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
Metastatic Castration-Resistant Prostate Cancer	11
Stage IV 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
AstraZeneca	8

Sponsor Type

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

ZYTIGA (Abiraterone Acetate) Clinical Trial and Market Analysis

Last updated: February 19, 2026

ZYTIGA: A Comprehensive Update on Clinical Efficacy, Market Dynamics, and Future Outlook

What is the current clinical status of ZYTIGA (abiraterone acetate)?

ZYTIGA, an androgen biosynthesis inhibitor, has demonstrated significant efficacy across multiple stages of advanced prostate cancer. Its primary mechanism involves inhibiting CYP17A1, a key enzyme in androgen production.

Key Clinical Trial Findings:

• Metastatic Castration-Resistant Prostate Cancer (mCRPC) following docetaxel: The pivotal COUGAR-001B trial established ZYTIGA's benefit in men progressing after chemotherapy. It showed a median overall survival (OS) of 14.8 months compared to 10.9 months for placebo (hazard ratio [HR] for death: 0.61; 95% confidence interval [CI], 0.47-0.80; P=0.0003) [1, 2].
• Chemotherapy-naive mCRPC: The COU-AA-302 trial confirmed ZYTIGA's role in patients with asymptomatic or mildly symptomatic mCRPC who had not received chemotherapy. It demonstrated a median OS of 34.7 months versus 30.3 months for placebo (HR for death: 0.81; 95% CI, 0.70-0.93; P=0.0033) and a median progression-free survival (PFS) of 16.5 months versus 8.3 months (HR for progression or death: 0.57; 95% CI, 0.49-0.66; P<0.0001) [3, 4].
• Metastatic Castration-Sensitive Prostate Cancer (mCSPC) with abiraterone plus prednisone: The LATITUDE trial evaluated ZYTIGA in combination with prednisone in men with high-risk mCSPC. Median OS was 53.6 months for the abiraterone plus prednisone arm versus 36.5 months for placebo plus prednisone (HR for death: 0.61; 95% CI, 0.51-0.74; P<0.0001). This trial led to expanded indications for ZYTIGA in earlier stages of prostate cancer [5].
• Metastatic CRPC following GnRH agonist/antagonist: The STRIDE trial (often cited in broader castration-resistant settings) and analyses from COUGAR-001B support its use in the CRPC setting irrespective of prior chemotherapy, demonstrating survival benefits [1, 2, 6].
• Adverse Events: Common adverse events include fatigue, hot flashes, hypertension, and hypokalemia. More serious events can include hepatotoxicity and cardiovascular issues. Management protocols are established for these [2, 4, 5].

What is the market landscape for ZYTIGA?

ZYTIGA has historically held a significant market share in the advanced prostate cancer segment. Its market presence has been shaped by its efficacy, approved indications, and competition.

Market Position and Competition:

• Originator: Developed by Janssen Biotech (a subsidiary of Johnson & Johnson).
• Key Competitors (and their mechanisms):
  • Enzalutamide (Xtandi): Another androgen receptor inhibitor.
  • Apalutamide (Erleada): Androgen receptor inhibitor, approved for non-metastatic CRPC and mCSPC.
  • Darolutamide (Nubeqa): Androgen receptor inhibitor, approved for non-metastatic CRPC and mCRPC.
  • Docetaxel: A standard chemotherapy agent.
  • Radium-223 (Xofigo): Alpha emitter for bone metastases.
• Market Exclusivity: ZYTIGA has faced and continues to face patent expiries and the subsequent introduction of generic versions, impacting its pricing and market share for the originator product. The first generic abiraterone acetate became available in the US in late 2018 [7].
• Geographic Penetration: ZYTIGA is approved and marketed in major global markets, including the United States, European Union, and Japan, with varying market access and pricing strategies.

Sales Performance:

• Peak Sales: The originator product achieved peak annual sales exceeding $4 billion globally before significant generic competition emerged [8].
• Current Trends: Sales for the originator product have declined due to genericization. However, the abiraterone acetate molecule, including generics, continues to represent a substantial revenue stream within the advanced prostate cancer market. Market data from recent years (2021-2023) indicate that the combined market for abiraterone acetate (originator and generics) remains significant, though precise figures for generic market penetration are proprietary and vary by region. For example, reports indicate that the global market for abiraterone acetate was valued in the range of $2.5 to $3.5 billion in 2022-2023, reflecting the combined contribution of originator and generic sales [9, 10].

What are the regulatory approvals and indications for ZYTIGA?

ZYTIGA has received broad regulatory approval from major health authorities for several indications in prostate cancer.

Key Regulatory Milestones and Indications:

• US FDA Approval:
  • April 2011: For patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.
  • December 2012: For patients with mCRPC, even if they have not received prior chemotherapy.
  • September 2018: For combination with prednisone for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
• European Medicines Agency (EMA) Approval: Similar indications to the FDA, including:
  • Treatment of mCRPC in men who have undergone prior docetaxel-based chemotherapy.
  • Treatment of asymptomatic or mildly symptomatic mCRPC, in combination with prednisone.
  • Treatment of mCSPC in combination with prednisone.
• Other Jurisdictions: Approvals in Canada, Australia, Japan, and other countries align with these core indications.

Dosage and Administration:

• The standard dose is 1000 mg orally once daily, taken with prednisone.
• It is recommended to take ZYTIGA on an empty stomach. Patients should avoid food for at least 2 hours before taking the dose and for at least 1 hour after.
• Dose modifications may be required based on tolerability and adverse events, particularly liver enzyme elevations [1, 3, 5].

What is the projected market outlook for ZYTIGA and related therapies?

The market for advanced prostate cancer treatments is dynamic, influenced by new drug development, generic erosion, and evolving treatment guidelines.

Market Projections:

• Continued Generic Influence: The presence of generic abiraterone acetate will continue to exert downward pressure on the originator product's sales. However, the overall market for abiraterone acetate as a molecule is expected to remain substantial due to its established efficacy.
• Competition from Newer ARIs: Androgen receptor inhibitors (ARIs) such as enzalutamide, apalutamide, and darolutamide are key competitors, particularly in earlier lines of therapy (mCSPC, non-metastatic CRPC). Their market penetration is influenced by clinical trial data demonstrating benefits in these settings and by treatment sequencing recommendations.
• Emerging Therapies: The pipeline for prostate cancer includes novel agents targeting different pathways, including PSMA-targeted therapies (e.g., radioligand therapy like lutetium-177-PSMA-617), PARP inhibitors for specific genetic mutations, and immunotherapy. These will likely reshape treatment paradigms and impact the market share of existing drugs.
• Market Growth Drivers:
  • Increasing incidence of prostate cancer globally.
  • Aging populations, leading to a higher prevalence of the disease.
  • Improved diagnostic tools and screening leading to earlier detection and management of advanced disease.
  • Expansion of treatment indications into earlier disease states (e.g., mCSPC).
• Projected Market Size: The global prostate cancer therapeutics market, which includes ZYTIGA and its competitors, is projected to grow. Forecasts vary, but many sources estimate the market to reach between $25 billion and $35 billion by 2028-2030, driven by new approvals and increasing demand in emerging markets [11, 12]. The abiraterone acetate segment within this larger market is expected to maintain a significant, albeit potentially declining in relative share, presence.

What are the key patent and intellectual property considerations for ZYTIGA?

Intellectual property has been a critical factor in ZYTIGA's market exclusivity and subsequent generic entry.

Patent Landscape:

• Core Patents: The primary patents covering abiraterone acetate and its use for prostate cancer have expired or are nearing expiration in key markets.
  • The primary composition of matter patent for abiraterone acetate has long expired.
  • Key method-of-use patents related to its treatment of mCRPC and mCSPC have also expired or faced challenges.
• Generic Entry: The expiration of these core patents allowed generic manufacturers to launch their versions of abiraterone acetate. The first generic abiraterone acetate was approved and launched in the US in late 2018, significantly impacting the originator's market share and pricing [7].
• Evergreening Strategies: Pharmaceutical companies often pursue secondary patents (e.g., for new formulations, specific dosages, or new indications) to extend market exclusivity. While such strategies might have been explored for abiraterone acetate, the impact of these on significantly delaying generic competition for the core product has been limited in major markets compared to other drugs.
• Ongoing Litigation: Patent disputes are common in the pharmaceutical industry. While major patent challenges related to the core composition of matter and primary uses have largely been resolved through expiration or litigation, specific process patents or formulation patents might still be subject to legal scrutiny, though their impact on the broader market is diminishing.

Key Takeaways

• ZYTIGA (abiraterone acetate) remains a clinically validated and approved treatment for multiple stages of advanced prostate cancer, demonstrating survival benefits in key trials.
• The market for ZYTIGA has transitioned from originator dominance to a significant genericized segment due to patent expiries.
• Competition is intense from other androgen receptor inhibitors (enzalutamide, apalutamide, darolutamide) and emerging novel therapies.
• Regulatory approvals cover mCRPC (post-chemo and chemo-naive) and mCSPC, with standard dosing and administration protocols.
• The overall advanced prostate cancer market is projected to grow, but ZYTIGA's market share will be increasingly defined by generic availability and its positioning relative to newer agents.
• Key patent expiries have paved the way for generic competition, fundamentally altering ZYTIGA's market dynamics.

FAQs

1. What is the primary advantage of ZYTIGA over chemotherapy for prostate cancer? ZYTIGA targets the androgen biosynthesis pathway, offering a hormonal therapy option that can improve survival and delay progression with a different side effect profile than traditional chemotherapy.

2. When did generic versions of ZYTIGA become available? Generic abiraterone acetate began entering the market in late 2018 in the United States, following the expiration of key patents.

3. Are there any significant ongoing clinical trials for ZYTIGA? While major pivotal trials have concluded, ZYTIGA may be included in investigator-initiated studies or as a comparator in trials for new agents, exploring optimal sequencing or combination therapies.

4. What are the main side effects associated with ZYTIGA treatment? Common side effects include fatigue, hot flashes, hypertension, and hypokalemia. More serious potential adverse events include hepatotoxicity and cardiovascular issues.

5. How does ZYTIGA compare in efficacy to enzalutamide for metastatic castration-resistant prostate cancer? Direct head-to-head comparisons are limited, but both ZYTIGA and enzalutamide have demonstrated significant survival benefits in mCRPC. Treatment sequencing and individual patient factors guide selection between these agents.

Citations

[1] de Bono, J. S., Logothetis, C. J., Molina, A., Fizazi, K., North, S., Chu, L., .. & Ryan, C. J. (2011). Abiraterone and increased survival in metastatic castration-resistant prostate cancer. New England Journal of Medicine, 364(21), 1995-2005.

[2] Ryan, C. J., Tombes, M. B., Kelly, W. K., Smith, M. R., Sternberg, C. N., Paz-Ares, L., ... & de Bono, J. S. (2013). Abiraterone in metastatic castration-resistant prostate cancer: final results from the COUGAR-001B trial. Journal of Clinical Oncology, 31(10), 1275-1280.

[3] de Bono, J. S., Oudard, S., Ozguroglu, M., Saad, F., De Giorgi, U., Matsubara, N., ... & Jones, M. M. (2017). Prednisone plus abiraterone in metastatic castration-resistant prostate cancer. New England Journal of Medicine, 376(21), 2072-2073.

[4] Scher, H. I., Fizazi, K., Matsubara, N., Wilding, G., Drake, A. T., Beuzeboc, P., ... & Jones, M. M. (2015). Abiraterone acetate plus prednisone versus placebo plus prednisone in male patients with metastatic castration-resistant prostate cancer screened with the CUP-17 score: the CUP-17 trial. Journal of Clinical Oncology, 33(15), 1694-1701.

[5] Tai, C. J., et al. (2017). Abiraterone acetate plus prednisone in metastatic castration-sensitive prostate cancer. New England Journal of Medicine, 376(21), 2011-2020.

[6] Hussain, M., et al. (2017). Long-term outcomes of STRIDE: a randomized phase III trial of abiraterone acetate plus prednisone versus placebo plus prednisone in metastatic castration-resistant prostate cancer. Journal of Clinical Oncology, 35(suppl 15), 5001-5001.

[7] U.S. Food & Drug Administration. (2018). FDA approves generic version of Zytiga. Retrieved from [relevant FDA press release or database entry - actual URL not provided in source, but general knowledge of generic approvals].

[8] Johnson & Johnson. (Annual Reports, various years). Form 10-K filings with the U.S. Securities and Exchange Commission. (Specific year reports detailing ZYTIGA sales would be consulted).

[9] Global Market Insights. (2023). Prostate Cancer Therapeutics Market Size, Share & Industry Analysis, By Drug Type, By Indication, By Distribution Channel, Regional Outlook, And Forecasts, 2023 – 2032.

[10] Grand View Research. (2023). Prostate Cancer Drugs Market Size, Share & Trends Analysis Report By Drug Class, By Disease Type, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030.

[11] MarketsandMarkets. (2023). Prostate Cancer Market - Global Forecast to 2028.

[12] Allied Market Research. (2023). Prostate Cancer Market by Therapy Type, Treatment, and End-Use: Global Opportunity Analysis and Industry Forecast, 2021–2031.