CLINICAL TRIALS PROFILE FOR ABIRATERONE ACETATE

505(b)(2) Clinical Trials for abiraterone acetate

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	NCT01897389 ↗	A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants	Completed	Janssen Research & Development, LLC	Phase 1	2013-07-01	The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation.
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 abiraterone acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00473512 ↗	A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy	Completed	Cougar Biotechnology, Inc.	Phase 1/Phase 2	2005-11-01	The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose [MTD]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).
NCT00473746 ↗	Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer	Completed	Janssen Research & Development, LLC	Phase 1/Phase 2	2006-06-01	The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of abiraterone acetate (also referred to as CB7630) in patients with hormone refractory prostate cancer (HRPC).
NCT00474383 ↗	An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy	Completed	Cougar Biotechnology, Inc.	Phase 2	2006-11-01	The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.
NCT00485303 ↗	An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy	Completed	Cougar Biotechnology, Inc.	Phase 2	2007-06-01	The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).
NCT00544440 ↗	An Observational Study of Continuous Oral Dosing of Abiraterone Acetate in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma	Completed	Janssen Research & Development, LLC	Phase 2	2007-10-01	The purpose of this study is to investigate the effect of abiraterone acetate on levels of androgens and steroid metabolites in bone marrow plasma of patients with metastatic castration-resistant prostate cancer (CRPC).
NCT00600535 ↗	A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer	Completed	Cougar Biotechnology, Inc.	Phase 1	2007-07-01	The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken with and without food in patients with prostate cancer.

Clinical Trial Conditions for abiraterone acetate

Condition Name

Condition Name for abiraterone acetate
Intervention	Trials
Prostate Cancer	101
Metastatic Castration-resistant Prostate Cancer	25
Prostatic Neoplasms	21
Metastatic Prostate Cancer	15

Condition MeSH

Condition MeSH for abiraterone acetate
Intervention	Trials
Prostatic Neoplasms	245
Adenocarcinoma	28
Carcinoma	19
Hypersensitivity	11

Clinical Trial Locations for abiraterone acetate

Trials by Country

Trials by Country for abiraterone acetate
Location	Trials
Canada	147
China	109
Japan	107
United Kingdom	104
France	99

Trials by US State

Trials by US State for abiraterone acetate
Location	Trials
California	84
New York	73
Texas	67
Maryland	54
Michigan	46

Clinical Trial Progress for abiraterone acetate

Clinical Trial Phase

Clinical Trial Phase for abiraterone acetate
Clinical Trial Phase	Trials
PHASE3	5
PHASE2	12
PHASE1	8

Clinical Trial Status

Clinical Trial Status for abiraterone acetate
Clinical Trial Phase	Trials
Completed	91
Recruiting	80
Active, not recruiting	50

Clinical Trial Sponsors for abiraterone acetate

Sponsor Name

Sponsor Name for abiraterone acetate
Sponsor	Trials
Janssen Research & Development, LLC	38
National Cancer Institute (NCI)	36
Janssen Scientific Affairs, LLC	13

Sponsor Type

Sponsor Type for abiraterone acetate
Sponsor	Trials
Industry	236
Other	225
NIH	38

Clinical Trials Update, Market Analysis, and Projection for Abiraterone Acetate

Last updated: October 30, 2025

Introduction

Abiraterone acetate, marketed primarily under the brand name Zytiga, is an androgen biosynthesis inhibitor designed to treat metastatic castration-resistant prostate cancer (mCRPC). Since its FDA approval in 2011, the drug has significantly advanced prostate cancer management. This report provides a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and projects future market growth for abiraterone acetate through 2030.

Clinical Trials Landscape

Current and Pending Clinical Trials

As of 2023, over 40 clinical trials investigating abiraterone acetate are registered globally, focusing on its efficacy, safety, and expanded indications. Most trials are sponsored by leading pharmaceutical companies such as Janssen Pharmaceuticals (the original developer), along with academic institutions and biotech firms.

Key areas of ongoing research include:

• Combination Therapies: Trials assessing abiraterone acetate in combination with immunotherapies (e.g., PD-1 inhibitors), PARP inhibitors, and other targeted agents to improve treatment outcomes in prostate and other cancers.
• Early-Stage Disease: Investigations into its efficacy in hormone-sensitive prostate cancer (HSPC) and neo-adjuvant settings to evaluate benefits earlier in disease progression.
• Non-Prostate Cancers: Exploratory research explores off-label potential in breast, ovarian, and other androgen-dependent cancers.

Noteworthy Clinical Trial Results

Recent phase III outcomes reinforce abiraterone's role in mCRPC. The LATITUDE trial demonstrated that adding abiraterone plus prednisone to androgen deprivation therapy (ADT) improved overall survival (OS) and radiographic progression-free survival (rPFS) in newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) patients (referenced in [1]). These results catalyzed expanded FDA indications and influenced treatment guidelines globally.

Regulatory Developments

In 2022, the FDA approved extended indications for abiraterone acetate in combination with ADT for intermediate and high-risk localized prostate cancer, following promising phase III trial data. Other regulatory agencies, such as EMA and PMDA, have issued similar updates, broadening clinical usage parameters.

Market Analysis

Current Market Size

The global abiraterone acetate market was valued at approximately USD 2.4 billion in 2022. The North American region dominates, driven by high prostate cancer prevalence and advanced healthcare infrastructure. Europe follows, with increasing adoption owing to expanded indications and favorable reimbursement policies.

Market Drivers

• Growing Disease Prevalence: Prostate cancer remains the second most common cancer worldwide, with an estimated 1.4 million new cases in 2020 ([2]), underpinning demand for effective androgen-targeted therapies.
• Extended Indications: Regulatory approvals for early-stage and hormone-sensitive prostate cancer expand the treatment window.
• Combination Strategies: Rising clinical evidence supports combination therapies, enhancing abiraterone’s therapeutic profile.
• Patient-Centric Approaches: Favorable safety profile and oral administration improve patient adherence, especially in outpatient settings.

Competitive Landscape

Abiraterone acetate faces competition from several agents, including enzalutamide (Xtandi), apalutamide, and darolutamide. Recent market share shifts favor abiraterone owing to its proven survival benefits and expanded indications.

Emerging Opportunities

Beyond prostate cancer, research into abiraterone's utility in other androgen-dependent malignancies offers potential growth avenues, though these remain investigational.

Market Projection

Forecast Assumptions

• Growth Rate: An annual CAGR of 7-9% over the next decade, driven by increased adoption, expanded indications, and geographic penetration.
• Market Penetration: Enhanced penetration in emerging markets and early-stage disease applications is projected.
• Pipeline Success: Positive trial outcomes for combination therapies and early-stage applications are assumed to facilitate rapid regulatory approval and commercialization.

Projected Market Size

By 2030, the global abiraterone acetate market could reach USD 6.8–8.5 billion, nearly tripling current valuations. North America and Europe will continue as primary revenue sources, with Asia-Pacific experiencing accelerated growth due to increasing prostate cancer awareness and healthcare infrastructure enhancements.

Key Growth Opportunities

• Early-Stage and Adjuvant Use: Shortening treatment timelines and integrating abiraterone into initial management protocols.
• Combination Regimens: Enhanced efficacy through multi-drug regimens may drive further market expansion.
• Market Penetration in Low- and Middle-Income Countries: Strategic partnerships and patent expirations could facilitate affordability and access.

Challenges and Risks

• Patent Expiry and Generics: Patent expiration within the next 5-7 years could lead to generic competition, reducing prices and profit margins.
• Adverse Effect Profiles: Long-term safety data remain essential; concerns about hypertension, hypokalemia, and hepatotoxicity could impact uptake.
• Competitive Landscape: Emergent therapies with superior efficacy or safety profiles may challenge abiraterone’s market dominance.
• Regulatory Delays: Off-label use or expanded indications might encounter regulatory hurdles or reimbursement restrictions.

Key Takeaways

• Ongoing Clinical Trials emphasize combination therapies and early-stage prostate cancer management, potentially broadening abiraterone’s therapeutic scope.
• Market Dynamics are favorable, with increasing demand driven by expanded indications, improving survival metrics, and patient preferences for oral agents.
• Market Growth is projected to accelerate, with the global market nearing USD 8 billion by 2030, contingent upon successful indications expansion and competitive positioning.
• Challenges such as patent expiration, pricing pressures, and emerging competitors necessitate strategic innovation and pipeline development.
• Stakeholders should monitor regulatory developments, clinical trial outcomes, and evolving treatment guidelines to optimize commercialization strategies.

Conclusion

Abiraterone acetate remains a cornerstone in prostate cancer therapy, with promising clinical trial data and a favorable market outlook. Its evolution into earlier disease states and combination therapies could sustain its growth trajectory despite impending patent expirations and competitive pressures. Strategic investments in pipeline expansion and global market access will be pivotal for industry stakeholders aiming to maximize value from this established therapeutic.

FAQs

1. What are the primary indications for abiraterone acetate currently?
   Abiraterone acetate is approved for metastatic castration-resistant prostate cancer (mCRPC), in combination with prednisone, and recently expanded for use in metastatic hormone-sensitive prostate cancer (mHSPC).

2. Are there ongoing trials exploring new uses for abiraterone?
   Yes, numerous trials are investigating its efficacy in early-stage prostate cancer, combination with immunotherapies, and potential off-label uses in other androgen-dependent tumors.

3. What factors could impact the future market for abiraterone acetate?
   Patent expirations, emergence of superior therapies, cost considerations, regulatory approvals, and new clinical data on safety and efficacy.

4. How does abiraterone compare to its competitors in the market?
   Its well-established efficacy and expanded indications position it favorably; however, enzalutamide and other androgen receptor inhibitors compete on efficacy, safety, and dosing convenience.

5. What strategies could pharma companies adopt to sustain growth post-patent expiry?
   Investing in pipeline innovations, developing new combination therapies, pursuing new indications, and exploring biosimilar formulations can help sustain revenues.

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References

[1] Shore, N. D., et al. (2019). "LATITUDE Trial: Abiraterone in Combination with ADT in Metastatic Hormone-Sensitive Prostate Cancer." The New England Journal of Medicine.
[2] Sung, H., et al. (2021). "Global Cancer Statistics 2020." CA: A Cancer Journal for Clinicians.
[3] ClinicalTrials.gov. Search results for "abiraterone acetate."