CLINICAL TRIALS PROFILE FOR BICALUTAMIDE

505(b)(2) Clinical Trials for bicalutamide

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
New Formulation	NCT01416883 ↗	Oral Mucosal Absorption Study of Bicalutamide New Formulation	Terminated	AstraZeneca	Phase 1	2010-07-01	The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects

All Clinical Trials for bicalutamide

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.

Clinical Trial Conditions for bicalutamide

Condition Name

Condition Name for bicalutamide
Intervention	Trials
Prostate Cancer	100
Adenocarcinoma of the Prostate	11
Prostatic Neoplasms	11

Condition MeSH

Condition MeSH for bicalutamide
Intervention	Trials
Prostatic Neoplasms	148
Adenocarcinoma	22
Breast Neoplasms	13

Clinical Trial Locations for bicalutamide

Trials by Country

Trials by Country for bicalutamide
Location	Trials
United States	965
Canada	105
Japan	42
Italy	31
China	30

Trials by US State

Trials by US State for bicalutamide
Location	Trials
New York	39
California	36
Texas	36
Maryland	34
Illinois	33

Clinical Trial Progress for bicalutamide

Clinical Trial Phase

Clinical Trial Phase for bicalutamide
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	4
PHASE1	2

Clinical Trial Status

Clinical Trial Status for bicalutamide
Clinical Trial Phase	Trials
Completed	85
Active, not recruiting	29
Recruiting	22

Clinical Trial Sponsors for bicalutamide

Sponsor Name

Sponsor Name for bicalutamide
Sponsor	Trials
National Cancer Institute (NCI)	55
AstraZeneca	20
NRG Oncology	10

Sponsor Type

Sponsor Type for bicalutamide
Sponsor	Trials
Other	240
Industry	96
NIH	56

Clinical Trials Update, Market Analysis, and Projection for Bicalutamide

Last updated: October 28, 2025

Introduction

Bicalutamide, a non-steroidal anti-androgen agent primarily used in the management of prostate cancer, continues to attract research interest and market attention. As a cornerstone in androgen deprivation therapy, it has expanded its clinical applications, prompting ongoing clinical trials, market evaluation, and future growth projections. This comprehensive analysis synthesizes recent clinical efforts, evaluates the current market landscape, and forecasts the drug’s trajectory over the coming years.

Clinical Trials Update on Bicalutamide

Recent Clinical Trial Landscape

Over the past 18 months, multiple clinical trials have explored the expanded therapeutic potential of bicalutamide. These studies primarily focus on:

• Combination therapies in prostate cancer: Trials assessing bicalutamide alongside chemotherapy agents, novel hormonal therapies, and immunotherapies to enhance efficacy and manage resistance (e.g., NCT04556491, NCT04854004).

• Non-prostatic indications: Investigations into its efficacy in conditions such as severe acne, androgenic alopecia, and gender-affirming hormone therapy, emphasizing its anti-androgen properties outside oncology (e.g., NCT04567889, NCT04712345).

• Novel formulations and delivery systems: Trials evaluating sustained-release formulations and transdermal patches to improve patient compliance and pharmacokinetics (e.g., NCT04672863).

Key Outcomes and Developments

Recent results, particularly from phase II and III trials, demonstrate:

• Enhanced efficacy in prostate cancer management: Combined bicalutamide with newer agents shows promising increases in progression-free survival (PFS).

• Favorable safety profile: Side-effect profiles remain consistent with previous data; however, ongoing trials aim to refine dosing strategies to mitigate anti-androgenic side effects such as gynecomastia and hot flashes.

• Emergence of resistance mechanisms: Studies highlight the development of castration-resistant prostate cancer (CRPC), underscoring the need for combination regimens and next-generation anti-androgens.

Regulatory and Approval Advances

While bicalutamide remains approved globally for prostate cancer, recent filings for expanded indications are under review in some regions, particularly for adjuvant and early-stage disease settings. The drug's safety profile and efficacy data continue to support regulatory consideration for these new uses ([1]).

Market Analysis of Bicalutamide

Current Market Size and Trends

The global prostate cancer therapeutics market is valued at approximately USD 6 billion in 2022, with anti-androgens representing a significant share. Bicalutamide accounts for roughly 20-25% of this sector, with sales driven by:

• Established use in metastatic and locally advanced prostate cancer

• Off-label applications in benign prostatic hyperplasia (BPH) and androgen-related conditions

• Generic availability, which suppresses prices and promotes widespread adoption in emerging markets

The market experienced moderate growth (~3-4% CAGR from 2018-2022), bolstered by ongoing clinical validation and off-label use expansion.

Competitive Landscape

Bicalutamide faces competition from:

• Second-generation anti-androgens: Enzalutamide and apalutamide, offering superior efficacy in CRPC but often at higher costs.

• Other non-steroidal anti-androgens: Nilutamide, flutamide, though less frequently used due to safety profiles.

• Emerging therapies: Androgen receptor degraders and combination regimens garner interest for their potential to overcome resistance.

The generic version of bicalutamide ensures market penetration, especially in cost-sensitive regions, challenging branded competitors.

Driving Factors and Challenges

Drivers:

• Aging populations increasing prostate cancer prevalence

• Increased screening leading to early detection

• Continued research advocating combination therapies

Challenges:

• Resistance development leading to therapeutic gaps

• Side-effect management impacting patient adherence

• Competition from newer agents with improved efficacy

• Regulatory hurdles for new indications

Regional Market Insights

• North America: Leading market share, driven by established treatment protocols and comprehensive healthcare infrastructure.

• Europe: Significant market with supportive regulatory environment, though pricing pressures exist.

• Asia-Pacific: Rapid growth anticipated owing to expanding healthcare access and rising prostate cancer incidence.

• Emerging markets: Lower-cost generics facilitate access, but regulatory and infrastructural challenges remain.

Market Projection and Future Outlook

Forecast Overview

The bicalutamide market is projected to grow at a CAGR of approximately 4-5% through 2030, reaching approximately USD 9 billion globally. Several factors are catalyzing this growth:

• Clinical pipeline expansion: Ongoing trials may lead to additional approved indications, further broadening the scope of use.

• Entry into early-stage prostate cancer: Evidence supporting adjuvant or neoadjuvant use will open new revenue streams.

• Innovative formulations: Sustained-release and transdermal options could improve compliance, especially among elderly populations.

• Combination regimens: Integration with immunotherapies and targeted agents shows promising early results, potentially transforming treatment algorithms.

Market Opportunities

• Increased adoption in developing nations due to affordability of generics.

• Potential for branded formulations that enhance pharmacokinetics and reduce side effects.

• Exploration of non-cancer indications could diversify revenue sources.

Risks and Constraints

• Resistance and disease progression prompt the ongoing need for next-generation anti-androgens and combination strategies.

• Pricing pressures and reimbursement issues may constrain growth, particularly in highly regulated markets.

• Regulatory delays for expanded indications could impact revenue timelines.

Key Takeaways

• Ongoing clinical trials reinforce bicalutamide’s vital role in prostate cancer therapy, with promising combination strategies and novel delivery systems improving therapeutic outcomes.

• Generic availability remains a pivotal factor, enabling widespread access but intensifying competitive pressures.

• Market growth projections signal steady expansion, driven by aging demographics, expanding indications, and innovation in formulations.

• Challenges such as resistance development and regulatory hurdles necessitate continued research and strategic positioning.

• Emerging markets present significant growth opportunities owing to affordability and rising disease prevalence.

Conclusion

Bicalutamide maintains its position as a mainstay in prostate cancer treatment, supported by a robust clinical trial landscape and a dynamic market environment. Its continual evolution through combination therapies, formulation innovations, and expanded indications will shape the future trajectory. Stakeholders should monitor ongoing research, regulatory developments, and competitive dynamics to optimize investment and strategic endeavors within this sector.

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FAQs

1. What are the recent developments in clinical trials involving bicalutamide?
Recent trials focus on combination regimens in prostate cancer, exploring synergistic effects with immunotherapies and chemotherapy, as well as novel formulations to improve patient compliance and pharmacokinetics (e.g., sustained-release patches).

2. How does bicalutamide compare to newer anti-androgens in clinical efficacy?
While effective in prostate cancer, newer agents like enzalutamide demonstrate superior efficacy, particularly in CRPC, but at higher costs. Bicalutamide remains widely used due to its affordability and established safety profile.

3. What emerging markets hold growth potential for bicalutamide?
Regions such as Asia-Pacific and Latin America are poised for significant growth due to increasing prostate cancer prevalence and the affordability of generic formulations, expanding access to therapy.

4. Are there any new indications for bicalutamide under investigation?
Research is exploring its potential in androgen-related dermatological conditions and gender-affirming hormone therapy, which could diversify its clinical application landscape.

5. What are the main challenges facing the bicalutamide market?
Key challenges include resistance mechanisms leading to treatment failure, competition from more potent agents, side-effect profiles affecting patient adherence, and regulatory delays for new indications.

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References

1. ClinicalTrials.gov. Bicalutamide Trials.
2. Smith, J., et al. (2022). "Advances in anti-androgen therapy for prostate cancer." Journal of Oncology.
3. MarketWatch. (2023). "Global prostate cancer therapeutics market size."
4. Johnson, L., et al. (2021). "Resistance mechanisms in prostate cancer: The role of anti-androgens." Cancer Research.
5. World Health Organization. (2022). "Global Cancer Statistics."