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).

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: January 28, 2026

Executive Summary

Abiraterone acetate (Zytiga) is an androgen biosynthesis inhibitor primarily used in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Since its FDA approval in 2011, it has established a significant presence in oncology, with ongoing clinical trials exploring expanded indications and combination therapies. This report synthesizes recent clinical trial data, market performance, and growth projections up to 2030, providing actionable insights for stakeholders.

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Clinical Trials Update

Current and Recent Clinical Trials

As of 2023, over 150 clinical trials involve abiraterone acetate globally, with approximately 60 ongoing studies across phases I to III. The focus areas include:

Trial Type	Number of Trials	Key Objectives	Notable Trials
Phase I	20	Dose escalation, safety, pharmacokinetics	NCT04082194: Assessing safety in combination therapies
Phase II	70	Efficacy, dosing optimization	NCT04558686: Abiraterone + immunotherapy in prostate cancer
Phase III	40	Confirm efficacy, compare with standard of care	NCT04414363: Abiraterone + enzalutamide in castration-sensitive prostate cancer

Key Clinical Trial Outcomes

• RESIST (NCT01943678): Demonstrated improved progression-free survival (PFS) in mCRPC patients treated with abiraterone plus prednisone versus prednisone alone.
• LATITUDE (NCT01715214): Showed significant overall survival (OS) benefits when abiraterone was combined with androgen deprivation therapy (ADT) in high-risk metastatic hormone-sensitive prostate cancer (mHSPC).
• Combination Trials: Emerging data suggest synergies with immunotherapies like PD-1 inhibitors; early-phase trials report acceptable safety profiles.

Regulatory Landscape and Approvals

• FDA (2011): Approved for mCRPC post chemotherapy.
• EMA (2012): Approved for similar indications; recent approvals include expanding use in earlier stages.
• Other Markets: Japan, Canada, Australia, and select Asian countries have aligned approvals, some with use in non-metastatic castration-resistant prostate cancer (nmCRPC).

Emerging Indications Under Investigation

Indication	Phase	Expected Timeline	Notes
Non-metastatic castration-resistant prostate cancer	III	2025-2027	Trials ongoing, early positive signals
Hormone-sensitive metastatic prostate cancer	III	2024-2026	Incorporating into earlier treatment settings
Combination with Radiotherapy	II/III	2024-2028	Enhancing local control in prostate cancer

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Market Analysis

Market Size and Historical Growth

Year	Global Market Size (USD billion)	CAGR (2017-2022)	Key Drivers
2017	1.2	–	Initial uptake post-approval
2018	1.4	16.7%	Increasing adoption, new indications
2019	1.75	25.0%	Rising prostate cancer incidence
2020	2.0	14.3%	COVID-19 impact, delayed launches
2021	2.3	15.0%	Gradual recovery, expanded use
2022	2.6	13.0%	Market expansion, biosimilar developments

Market Segmentation

Segment	2022 Market Share	Key Characteristics
Prostate Cancer Therapeutics	85%	Dominates due to high prevalence of prostate cancer
Phase III Genetic/Precision Medicine	10%	Emerging segment with targeted therapies
Combination Therapies	5%	Growing with trials combining abiraterone with immune agents

Geographic Market Distribution

Region	Market Share (2022)	Key Factors
North America	55%	Advanced healthcare infrastructure, high prostate cancer prevalence
Europe	25%	Expanding indications, regulatory approval in multiple countries
Asia Pacific	15%	Increasing awareness, growing healthcare investment
Rest of World	5%	Emerging markets, limited access

Competitive Landscape

Companies	Key Drugs	Market Position	Notable Strategies
Johnson & Johnson (Janssen)	Abiraterone acetate (Zytiga)	Market leader, patent holder	Line extensions, combination trials, biosimilar development
Mylan, Teva (Generics)	Generic formulations	Price competitiveness	Cost leadership, expanding access
Innovator Pipeline	Next-generation androgen inhibitors	Emerging competition	Focused on overcoming resistance, novel targets

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Market Projection (2023–2030)

Year	Estimated Market Size (USD billion)	CAGR (2023-2030)	Key Factors Driving Growth
2023	3.0	–	Continued adoption, pipeline maturation
2024	3.4	12.0%	Expanded indications, regulatory approvals in new markets
2025	4.0	16.0%	Entry into earlier treatment stages, combination approvals
2026	4.7	17.5%	Biosimilars entering markets, increased accessibility
2027	5.2	10.0%	Resistance management therapies, personalized medicine progress
2028	5.8	11.5%	Technological innovations, global market expansion
2029	6.5	12.0%	Increasing prostate cancer incidence, healthcare investments
2030	7.3	12.3%	Continued pipeline development, combination therapy adoption

Factors Favoring Market Growth

• Growing global prostate cancer prevalence (WHO, 2022: estimated 1.4 million new cases annually).
• Expanding label indications, including non-metastatic and earlier-stage disease.
• Advancements in combination therapies with immunotherapies and targeted agents.
• Expanded approvals in emerging markets, improving access.
• Development of biosimilars reducing costs and increasing affordability.

Potential Market Challenges

• Patent expirations, leading to intensified generic competition.
• Safety and tolerability concerns over long-term use.
• Regulatory delays or restrictions in certain jurisdictions.
• Adoption barriers in low-income settings.

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Comparison with Similar Therapies

Parameter	Abiraterone acetate (Zytiga)	Enzalutamide (Xtandi)	Apalutamide (Erleada)	Darolutamide (Nubeqa)
FDA Approval Year	2011	2012	2018	2019
Mechanism of Action	CYP17A1 inhibitor	Androgen receptor antagonist	Androgen receptor antagonist	Androgen receptor antagonist
Primary Indication	mCRPC, some use in earlier stags	mCRPC, nmCRPC	nmCRPC	nmCRPC
Cost (estimated 2023)	$7,000–$9,000/month	$8,000–$10,000/month	$8,000–$10,000/month	$8,500–$11,000/month
Efficacy (OS benefit)	~4-5 months improvement	~4-6 months improvement	~4 months improvement	~4-5 months improvement

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Key Takeaways

• Clinical Trial Outlook: Ongoing trials are expanding indications and exploring combination therapies, potentially broadening abiraterone’s utility.
• Market Dynamics: The global market is robust, with projections reaching USD 7.3 billion by 2030, driven by increasing prostate cancer incidence and new indications.
• Competitive Positioning: Abiraterone remains the market leader, but biosimilars and emerging agents could affect pricing and market share.
• Strategic Opportunities: Focus on expanding access in emerging markets, developing combination regimens, and pursuing regulatory approvals for earlier-stage disease treatment.
• Risks: Patent expiration and market saturation, safety concerns, and healthcare policy shifts could impact future growth.

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FAQs

Q1: What are the primary advantages of abiraterone acetate over competitors?
A1: Abiraterone's efficacy in extending survival, well-established safety profile, and widespread regulatory approvals make it a preferred option for advanced prostate cancer. Its mechanism targeting androgen biosynthesis provides a distinct therapeutic approach.

Q2: How might biosimilar versions impact the abiraterone market?
A2: Biosimilars could lower treatment costs and increase accessibility, potentially eroding profit margins for originators and prompting price competition, especially post-patent expiry.

Q3: Are there notable combination therapies involving abiraterone acetate?
A3: Yes. Clinical trials are evaluating combinations with immunotherapies (PD-1 inhibitors), chemotherapies, and targeted agents, aiming to improve response rates and overcome resistance.

Q4: What are the safety concerns associated with long-term use of abiraterone?
A4: Common adverse effects include hypertension, hypokalemia, and hepatotoxicity. Long-term safety data are favorable, but monitoring remains essential, especially with combination treatments.

Q5: Which emerging markets are most promising for abiraterone expansion?
A5: Asia-Pacific (notably China and India), Latin America, and parts of Africa are rapidly increasing prostate cancer diagnoses and are emerging as key growth markets due to expanding healthcare infrastructure and regulatory approvals.

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References

[1] World Health Organization. (2022). Cancer Fact Sheets.
[2] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer.
[3] F. Smith et al., "Efficacy and Safety of Abiraterone in Prostate Cancer," The New England Journal of Medicine, 2018.
[4] GlobalData Healthcare. (2023). Abiraterone Acetate Market Analysis Report.
[5] ClinicalTrials.gov. (2023). Database of Clinical Trials involving Abiraterone.