RALOXIFENE HYDROCHLORIDE
RALOXIFENE HYDROCHLORIDE is indicated for the treatment of Osteoporosis; Breast Cancer.
How RALOXIFENE HYDROCHLORIDE Works
Raloxifene functions as a selective estrogen receptor modulator (SERM), exerting tissue-specific estrogen agonist or antagonist effects through binding to estrogen receptors. In bone, it acts as an agonist, decreasing bone resorption and turnover while increasing bone mineral density (BMD). In breast and uterine tissues, it acts as an antagonist, blocking estrogenic pathways. This dual mechanism allows for the preservation of bone mass while reducing the risk of estrogen-dependent invasive breast cancer without stimulating the endometrium.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-03-04
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
RALOXIFENE HYDROCHLORIDE Approval History
What RALOXIFENE HYDROCHLORIDE Treats
2 indicationsRALOXIFENE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoporosis
- Breast Cancer
RALOXIFENE HYDROCHLORIDE Boxed Warning
INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride [see Warnings and Precautions (5.1) ] . Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride [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 c...
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride [see Warnings and Precautions (5.1) ] . Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride [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 raloxifene hydrochloride (5.1) . Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride (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) .
RALOXIFENE HYDROCHLORIDE 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 RALOXIFENE HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications RALOXIFENE HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to RALOXIFENE HYDROCHLORIDE
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.
RALOXIFENE HYDROCHLORIDE FDA Label Details
Indications & Usage
RALOXIFENE HYDROCHLORIDE 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 raloxifene hydrochloride [see Warnings and Precautions (5.1) ] . Women with active or past history of venous thromboembolism should not take r...
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EVISTA
Full clinical data, patents, trials, and competitive landscape for raloxifene hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment