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.
NCT00004915 ↗	Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1998-11-01	RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using raloxifene may fight endometrial cancer by reducing the production of estrogen. PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who have persistent or recurrent endometrial cancer.
NCT00004915 ↗	Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer	Completed	Northwestern University	Phase 2	1998-11-01	RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using raloxifene may fight endometrial cancer by reducing the production of estrogen. PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who have persistent or recurrent endometrial cancer.

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
Pennsylvania	12
California	12
Ohio	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 Market Analysis and Financial Projection

Last updated: April 30, 2026

Raloxifene Hydrochloride: Clinical Trials Update, Market Analysis, and Projection

What is raloxifene hydrochloride and how is it used in current practice?

Raloxifene hydrochloride is a selective estrogen receptor modulator (SERM) used primarily for:

• Prevention and treatment of osteoporosis in postmenopausal women (fracture risk reduction).
• Reduction of invasive breast cancer risk in specific high-risk postmenopausal populations (indication depends on jurisdiction and label language).

Key branded origin in major markets:

• Evista (raloxifene).

Raloxifene is an established, older-generation therapy. Current market and clinical trial activity is shaped by generic competition, label-defined use patterns, and safety monitoring needs (notably thromboembolic and endometrial safety considerations typical for SERMs).

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What does the clinical trials landscape look like (status, focus, and why it matters commercially)?

Public clinical development for raloxifene is dominated by three buckets:

1. Bioequivalence and formulation/PK work (typical for generics and line extensions).
2. Comparative effectiveness and observational evidence (often not registered as interventional late-stage trials).
3. Mechanism-adjacent studies (smaller designs, limited probability of label expansion at scale).

Interventional Phase 3/registrational programs for new raloxifene indications are not a defining feature of the recent pipeline in the way they are for newer SERMs, ER degraders, or osteoporosis agents. Commercial outcomes therefore tend to be driven by:

• Generic uptake rates,
• Price compression and payer formularies,
• Persistence and adherence in osteoporosis,
• Ongoing risk-benefit management for thromboembolism, stroke, and related adverse events.

Market consequence: When a molecule is mature and non-expanding, “clinical trials update” translates into whether any trial signals translate into measurable uptake. For raloxifene, the dominant signals are typically around tolerability, switching patterns, and adherence rather than new efficacy endpoints large enough to restart category demand.

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What clinical trial updates are most likely to move the needle right now?

Because raloxifene is off-patent in most major regions, the highest volume of “activity” tends to be:

• Generic bioequivalence (BE) filings and supplemental data for manufacturing changes.
• Post-marketing studies or registry work that reinforce real-world fracture and adherence outcomes.

From a business perspective, these updates impact:

• Regulatory approvals for generics (faster time to market, fewer barriers for entrants),
• Formulary positioning (evidence-backed adherence and risk monitoring),
• Physician switching behavior within osteoporosis risk tiers.

Bottom line: The clinical trial “update” cycle for raloxifene is less about headline Phase 3 readouts and more about whether generics can land quickly and whether real-world persistence supports sustained volumes.

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Market Analysis

How big is the raloxifene market and how does competition shape it?

Raloxifene is widely used but faces strong generic competition. Market value performance typically lags units because:

• Entry of multiple generic manufacturers drives net price erosion.
• Payers shift usage based on cost-effectiveness versus alternatives such as denosumab, bisphosphonates, and other osteoporosis therapies.

Competitive dynamics that matter:

• Price compression after generic approvals.
• Formulary narrowing where insurers reduce SERM use if competing options offer better payer economics or simplified administration.
• Regional label nuances affecting breast cancer risk reduction use.

Commercial implication: Even with stable demand in osteoporosis, total revenue growth is structurally constrained unless either:

• a meaningful reassessment of risk-benefit expands prescribing, or
• there is a major formulary shift back toward SERMs for selected payer populations.

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Where does demand concentrate? (use-case mapping)

Raloxifene demand concentrates in:

• Postmenopausal osteoporosis prevention/treatment in women for whom clinicians select SERMs due to profile preferences (e.g., when avoidance of certain risks drives selection).
• Breast cancer risk reduction in eligible postmenopausal women in jurisdictions where the label supports use for invasive breast cancer risk reduction.

Within osteoporosis, prescribing patterns increasingly reflect:

• FRAX and fracture history, and
• alignment with payer criteria where generic oral therapies remain the cost baseline.

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What are the dominant market risks and headwinds?

The main headwinds for revenue expansion are structural:

• Generic price pressure.
• Competing osteoporosis standards: denosumab and bisphosphonates dominate in many payer algorithms; anabolic agents and newer mechanisms are used in subsets.
• Safety monitoring requirements: thromboembolic risk means prescribing is sensitive to patient risk profiling and adherence to counseling.

Key market risk: even if units remain steady, revenue can decline via pricing and substitution to lower-cost alternatives.

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What are the key tailwinds?

Tailwinds are also real but mostly stabilize rather than expand revenue:

• Long-standing clinical comfort and familiarity with raloxifene in osteoporosis practice.
• Ongoing need for oral, daily or scheduled therapies in populations that prefer tablets over injections.
• Persistent incidence of osteoporosis in aging populations.

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Forward Projection

How will the market likely evolve over the next 5 years?

A practical projection for an established generic SERM typically looks like:

• Units: relatively stable to modestly growing in line with demographics and osteoporosis screening/management.
• Revenue: flat-to-declining due to price compression and switching to lowest-cost options in payer formularies.

Scenario framing (directional, not probabilistic):

• Base case: units grow modestly, revenue declines or stays flat because generics and price competition offset volume growth.
• Downside: increased substitution to other osteoporosis mechanisms reduces SERM share; revenue declines faster.
• Upside: regional payer preference for oral therapies and adherence improvements stabilizes SERM share; revenue stabilizes rather than declines.

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What investment-relevant conclusions follow for R&D and business strategy?

For companies considering development or commercialization investment around raloxifene:

• Expect limited incentive for label-expansion trials unless a narrow, payer-specific, clinically meaningful endpoint can be shown.
• If pursuing new development, the highest ROI typically comes from:
  • formulation differentiation that improves adherence,
  • manufacturing reliability to reduce supply disruptions,
  • lifecycle management in competitive procurement markets.

For investors, the molecule behaves more like a cash-flow and formulation/generic operations play than a high-growth innovation asset.

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Key Takeaways

• Raloxifene hydrochloride is a mature SERM with clinical use centered on postmenopausal osteoporosis and selected breast cancer risk reduction populations.
• Recent “clinical trials activity” is expected to be dominated by generic bioequivalence and non-registrational evidence, not major Phase 3 label-expansion programs.
• Market performance is constrained by generic price erosion and strong competition from other osteoporosis therapies.
• Over the next 5 years, the base-case direction is modest unit stability or growth with flat-to-declining revenue unless payer/formulary dynamics shift toward SERMs.

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FAQs

1) Is raloxifene still undergoing major Phase 3 development for new indications?

Not as a defining feature of current development compared with newer osteoporosis and endocrine pipeline agents; activity is largely formulation/BE and evidence reinforcement.

2) What drives raloxifene demand: osteoporosis or breast cancer risk reduction?

Both contribute, but osteoporosis use typically anchors the bulk of prescribing volume, while breast cancer risk reduction depends on label and population targeting by jurisdiction.

3) Why does market revenue tend to lag units for raloxifene?

Generic competition compresses net prices and increases formulary substitution toward lowest-cost options.

4) What clinical safety issues influence prescribing behavior?

Thromboembolic and related risks typical for SERMs shift patient selection and counseling requirements, affecting uptake and persistence.

5) What is the most realistic business path for raloxifene-based initiatives?

Lifecycle and market-structure plays: formulation differentiation, manufacturing and supply reliability, and payer-facing evidence packages rather than broad registrational expansion.

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References

[1] ClinicalTrials.gov. (n.d.). Raloxifene hydrochloride trials database. https://clinicaltrials.gov/
[2] FDA. (n.d.). Evista (raloxifene hydrochloride) prescribing information and labeling. https://www.accessdata.fda.gov/