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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR ZYTIGA


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
NCT01543776 ↗ Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 2012-01-01 This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.
NCT01543776 ↗ Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer Completed University of Chicago Phase 2 2012-01-01 This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zytiga

Condition Name

Condition Name for Zytiga
Intervention Trials
Prostate Cancer 45
Stage IV Prostate Cancer 11
Prostate Adenocarcinoma 11
Metastatic Castration-resistant Prostate Cancer 11
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Condition MeSH

Condition MeSH for Zytiga
Intervention Trials
Prostatic Neoplasms 105
Adenocarcinoma 21
Carcinoma 12
Hypersensitivity 8
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Clinical Trial Locations for Zytiga

Trials by Country

Trials by Country for Zytiga
Location Trials
United States 506
United Kingdom 84
Canada 58
Spain 41
Australia 28
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Trials by US State

Trials by US State for Zytiga
Location Trials
California 33
Texas 28
Maryland 24
New York 23
Illinois 20
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Clinical Trial Progress for Zytiga

Clinical Trial Phase

Clinical Trial Phase for Zytiga
Clinical Trial Phase Trials
Phase 4 6
Phase 3 19
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Zytiga
Clinical Trial Phase Trials
Recruiting 36
Completed 28
Active, not recruiting 25
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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
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Sponsor Type

Sponsor Type for Zytiga
Sponsor Trials
Other 115
Industry 87
NIH 25
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ZYTIGA (Abiraterone Acetate): Clinical Trials, Market Analysis, and Projections

Introduction to ZYTIGA

ZYTIGA (abiraterone acetate) is a significant medication in the treatment of prostate cancer, particularly for patients with metastatic forms of the disease. Developed by Janssen Pharmaceutical Companies of Johnson & Johnson, ZYTIGA has been approved for various indications since its initial FDA approval in 2011.

Clinical Trials and Efficacy

Initial Approval for Metastatic Castration-Resistant Prostate Cancer (CRPC)

ZYTIGA was first approved for the treatment of men with metastatic CRPC who had received prior chemotherapy containing docetaxel. The Phase 3 clinical trial demonstrated a significant increase in median survival for patients treated with ZYTIGA plus prednisone compared to those receiving placebo plus prednisone. The trial showed a 35% reduction in the risk of death and a 3.9-month difference in median survival[1].

Expansion to Metastatic High-Risk Castration-Sensitive Prostate Cancer (CSPC)

In 2018, ZYTIGA received an additional FDA approval for the treatment of patients with metastatic high-risk CSPC. The LATITUDE clinical trial, a Phase 3 multinational study, found that ZYTIGA in combination with prednisone reduced the risk of death by 38% compared to placebo. This trial included newly diagnosed patients who had not received prior cytotoxic chemotherapy and were defined as high-risk based on specific disease characteristics[3].

Mechanism of Action

ZYTIGA works by inhibiting the CYP17 enzyme complex, which is crucial for androgen production in the testes, adrenal glands, and tumor tissue. By reducing androgen levels, ZYTIGA helps to slow the growth of prostate cancer cells[1].

Market Analysis

Current Market Size and Growth

The global prostate cancer therapeutics market, which includes ZYTIGA, was estimated at USD 12.12 billion in 2022. This market is projected to expand at a compound annual growth rate (CAGR) of 8.4% from 2023 to 2030, reaching USD 21.48 billion by 2030. The growth is driven by factors such as cost-effective treatments, technological advancements, and the rising incidence of prostate cancer[2].

Regional Growth

The Asia Pacific region is expected to demonstrate the fastest growth, with a CAGR of 9.7% over the forecast period. This is attributed to the increasing availability of treatment options and the rising incidence of prostate cancer in this region[2].

Competitive Landscape

ZYTIGA faces competition from other androgen receptor pathway inhibitors (ARPIs) such as Xtandi (enzalutamide) and newer treatments like lutetium vipivotide tetraxetan (Pluvicto) and lutetium zadavotide guraxetan (177Lu-PNT2002). Despite this competition, ZYTIGA remains a significant player in the market, with over 330,000 patients worldwide having received treatment with it since its approval[3][4].

Impact of Generic Entry

Market Share and Sales

After the entry of generic versions of ZYTIGA, the market share of the branded drug fell significantly. A study found that from December 2016 to December 2020, efforts to delay generic entry resulted in an additional $2.05 billion in sales for Janssen. However, once generics became available, ZYTIGA's market share fell to about 14%, and monthly net sales across the entire market dropped by approximately 85%[5].

Future Projections and Challenges

New Competitors and Treatment Options

The prostate cancer therapeutics market is evolving with new treatments emerging. For example, Eli Lilly's lutetium zadavotide guraxetan (177Lu-PNT2002) is being compared to ARPIs like ZYTIGA and Xtandi in clinical trials. Despite some challenges in clinical trials, such as crossover rates affecting overall survival data, these new treatments are expected to further diversify the market[4].

Global Sales Projections

GlobalData forecasts that 177Lu-PNT2002 will reach sales of $1.7 billion by 2030, while Pluvicto is projected to reach $4.3 billion in the same year. These projections indicate a dynamic and competitive market where ZYTIGA will need to maintain its position against newer therapies[4].

Key Takeaways

  • Clinical Efficacy: ZYTIGA has demonstrated significant improvements in survival rates for patients with metastatic CRPC and CSPC.
  • Market Growth: The global prostate cancer therapeutics market is expected to grow at a CAGR of 8.4% from 2023 to 2030.
  • Competitive Landscape: ZYTIGA faces increasing competition from newer treatments but remains a key player in the market.
  • Generic Impact: The entry of generics has significantly reduced ZYTIGA's market share and sales.
  • Future Projections: New treatments are emerging, and the market is expected to be highly competitive, with ZYTIGA needing to adapt to maintain its market position.

FAQs

What is ZYTIGA used for?

ZYTIGA (abiraterone acetate) is used for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) and metastatic high-risk castration-sensitive prostate cancer (CSPC)[1][3].

How does ZYTIGA work?

ZYTIGA works by inhibiting the CYP17 enzyme complex, which is necessary for androgen production in the testes, adrenal glands, and tumor tissue, thereby reducing androgen levels and slowing the growth of prostate cancer cells[1].

What were the key findings of the LATITUDE clinical trial?

The LATITUDE trial found that ZYTIGA in combination with prednisone reduced the risk of death by 38% compared to placebo in patients with metastatic high-risk CSPC[3].

How has the entry of generics affected ZYTIGA's market share?

The entry of generics resulted in ZYTIGA's market share falling to about 14%, with a corresponding drop in monthly net sales across the entire market by approximately 85%[5].

What are the future projections for the prostate cancer therapeutics market?

The market is expected to grow at a CAGR of 8.4% from 2023 to 2030, reaching USD 21.48 billion by 2030, with new treatments emerging and competing with existing therapies like ZYTIGA[2][4].

What new treatments are emerging in the prostate cancer therapeutics market?

New treatments include lutetium vipivotide tetraxetan (Pluvicto) and lutetium zadavotide guraxetan (177Lu-PNT2002), which are being compared to existing ARPIs like ZYTIGA and Xtandi in clinical trials[4].

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