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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Faslodex (generic drugs available since 2019-03-04)
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 |
|---|---|---|---|---|
| FASLODEX | AstraZeneca | N-021344 RX | 2002-04-25 | 1 products, RLD, RS |
| FULVESTRANT | Fresenius Kabi | N-210326 RX | 2019-05-20 | 1 products |
| FULVESTRANT | Teva | N-210063 RX | 2019-08-19 | 1 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| faslodex | New Drug Application | 2020-10-01 |
| fulvestrant | ANDA | 2024-01-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
479 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 | 76 | 201 | 59 | 10 | 42 | 357 |
| Triple negative breast neoplasms | D064726 | — | — | 9 | 20 | 2 | 1 | — | 27 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 3 | 1 | — | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 22 | 14 | 2 | — | 2 | 32 |
| Male breast neoplasms | D018567 | — | — | — | 3 | 3 | — | 1 | 7 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 3 | 2 | 1 | — | — | 5 |
| Ductal carcinoma breast | D018270 | — | — | 1 | 1 | 1 | — | — | 2 |
| Neoadjuvant therapy | D020360 | — | — | — | 1 | 1 | — | — | 1 |
| Progression-free survival | D000077982 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 7 | 6 | — | — | — | 10 |
| Non-small-cell lung carcinoma | D002289 | — | — | 5 | 5 | — | — | — | 8 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | 6 | — | — | — | 7 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 4 | — | — | — | 5 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | 2 | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 2 | — | — | — | 2 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | 1 | 1 | — | — | — | 2 |
| Liposarcoma | D008080 | — | — | 2 | 1 | — | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 2 | — | — | — | — | 2 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | — | — | — | 2 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | — | — | — | — | 2 |
| Endometrioid carcinoma | D018269 | — | — | 1 | — | — | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Malignant mesothelioma | D000086002 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postmenopause | D017698 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fulvestrant |
| INN | fulvestrant |
| 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 class | estrogens; estrogen antagonists |
| Image (chem structure or protein) |  |
| 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-ID | 129453-61-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1358 |
| ChEBI ID | 31638 |
| PubChem CID | 104741 |
| DrugBank | DB00947 |
| UNII ID | 22X328QOC4 (ChemIDplus, GSRS) |
Target
Agency Approved
ESR2
ESR2
ESR1
ESR1
Organism
Homo sapiens
Gene name
ESR2
Gene synonyms
ESTRB, NR3A2
NCBI Gene ID
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
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
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
Mouse ortholog
Gper1 (76854)
G-protein coupled estrogen receptor 1 (Q9D392)
Variants
No data
Financial
Revenue by drug
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â‚£
Faslodex – AstraZeneca
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,789 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,250 adverse events reported
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