CLINICAL TRIALS PROFILE FOR DEGARELIX ACETATE

All Clinical Trials for degarelix acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01309672 ↗	S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2011-08-09	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.
NCT01309672 ↗	S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy	Active, not recruiting	Southwest Oncology Group	Phase 2	2011-08-09	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.
NCT01220869 ↗	A Study of Degarelix in Taiwanese Patients With Prostate Cancer	Completed	Ferring Pharmaceuticals	Phase 3	2010-12-01	A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.
NCT01242748 ↗	A Degarelix Trial in Patients With Prostate Cancer	Terminated	Ferring Pharmaceuticals	Phase 3	2010-10-01	A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
NCT00946920 ↗	A Trial of Degarelix in Patients With Prostate Cancer	Completed	Ferring Pharmaceuticals	Phase 3	2009-06-01	A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.
NCT00215683 ↗	An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer	Completed	Ferring Pharmaceuticals	Phase 2/Phase 3	2005-02-01	This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).

Clinical Trial Conditions for degarelix acetate

Condition Name

Condition Name for degarelix acetate
Intervention	Trials
Prostate Cancer	15
Prostate Adenocarcinoma	6
Stage III Prostate Cancer	4
Stage IVA Prostate Cancer AJCC v8	4

Condition MeSH

Condition MeSH for degarelix acetate
Intervention	Trials
Prostatic Neoplasms	31
Adenocarcinoma	11
Hypersensitivity	3
Neoplasm Metastasis	2

Clinical Trial Locations for degarelix acetate

Trials by Country

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Trials by Country for degarelix acetate
Location	Trials
United States	235
Canada	6
Mexico	5
Belgium	4
Hungary	3

Trials by US State

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−

Trials by US State for degarelix acetate
Location	Trials
Texas	10
New York	10
California	10
Washington	9
Colorado	9

Clinical Trial Progress for degarelix acetate

Clinical Trial Phase

Clinical Trial Phase for degarelix acetate
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for degarelix acetate
Clinical Trial Phase	Trials
Recruiting	13
Completed	11
Active, not recruiting	4

Clinical Trial Sponsors for degarelix acetate

Sponsor Name

Sponsor Name for degarelix acetate
Sponsor	Trials
National Cancer Institute (NCI)	10
Ferring Pharmaceuticals	7
Sidney Kimmel Comprehensive Cancer Center	3

Sponsor Type

Sponsor Type for degarelix acetate
Sponsor	Trials
Other	52
Industry	18
NIH	11

Degarelix Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Degarelix acetate is a synthetic peptide antagonist of gonadotropin-releasing hormone (GnRH) that plays a crucial role in the treatment of prostate cancer. By inhibiting the action of GnRH, Degarelix effectively reduces testosterone levels, which can help slow the progression of hormone-sensitive prostate tumors. Here, we will delve into the latest clinical trials, market analysis, and projections for Degarelix acetate.

Clinical Trials Overview

Recent Studies and Outcomes

Several clinical trials have been conducted to evaluate the safety and efficacy of Degarelix acetate in patients with prostate cancer.

• Randomized Clinical Trials: A post hoc analysis of two randomized clinical trials compared Degarelix with other GnRH agonists like leuprolide acetate and degarelix itself. The study found that Degarelix appeared safe and effective at inducing rapid and sustained testosterone suppression. Patients receiving Degarelix showed significant castration rates, with testosterone levels below 50 ng/dL at all scheduled visits[1].

• Terminated Trials: A study listed on ClinicalTrials.gov (NCT00928434) involving Degarelix in patients with prostate cancer was terminated. This trial had a median follow-up of 33.6 months and included 413 patients. Although the trial was terminated, it contributed valuable insights into the long-term effects of Degarelix[4].

Safety and Efficacy

The safety profile of Degarelix has been closely monitored in these trials. Adverse events (AEs) associated with Degarelix were reported in a small percentage of patients, with the most common AEs being related to the mechanism of action, such as hot flashes and injection site reactions. The incidence of grade 3 adverse events was relatively low, indicating a favorable safety profile[1][3].

Market Analysis

Current Market Size and Growth

The global Degarelix market has witnessed substantial growth in recent years, driven by the increasing incidence of prostate cancer and rising awareness of advanced treatments.

• Market Size: The global Degarelix market size was estimated at approximately $500 million in 2022. The market is projected to grow at a compound annual growth rate (CAGR) of around 6% over the next five years, although some forecasts suggest a higher CAGR of 18.50% from 2024 to 2031[5].

• Regional Growth: The market is segmented by region, with significant growth expected in the Americas, APAC, Europe, and the Middle East & Africa. Emerging markets, particularly in APAC, are anticipated to contribute significantly to this growth due to increasing healthcare infrastructure and rising disposable incomes[2][5].

Market Segmentation

The Degarelix market is segmented by several factors:

• Purity: The market is segmented by the purity of the API, including 0.98, 0.99, and other purity levels[2].

• Application: Degarelix is primarily used in medical pharmaceuticals, with a smaller segment in scientific research[2].

• Dosage Forms: Degarelix is available in different dosage forms, including 120 mg and 80 mg per vial[5].

Competitive Landscape

Degarelix competes with other treatments for prostate cancer, including Abiraterone acetate by AstraZeneca and Enzalutamide by Johnson & Johnson. While these treatments have different mechanisms of action, they represent significant competition in terms of efficacy, safety, and patient preference[5].

Market Projections

Future Growth Drivers

The future growth of the Degarelix market is expected to be driven by several factors:

• Increasing Prevalence of Prostate Cancer: The growing incidence of prostate cancer, particularly among the aging population, is a key driver of market growth[5].

• Advances in Medical Technologies: Continuous research and development in hormone therapy and combination therapies are likely to enhance the therapeutic potential of Degarelix, reinforcing its position in cancer management[5].

• Emerging Markets: Increasing healthcare infrastructure and rising disposable incomes in emerging markets are expected to aid access to Degarelix treatments, contributing to market growth[2][5].

Key Takeaways

• Clinical Efficacy: Degarelix acetate has shown significant efficacy in clinical trials, particularly in inducing rapid and sustained testosterone suppression.
• Safety Profile: The safety profile of Degarelix is favorable, with a low incidence of grade 3 adverse events.
• Market Growth: The global Degarelix market is projected to grow at a CAGR of around 6% to 18.50% over the next several years.
• Regional Expansion: Emerging markets are expected to contribute significantly to the growth of the Degarelix market.
• Competitive Landscape: Degarelix competes with other prostate cancer treatments, but its unique mechanism of action and favorable safety profile position it well in the market.

FAQs

What is Degarelix acetate used for?

Degarelix acetate is primarily used in the treatment of prostate cancer to reduce testosterone levels by inhibiting the action of gonadotropin-releasing hormone (GnRH).

How does Degarelix acetate work?

Degarelix acetate works by antagonizing GnRH receptors, which leads to a rapid reduction in testosterone levels, helping to slow the progression of hormone-sensitive prostate tumors.

What are the common adverse events associated with Degarelix acetate?

Common adverse events include hot flashes and injection site reactions, with a relatively low incidence of grade 3 adverse events.

What is the current market size of Degarelix acetate?

The global Degarelix market size was estimated at approximately $500 million in 2022.

What is the projected growth rate of the Degarelix market?

The market is projected to grow at a CAGR of around 6% to 18.50% from 2024 to 2031.

Sources

1. JAMA Oncology: Relugolix Plus Radiotherapy in Localized or Advanced Prostate Cancer.
2. Precision Reports: Global Degarelix Acetate API Market Growth 2022-2028.
3. Synapse: Degarelix Acetate - Drug Targets, Indications, Patents.
4. ClinicalTrials.gov: A Study of Degarelix in Patients With Prostate Cancer.
5. OpenPR: Degarelix Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2031).