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.
NCT00003906 ↗	Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women	Completed	NSABP Foundation Inc	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
Schizophrenia	9
Osteoporosis, Postmenopausal	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
Australia	13
Germany	13
Spain	10

Trials by US State

Trials by US State for RALOXIFENE HYDROCHLORIDE
Location	Trials
Illinois	15
Florida	13
Minnesota	12
Texas	12
Pennsylvania	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
Unknown status	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

Clinical Trials Update, Market Analysis, and Projections for Raloxifene Hydrochloride

Last updated: October 31, 2025

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Introduction

Raloxifene Hydrochloride, a selective estrogen receptor modulator (SERM), primarily indicated for osteoporosis treatment in postmenopausal women and also used for breast cancer risk reduction, continues to be a significant player within the pharmaceutical landscape. With evolving clinical evidence and changing market dynamics, understanding the current status and future outlook of raloxifene is crucial for stakeholders including manufacturers, healthcare providers, and investors.

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Clinical Trials Landscape

Current Clinical Trials and Focus Areas

Raloxifene's clinical development has transitioned from initial osteoporosis and breast cancer prevention to exploring broader therapeutic applications. Recent trials focus on:

• Bone health in diverse populations: Trials [1] continue to examine efficacy and safety in populations beyond postmenopausal women, including men with osteoporosis or at risk for fracture, reflecting broader indications.

• Cardiovascular outcomes: New studies are assessing the impact of raloxifene on cardiovascular health, owing to its estrogen-mimicking effects on lipid profiles. A landmark trial [2] demonstrates modest benefits but with concerns over thromboembolic risks.

• Neuroprotective effects: Emerging researches are evaluating whether raloxifene exhibits neuroprotective properties, potentially extending its usage to cognitive decline and Alzheimer's disease, though these are preliminary [3].

• Combination therapies: Ongoing studies are investigating raloxifene in combination with other agents such as bisphosphonates or statins, aiming to enhance therapeutic efficacy [4].

Regulatory and Post-market Surveillance

While raloxifene has long-standing regulatory approval (e.g., FDA approval in 1997), recent focus shifts to post-market safety assessments, especially related to venous thromboembolism (VTE) risks. The European Medicines Agency (EMA) mandates continuous safety monitoring, which influences ongoing clinical research priorities [5].

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Market Analysis

Current Market Size and Segmentation

The global raloxifene market was valued at approximately USD 1.2 billion in 2022, driven predominantly by osteoporosis and breast cancer prevention segments [6]. North America leads the market due to high prevalence of osteoporosis among postmenopausal women and robust healthcare infrastructure, followed by Europe and Asia-Pacific.

Key Market Drivers

• Increasing aging population worldwide elevates osteoporosis burden.
• Growing awareness and screening programs improve diagnosis.
• Proven efficacy and safety profile of raloxifene bolster prescription rates.
• Favorable oral administration route enhances compliance.

Market Challenges

• Side-effect profile: Risks of VTE, stroke, and hot flashes discourage widespread use, especially among women with cardiovascular risk factors.
• Competition: Bisphosphonates (e.g., alendronate), newer agents like denosumab, and emerging SERMs (e.g., bazedoxifene) create competitive pressures.
• Generics and pricing: Patent expirations (e.g., in the US filed around 2014) pressure pricing strategies and profit margins.

Regional Dynamics

In emerging economies like China and India, increasing osteoporosis awareness and expanding healthcare coverage are promoting raloxifene adoption, albeit with affordability constraints. Local regulations and healthcare policies significantly affect market penetration.

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Future Market Projections

Growth Forecast (2023-2030)

The global raloxifene market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-5% over the next seven years, reaching nearly USD 1.8 billion by 2030 [6].

Drivers Supporting Growth

• Introduction of biosimilar and generic versions, reducing prices.
• Expanded clinical indications, for instance, exploration of neuroprotective effects.
• Increased screening for osteoporosis, particularly in aging populations.
• Growth in healthcare expenditure, especially in Asia-Pacific.

Potential Market Constraints

• Safety concerns may limit new indications’ approval or market acceptance.
• Competition from other osteoporosis treatments and lifestyle interventions.
• Regulatory hurdles for novel uses—such as neurodegenerative conditions—could delay commercialization.

Innovative Trends and Opportunities

• Digital health and data analytics for personalized treatment strategies.
• Combining raloxifene with emerging therapies to enhance efficacy.
• Development of formulations with improved bioavailability or reduced side effects.

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Regulatory Outlook

Regulatory agencies are emphasizing post-market safety evaluations, and recent updates include label modifications to address thromboembolic risks. Future approvals for new indications hinge on comprehensive clinical evidence, especially for off-label uses.

The trend toward personalized medicine may stimulate regulatory pathways for safety and efficacy data tailored to specific populations, thus broadening raloxifene's therapeutic scope.

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Conclusion

Raloxifene hydrochloride remains a vital SERMs in managing osteoporosis and breast cancer risk reduction, with ongoing research expanding its potential applications. Market dynamics reflect a blend of robust demand driven by aging demographics and emerging challenges from safety concerns and competitive therapies. Stakeholders should closely monitor clinical developments, regulatory updates, and regional market trends to optimize strategic decisions.

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Key Takeaways

• Clinical trials are evolving, exploring raloxifene’s broader roles, including neuroprotection and combination therapies, though safety remains paramount.
• The global market is projected to grow steadily, supported by demographic shifts and increasing osteoporosis awareness.
• The advent of biosimilars and improved formulations will likely reduce costs and expand access.
• Regulatory agencies focus on safety surveillance, shaping future indication approvals.
• Strategic opportunities lie in personalized treatment approaches and expanding into emerging markets with tailored regulatory strategies.

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FAQs

1. What are the current approved uses of raloxifene hydrochloride?
Raloxifene is approved for preventing and treating osteoporosis in postmenopausal women and reducing the risk of invasive breast cancer in high-risk women.

2. Are there ongoing clinical trials investigating new indications for raloxifene?
Yes, trials are assessing raloxifene’s potential neuroprotective effects and its use in combination therapies, although none have yet led to new approvals.

3. How does the safety profile of raloxifene affect its market?
Concerns over thromboembolic events limit its widespread use, especially in populations with cardiovascular risk factors, impacting market growth and prescribing patterns.

4. What are competitive alternatives to raloxifene?
Bisphosphonates (e.g., alendronate), denosumab, and other SERMs like bazedoxifene are primary competitors, each with distinct safety and efficacy profiles.

5. What is the outlook for biosimilars and generics in the raloxifene market?
Patent expirations pave the way for biosimilars and generics, likely to reduce prices and increase accessibility, fostering market expansion.

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References

[1] ClinicalTrials.gov. Raloxifene osteoporosis studies. (2023).
[2] Barrett-Connor, E., et al. (2018). Raloxifene and cardiovascular outcomes. J Am Coll Cardiol.
[3] Smith, D.J., et al. (2020). Neuroprotective potential of SERMs. Neuropharmacology.
[4] Lee, S., et al. (2019). Combination therapies involving Raloxifene. J Osteoporos.
[5] EMA. (2022). Post-market safety updates on SERMs.
[6] MarketsandMarkets. (2023). Global osteoporosis therapeutics market forecast.

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This comprehensive analysis offers actionable insights into raloxifene hydrochloride’s clinical and commercial landscape, empowering strategic decision-making for healthcare professionals, investors, and policymakers.