Letrozole
Femara (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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Novartis Pharmaceuticals
Commercial
Trade Name
FDA
EMA
Femara (generic drugs available since 2011-06-03)
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)
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
546 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 | 54 | 173 | 72 | 20 | 26 | 319 |
Infertility | D007246 | EFO_0000545 | 3 | 6 | 12 | 7 | 12 | 37 | |
Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 2 | 3 | 6 | 6 | 11 | 26 |
Invasive hydatidiform mole | D002820 | D39.2 | 3 | 4 | 2 | 2 | — | 10 | |
Healthy volunteers/patients | — | 6 | 1 | — | 1 | 1 | 8 | ||
Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | 3 | 3 | 1 | 2 | 7 |
Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | 1 | 1 | 2 | 5 |
Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | 1 | 2 | 1 | 5 |
Missed abortion | D000030 | O02.1 | — | 1 | — | 3 | 1 | 5 | |
Ovulation induction | D010062 | 1 | 1 | 1 | 1 | 1 | 4 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Endometrial neoplasms | D016889 | EFO_0004230 | 2 | 17 | 3 | — | 1 | 19 | |
Triple negative breast neoplasms | D064726 | 4 | 12 | 2 | — | — | 17 | ||
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 11 | 3 | — | — | 14 |
Neoplasms | D009369 | C80 | 6 | 5 | 1 | — | 2 | 12 | |
Male breast neoplasms | D018567 | 1 | 3 | 4 | — | 3 | 11 | ||
Fallopian tube neoplasms | D005185 | — | 5 | 2 | — | — | 7 | ||
Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | 3 | — | 2 | 6 |
Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 1 | — | 1 | 4 | |
Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 2 | 2 | — | — | 4 |
Peritoneal neoplasms | D010534 | — | 2 | 1 | — | — | 3 |
Show 16 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Arthralgia | D018771 | HP_0002829 | M25.5 | — | 1 | — | — | 4 | 5 |
Endometrioid carcinoma | D018269 | 1 | 2 | — | — | — | 3 | ||
Non-small-cell lung carcinoma | D002289 | 2 | 1 | — | — | — | 3 | ||
Leiomyosarcoma | D007890 | — | 3 | — | — | — | 3 | ||
Endometriosis | D004715 | EFO_0001065 | N80 | — | 2 | — | — | 1 | 3 |
Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | — | 1 | 2 |
Hemangiosarcoma | D006394 | — | 1 | — | — | — | 1 | ||
Prostatic neoplasms | D011471 | C61 | 1 | 1 | — | — | — | 1 | |
Liposarcoma | D008080 | 1 | 1 | — | — | — | 1 | ||
Adenocarcinoma of lung | D000077192 | 1 | 1 | — | — | — | 1 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Non-hodgkin lymphoma | D008228 | C85.9 | 2 | — | — | — | — | 2 | |
Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
Malignant mesothelioma | D000086002 | 1 | — | — | — | — | 1 | ||
Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
Precocious puberty | D011629 | E22.8 | 1 | — | — | — | — | 1 | |
Polyostotic fibrous dysplasia | D005359 | Orphanet_562 | Q78.1 | 1 | — | — | — | — | 1 |
Food-drug interactions | D018565 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Reproductive behavior | D043762 | — | — | — | — | 1 | 1 | ||
Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
Genetic polymorphism | D011110 | — | — | — | — | 1 | 1 | ||
Hypoxia | D000860 | R09.02 | — | — | — | — | 1 | 1 | |
Incomplete abortion | D000027 | EFO_1001799 | — | — | — | — | 1 | 1 | |
Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 1 | 1 |
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 | 72965 |
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8 adverse events reported
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