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Drug ReportsFulvestrant
Faslodex(fulvestrant)
Faslodex, Fulvestrant (fulvestrant) is a small molecule pharmaceutical. Fulvestrant was first approved as Faslodex on 2002-04-25. It is used to treat breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms. The pharmaceutical is active against estrogen receptor beta and estrogen receptor. In addition, it is known to target G-protein coupled estrogen receptor 1.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Faslodex, Fulvestrant (discontinued: Faslodex, Fulvestrant)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fulvestrant
Tradename
Company
Number
Date
Products
FASLODEXAstraZenecaN-021344 RX2002-04-25
1 products, RLD, RS
FULVESTRANTFresenius KabiN-210326 RX2019-05-20
1 products
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
faslodexNew Drug Application2020-10-01
fulvestrantANDA2025-03-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Fulvestrant, Fulvestrant, Fresenius Kabi Usa
92719902034-05-17DPU-2540
98334592034-02-14DPU-2540
101886632034-02-14DPU-2540
ATC Codes
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02B: Hormone antagonists and related agents
— L02BA: Anti-estrogens
— L02BA03: Fulvestrant
HCPCS
Code
Description
J9393
Injection, fulvestrant (teva) not therapeutically equivalent to j9395, 25 mg
J9394
Injection, fulvestrant (fresenius kabi) not therapeutically equivalent to j9395, 25 mg
J9395
Injection, fulvestrant, 25 mg
Clinical
Clinical Trials
528 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50————11
Male breast neoplasmsD018567——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFulvestrant
INNfulvestrant
Description
Fulvestrant is a 3-hydroxy steroid that is 17beta-estradiol in which the 7alpha hydrogen has been replaced by a nonyl group in which one of the hydrogens of the terminal methyl has been replaced by a (4,4,5,5,5-pentafluoropentyl)sulfinyl group. An estrogen receptor antagonist, it is used in the treatment of breast cancer. It has a role as an antineoplastic agent, an estrogen receptor antagonist and an estrogen antagonist. It is a 3-hydroxy steroid, a 17beta-hydroxy steroid, an organofluorine compound and a sulfoxide. It derives from a hydride of an estrane.
Classification
Small molecule
Drug classestrogens; estrogen antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@]12CC[C@@H]3c4ccc(O)cc4C[C@@H](CCCCCCCCC[S+]([O-])CCCC(F)(F)C(F)(F)F)[C@H]3[C@@H]1CC[C@@H]2O
Identifiers
PDB—
CAS-ID129453-61-8
RxCUI—
ChEMBL IDCHEMBL1358
ChEBI ID31638
PubChem CID104741
DrugBankDB00947
UNII ID22X328QOC4 (ChemIDplus, GSRS)
Target
Agency Approved
ESR2
ESR2
ESR1
ESR1
Organism
Homo sapiens
Gene name
ESR2
Gene synonyms
ESTRB, NR3A2
NCBI Gene ID
2100
Protein name
estrogen receptor beta
Protein synonyms
estrogen receptor beta 2, estrogen receptor beta 4, Nuclear receptor subfamily 3 group A member 2, oestrogen receptor beta
Uniprot ID
Q92731
Mouse ortholog
Esr2 (13983)
estrogen receptor beta (Q91Z86)
Alternate
GPER1
GPER1
Organism
Homo sapiens
Gene name
GPER1
Gene synonyms
CEPR, CMKRL2, DRY12, GPER, GPR30
NCBI Gene ID
2852
Protein name
G-protein coupled estrogen receptor 1
Protein synonyms
Chemoattractant receptor-like 2, chemokine receptor-like 2, constitutively expressed peptide-like receptor, FEG-1, Flow-induced endothelial G-protein coupled receptor 1, G protein-coupled estrogen receptor 1, G protein-coupled receptor 30, G-protein coupled receptor 30, GPCR-Br, heptahelix receptor, IL8-related receptor DRY12, LYGPR, Lymphocyte-derived G-protein coupled receptor, Membrane estrogen receptor, mER
Uniprot ID
Q99981
Mouse ortholog
Gper1 (76854)
G-protein coupled estrogen receptor 1 (Q9D392)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Faslodex – AstraZeneca
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,945 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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17,600 adverse events reported
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