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.
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.
NCT00002651 ↗	SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer	Completed	Cancer and Leukemia Group B	Phase 3	1995-05-01	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with 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
Stage IV Prostate Cancer	9

Condition MeSH

Condition MeSH for BICALUTAMIDE
Intervention	Trials
Prostatic Neoplasms	148
Adenocarcinoma	22
Breast Neoplasms	13
COVID-19	6

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

Bicalutamide: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is bicalutamide’s clinical development status?

Bicalutamide is an established androgen receptor (AR) antagonist used primarily in prostate cancer. Development is no longer in early-phase global pivot territory; activity concentrates in new combinations, expanded indications, and lifecycle management in specific geographies and formulations.

Where is bicalutamide used clinically

Setting	Use pattern	Regulatory reality
Metastatic prostate cancer (hormone-sensitive)	Often used with LHRH therapy in advanced disease pathways	Historical standard in many label frameworks; practices vary by region and current guidelines
Locally advanced prostate cancer	Typically combined with androgen deprivation therapy (ADT) in older regimens	Used in specific guideline and label contexts
Biomarker-driven and combination studies	Studies evaluate AR-axis intensification alongside modern ADT backbones	Newer trials increasingly benchmark against next-gen AR pathway inhibitors

What does the “clinical trials update” look like in 2024-2026?

Across major registries, bicalutamide remains present in trials mainly as:

• Comparator or background androgen blockade in combination regimens
• Control arm in prostate cancer studies assessing newer AR pathway therapies or novel ADT intensification
• Regional protocol-specific use rather than a standalone new-drug development program

Because bicalutamide is off-patent in most markets, trial activity tends to be lower-intensity, sponsor-light, and geography-specific compared with on-patent AR competitors.

How does bicalutamide perform versus newer prostate cancer AR therapies?

Bicalutamide competes indirectly in treatment pathways that now include agents such as abiraterone, enzalutamide, apalutamide, darolutamide, and next-line ADT intensification. The practical market impact is that bicalutamide is increasingly positioned as a cost and access lever.

Relative positioning in prostate cancer treatment pathways

Attribute	Bicalutamide role	Compared with newer AR agents
AR blockade strength and sequencing	Standard AR antagonist option in older sequences	Newer AR agents dominate many intensification lines
Cost and access	Lower-cost option where formularies restrict spend	Higher-cost agents drive premium utilization in eligible settings
Trial prevalence	More likely in comparator/background arms	More likely as investigational actives
Geographic uptake	Strong historical penetration in multiple countries	Uptake depends on reimbursement and guideline alignment

What is the current market size and demand profile?

Bicalutamide’s market is shaped less by global “new starts” and more by:

• The size of the treated prostate cancer population
• ADT duration trends
• Formularies and reimbursement pressure on AR-axis drug spend
• Competitive substitution by next-generation AR inhibitors

Market drivers

• Prostate cancer incidence base: Large prevalent population supports ongoing ADT/AR blocker use in multiple settings.
• Health system cost constraints: Bicalutamide often wins procurement tenders in price-sensitive environments.
• Guideline drift: Newer AR agents shift usage in advanced disease; bicalutamide persists where guidelines or reimbursement still allow it.

Market headwinds

• Substitution: Treatment intensification with modern AR agents reduces incremental share in advanced lines.
• Lifecycle saturation: No major waves of new-drug use; growth depends on patient volume and access.

How should you project bicalutamide market growth through 2030?

A realistic projection assumes low-to-moderate volume continuity with pricing pressure as formularies increasingly prefer next-gen AR inhibitors in high-income markets, while bicalutamide retains value in cost-controlled markets.

Projection framework (base case)

• Volume: flat to slightly down in regions with rapid uptake of enzalutamide/abiraterone/apalutamide/darolutamide in intensification lines.
• Price: downward trend due to generic competition and tendering.
• Net revenue: low single-digit CAGR, with regional variance.

Market forecast (directional, high-level)

Period	Expected dynamics	Net effect on market value
2024-2026	Generic dominance stabilizes volumes; price declines continue	Slight decline to low growth depending on country mix
2027-2030	Continued substitution in advanced settings; persistent uptake in cost-sensitive systems	Low single-digit growth or flat-to-down value

Actionable implication: bicalutamide’s revenue future is defensive rather than expansionary. The winners in this profile are manufacturers with procurement scale, strong regulatory filings, and stable tender access, not those relying on differentiation.

What is the IP and regulatory landscape that shapes supply economics?

Bicalutamide is a well-established molecule; most major markets are supplied by generic manufacturers. The business impact is that market share shifts on:

• Cost and supply reliability
• Local registration breadth
• Tender compliance and bioequivalence packages
• Pack architecture and dosing formats

Competitive landscape by drug class

Class	Example therapies	Competition impact on bicalutamide
Next-gen AR inhibitors	enzalutamide, abiraterone, apalutamide, darolutamide	Drives substitution in advanced disease intensification
ADT backbones	LHRH agonists/antagonists	Makes AR blockade optional or sequence-dependent
Generic AR antagonists	bicalutamide (primary) and other older options	Keep floor pricing in many formularies

What should investors and R&D leaders watch next?

Clinical signals

• Prostate cancer trials continue to use bicalutamide in combination baselines. Watch protocols where bicalutamide is either a comparator or background androgen blockade, because those reflect where systems still tolerate older AR antagonism.
• Evidence trends will keep testing whether older AR antagonists remain acceptable in specific disease stratifications.

Market and pricing signals

• Tender cycles and procurement changes in major public payer systems.
• Generic competition and supply interruptions that change effective pricing.

Manufacturing and portfolio tactics

• Contract manufacturing scale, QC capacity, and regulatory coverage across major jurisdictions.
• Product differentiation through packaging and dosing convenience rather than molecule innovation.

Key Takeaways

• Clinical development is mature: bicalutamide’s trial presence is dominated by comparator/background roles rather than major new-drug programs.
• Market growth is defensive: volumes can persist with prostate cancer prevalence, but pricing is structurally pressured by generics and substitution by next-gen AR agents.
• By 2030, base-case expectations are flat to low single-digit revenue growth driven by geography mix and procurement access, not breakthrough demand expansion.
• Commercial winners are manufacturers with reliable low-cost supply and broad regulatory access; R&D value is more likely in formulation, positioning, and trial design support than in differentiation of the active.

FAQs

1) Why do clinical trials still include bicalutamide?
It is commonly used as a comparator or background androgen blockade in prostate cancer protocols evaluating ADT intensification and newer AR-axis therapies.

2) Is bicalutamide still used in advanced prostate cancer?
Yes in many settings depending on label history, clinical pathway, and payer acceptance, though newer AR inhibitors increasingly dominate intensification choices in regions with broad reimbursement.

3) What limits market growth for bicalutamide?
Generic-driven pricing pressure and clinical substitution toward higher-potency AR pathway inhibitors in advanced disease lines.

4) What factors most influence near-term revenue?
Tender pricing, reimbursement coverage, dosing format competitiveness, and regional mix across public and private payers.

5) Where can bicalutamide retain share?
Cost-sensitive formularies, systems with slower adoption of next-gen AR inhibitors, and regions where existing guideline pathways still tolerate older AR antagonism.

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References

[1] ClinicalTrials.gov. Bicalutamide results and study listings. National Library of Medicine. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. Clinical Pharmacology Review(s) and labeling resources for bicalutamide-related submissions (where applicable). https://www.accessdata.fda.gov/
[3] European Medicines Agency. Public assessment reports and EPAR resources for bicalutamide-containing products (where applicable). https://www.ema.europa.eu/