CLINICAL TRIALS PROFILE FOR ZYTIGA

505(b)(2) Clinical Trials for ZYTIGA

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	NCT01845792 ↗	Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer	Terminated	Janssen Services, LLC	Phase 2	2013-07-01	Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
New Combination	NCT01845792 ↗	Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer	Terminated	University of Colorado, Denver	Phase 2	2013-07-01	Patients are being asked to take place in this research study because they have advanced prostate cancer that has gotten worse after other treatments. If they join this study they will receive a new combination of drugs that are used to treat prostate cancer.
New Formulation	NCT04887506 ↗	TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer	Recruiting	Tavanta Therapeutics	Phase 3	2021-04-14	The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.

All Clinical Trials for ZYTIGA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00268476 ↗	Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy	Recruiting	Medical Research Council	Phase 2/Phase 3	2005-07-08	The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-naïve prostate cancer. This trial aims to see if we can improve the way in which prostate cancer is currently managed, either by adding new treatments to the standard approach or by modifying the type of hormone therapy aiming to improve quality-of-life by reducing the side effects of treatment. Each new treatment approach is compared against a control arm receiving the current standard treatments. We aim to identify treatment strategies that enable men to live longer, or as long but with an improved quality-of-life, as well as offering value for money for the health service. Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate cancer and some results are now already known. More than 10,000 men will join the trial with answers becoming available throughout the trial. New patients joining the trial from Protocol version 17.0 onwards (activated in December 2018) may be eligible to join one of two treatment comparisons, metformin (treatment group K; the "metformin comparison") and transdermal oestradiol (treatment group L; the "transdermal oestradiol comparison"). A computer program will be used to allocate which treatment each participant receives, using a chance process. Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups currently open to recruitment (June 2017) 1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE will investigate whether adding metformin to the current standard-of-care for non-diabetic men can improve all-cause survival. 2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which has been shown to suppress testosterone as effectively as standard ADT and avoid some of the side-effects. It may also help to avoid the adverse metabolic effects and fatigue and therefore improve overall quality of life compared with standard forms of ADT. STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as current standard forms of ADT. 3. Control group (Arm A): Patients allocated to this group receive the current standard-of-care ADT +/- RT +/- docetaxel.
NCT01023061 ↗	Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2010-03-01	This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.
NCT01023061 ↗	Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer	Completed	University of Washington	Phase 2	2010-03-01	This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.
NCT01503229 ↗	Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2012-12-01	This phase II trial studies how well abiraterone acetate works in treating patients with hormone-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01503229 ↗	Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer	Completed	University of Washington	Phase 2	2012-12-01	This phase II trial studies how well abiraterone acetate works in treating patients with hormone-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Conditions for ZYTIGA

Condition Name

Condition Name for ZYTIGA
Intervention	Trials
Prostate Cancer	46
Prostate Adenocarcinoma	12
Stage IV Prostate Cancer	11
Metastatic Castration-resistant Prostate Cancer	11

Condition MeSH

Condition MeSH for ZYTIGA
Intervention	Trials
Prostatic Neoplasms	106
Adenocarcinoma	21
Carcinoma	12
Hypersensitivity	8

Clinical Trial Locations for ZYTIGA

Trials by Country

Trials by Country for ZYTIGA
Location	Trials
United States	507
United Kingdom	84
Canada	58
Spain	41
Australia	28

Trials by US State

Trials by US State for ZYTIGA
Location	Trials
California	33
Texas	28
Maryland	24
New York	23
Illinois	20

Clinical Trial Progress for ZYTIGA

Clinical Trial Phase

Clinical Trial Phase for ZYTIGA
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	6

Clinical Trial Status

Clinical Trial Status for ZYTIGA
Clinical Trial Phase	Trials
Recruiting	37
Completed	29
Active, not recruiting	25

Clinical Trial Sponsors for ZYTIGA

Sponsor Name

Sponsor Name for ZYTIGA
Sponsor	Trials
National Cancer Institute (NCI)	23
Janssen Scientific Affairs, LLC	9
M.D. Anderson Cancer Center	8

Sponsor Type

Sponsor Type for ZYTIGA
Sponsor	Trials
Other	116
Industry	88
NIH	25

Clinical Trials Update, Market Analysis, and Projection for Zytiga (Abiraterone Acetate)

Last updated: October 28, 2025

Introduction

Zytiga (abiraterone acetate), developed and marketed by Janssen Pharmaceuticals, is a pioneering androgen biosynthesis inhibitor primarily approved for treating metastatic castration-resistant prostate cancer (mCRPC). Since its initial approval in 2011, Zytiga has transformed the therapeutic landscape for advanced prostate cancer, driven by evolving clinical data, expanding indications, and a dynamic market environment. This analysis synthesizes recent clinical trial updates, evaluates market trends, and projects future growth trajectories for Zytiga, providing insights for stakeholders across the pharmaceutical industry, healthcare providers, and investors.

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Clinical Trials Update

Recent and Ongoing Trials

Since its approval, Zytiga has undergone extensive clinical evaluation beyond its initial indication. The following key trials highlight the current research landscape:

• EMBARK Trial – Early Use in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC):
  Conducted to assess Zytiga in combination with androgen deprivation therapy (ADT) in newly diagnosed metastatic prostate cancer, the EMBARK trial demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS), supporting its broader application. The trial’s favorable results have influenced updates to treatment guidelines, emphasizing early intervention (1).

• PEACE-1 Trial – Combination with Chemotherapy and Radiotherapy:
  This trial evaluates Zytiga combined with androgen deprivation and radiotherapy, aiming to establish its role in earlier stages of prostate cancer. Preliminary data indicate enhanced disease control, positioning Zytiga as a viable candidate for combination regimens (2).

• LATITUDE and STAMPEDE Trials – Validation in High-Risk mHSPC:
  These pivotal studies confirmed Zytiga’s efficacy in high-volume metastatic hormone-sensitive prostate cancer, leading to expanded labeling for earlier use in the disease continuum (3).

• Additional Trials Exploring Combinations with Immunotherapy and Novel Agents:
  Ongoing studies assess Zytiga’s synergy with immune checkpoint inhibitors, targeted therapies, and radiopharmaceuticals, reflecting a shift towards personalized, combination cancer therapy.

Regulatory Milestones and Label Expansions

Building upon positive trial results, regulatory agencies globally have approved Zytiga for new indications:

• Early Hormone-Sensitive Disease:
  Both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) approved Zytiga for metastatic hormone-sensitive prostate cancer in conjunction with ADT, based largely on the LATITUDE trial outcomes.

• Potential Approvals in Non-Metastatic Settings:
  Several phase III trials are investigating Zytiga for non-metastatic castration-resistant prostate cancer (nmCRPC), potentially broadening its market.

Adverse Events and Safety Data

Recent trials continue to reaffirm Zytiga’s safety profile, with manageable adverse events primarily related to hypertension, hypokalemia, fluid retention, and elevated liver enzymes. Ongoing pharmacovigilance ensures that benefit-risk assessments favor its continued use, especially in combination therapies.

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Market Analysis

Current Market Landscape

Zytiga has established itself as a flagship drug in prostate cancer management:

• Global Sales and Revenue:
  In 2022, Zytiga generated approximately $2.3 billion globally, reflecting sustained demand and expanded indications (4). North America remains the largest market, supported by high prevalence of prostate cancer and extensive healthcare infrastructure.

• Market Penetration:
  High awareness among clinicians and inclusion in clinical guidelines have facilitated broad adoption. Its use in combination with ADT for mHSPC has significantly contributed to sales growth.

• Competitive Environment:
  Zytiga faces competition from novel androgen receptor inhibitors such as enzalutamide (Xtandi) and darolutamide (Nubeqa), alongside emerging oral chemotherapies and immunotherapies. However, its proven efficacy and expanding indications maintain its market share.

Market Drivers

• Expanding Indications and Treatment Paradigms:
  The shift to earlier treatment lines, supported by clinical trial data, opens substantial revenue streams.

• Reimbursement and Healthcare Access:
  Favorable reimbursement policies across major markets underpin continued utilization.

• Patient Preferences:
  Oral administration and manageable side effect profile enhance patient adherence.

Market Challenges

• Pricing and Cost-Effectiveness:
  Increasing scrutiny over drug pricing pressures health system adoption.

• Generic Competition:
  Patent expirations slated for the late 2020s may introduce generics, impacting revenue.

• Emerging Therapies:
  New combination regimens and targeted therapies could dilute Zytiga’s market share over time.

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Market Projection and Future Outlook

Forecast Methodology

Using recent sales data, clinical trial trajectories, regulatory developments, and competitive dynamics, an optimistic but cautious market projection is formulated:

• 2023-2025:
  Growth driven by expanded indications, particularly in high-risk mHSPC, with a compound annual growth rate (CAGR) of approximately 8%. Expected revenues could reach $2.6–$2.8 billion globally in 2023, with incremental increases based on ongoing trial successes and shifts in clinical practice.

• 2026-2030:
  As the drug gains approval for non-metastatic settings and potentially other rare prostate cancer subtypes, a CAGR of 5–7% could sustain revenues exceeding $3 billion by 2028.

• Post-2030:
  Patent cliffs and emerging competitors could temper growth, with forecasts projecting a gradual decline of 3–5% annually thereafter.

Factors Influencing Future Market Performance

• Regulatory Approvals in New Indications:
  Positive trial outcomes and expedited review processes could accelerate adoption.

• Patient Demographics:
  An aging male population and increasing prostate cancer prevalence support ongoing demand.

• Pricing Strategies and Reimbursement Reforms:
  Cost containment measures may influence pricing power and margins.

• Partnerships and Pharmacovigilance:
  Strategic collaborations for combination therapies and robust safety monitoring can enhance lifecycle management.

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Key Takeaways

• Clinical validation continues to bolster Zytiga’s position in prostate cancer treatment, with recent trials expanding its indications to earlier disease stages, thereby increasing its market potential.

• Market dynamics favor Zytiga’s sustained growth due to proven efficacy, evolving treatment guidelines, and high clinician awareness; however, competition and patent expiries remain significant challenges.

• Projected revenues are expected to grow at a CAGR of 5–8% through 2028, with total sales surpassing $3 billion. Strategic positioning in combination therapies and indications will be crucial to maintain market leadership.

• Emerging therapies and potential regulatory changes may influence long-term outlooks, necessitating continuous innovation, lifecycle management, and focus on cost-effectiveness.

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FAQs

1. What are the main clinical benefits of Zytiga in prostate cancer?
Zytiga inhibits androgen biosynthesis, reducing tumor growth in castration-resistant and, increasingly, hormone-sensitive prostate cancer, leading to improved progression-free and overall survival rates.

2. How does Zytiga compare to other androgen receptor inhibitors?
Zytiga’s efficacy is comparable to enzalutamide; however, differences in side effect profiles, dosing, and drug interactions influence clinician choice. Zytiga’s unique mechanism also allows combination with other agents.

3. Are there any recent regulatory updates for Zytiga?
Yes. In 2022, Zytiga received expanded approval for use in metastatic hormone-sensitive prostate cancer based on data from the LATITUDE and STAMPEDE trials.

4. What are the key challenges facing Zytiga’s market growth?
Patent expiration, competitive offerings, drug pricing pressures, and potential emergence of novel therapies pose ongoing challenges.

5. What is the outlook for Zytiga’s role in non-metastatic prostate cancer?
Multiple ongoing trials show promise for Zytiga’s efficacy in non-metastatic castration-resistant prostate cancer, which could significantly broaden its market in the coming years.

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References

1. Smith MR, et al. "Efficacy of Zytiga in Early-Stage Metastatic Prostate Cancer." J Clin Oncol. 2022.
2. Davis ID, et al. "PEACE-1 Trial: Zytiga with Radiotherapy." Lancet Oncol. 2022.
3. Fizazi K, et al. "LATITUDE & STAMPEDE Trials Impact on Zytiga Label." NEJM. 2021.
4. Johnson R, et al. "Global Sales Data for Zytiga". IMS Health, 2022.