CLINICAL TRIALS PROFILE FOR FIRMAGON

All Clinical Trials for Firmagon

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00451958 ↗	A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy	Completed	Ferring Pharmaceuticals	Phase 3	2007-03-01	Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
NCT00801242 ↗	Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer	Completed	Ferring Pharmaceuticals	Phase 3	2008-12-01	The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.
NCT00833248 ↗	Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer	Completed	Ferring Pharmaceuticals	Phase 3	2009-04-01	The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
NCT00884273 ↗	Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients	Completed	Ferring Pharmaceuticals	Phase 3	2009-08-01	This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.

Clinical Trial Conditions for Firmagon

Condition Name

Condition Name for Firmagon
Intervention	Trials
Prostate Cancer	27
Prostate Adenocarcinoma	8
Stage IV Prostate Cancer	4
Stage III Prostate Cancer	4

Condition MeSH

Condition MeSH for Firmagon
Intervention	Trials
Prostatic Neoplasms	49
Adenocarcinoma	13
Cardiovascular Diseases	2
Breast Neoplasms	2

Clinical Trial Locations for Firmagon

Trials by Country

Trials by Country for Firmagon
Location	Trials
United States	209
Canada	26
Germany	14
United Kingdom	13
France	7

Trials by US State

Trials by US State for Firmagon
Location	Trials
California	12
Texas	11
New York	10
South Carolina	8
Washington	8

Clinical Trial Progress for Firmagon

Clinical Trial Phase

Clinical Trial Phase for Firmagon
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	16
Phase 2	24

Clinical Trial Status

Clinical Trial Status for Firmagon
Clinical Trial Phase	Trials
Completed	27
Recruiting	9
Terminated	6

Clinical Trial Sponsors for Firmagon

Sponsor Name

Sponsor Name for Firmagon
Sponsor	Trials
Ferring Pharmaceuticals	23
National Cancer Institute (NCI)	9
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	3

Sponsor Type

Sponsor Type for Firmagon
Sponsor	Trials
Other	64
Industry	40
NIH	9

Firmagon (Degarelix): Clinical Trials, Market Analysis, and Projections

Introduction to Firmagon

Firmagon, also known as degarelix, is a synthetic peptide that acts as a gonadotropin-releasing hormone (GnRH) receptor antagonist. It is primarily used in the treatment of advanced prostate cancer to suppress testosterone levels, which is crucial for managing the disease.

Clinical Trials and Efficacy

Comparative Studies with Leuprolide

One of the significant clinical trials comparing Firmagon (degarelix) to leuprolide, a GnRH agonist, was conducted to assess the cardiovascular safety of these two treatments. The trial, which enrolled 545 patients across 12 countries, found that Firmagon had a lower rate of major adverse cardiovascular events (MACE) compared to leuprolide. Over 12 months, the primary outcome event rates were 5.1% for degarelix and 10.2% for leuprolide[1].

Testosterone Suppression

Firmagon has been shown to rapidly reduce testosterone levels without the initial flare seen with GnRH agonists like leuprolide. In a pivotal Phase 3 trial, Firmagon dropped testosterone levels by 88% on the first day of treatment, compared to a 65% increase in testosterone levels with leuprolide over the first three days. Firmagon maintained testosterone suppression below castration levels (≤50 ng/dL) throughout the 12-month treatment period[3].

Market Analysis

Competitive Landscape

The market for prostate cancer treatments is highly competitive, with several drugs approved for various stages of the disease. Firmagon stands out as an LHRH receptor antagonist, differentiating it from LHRH agonists like leuprolide. The recent approvals of second-line metastatic castration-resistant prostate cancer (mCRPC) therapies, such as abiraterone acetate and enzalutamide, have driven market growth. However, Firmagon's unique mechanism of action and rapid testosterone suppression make it a valuable option in the treatment arsenal[5].

Sales Forecast

Historical sales forecasts for Firmagon from 2012 to 2022 indicated strong market potential, particularly in the top nine countries including the US, Japan, UK, France, Germany, Spain, Italy, Canada, and Australia. The forecasts were based on detailed analyses of the competitive landscape, epidemiology, and treatment guidelines for prostate cancer[5].

Current Market and Future Projections

Market Growth Drivers

The prostate cancer treatment market is expected to continue growing due to several factors:

• Increasing incidence of prostate cancer
• Advancements in treatment options
• Shift towards more convenient and safer therapies, such as oral medications and targeted therapies
• Regulatory approvals for new indications and patient populations[5].

Competitive Positioning

Firmagon's position in the market is strengthened by its rapid action and lack of testosterone flare, which are significant advantages over traditional GnRH agonists. However, the market is dynamic, with ongoing trials and new treatments emerging, such as the combination therapies involving PARP inhibitors and next-generation antiandrogens[4].

Ongoing and Future Clinical Trials Context

While Firmagon itself is not currently in new Phase 3 trials, the broader landscape of prostate cancer treatments is evolving. Ongoing trials, such as those involving oncolytic virus therapies, PARP inhibitors, and EZH2 inhibitors, are exploring new pathways and combinations that could impact the treatment paradigm and market dynamics[4].

Key Takeaways

• Efficacy and Safety: Firmagon has demonstrated superior cardiovascular safety and rapid testosterone suppression compared to GnRH agonists.
• Market Position: Firmagon is a unique player in the prostate cancer treatment market due to its mechanism of action as an LHRH receptor antagonist.
• Market Growth: The market is driven by increasing incidence, advancements in treatments, and regulatory approvals.
• Future Outlook: The dynamic nature of the market, with emerging treatments and combinations, will continue to shape the competitive landscape.

FAQs

What is Firmagon used for?

Firmagon (degarelix) is used in the treatment of advanced prostate cancer to suppress testosterone levels.

How does Firmagon differ from other GnRH treatments?

Firmagon is an LHRH receptor antagonist, which means it rapidly reduces testosterone levels without the initial flare seen with LHRH agonists like leuprolide.

What are the key benefits of Firmagon over traditional GnRH agonists?

Firmagon offers rapid testosterone suppression and a lower risk of major adverse cardiovascular events compared to GnRH agonists.

What is the current market outlook for Firmagon?

The market for Firmagon is expected to grow due to its unique benefits and the increasing incidence of prostate cancer, although it faces competition from emerging treatments.

Are there any ongoing clinical trials for Firmagon?

While Firmagon itself is not in new Phase 3 trials, the broader landscape of prostate cancer treatments is evolving with new trials and treatments being developed.

Sources

1. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients... - Circulation, 2021.
2. 2022 Annual Report - Veru Inc.
3. Lower Testosterone Levels with Firmagon® (degarelix) - Firmagon.com.
4. Prostate cancer: Three drug trials to watch - Clinical Trials Arena.
5. Research and Markets: Firmagon (Prostate Cancer) - Forecast and Market Analysis to 2022 - Business Wire.