EVISTA (raloxifene hydrochloride)
EVISTA is indicated for the treatment of Osteoporosis; Breast Cancer.
How EVISTA Works
Raloxifene is a selective estrogen receptor modulator (SERM). Its biological actions are mediated through binding to estrogen receptors, resulting in tissue-specific activation or blockade of estrogenic pathways. In the skeletal system, it acts as an agonist to decrease bone resorption and turnover, thereby increasing bone mineral density and reducing fracture risk. In breast and uterine tissues, it acts as
Details
- Status
- Prescription
- First Approved
- 1997-12-09
- Routes
- ORAL
- Dosage Forms
- TABLET
EVISTA Approval History
What EVISTA Treats
2 indicationsEVISTA is approved for 2 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoporosis
- Breast Cancer
EVISTA Boxed Warning
INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA [see Warnings and Precautions ( 5.1 )] . Women with active or past history of venous thromboembolism should not take EVISTA [see Contraindications ( 4.1 )]. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-bene...
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA [see Warnings and Precautions ( 5.1 )] . Women with active or past history of venous thromboembolism should not take EVISTA [see Contraindications ( 4.1 )]. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke [see Warnings and Precautions ( 5.2 ) and Clinical Studies ( 14.5 )]. WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE See full prescribing information for complete boxed warning. Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA ( 5.1 ). Women with active or past history of venous thromboembolism should not take EVISTA ( 4.1 ). Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke ( 5.2 , 14.5 ).
EVISTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in EVISTA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications EVISTA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to EVISTA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01481883 | 486/11 | Ph 4 | completed | Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men? |
| NCT02354001 | 94/06 | Ph 4 | completed | Selective Estrogen Receptor Modulators for Women of Child-bearing Age With Schizophrenia |
| NCT03418831 | 2017-YJ-01 | Ph 4 | completed | Adjunctive Selective Estrogen Receptor Modulators on Negative and Cognitive Symptoms of Schizophrenia in Women |
| NCT03147196 | MC1552 NCI-2017-00773, MC1552 | Ph 2 | withdrawn | Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EVISTA FDA Label Details
Indications & Usage
FDA Label (PDF)EVISTA is indicated for the treatment of Osteoporosis; Breast Cancer.
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA [see Warnings and Precautions ( 5.1 )] . Women with active or past history of venous thromboembolism should not take EVISTA [see Contra...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.