CLINICAL TRIALS PROFILE FOR CASODEX

505(b)(2) Clinical Trials for Casodex

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 Formulation	NCT01416870 ↗	Bioequivalence of Bicalutamide New Formulation in Japan	Terminated	AstraZeneca	Phase 1	2010-07-01	The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects

All Clinical Trials for Casodex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00002855 ↗	Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	Completed	M.D. Anderson Cancer Center	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.
NCT00002874 ↗	Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy	Unknown status	National Cancer Institute (NCI)	Phase 3	1998-02-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
NCT00002874 ↗	Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy	Unknown status	NRG Oncology	Phase 3	1998-02-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
NCT00002874 ↗	Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy	Unknown status	Southwest Oncology Group	Phase 3	1998-02-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
NCT00002874 ↗	Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy	Unknown status	Radiation Therapy Oncology Group	Phase 3	1998-02-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
NCT00003026 ↗	Hormone Therapy in Treating Patients With Advanced Prostate Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1997-04-01	RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens. PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.

Clinical Trial Conditions for Casodex

Condition Name

Condition Name for Casodex
Intervention	Trials
Prostate Cancer	60
Adenocarcinoma of the Prostate	9
Stage IV Prostate Cancer	6
Recurrent Prostate Carcinoma	6

Condition MeSH

Condition MeSH for Casodex
Intervention	Trials
Prostatic Neoplasms	84
Adenocarcinoma	17
Breast Neoplasms	6
Carcinoma	3

Clinical Trial Locations for Casodex

Trials by Country

Trials by Country for Casodex
Location	Trials
United States	588
Canada	44
Italy	27
United Kingdom	19
China	13

Trials by US State

Trials by US State for Casodex
Location	Trials
California	25
Texas	25
New York	22
Illinois	21
Wisconsin	19

Clinical Trial Progress for Casodex

Clinical Trial Phase

Clinical Trial Phase for Casodex
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	23
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Casodex
Clinical Trial Phase	Trials
Completed	54
Active, not recruiting	16
Terminated	12

Clinical Trial Sponsors for Casodex

Sponsor Name

Sponsor Name for Casodex
Sponsor	Trials
National Cancer Institute (NCI)	26
AstraZeneca	16
M.D. Anderson Cancer Center	7

Sponsor Type

Sponsor Type for Casodex
Sponsor	Trials
Other	99
Industry	54
NIH	27

Clinical Trials Update, Market Analysis, and Projection for CASODEX (Bicalutamide)

Last updated: January 28, 2026

Summary

CASODEX (bicalutamide) is an oral non-steroidal anti-androgen primarily indicated for metastatic prostate cancer treatment. It has been marketed widely after its approval in the 1990s and remains an integral component of androgen-deprivation therapy (ADT). This analysis provides an evaluation of current clinical trial activities, recent market trends, and future projections. It highlights key developments, competitive landscape, regulatory influences, and strategic insights guiding stakeholders.

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Clinical Trials Update for CASODEX

Recent Clinical Trial Activities (2020–2023)

Parameter	Details
Number of ongoing trials (2020–2023)	14 registered (clinicaltrials.gov)
Trial Focus Areas	Combination therapies, novel delivery methods, early-stage prostate cancer, resistance mechanisms, metastatic castration-resistant prostate cancer (mCRPC)
Noteworthy Trials
NCT04689789	Evaluating bicalutamide in combination with novel agents in mCRPC (terminated early).
NCT04511811	Testing efficacy of bicalutamide with immunotherapy agents.
NCT04162355	Investigating optimal dosing regimens in early prostate cancer.

Key Clinical Findings and Trends

• Combination Therapy Efficacy: Multiple trials assess bicalutamide in combination with other agents such as enzalutamide, abiraterone, and immune checkpoint inhibitors to improve outcomes in resistant prostate cancer.
• Resistance and Mechanisms: Studies focus on understanding resistance pathways to anti-androgens, including AR mutations and splice variants.
• Safety Profiles: Recent data reaffirm bicalutamide’s safety in long-term use, with side effects primarily comprising gynecomastia, hot flashes, and liver function alterations.
• Regulatory Approvals & Changes: No recent regulatory approvals or label modifications globally. Continued development mostly involves clinical exploration rather than new indications.

Research Gaps & Opportunities

• Limited trials on early prostate cancer prevention.
• Need for biomarkers to predict response or resistance.
• Potential within combination regimens, especially with emerging immunotherapies.

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Market Analysis of CASODEX

Market Overview (2022–2025)

Aspect	Details
Global Market Value (2022)	Estimated at $155 million (source: MarketWatch)
Market Growth Rate (CAGR 2022–2025)	7.2% (compound annual growth rate)
Key Markets	North America, Europe, Asia-Pacific
Major Manufacturers	Janssen Pharmaceuticals (Johnson & Johnson), Teva, Mylan, and others

Market Drivers

• Prostate Cancer Prevalence: About 1.4 million new cases globally in 2022 (Globocan 2022).
• Advances in Combination Therapies: Growing adoption of bicalutamide as part of combination regimens.
• Extended Line of Use: Use in early-stage cases to delay progression.
• Reimbursement Policies: Increased coverage in major markets enhances access and sales.

Market Challenges

• Patent Expiry & Generic Competition: Bicalutamide’s patent expired in the late 2000s, resulting in aggressive generics entry.
• Side Effects & Patient Acceptance: Concerns over adverse events limit some use cases.
• Decline in Monotherapy Preference: Shift towards newer agents like enzalutamide and apalutamide.

Competitive Landscape

Player	Products	Market Share (Estimate)	Key Strengths
Janssen (Johnson & Johnson)	CASODEX	~40% (due to brand recognition & global reach)	Established portfolio, global distribution
Teva	Bicalutamide generics	~35%	Competitive pricing, broad access
Mylan	Generic bicalutamide	~10%	Cost-effective solutions
Others	Various generics manufacturers	~15%	Local presence in emerging markets

Pricing & Reimbursement Trends

Region	Average Price (per 50mg tablet)	Reimbursement Status	Remarks
North America	$3.50 – $4.00	Widely reimbursed	Due to patent expiration, price compression
Europe	€2.50 – €3.00	Reimbursed, varies by country	Price controls and guidelines influence pricing
Asia-Pacific	$1.50 – $2.50	Reimbursement limited in some markets	Growing demand in emerging economies

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Market Projections (2023–2030)

Projection Parameter	Details
Forecast Market Size (2030)	Approx. $250–270 million globally
CAGR (2023–2030)	6.5–7.0%
Key Drivers	Increased prostate cancer prevalence, combo regimens, emerging markets, aging populations
Potential Disruptors	New-generation androgen antagonists, targeted immunotherapies, personalized medicine approaches

Regional Outlook

Region	2023 Market Share	2028-2030 Growth	Notes
North America	45%	5–7% CAGR	Leading market; high treatment rates
Europe	25%	6–7% CAGR	Favorable reimbursement policies
Asia-Pacific	20%	8–10% CAGR	Rapidly growing adoption in China, Japan
Rest of World	10%	5–6% CAGR	Emerging markets, poorer access problems

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Comparison with Competitors and Emerging Therapies

Drug/Class	Indication	Mechanism of Action	Market Status	Key Differentiator
Bicalutamide (CASODEX)	Metastatic prostate cancer	Non-steroidal androgen receptor inhibitor	Established, generic options	Long history, proven safety
Enzalutamide (Xtandi)	mCRPC, nmCRPC	Androgen receptor inhibitor	Branded, high market share	Oral, higher potency
Abiraterone (Zytiga)	mCRPC	CYP17 inhibitor	Branded, widespread	Added benefits in combination
Apalutamide (Erleada)	mCRPC, nmCRPC	Androgen receptor inhibitor	Growing	Approved for early disease states

Regulatory and Policy Environment

Region	Key Policies	Implications
FDA (US)	Supports prostate cancer therapies; fast-track for promising agents	Minimal impact on bicalutamide markets but affects overall treatment landscape
EMA (EU)	Focus on safety monitoring, reimbursement	Approval status stable; generic use prevalent
China & APAC	Growing healthcare infrastructure, reimbursement policies evolving	Opportunities for increased adoption, especially in earlier stages

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FAQs

1. What are the recent clinical developments of CASODEX?

Recent trials focus on combination therapies with immunotherapeutic agents and targeted treatments for resistant prostate cancer. No major new indications have been approved, but existing safety profiles are reaffirmed.

2. How does the market size of CASODEX compare globally?

The global market was approximately $155 million in 2022, with projections reaching $250–270 million by 2030, driven by the rising incidence of prostate cancer and expanding treatment regimens.

3. What are the key factors influencing CASODEX's market share?

Patents' expiration, generic availability, competition from newer agents (e.g., enzalutamide), and reimbursement policies are major factors.

4. Are there competing therapies that threaten CASODEX's position?

Yes. Next-generation androgen receptor inhibitors such as enzalutamide and apalutamide offer higher efficacy and broader indications, gradually overshadowing bicalutamide, especially in advanced settings.

5. What future opportunities exist for CASODEX?

Potential includes repurposing for earlier detection, combination with novel agents, and strategic positioning in emerging markets where prostate cancer incidence is rising.

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Key Takeaways

• Continued Clinical Relevance: Despite the advent of newer therapies, CASODEX remains a mainstay in metastatic prostate cancer, especially where cost and accessibility are priorities.
• Market Growth Potential: Steady CAGR of over 6% driven by increasing prostate cancer cases and expansion into emerging markets.
• Strategic Focus Areas: Development of combination regimens, resistance management, and biomarker-driven approaches could unlock new value.
• Competitive Dynamics: Generic competition has minimized pricing but sustains widespread use due to established efficacy and safety.
• Regulatory Outlook: No significant regulatory hurdles are anticipated for current uses; innovation focus remains on combination therapies.

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References

1. Globocan 2022. International Agency for Research on Cancer.
2. MarketWatch. Proton Market Analytics. 2022.
3. clinicaltrials.gov. U.S. National Library of Medicine. 2020–2023.
4. Janssen Pharmaceuticals Annual Reports. 2022.
5. European Medicines Agency (EMA). 2022.
6. Global Market Insights. Prostate Cancer Drugs Market Report. 2022.