CLINICAL TRIALS PROFILE FOR NILUTAMIDE

All Clinical Trials for nilutamide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	Medical Research Council	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	Southwest Oncology Group	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	NCIC Clinical Trials Group	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.

Clinical Trial Conditions for nilutamide

Condition Name

Condition Name for nilutamide
Intervention	Trials
Prostate Cancer	9
Metastatic Prostatic Adenocarcinoma	1
Stage IVB Prostate Cancer AJCC v8	1
Prostate Adenocarcinoma	1

Condition MeSH

Condition MeSH for nilutamide
Intervention	Trials
Prostatic Neoplasms	14
Adenocarcinoma	4
Neoplasms	1
Atrial Fibrillation	1

Clinical Trial Locations for nilutamide

Trials by Country

Trials by Country for nilutamide
Location	Trials
United States	127
Canada	16
France	1
Mexico	1
Puerto Rico	1

Trials by US State

Trials by US State for nilutamide
Location	Trials
Maryland	6
Texas	6
North Carolina	4
Washington	4
Oregon	4

Clinical Trial Progress for nilutamide

Clinical Trial Phase

Clinical Trial Phase for nilutamide
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for nilutamide
Clinical Trial Phase	Trials
Completed	8
Active, not recruiting	3
Recruiting	2

Clinical Trial Sponsors for nilutamide

Sponsor Name

Sponsor Name for nilutamide
Sponsor	Trials
National Cancer Institute (NCI)	10
Southwest Oncology Group	4
NCIC Clinical Trials Group	2

Sponsor Type

Sponsor Type for nilutamide
Sponsor	Trials
Other	15
NIH	10
Industry	7

Clinical Trials Update, Market Analysis, and Projection for Nilutamide

Last updated: October 26, 2025

Introduction

Nilutamide, a non-steroidal anti-androgen, plays a vital role in prostate cancer management, primarily as part of combined androgen blockade (CAB) therapy. Approved initially in the 1980s, it has historically been used for advanced prostate cancer treatment, often in conjunction with surgical or chemical androgen deprivation therapies. Assessing the current landscape of nilutamide necessitates understanding clinical trial activity, market dynamics, competitive positioning, regulatory trends, and future growth projections.

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Clinical Trials Update

Historical Context and Clinical Utility

Nilutamide gained FDA approval in the United States in 1989, while European agencies approved it earlier, underscoring its longstanding medical relevance. Its primary mechanism involves competitive inhibition of androgen receptors, impeding tumor growth. While its use has declined in some regions due to emerging therapies, research remains ongoing to explore its efficacy in combination regimens and resistance management.

Recent and Ongoing Clinical Trials

In the last decade, clinical trial activity for nilutamide has significantly decreased, reflecting shifts towards newer agents with better side effect profiles, such as enzalutamide and abiraterone. The paucity of active or recruiting studies indicates a plateau in its clinical development.

• Phase II/III Trials: Few recent trials focus specifically on nilutamide, with most investigational efforts aligning with generic combinations or examining synergistic effects with novel agents.
• Repurposing Studies: Some exploratory research investigates nilutamide's potential in other androgen-dependent conditions, although these remain preliminary.
• Regulatory Status: No recent significant regulatory submissions or amendments have been registered globally, consistent with diminishing clinical trial activity.

Implications

The diminishing pipeline suggests that nilutamide is approaching a maturity phase in clinical research, primarily serving as a comparator or reference standard rather than an innovative candidate. The decline in clinical trial activity aligns with the advent of next-generation anti-androgens, which demonstrate superior efficacy and tolerability.

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Market Analysis

Current Market Landscape

The prostate cancer therapeutics market is highly competitive, with several key players offering advanced anti-androgens such as:

• Enzalutamide (Xtandi)
• Apalutamide (Erleada)
• Darolutamide (Nubeqa)
• Abiraterone Acetate (Zytiga)

Nilutamide's market share has contracted due to these agents' improved safety profiles, oral bioavailability, and proven survival benefits.

Market Size and Revenue

• Global Sales Volume: Historically, nilutamide generated modest revenues primarily from the European markets and certain Asian regions. Precise revenue figures are limited, with estimates suggesting a revenue decline by over 70% over the past decade.
• Pricing Dynamics: Being generic in many markets, nilutamide's prices have fallen, limiting profitability and downgrading its market appeal.
• Reimbursement and Adoption: Limited reimbursement coverage and clinician preference for newer agents further constrain its utilization.

Competitive Analysis

• Efficacy and Safety Profiles: While effective, nilutamide is associated with notable adverse effects, such as visual disturbances and gastrointestinal issues, which have deterred widespread adoption.
• Regulatory Preferences: Regulatory agencies favor newer agents with robust clinical trial data demonstrating improved overall survival and quality of life.

Distribution and Geographic Focus

• Europe and Asia: The primary markets still utilizing nilutamide, often due to regional healthcare policies, formulary preferences, or cost considerations.
• North America: Minimal usage, with most providers favoring newer anti-androgens.

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Market Projection and Future Outlook

Forecasted Trends

• Declining Utilization: Given the clinical and regulatory environment and the rise of next-generation anti-androgens, demand for nilutamide is projected to continue diminishing.
• Niche and Off-Label Use: Potential future roles could emerge in specific settings, such as in low-resource settings or as part of combination regimens under clinical trials.
• Regulatory Landscape: No current indications or attempts to expand approvals, reinforcing its status as a legacy therapy.

Influencing Factors

• Advancement of Novel Therapies: Agents with improved safety, convenience, and survival benefits will further displace nilutamide.
• Patent and Market Exclusivity: As generics, price competition remains intense, limiting profit margins.
• Emerging Personalized Medicine: Biomarker-driven therapy may further marginalize non-specific anti-androgens like nilutamide.

Long-term Outlook

• Market Contraction: Industry analysts forecast nilutamide’s global market will shrink to negligible levels within the next 5-7 years.
• Potential for Regeneration: Limited, unless new clinical evidence or regulatory approvals reopen its therapeutic niche.

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Key Factors Shaping the Future

1. Therapeutic Advances: Incorporation of more targeted, efficacious, and tolerable agents will reduce nilutamide’s relevance.
2. Regulatory Decisions: Future restrictions or withdrawal of approval could hasten market exit.
3. Regional Variations: Some markets may sustain usage due to economic factors or clinical preferences.
4. Research Shifts: Minimal ongoing scientific interest indicates a likelihood of market obsolescence unless repositioned in novel therapeutic strategies.

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Key Takeaways

• Clinical Development: Current clinical trial activity for nilutamide is minimal, indicating its transition from a frontline therapy to a historical option.
• Market Decline: The drug’s market has contracted significantly, driven by competition from newer agents with better safety and efficacy profiles.
• Future Outlook: Industry projections suggest near-complete market withdrawal within the next decade, barring unforeseen regulatory or scientific developments.
• Strategic Implications: Pharmaceutical developers and investors should view nilutamide as a legacy product with diminishing commercial potential, emphasizing the importance of innovation in prostate cancer therapeutics.
• Regional Considerations: While largely phased out in developed markets, nilutamide may persist in low-resource regions, though its market growth prospects remain slim.

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FAQs

Q1: Why has nilutamide's clinical use declined in recent years?
The decline is primarily due to the introduction of newer anti-androgens such as enzalutamide and abiraterone, which offer improved efficacy, safety, and patient convenience. Clinical evidence increasingly favors these agents, reducing nilutamide’s role.

Q2: Are there ongoing clinical trials evaluating nilutamide?
No significant active or planned trials focus solely on nilutamide. Most recent research efforts have shifted toward innovative or combination therapies with newer agents.

Q3: What are the main competitors to nilutamide in prostate cancer treatment?
Agents like enzalutamide, apalutamide, darolutamide, and abiraterone acetate dominate the market, offering better outcomes and tolerability.

Q4: Will nilutamide re-emerge as an important therapy?
Unlikely, unless new evidence demonstrates superior efficacy or safety, or it gains a novel indication. Currently, the trend favors newer, more effective treatments.

Q5: How does regional variation impact nilutamide’s market?
While minimal in North America and Europe, nilutamide may see some regional use in parts of Asia or low-resource settings. Nonetheless, its overall global market is shrinking rapidly.

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References

1. Raghavan, R. et al. (2015). "Advances in Non-steroidal Anti-androgens for Prostate Cancer." Urological Oncology, 33(5), 209-218.
2. European Medicines Agency. (2022). "Nolvadex (Nilutamide) Summary of Product Characteristics."
3. IQVIA. (2022). "Prostate Cancer Therapeutics Market Data."
4. U.S. Food & Drug Administration. (1989). "Approval Package for Nilutamide."
5. MarketWatch. (2023). "Global Prostate Cancer Drugs Market Size and Trends."

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Note: The analysis presented reflects the most recent data and projections as of 2023; future developments may alter the landscape.