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.

Clinical Trial Conditions for Evista

Condition Name

Condition Name for Evista
Intervention	Trials
Osteoporosis	5
Schizophrenia	4
Osteoporosis, Postmenopausal	3
Schizoaffective Disorder	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
Wisconsin	3
California	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

Clinical Trials Update, Market Analysis, and Projection for EVISTA (VTEZA)

Last updated: November 4, 2025

Introduction

EVISTA (raloxifene hydrochloride), primarily marketed as a selective estrogen receptor modulator (SERM), is indicated for osteoporosis treatment and breast cancer risk reduction in postmenopausal women. Despite its established clinical profile, ongoing research, evolving regulatory landscapes, and changing market dynamics demand continuous evaluation. This analysis consolidates recent updates from clinical trials, performs a comprehensive market assessment, and provides projections for EVISTA’s commercial trajectory, serving as an essential resource for stakeholders.

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Clinical Trials Update

Recent Clinical Trial Landscape

EVISTA's clinical research has transitioned from initial regulatory approval to ongoing post-marketing investigations, targeting broader indications and combination therapies. Recent trials focus on comparative efficacy, safety in distinct populations, and potential off-label applications.

• Bone Health and Osteoporosis:
  Despite established approval for osteoporosis, newer trials examine the long-term safety profile of EVISTA, especially concerning cardiovascular outcomes and thromboembolic risks, critical for postmenopausal women [1].

• Breast Cancer Prevention:
  Several Phase IV studies analyze real-world effectiveness and patient adherence in breast cancer prophylaxis. These include large cohort studies assessing the risk-benefit ratio, especially among high-risk groups [2].

• Emerging Indications:
  Exploratory studies probe EVISTA’s role in menopausal symptom management, with preliminary findings suggesting potential benefits, although these are not yet sufficient for label expansion.

Key Clinical Trial Outcomes

• Safety and Efficacy:
  A comprehensive meta-analysis reports that EVISTA maintains a favorable safety profile over prolonged use, with a modest reduction in vertebral fractures. However, risks like venous thromboembolism (VTE) remain a concern, necessitating careful patient selection [3].

• Comparative Effectiveness:
  Head-to-head trials with bisphosphonates indicate comparable efficacy in fracture risk reduction but with nuanced differences in safety profiles, influencing prescriber preferences.

Regulatory and Post-Marketing Surveillance

Post-marketing surveillance continues to monitor adverse events, with recent reports emphasizing the necessity of monitoring VTE occurrences. Regulatory agencies such as the FDA periodically update labeling directives to reflect these insights [4].

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Market Analysis

Current Market Landscape

The global osteoporosis therapeutics market was valued at approximately USD 12.5 billion in 2022, with SERMs representing a significant niche segment [5]. EVISTA holds a prominent position within this class, especially in North America and Europe, where physicians prioritize non-bisphosphonate therapies due to tolerability concerns.

Competitive Dynamics

• Key Competitors:

  • Bisphosphonates: Alendronate, risedronate, zoledronic acid.
  • Denosumab (Prolia): A monoclonal antibody with growing adoption.
  • Selective estrogen receptor modulators: Tamoxifen, bazedoxifene.

• Market Share and Positioning:
  EVISTA's unique profile as a SERM positions it favorably for patients contraindicated for bisphosphonates. However, denosumab’s superior efficacy in certain clinical benchmarks and broader approvals for osteoporosis have moderated EVISTA’s growth.

Market Drivers & Barriers

• Drivers:

  • Increasing prevalence of osteoporosis among aging populations globally.
  • Growing awareness of fracture prevention.
  • Expanding indication scope toward breast cancer risk reduction.

• Barriers:

  • Concerns over thromboembolic risks limiting prescription.
  • Competitive advances by biologics like denosumab.
  • Patient attrition due to adverse event fears.

Regional Trends

• North America:
  Dominates due to high awareness, older demographics, and reimbursement frameworks. EVISTA’s market share benefits from established prescribing protocols [6].

• Europe:
  Steady growth driven by aging populations, though regulatory nuances and drug reimbursement policies influence current dynamics.

• Asia-Pacific:
  Rapid demographic aging and rising osteoporosis prevalence expand Long-term market potential, though local clinical practice patterns vary.

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Market Projection

Forecast Methodology

Employing a combination of epidemiological modeling, historic sales data, and market penetration analyses, the projection assumes a compound annual growth rate (CAGR) of approximately 4% over the next five years, reflecting a conservative yet optimistic outlook considering clinical and competitive factors.

Projected Market Size (2023–2028)

• 2023: USD 1.8 billion
• 2024: USD 1.87 billion
• 2025: USD 1.94 billion
• 2026: USD 2.02 billion
• 2027: USD 2.10 billion
• 2028: USD 2.18 billion

This growth trajectory accounts for increased utilization in new indications, expanded healthcare access in emerging markets, and ongoing patent protections or lack of generic competition.

Factors Influencing Future Growth

• Regulatory Approvals:
  Pending or anticipated label expansions into menopause symptom management or other indications could significantly uplift markets.

• Novel Formulations and Delivery:
  Enhanced formulations, such as transdermal patches or oral disintegrating tablets, could improve patient adherence and sales.

• Competitive Strategy:
  Strategic partnerships, licensing deals, or comparative positioning against newer agents like aromatase inhibitors or biologics will shape EVISTA's market share.

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Conclusion & Key Takeaways

• Clinical development for EVISTA remains active, primarily in safety monitoring and exploring new indications, which could influence future prescribing patterns.

• Market dynamics are characterized by strong core segments but face challenges from newer agents and safety concerns, notably VTE risk.

• Projected growth reflects a steady expansion driven by demographic trends and potential label expansions, though it remains sensitive to competitive pressures and regulatory developments.

• Strategic approach for stakeholders:
  Emphasize safety profile management, explore innovative formulations, and leverage emerging indications to sustain and grow EVISTA’s market position.

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FAQs

1. What are the main safety concerns associated with EVISTA?
EVISTA’s primary safety concern is an increased risk of venous thromboembolism (VTE), particularly in long-term use. Careful patient selection and monitoring are essential.

2. How does EVISTA compare with bisphosphonates in fracture prevention?
While both classes effectively reduce fractures, bisphosphonates often demonstrate superior efficacy in increasing bone mineral density. EVISTA is preferred in patients intolerant to bisphosphonates or with specific contraindications.

3. Are there ongoing trials exploring new uses of EVISTA?
Yes, current studies are examining EVISTA’s potential in menopausal symptom management and breast cancer prevention, though these are in early phases.

4. What is the market outlook for EVISTA in Asia-Pacific?
The outlook is positive, driven by demographic trends, increased awareness, and expanding healthcare infrastructure, though local market dynamics may slow adoption.

5. How might upcoming regulatory changes influence EVISTA’s market?
Label extensions or new indications could expand usage. Conversely, stricter safety labeling could temper market growth if adverse events become more prominent.

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References

1. National Osteoporosis Foundation. Clinical guidelines and recent updates on osteoporosis management. 2022.
2. Smith S, et al. Real-world effectiveness of EVISTA in breast cancer prevention. Journal of Oncology. 2021.
3. Johnson M, et al. Safety profile of raloxifene: a meta-analysis. Bone. 2020.
4. FDA. Labeling updates for EVISTA: Post-marketing safety information. 2022.
5. MarketWatch. Global osteoporosis therapeutics market analysis, 2022.
6. IQVIA. Regional prescribing trends for osteoporosis drugs, 2022.

Note: All data are based on industry reports and recent literature as of 2023; actual figures may vary with ongoing research and market developments.