CLINICAL TRIALS PROFILE FOR EVISTA

All Clinical Trials for EVISTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001848 ↗	The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1998-11-01	Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of endometriosis is usually made at surgery. The treatment of endometriosis includes medical and surgical approaches alone or in combination. The hormone estrogen stimulates the growth of the endometrium and may also stimulate the growth of endometriosis. Medical therapies that act to decrease the level of estrogen can reduce the amount of endometriosis and pain. When therapies are discontinued, symptoms often return. In addition, medical treatment for endometriosis is expensive and is often associated with weak bones (osteoporosis) and hot flashes as a result of low levels of estrogen. Surgical treatment is removal or destruction of the endometriosis tissue. Studies show the pain from endometriosis is relieved longer with tissue removal than with destruction. This study was developed to see if surgery followed by daily doses of Raloxifene (Evista) is effective in reducing pain, for a longer time than surgery in combination with a placebo (inactive "sugar pill") treatment. Raloxifene acts like estrogens in some tissues and not like estrogens in others. Postmenopausal women receiving Raloxifene for the prevention of osteoporosis had an increase in bone density and an improvement of their blood lipids (fat content in the blood). However, unlike estrogen, Raloxifene does not promote the growth of breast tissue or the uterus. If Raloxifene blocks estrogen action in the lining of the uterus (endometrium) of reproductive age women, as it does in post-menopausal women, it may also limit the growth of endometriosis and prevent the return of pain.
NCT00030147 ↗	Raloxifene and Rimostil for Perimenopause-Related Depression	Completed	National Institute of Mental Health (NIMH)	Phase 4	2002-02-01	The purpose of this study is to evaluate the effectiveness of the drugs raloxifene and rimostil in treating perimenopause-related depression. Perimenopause-related mood disorders cause significant distress to a large number of women; the demand for effective therapies to treat these mood disorders is considerable. Estradiol replacement therapy (ERT) has demonstrated efficacy in treating perimenopause-related depression. Unfortunately, there are long-term risks associated with ERT. Selective estrogen receptor modulators (SERMS), such as raloxifene, and phytoestrogens, such as rimostil, have estrogen-like properties and may offer a safer alternative to ERT. The effect of SERMS and phytoestrogens on mood and cognitive functioning need to be examined in women with perimenopause-related depression. Participants in this study will undergo a medical history, physical examination, electrocardiogram (EKG), and blood and urine tests. They will then be randomly assigned to receive one of four treatments for 8 weeks: raloxifene pills plus a placebo (an inactive substance) skin patch, rimostil pills plus placebo skin patch, estradiol skin patch plus placebo pills, or placebo patch plus placebo pills. Participants will have clinic visits every 2 weeks. During the visits, blood will be drawn and participants will meet with staff members and complete symptom self-rating scales. A urine and blood sample will be collected at the beginning and end of the study. At the end of the study, participants who received placebo or whose study medication was ineffective will be offered treatment with standard antidepressant medications for 8 weeks. Non-menstruating women will receive progesterone for 10 days to induce menstrual bleeding and shedding of the inner layer of the uterus, which may have been stimulated by the study medications.
NCT00035971 ↗	EVA: Evista Alendronate Comparison	Completed	Eli Lilly and Company	Phase 4	1969-12-31	The purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures
NCT00062595 ↗	Vitamin K and Bone Turnover in Postmenopausal Women	Completed	Eisai Co., Ltd.	Phase 3	2000-09-01	This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible: alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.
NCT00062595 ↗	Vitamin K and Bone Turnover in Postmenopausal Women	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2000-09-01	This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible: alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.
NCT00310531 ↗	3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women	Completed	Bayer	Phase 3	2004-02-01	The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for prevention and treatment of osteoporosis.

Clinical Trial Conditions for EVISTA

Condition Name

Condition Name for EVISTA
Intervention	Trials
Osteoporosis	5
Schizophrenia	4
Schizoaffective Disorder	3
Osteoporosis, Postmenopausal	3

Condition MeSH

Condition MeSH for EVISTA
Intervention	Trials
Osteoporosis	11
Osteoporosis, Postmenopausal	5
Schizophrenia	4
Psychotic Disorders	3

Clinical Trial Locations for EVISTA

Trials by Country

Trials by Country for EVISTA
Location	Trials
United States	55
Canada	12
Spain	4
Australia	4
Netherlands	3

Trials by US State

Trials by US State for EVISTA
Location	Trials
Indiana	3
California	3
Wisconsin	3
Arizona	3
Maryland	3

Clinical Trial Progress for EVISTA

Clinical Trial Phase

Clinical Trial Phase for EVISTA
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for EVISTA
Clinical Trial Phase	Trials
Completed	18
Recruiting	3
Unknown status	1

Clinical Trial Sponsors for EVISTA

Sponsor Name

Sponsor Name for EVISTA
Sponsor	Trials
Eli Lilly and Company	4
The Alfred	2
Mayo Clinic	2

Sponsor Type

Sponsor Type for EVISTA
Sponsor	Trials
Other	28
Industry	6
NIH	4

EVISTA (Raloxifene): Clinical Trial Update, Market Analysis, and 2025-2035 Projection

Last updated: May 4, 2026

What is EVISTA and what is the current clinical footprint?

EVISTA is the brand name for raloxifene, a selective estrogen receptor modulator (SERM) indicated for prevention and treatment of osteoporosis in postmenopausal women and reduction of risk of invasive breast cancer in high-risk postmenopausal women. EVISTA is a legacy product with an ongoing clinical footprint driven by long-term outcomes and comparative effectiveness in osteoporosis and breast cancer risk reduction, rather than new pivotal regulatory filings.

Core historical pivotal basis (context for ongoing trial relevance)

• Osteoporosis prevention/treatment: EVISTA’s benefit is anchored in fracture risk reduction and bone density improvements reported across late-1990s and early-2000s randomized programs (the prescribing label reflects these outcomes).
• Breast cancer risk reduction: EVISTA’s preventive effect in high-risk populations underpins the “reduction in risk” indication. Trial outcomes remain the key clinical reference point for market access and payer coverage.

Current trial status signal (what “update” means for a legacy SERM)

For EVISTA, “clinical trials update” in market terms typically means:

1. Post-marketing comparative studies (real-world evidence, adherence, sequencing versus other osteoporosis therapies).
2. Long-horizon observational follow-up in cohorts linked to the original SERM prevention strategy.
3. Head-to-head pharmacovigilance and safety characterization (notably VTE and endometrial safety monitoring).

No evidence is provided here of any new, current-generation pivotal randomized trials that would materially reset the product’s benefit profile or expand indications beyond the established label framework. Clinical activity is therefore expected to be incremental and payer-impacting mostly through outcomes confirmation, adherence, and safety monitoring rather than new mechanism-of-action differentiation.

How does EVISTA perform clinically versus modern osteoporosis standards?

EVISTA’s commercial positioning depends on the trade-off versus more potent antiresorptives and bone-forming agents.

Comparative positioning by mechanism and typical payer framing

• EVISTA (raloxifene): reduces fracture risk in postmenopausal osteoporosis and is also used where breast cancer risk reduction is valued.
• Denosumab and bisphosphonates: are standard “primary” fracture prevention in many formularies due to higher anti-fracture efficacy in broader populations.
• Anabolic agents: tend to be reserved for very high-risk disease, where EVISTA is less often the anchor.

This creates a market structure where EVISTA is strongest when:

• breast cancer risk reduction is part of the decision, or
• SERM choice aligns with patient preferences and safety tolerances, or
• payer formularies keep it accessible under cost/step therapy.

Key safety parameters that drive use

EVISTA’s risk management profile has consistent commercial impact:

• Venous thromboembolism (VTE) risk
• Hot flashes and vasomotor symptoms
• Endometrial safety remains a differentiator versus estrogen therapy, but not a replacement for ongoing gynecologic monitoring

These factors determine adherence, patient selection, and whether prescribers position EVISTA as first-line versus sequential therapy.

What is the market structure for raloxifene and where is growth (or decline) coming from?

EVISTA is a small-molecule oral therapy in a mature category. Market movement is driven by:

• generic penetration and pricing compression (EVISTA branding is challenged when generics are available),
• switching to higher-efficacy osteoporosis drugs under guideline-concordant care,
• segment-specific demand for patients where the dual osteo-breast benefit matters,
• formulary tightening and prior authorization rules for expensive biologics, which can temporarily shift volume back to oral generics.

Demand drivers that still matter

• Cost and coverage: oral generics typically retain coverage in many commercial plans and Medicare Part D tiers.
• Clinical niche: the “SERM benefit package” (bone plus breast risk reduction) sustains a subset of prescribers who prefer raloxifene for appropriate patients.
• Persistence and adherence: EVISTA’s adherence profile is influenced by vasomotor symptoms and VTE screening practices, which can reduce persistence in real-world settings.

Headwinds

• Competing osteoporosis efficacy: modern regimens often produce larger absolute fracture risk reductions, which reduces EVISTA share in high-risk lines.
• Class substitution: formulary designs often create a hierarchy where raloxifene is used for moderate-risk patients or when other therapies are unsuitable.
• Aging and comorbidity: older cohorts can increase contraindication concerns for VTE risk, affecting selection.

What is the commercial trajectory for EVISTA from 2025 through 2035?

A robust projection depends on competitive intensity, pricing, and utilization patterns. For a mature, legacy SERM:

• EVISTA’s brand-level growth is not the base case.
• The base case is low-growth to declining volume with continued price erosion if generic competition remains the dominant driver.
• Any upside scenario typically comes from stable payer access and persistent niche use for breast-risk-reduction cohorts.

Given EVISTA’s mature lifecycle, the projection below is presented as a scenario-based market view for raloxifene/SERM segment demand rather than a brand-only forecast.

2025-2030: base-case dynamics

• Utilization: modest decline or flat-to-slight growth in SERM share as long as oral osteoporosis therapy remains accessible and VTE screening does not materially worsen access.
• Pricing: continued compression versus brand pricing due to generic market structure.
• Revenue: largely constrained by price erosion, with volume offsets only if SERM niche prescribing holds.

2030-2035: second-order effects

• Guideline evolution: continues favoring antiresorptives and anabolic-first strategies for higher-risk patients, keeping EVISTA limited to specific segments.
• Safety policy: VTE-related prescriber behavior stabilizes use but prevents broad expansion.
• Generic maturation: as generic supply stabilizes, the market trends remain price-driven rather than innovation-driven.

Quantitative forecast for EVISTA/raloxifene market (scenario ranges)

The market size for “EVISTA” specifically depends on brand share, and “EVISTA” is not the same thing as total “raloxifene.” Without a defined dataset in this response, the only defensible approach is scenario ranges for the raloxifene/SERM segment and directionality for EVISTA-branded revenue.

Scenario framework (directional, strategy-relevant)

| Time window | Base case (most likely) | Bear case | Bull case | |---|---|---| | 2025-2030 | Flat-to-slight decline in utilization; price erosion continues; EVISTA brand share continues to drift to generics | Utilization declines faster as prescribers switch to higher-efficacy agents; tougher step therapy | SERM niche expands via payer programs that preserve oral options and stable breast-risk-reduction demand | | 2030-2035 | Continued low growth or slow decline; growth does not restart without new clinical differentiation | Rapid share loss if formulary hierarchies move away from SERMs | Persistent niche and favorable coverage maintain SERM share; mild revenue stabilization |

What investors should treat as “key variables”

• Formulary tier placement for raloxifene versus bisphosphonates and denosumab
• Generic vs branded price differentials and reimbursement rules
• Persistence rates (vasomotor symptoms, adherence, VTE selection)
• Niche cohort stability for breast cancer risk reduction

What do payers and formularies typically do with EVISTA?

EVISTA’s payer treatment tends to follow a stable pattern for legacy oral osteoporosis agents:

• Preferred access for moderate-risk patients when injectable therapies require prior authorization or higher copays.
• Step therapy where denosumab/bisphosphonate use is required unless contraindications exist.
• Brand is disadvantaged where generics are available.

In practical terms, EVISTA’s market share is most sensitive to:

• relative copay and coverage changes,
• and any payer edits to step therapy rules for oral SERMs.

What are the strategic implications for R&D and BD using EVISTA’s clinical and market profile?

EVISTA’s market role is limited by lack of new indication expansion and by substitution pressure from modern osteoporosis drugs. The product still has a commercially defensible niche because:

• it is oral,
• it is cost-accessible in a generic era,
• it offers bone plus breast cancer risk reduction in appropriate patients.

For late-stage BD, the focus typically shifts to:

• comparative outcomes in SERM vs antiresorptive sequencing,
• patient selection and adherence optimization to preserve persistence,
• real-world VTE risk mitigation workflows to reduce discontinuations.

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Key Takeaways

• EVISTA (raloxifene) is a mature oral SERM with established indications in osteoporosis and reduction of invasive breast cancer risk in high-risk postmenopausal women.
• Clinical activity in this lifecycle is typically post-marketing and comparative, not new pivotal expansion that would reset growth.
• Market performance is constrained by generic penetration, formulary step therapy, and substitution toward higher-efficacy osteoporosis regimens.
• The 2025-2035 base case is low growth to slow decline for EVISTA-branded revenue, with raloxifene/SERM segment demand remaining stable-to-slightly negative depending on payer coverage and persistence.

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FAQs

1) Is EVISTA still used for breast cancer risk reduction?
Yes. EVISTA retains an indication for reduction of risk of invasive breast cancer in high-risk postmenopausal women based on established trial evidence reflected in its approved labeling.

2) Why does EVISTA face competition in osteoporosis care?
Modern osteoporosis therapies (notably potent antiresorptives and selected anabolic options) often provide larger fracture risk reductions across higher-risk categories, which drives formulary preference and prescriber switching.

3) What is the main safety factor affecting EVISTA utilization?
VTE risk and associated patient selection practices, which can limit prescribing and affect persistence in real-world settings.

4) How do generics typically impact EVISTA’s economics?
Generic raloxifene compresses branded EVISTA pricing and shifts volume to the lowest-cost covered option, limiting brand revenue growth.

5) What would most likely improve EVISTA’s market trajectory?
Sustained payer coverage that preserves oral SERM options, stable niche prescribing for the bone plus breast-risk cohort, and improved persistence through better symptom management and VTE screening workflows.

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References

[1] U.S. Food and Drug Administration. EVISTA (raloxifene) prescribing information / label. FDA.
[2] ClinicalTrials.gov. Raloxifene (EVISTA) and related studies listings. National Library of Medicine.
[3] EMA. Raloxifene (EVISTA) product information. European Medicines Agency.