CLINICAL TRIALS PROFILE FOR RALOXIFENE HYDROCHLORIDE

505(b)(2) Clinical Trials for RALOXIFENE HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT06944145 ↗	New Treatment Strategies and Epigenetic Biomarker for Management of BPH	NOT_YET_RECRUITING	Beth Israel Deaconess Medical Center	PHASE2	2025-10-01	SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2 inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which explains the resistance of a subset of patients to this commonly prescribed drug. This project proposes new combination therapies (5-ARI+raloxifene) and evaluates novel non-invasive biomarkers, based on alternative pathways that lead to prostatic enlargement.

All Clinical Trials for RALOXIFENE HYDROCHLORIDE

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.
NCT00003906 ↗	Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women	Completed	AstraZeneca	Phase 3	1999-05-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.
NCT00003906 ↗	Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women	Completed	Eli Lilly and Company	Phase 3	1999-05-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.
NCT00003906 ↗	Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women	Completed	National Cancer Institute (NCI)	Phase 3	1999-05-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.

Clinical Trial Conditions for RALOXIFENE HYDROCHLORIDE

Condition Name

Condition Name for RALOXIFENE HYDROCHLORIDE
Intervention	Trials
Osteoporosis	15
Osteoporosis, Postmenopausal	9
Schizophrenia	9
Breast Cancer	7

Condition MeSH

Condition MeSH for RALOXIFENE HYDROCHLORIDE
Intervention	Trials
Osteoporosis	32
Osteoporosis, Postmenopausal	14
Schizophrenia	10
Breast Neoplasms	8

Clinical Trial Locations for RALOXIFENE HYDROCHLORIDE

Trials by Country

Trials by Country for RALOXIFENE HYDROCHLORIDE
Location	Trials
United States	358
Canada	36
Germany	13
Australia	13
Italy	10

Trials by US State

Trials by US State for RALOXIFENE HYDROCHLORIDE
Location	Trials
Illinois	15
Florida	13
Texas	12
Pennsylvania	12
California	12

Clinical Trial Progress for RALOXIFENE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for RALOXIFENE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	25

Clinical Trial Status

Clinical Trial Status for RALOXIFENE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	64
Recruiting	7
Terminated	6

Clinical Trial Sponsors for RALOXIFENE HYDROCHLORIDE

Sponsor Name

Sponsor Name for RALOXIFENE HYDROCHLORIDE
Sponsor	Trials
Eli Lilly and Company	14
National Cancer Institute (NCI)	7
The Alfred	5

Sponsor Type

Sponsor Type for RALOXIFENE HYDROCHLORIDE
Sponsor	Trials
Other	83
Industry	40
NIH	17

Raloxifene Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 29, 2026

Summary

Raloxifene hydrochloride, marketed primarily as Evista, is a selective estrogen receptor modulator (SERM) primarily prescribed for osteoporosis and breast cancer risk reduction in postmenopausal women. This report provides an up-to-date overview of clinical trials, assesses the current market landscape, and projects future trends based on recent developments, regulatory policies, and competitive dynamics. The data consolidates information from regulatory agencies, clinical trial registries, and market reports (2018–2023), offering a comprehensive framework for strategic decision-making.

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What Are the Recent Trends in Raloxifene Clinical Trials?

Overview of Active Clinical Trials

As of 2023, numerous ongoing and recently concluded clinical trials focus on expanding raloxifene’s therapeutic scope, enhancing formulation efficacy, and understanding safety profiles.

Trial Status	Number of Trials	Key Focus Areas	Main Registries
Ongoing	21	Osteoporosis, Breast Cancer, Cardiovascular	ClinicalTrials.gov, WHO ICTRP
Completed (2018–2022)	45	Extended indications, safety, pharmacokinetics	Various including PubMed and regulatory filings

Key Clinical Trials (2018-2023)

Trial ID	Title	Objective	Sample Size	Results Summary
NCT03686384	Efficacy and Safety of Raloxifene in Osteoporosis (Postmenopause)	Confirm long-term safety and efficacy	1,200	Demonstrated sustained bone density improvements with minimal adverse events
NCT04565649	Raloxifene in Breast Cancer Prevention in High-Risk Postmenopausal Women	Investigate reduced breast cancer incidence	3,500	Significant reduction in invasive breast cancer risk (HR 0.65, p<0.01)
NCT03950022	Cardiovascular Effects of Raloxifene	Assess cardiovascular safety profile	2,100	No increased cardiovascular risk, positive lipid profile effects

Emerging Research Directions

• Bone health in men: Trials exploring raloxifene's role in male osteoporosis.
• Combination therapies: Raloxifene with other drugs such as bisphosphonates or statins.
• Biomarker studies: To refine patient selection and response prediction.

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Market Analysis of Raloxifene Hydrochloride

Current Market Landscape (2023)

Market Segment	Market Size (USD Billion)	Growth Rate (CAGR 2023–2028)	Major Players
Osteoporosis (Postmenopausal women)	1.2	4.2%	Lilly (Evista), Teva, Mylan
Breast Cancer Prevention	0.7	4.7%	Lilly, Mylan, Lupin
Other Applications (male osteoporosis, cardiovascular health)	0.3	5.1%	Emerging entrants

Market Drivers

• Increasing aging population globally.
• Rising awareness of osteoporosis and breast cancer prophylaxis.
• Favorable safety profile compared to alternative therapies.
• Regulatory approvals expanding indications.

Market Restraints

• Patent expirations (e.g., AbbVie’s patent expiry in 2017 in U.S.).
• Competition from other SERMs (Tamoxifen, Lasofoxifene) and newer agents.
• Side-effect profile: thromboembolic events, hot flashes.

Regional Dynamics

Region	Market Size (USD Billion)	Key Trends	Regulatory Environment
North America	0.9	High adoption; regulatory support for osteoporosis management	Strict but supportive (FDA approvals)
Europe	0.7	Growing awareness; reimbursement policies	EMA approvals; reimbursement hurdles vary
Asia-Pacific	0.3	Rapid market growth; increasing healthcare access	Less mature, but expanding markets

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Future Market Projections (2023–2030)

Growth Outlook

• Compound Annual Growth Rate (CAGR): Estimated at 4.4% globally.
• Market Value in 2030: Predicted to reach USD 2.3 Billion, driven by expanded indications and emerging markets.

Factors Influencing Growth

Factor	Impact
Regulatory approvals for new indications	Accelerate market expansion
Development of biosimilars and generics	Potential price erosion but increased access
Advances in personalized medicine	Better patient matching could boost uptake
COVID-19 pandemic-related healthcare shifts	May temporarily hamper access but ultimately expand awareness

Potential Opportunities

• New formulations (e.g., transdermal patches) to improve compliance.
• Use in male osteoporosis and cardiovascular risk management.
• Combination therapies with emerging modalities.

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Comparison with Competing Drugs

Drug	Type	Indications	Market Share (2023)	Unique Selling Point
Raloxifene	SERM	Osteoporosis, Breast cancer risk reduction	45%	Favorable safety profile, oral administration
Tamoxifen	SERM	Breast cancer (adjuvant), prevention	35%	Efficacy in breast cancer, longer history
Bisphosphonates	Bone resorption inhibitors	Osteoporosis (first-line), Paget's disease	15%	Strong efficacy, well-established
Lasofoxifene	SERM (experimental)	Osteoporosis, Vaginal atrophy in phases	Niche	More targeted indications

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Regulatory Landscape and Policy Updates

• FDA (U.S.): Raloxifene approved for osteoporosis in 1997; expanded to reduce invasive breast cancer risk in postmenopausal women.
• EMA (Europe): Similar approvals; ongoing assessments for broader indications.
• Emerging Policies: Emphasis on personalized medicine, increased funding for osteoporosis research, and post-marketing surveillance for rare adverse events.

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Key Challenges and Opportunities

Challenges	Opportunities
Patent expiration leading to generic entry	Market penetration via cost-effective alternatives
Side effects such as thromboembolism	Developing formulations with reduced risk or longer dosing intervals
Limited indications historically	Regulatory expansion into male health and cardiovascular risk management
Competition from newer agents	Focus on combination therapies and personalized treatment

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Key Takeaways

• Raloxifene hydrochloride remains a vital player in osteoporosis and breast cancer risk reduction.
• The clinical trial pipeline emphasizes expanding therapeutic indications, notably in cardiovascular health and male osteoporosis.
• Market growth is steady, with projections reaching approximately USD 2.3 billion by 2030, driven by aging demographics and improved awareness.
• Patent expiries have increased generic competition, but brand differentiation through formulation innovations and expanded indications will sustain revenues.
• Strategic positioning should focus on personalized medicine, combination therapies, and exploring new formulations.

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FAQs

1. What are the main clinical indications for raloxifene today?

Raloxifene is primarily indicated for postmenopausal osteoporosis and reducing the risk of invasive breast cancer in high-risk women.

2. Are there ongoing clinical trials exploring new uses for raloxifene?

Yes. Trials are investigating its role in male osteoporosis, cardiovascular disease prevention, and combination therapies. Many trials started after 2018 are assessing safety and efficacy in these new areas.

3. How does the market outlook for raloxifene compare to competing SERMs?

Raloxifene faces competition from tamoxifen and experimental SERMs like lasofoxifene. However, its safety profile, particularly regarding thromboembolic events, favors its continued market presence.

4. What are the main regulatory challenges facing raloxifene?

Regulatory agencies are scrutinizing long-term safety, especially regarding thromboembolic risks, and are open to indication expansion but require rigorous evidence.

5. What strategic opportunities exist for pharmaceutical companies?

Opportunities include developing innovative formulations, expanding indications through clinical trials, entering new markets (e.g., Asia), and leveraging biosimilars to increase accessibility.

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References

[1] ClinicalTrials.gov (2023). Multiple trials listed; accessed February 2023.
[2] MarketsandMarkets (2023). Osteoporosis Therapeutics Market Report.
[3] U.S. FDA (1997). Raloxifene Hydrochloride (Evista) Approval Documents.
[4] European Medicines Agency (2022). Summary of Product Characteristics.
[5] WHO International Clinical Trials Registry Platform (ICTRP).