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 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.
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.

All Clinical Trials for ABIRATERONE ACETATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).
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).
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.
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).
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).

Clinical Trial Conditions for ABIRATERONE ACETATE

Condition Name

Condition Name for ABIRATERONE ACETATE
Intervention	Trials
Prostate Cancer	94
Metastatic Castration-resistant Prostate Cancer	19
Prostatic Neoplasms	19
Stage IV Prostate Cancer	14

Condition MeSH

Condition MeSH for ABIRATERONE ACETATE
Intervention	Trials
Prostatic Neoplasms	226
Adenocarcinoma	26
Carcinoma	19
Hypersensitivity	11

Clinical Trial Locations for ABIRATERONE ACETATE

Trials by Country

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−

Trials by Country for ABIRATERONE ACETATE
Location	Trials
Canada	139
United Kingdom	98
Spain	90
Japan	86
France	77

Trials by US State

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−

Trials by US State for ABIRATERONE ACETATE
Location	Trials
California	80
New York	67
Texas	62
Maryland	52
Michigan	44

Clinical Trial Progress for ABIRATERONE ACETATE

Clinical Trial Phase

Clinical Trial Phase for ABIRATERONE ACETATE
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	35
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for ABIRATERONE ACETATE
Clinical Trial Phase	Trials
Completed	91
Recruiting	64
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)	34
Cougar Biotechnology, Inc.	12

Sponsor Type

Sponsor Type for ABIRATERONE ACETATE
Sponsor	Trials
Industry	218
Other	205
NIH	36

Abiraterone Acetate: Clinical Trials, Market Analysis, and Projections

Introduction to Abiraterone Acetate

Abiraterone acetate is an orally administered androgen biosynthesis inhibitor, primarily used in the treatment of metastatic castration-resistant prostate cancer (mCRPC) and high-risk metastatic castration-sensitive prostate cancer (mCSPC). It is often administered in combination with prednisone or prednisolone.

Current Clinical Trials

Several clinical trials are ongoing or recently completed to evaluate the efficacy and safety of abiraterone acetate in various combinations and patient populations.

AMPLITUDE Study

The AMPLITUDE study, conducted by Johnson & Johnson, is evaluating Akeega, a dual-action tablet combining niraparib (a PARP inhibitor) with abiraterone acetate, given with prednisone. This trial is focused on patients with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated mCSPC. The primary completion date is November 2024, and the trial has enrolled 696 patients across 387 sites globally. The primary endpoint is radiographic progression-free survival (rPFS)[1].

MAGNITUDE Study

The MAGNITUDE study led to the approval of AKEEGA™ (niraparib and abiraterone acetate) by the European Commission, Health Canada, and the U.S. Food and Drug Administration in 2023. This study demonstrated clinically relevant improvements in time to progression and overall survival when compared to standard care for patients with mCRPC and BRCA mutations[3].

Other Ongoing Trials

Other notable trials include the PRESTO study, which is investigating androgen annihilation in high-risk biochemically relapsed prostate cancer, and the First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer study. These trials are exploring various combinations of therapies including abiraterone acetate, prednisone, and other agents like bicalutamide, apalutamide, and leuprolide acetate[4].

Market Analysis

Global Market Overview

The global abiraterone acetate drugs market is highly competitive, driven by a large number of players and innovative product offerings. Key companies in this market include Janssen Global Services, LLC, Dr Reddy's Laboratories, Avalon Pharma Pvt Ltd, Amneal Pharmaceuticals, and others[2].

Market Drivers

The market is expected to grow due to several factors:

• Increasing Incidence of Prostate Cancer: More than 3.1 million men in the United States have been diagnosed with prostate cancer, with about 248,530 new cases detected in 2021[2].
• Advancements in Medical Sector: Rapid advancements in medical technology and the development of advanced solutions are driving the market.
• Changing Lifestyle Patterns: Unhealthy lifestyle choices are contributing to the rise in prostate cancer cases[2].

Market Segmentation

The market is segmented by dosage form, strength, and distribution channel. The film-coated tablet segment is expected to account for a significant revenue share. Distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies[2].

Regional Analysis

• North America: This region is expected to account for a major revenue share due to the high percentage of people suffering from cancer, developed R&D infrastructure, and increasing clinical trial activities[2].
• Asia Pacific: This region is expected to witness faster growth due to increasing government spending on healthcare and various health-related schemas to increase patient awareness and adoption of better treatments[2].

Market Projections

Growth Forecast

The global abiraterone acetate drugs market is forecasted to grow significantly from 2021 to 2028. The market is driven by increasing investment in the healthcare sector, high government spending on healthcare infrastructure, and a rising number of clinical trials[2].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as high development costs, stringent government regulations, and lack of developed infrastructure in developing countries for R&D activities. However, increasing strategic partnerships among major players and investments in healthcare infrastructure are expected to create new opportunities[2].

Safety and Efficacy

Adverse Events

Clinical trials have reported various adverse events associated with abiraterone acetate, including hepatotoxicity, anemia, decreased appetite, and fatigue. The MAGNITUDE study noted Grade 3-4 ALT or AST increases in 1.8% of patients[3][4].

Combination Therapies

Studies have shown that combination therapies involving abiraterone acetate, such as with niraparib or olaparib, can offer clinically relevant improvements and manageable safety profiles. However, these combinations also come with increased risks, such as fractures and deaths when combined with radium Ra 223 dichloride[3][4].

Key Takeaways

• Clinical Trials: Ongoing trials like the AMPLITUDE and MAGNITUDE studies are evaluating the efficacy of abiraterone acetate in combination with other therapies.
• Market Growth: The global market is expected to grow driven by increasing incidence of prostate cancer, advancements in medical technology, and government spending on healthcare.
• Regional Focus: North America and Asia Pacific are key regions for market growth due to their healthcare infrastructure and government initiatives.
• Safety and Efficacy: Abiraterone acetate has shown efficacy but also comes with significant adverse events, highlighting the need for careful patient monitoring.

FAQs

What is the primary use of abiraterone acetate?

Abiraterone acetate is primarily used in the treatment of metastatic castration-resistant prostate cancer (mCRPC) and high-risk metastatic castration-sensitive prostate cancer (mCSPC).

Which companies are key players in the abiraterone acetate market?

Key companies include Janssen Global Services, LLC, Dr Reddy's Laboratories, Avalon Pharma Pvt Ltd, Amneal Pharmaceuticals, and others.

What are the main drivers of the abiraterone acetate market?

The market is driven by the increasing incidence of prostate cancer, advancements in medical technology, and changing lifestyle patterns.

What are the common adverse events associated with abiraterone acetate?

Common adverse events include hepatotoxicity, anemia, decreased appetite, and fatigue.

Are there any recent approvals for abiraterone acetate combinations?

Yes, AKEEGA™ (niraparib and abiraterone acetate) was recently approved by the European Commission, Health Canada, and the U.S. Food and Drug Administration in 2023[3].

Sources

1. Clinical Trials Arena: Prostate cancer: Three drug trials to watch[1].
2. Acumen Research and Consulting: Abiraterone Acetate Drugs - Global Market and Forecast Till 2028[2].
3. Janssen: Final Multivariate Analysis from the Phase 3 MAGNITUDE Study[3].
4. LARVOL VERI: News - abiraterone acetate[4].
5. Valuates Reports: Global Abiraterone Acetate API Market Research Report 2024[5].