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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| musculoskeletal diseases | D009140 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Evista, Raloxifene
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| evista | New Drug Application | 2023-05-19 |
| raloxifene hydrochloride | ANDA | 2024-10-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| postmenopausal osteoporosis | EFO_0003854 | D015663 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
83 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoporosis | D010024 | HP_0000939 | M81.0 | 2 | — | 9 | 14 | 9 | 34 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | — | 4 | 8 | 1 | 13 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | 3 | 5 | — | 9 |
| Psychotic disorders | D011618 | — | F20.81 | — | 1 | 2 | 3 | — | 6 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | 1 | 3 | — | 4 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | 1 | — | 4 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | 2 | — | 2 |
| Depression | D003863 | — | F33.9 | — | — | — | 1 | — | 1 |
| Neurobehavioral manifestations | D019954 | EFO_0004364 | — | — | — | — | 1 | — | 1 |
| Compliance | D003187 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 4 | 2 | — | 8 | 14 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 1 | — | 1 | 2 |
| Syndrome | D013577 | — | — | — | — | 1 | — | 1 | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | 1 | — | — | 2 |
| Endometrial hyperplasia | D004714 | — | N85.0 | — | — | 1 | — | — | 1 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | — | 1 | — | — | 1 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | 1 | — | — | 1 |
| Cognition | D003071 | EFO_0003925 | — | — | — | 1 | — | — | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | 1 | — | — | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postmenopause | D017698 | — | — | — | 1 | — | — | 2 | 3 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | 1 | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | — | — | — | 2 |
| Hot flashes | D019584 | — | — | — | 1 | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | — | 1 | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 1 | — | — | — | 1 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | 1 | — | — | — | 1 |
| Pelvic pain | D017699 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | — | — | 2 | 2 |
| Back pain | D001416 | HP_0003418 | M54 | — | — | — | — | 1 | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | — | — | — | 1 | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | — | — | 1 | 1 |
| Squamous cell carcinoma | D002294 | — | — | — | — | — | — | 1 | 1 |
| Squamous cell neoplasms | D018307 | — | — | — | — | — | — | 1 | 1 |
| Xerostomia | D014987 | — | K11.7 | — | — | — | — | 1 | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Raloxifene |
| INN | raloxifene |
| 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 class | antiestrogens of the clomifene and tamoxifen groups |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(c1ccc(OCCN2CCCCC2)cc1)c1c(-c2ccc(O)cc2)sc2cc(O)ccc12 |
Identifiers
| PDB | — |
| CAS-ID | 84449-90-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL81 |
| ChEBI ID | 8772 |
| PubChem CID | 5035 |
| DrugBank | DB00481 |
| UNII ID | YX9162EO3I (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
$
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Evista – Eli Lilly
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Tabular view
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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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,444 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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10,596 adverse events reported
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