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Elacestrant
Orserdu (elacestrant) is a small molecule pharmaceutical. Elacestrant was first approved as Orserdu on 2023-01-27.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Orserdu
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Elacestrant dihydrochloride
Tradename
Company
Number
Date
Products
ORSERDUStemline TherapeuticsN-217639 RX2023-01-27
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
orserduNew Drug Application2023-02-08
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
ELACESTRANT DIHYDROCHLORIDE, ORSERDU, STEMLINE THERAP
2028-01-27NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Elacestrant Dihydrochloride, Orserdu, Stemline Therap
103850082038-01-05DS, DP
107453432038-01-05U-3523
100710662034-10-10U-3524
104207342034-10-10U-3524
76121142026-08-18DS, DPU-3523
83995202023-12-25DS, DPU-3523
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50652——9
Triple negative breast neoplasmsD0647261—1——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hot flashesD019584—2———2
Brain neoplasmsD001932EFO_0003833C7111———1
NeoplasmsD009369C8011———1
Central nervous system neoplasmsD01654311———1
Central nervous system diseasesD002493HP_0002011G96.911———1
Brain diseasesD001927HP_0001298G93.4011———1
Neoplasms by siteD00937111———1
Breast diseasesD001941N60-N6511———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameELACESTRANT
INNelacestrant
Description
Elacestrant, sold under the brand name Orserdu, is an anticancer medication which is used in the treatment of breast cancer. It is taken by mouth.
Classification
Small molecule
Drug classestrogens; estrogen antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCNCCc1ccc(CN(CC)c2cc(OC)ccc2[C@@H]2CCc3cc(O)ccc3C2)cc1
Identifiers
PDB—
CAS-ID722533-56-4
RxCUI—
ChEMBL IDCHEMBL4297509
ChEBI ID—
PubChem CID23642301
DrugBankDB06374
UNII IDFM6A2627A8 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 139 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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