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Drug ReportsRaloxifene
Evista, Optruma(raloxifene)
Evista, Optruma, Raloxifene (raloxifene) is a small molecule pharmaceutical. Raloxifene was first approved as Evista on 1997-12-09. It is used to treat postmenopausal osteoporosis in the USA. It has been approved in Europe to treat postmenopausal osteoporosis. 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
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Evista, Raloxifene
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Raloxifene hydrochloride
Tradename
Company
Number
Date
Products
EVISTAEli LillyN-020815 RX1997-12-09
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
evistaNew Drug Application2026-02-11
raloxifene hydrochlorideANDA2026-04-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postmenopausal osteoporosisEFO_0003854D015663—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03X: Other sex hormones and modulators of the genital system in atc
— G03XC: Selective estrogen receptor modulators
— G03XC01: Raloxifene
HCPCS
No data
Clinical
Clinical Trials
87 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteoporosisD010024EFO_0003882M81.02—57721
Postmenopausal osteoporosisD015663EFO_0003854———48113
SchizophreniaD012559EFO_0000692F20—135—9
Psychotic disordersD011618—F20.81—123—6
Mental disordersD001523EFO_0000677F91.9—113—5
Healthy volunteers/patients———3——1—4
Metabolic bone diseasesD001851————12—3
Depressive disorderD003866EFO_1002014F32.A———1—1
DepressionD003863—F33.9———1—1
Mood disordersD019964EFO_0004247F30-F39———1—1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PostmenopauseD017698———1——23
AdenocarcinomaD000230———1——12
Neoplasm metastasisD009362EFO_0009708—11———2
Hot flashesD019584———1———1
Urinary bladder neoplasmsD001749—C67—1———1
Transitional cell carcinomaD002295———1———1
Endometrial neoplasmsD016889EFO_0004230——1———1
EndometriosisD004715EFO_0001065N80—1———1
Pelvic painD017699———1———1
Prostatic hyperplasiaD011470EFO_0000284N40—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C611————1
Colorectal neoplasmsD015179——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80————22
Rheumatoid arthritisD001172EFO_0000685M06.9————11
Esophageal neoplasmsD004938—C15————11
Squamous cell carcinomaD002294——————11
Squamous cell neoplasmsD018307——————11
XerostomiaD014987—K11.7————11
SyndromeD013577——————11
Chronic renal insufficiencyD051436—N18————11
Kidney diseasesD007674EFO_0003086N08————11
Myocardial infarctionD009203EFO_0000612I21————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRaloxifene
INNraloxifene
Description
Raloxifene is a member of the class of 1-benzothiophenes that is 1-benzothiophene in which the hydrogens at positions 2, 3, and 6 have been replaced by p-hydroxyphenyl, p-[2-(piperidin-1-yl)ethoxy]benzoyl, and hydroxy groups, respectively. It has a role as a bone density conservation agent, an estrogen receptor modulator and an estrogen antagonist. It is a member of phenols, an aromatic ketone, a member of 1-benzothiophenes and a N-oxyethylpiperidine. It is a conjugate base of a raloxifene(1+).
Classification
Small molecule
Drug classantiestrogens of the clomifene and tamoxifen groups
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(c1ccc(OCCN2CCCCC2)cc1)c1c(-c2ccc(O)cc2)sc2cc(O)ccc12
Identifiers
PDB—
CAS-ID84449-90-1
RxCUI—
ChEMBL IDCHEMBL81
ChEBI ID8772
PubChem CID5035
DrugBankDB00481
UNII IDYX9162EO3I (ChemIDplus, GSRS)
Target
Agency Approved
ESR2
ESR2
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 (O08537)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Evista – Eli Lilly
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Estimated US medical usage
Raloxifene
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Evista, Raloxifene hydrochloride
Adverse Events
Top Adverse Reactions
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10,555 adverse events reported
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