Skip to content
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.
Download report
Favorite
Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Femara (generic drugs available since 2011-06-03)
Combinations
Kisqali 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)
Letrozole
Tradename
Company
Number
Date
Products
FEMARANovartisN-020726 RX1997-07-25
1 products, RLD, RS
Letrozole
+
Ribociclib succinate
Tradename
Company
Number
Date
Products
KISQALI FEMARA CO-PACK (COPACKAGED)NovartisN-209935 RX2017-05-04
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
femaraNew Drug Application2023-05-04
letrozoleANDA2023-05-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
Agency Specific
FDA
EMA
Expiration
Code
LETROZOLE / RIBOCICLIB SUCCINATE, KISQALI FEMARA CO-PACK (COPACKAGED), NOVARTIS
2024-12-10NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Letrozole / Ribociclib Succinate, Kisqali Femara Co-Pack (Copackaged), Novartis
107995062036-04-14DP
91937322031-11-09DS, DP
98687392031-11-09U-2505, U-3264
84153552031-03-13DS, DP
86859802030-05-25DS, DP
89626302029-12-09U-2505, U-3264
94161362029-08-20U-2505, U-3264
83242252028-06-17DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02B: Hormone antagonists and related agents
— L02BG: Aromatase inhibitors
— L02BG04: Letrozole
HCPCS
No data
Clinical
Clinical Trials
546 clinical trials
View more details
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5054173722026319
InfertilityD007246EFO_0000545361271237
Polycystic ovary syndromeD011085EFO_0000660E28.223661126
Invasive hydatidiform moleD002820D39.23422—10
Healthy volunteers/patients—61—118
Spontaneous abortionD000022EFO_1001255O00.1—33127
ObesityD009765EFO_0001073E66.9111125
Female infertilityD007247EFO_0008560N971—1215
Missed abortionD000030O02.1—1—315
Ovulation inductionD010062111114
Show 16 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Endometrial neoplasmsD016889EFO_00042302173—119
Triple negative breast neoplasmsD0647264122——17
Ovarian neoplasmsD010051EFO_0003893C561113——14
NeoplasmsD009369C80651—212
Male breast neoplasmsD018567134—311
Fallopian tube neoplasmsD005185—52——7
OsteoporosisD010024EFO_0003882M81.0—13—26
Neoplasm metastasisD009362EFO_0009708—21—14
PregnancyD011247EFO_0002950Z33.1—22——4
Peritoneal neoplasmsD010534—21——3
Show 16 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ArthralgiaD018771HP_0002829M25.5—1——45
Endometrioid carcinomaD01826912———3
Non-small-cell lung carcinomaD00228921———3
LeiomyosarcomaD007890—3———3
EndometriosisD004715EFO_0001065N80—2——13
PainD010146EFO_0003843R52—1——12
HemangiosarcomaD006394—1———1
Prostatic neoplasmsD011471C6111———1
LiposarcomaD00808011———1
Adenocarcinoma of lungD00007719211———1
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228C85.92————2
Castration-resistant prostatic neoplasmsD0641291————1
Malignant mesotheliomaD0000860021————1
DiseaseD004194EFO_0000408R691————1
Brain neoplasmsD001932EFO_0003833C711————1
Precocious pubertyD011629E22.81————1
Polyostotic fibrous dysplasiaD005359Orphanet_562Q78.11————1
Food-drug interactionsD0185651————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Reproductive behaviorD043762————11
Pregnancy rateD018873————11
ArthritisD001168EFO_0005856M05-M14————11
Genetic polymorphismD011110————11
HypoxiaD000860R09.02————11
Incomplete abortionD000027EFO_1001799————11
Vitamin d deficiencyD014808EFO_0003762E55————11
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameLETROZOLE
INNletrozole
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 classaromatase 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-ID112809-51-5
RxCUI72965
ChEMBL IDCHEMBL1444
ChEBI ID6413
PubChem CID3902
DrugBankDB01006
UNII ID7LKK855W8I (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:
Mock data
Subscribe for the real data
Additional graphs summarizing 14,046 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
8 adverse events reported
View more details