), NOVARTIS | |||
| 2024-12-10 | NPP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Letrozole / Ribociclib Succinate, Kisqali Femara Co-Pack (Copackaged), Novartis | |||
| 10799506 | 2036-04-14 | DP | |
| 9193732 | 2031-11-09 | DS, DP | |
| 9868739 | 2031-11-09 | U-2505, U-3264 | |
| 8415355 | 2031-03-13 | DS, DP | |
| 8685980 | 2030-05-25 | DS, DP | |
| 8962630 | 2029-12-09 | U-2505, U-3264 | |
| 9416136 | 2029-08-20 | U-2505, U-3264 | |
| 8324225 | 2028-06-17 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
812 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 | 83 | 279 | 123 | 31 | 73 | 549 |
| Infertility | D007246 | EFO_0000545 | — | 6 | 9 | 16 | 14 | 22 | 63 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 6 | 3 | 16 | 6 | 20 | 49 |
| Neoplasms | D009369 | — | C80 | 13 | 19 | 8 | 2 | 8 | 44 |
| Syndrome | D013577 | — | — | 4 | 4 | 9 | 5 | 15 | 35 |
| Carcinoma | D002277 | — | C80.0 | 7 | 19 | 5 | 1 | 2 | 33 |
| Triple negative breast neoplasms | D064726 | — | — | 7 | 16 | 3 | 1 | 1 | 27 |
| Male breast neoplasms | D018567 | — | — | 3 | 8 | 7 | 1 | 5 | 23 |
| Postmenopause | D017698 | — | — | 3 | 6 | 1 | 1 | 1 | 11 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | 3 | 2 | 5 | 11 |
Show 41 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 4 | 22 | 4 | — | 1 | 25 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 16 | 6 | — | — | 23 |
| Recurrence | D012008 | — | — | 2 | 14 | 4 | — | 3 | 22 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 3 | 10 | 6 | — | — | 17 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 6 | 2 | — | — | 8 |
| Carcinoma in situ | D002278 | — | D09.9 | 3 | 4 | 1 | — | — | 7 |
| Intraductal carcinoma noninfiltrating | D002285 | — | D05.1 | 2 | 4 | 1 | — | 1 | 7 |
| Serous cystadenocarcinoma | D018284 | — | — | — | 4 | 4 | — | — | 6 |
| Ductal carcinoma | D044584 | — | — | 2 | 4 | 1 | — | — | 6 |
| Breast diseases | D001941 | — | N60-N65 | — | 4 | 1 | — | 1 | 5 |
Show 21 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 2 | — | — | 3 | 5 |
| Disease progression | D018450 | — | — | — | 2 | — | — | 1 | 3 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 3 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 1 | — | — | — | 3 |
| Leiomyosarcoma | D007890 | — | — | — | 3 | — | — | — | 3 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | — | 2 | 3 |
| Sarcoma | D012509 | — | — | 1 | 2 | — | — | — | 3 |
| Lobular carcinoma | D018275 | EFO_0000570 | — | 1 | 1 | — | — | — | 2 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | 1 | — | — | 1 | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 1 | — | — | — | 2 |
Show 33 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | — | — | — | — | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | — | — | — | — | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Overweight | D050177 | — | E66.3 | 1 | — | — | — | 1 | 2 |
| Premenopause | D017697 | — | — | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Liposarcoma | D008080 | — | — | 1 | — | — | — | — | 1 |
| Adenocarcinoma of lung | D000077192 | — | — | 1 | — | — | — | — | 1 |
| Malignant mesothelioma | D000086002 | — | — | 1 | — | — | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | 1 | — | — | — | — | 1 |
Show 7 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cicatrix | D002921 | — | L90.5 | — | — | — | — | 2 | 2 |
| Reproductive behavior | D043762 | — | — | — | — | — | — | 1 | 1 |
| Mouth neoplasms | D009062 | EFO_0003868 | C06.9 | — | — | — | — | 1 | 1 |
| Thrombosis | D013927 | — | — | — | — | — | — | 1 | 1 |
| Vaginitis | D014627 | EFO_0005757 | N76 | — | — | — | — | 1 | 1 |
| Atrophic vaginitis | D059268 | EFO_1001271 | — | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
| Radiotherapy | D011878 | — | — | — | — | — | — | 1 | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 1 | 1 |
| Periodontal diseases | D010510 | — | K05.6 | — | — | — | — | 1 | 1 |
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Letrozole |
| INN | letrozole |
| Description | Letrozole is a member of triazoles and a nitrile. It has a role as an antineoplastic agent and an EC 1.14.14.14 (aromatase) inhibitor. |
| Classification | Small molecule |
| Drug class | aromatase inhibitors (imidazole/triazole derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 112809-51-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1444 |
| ChEBI ID | 6413 |
| PubChem CID | 3902 |
| DrugBank | DB01006 |
| UNII ID | 7LKK855W8I (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
No data
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Letrozole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,224 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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37,470 adverse events reported
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