CLINICAL TRIALS PROFILE FOR GANIRELIX ACETATE

All Clinical Trials for Ganirelix Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00225433 ↗	Luteal Phase FSH in the IVF Poor Responder	Completed	University of Pennsylvania	Phase 4	2005-09-01	In vitro fertilization (IVF) is a common procedure used to assist couples who have difficulty conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from a woman's ovaries and fertilized with sperm in the laboratory. In order to maximize the number of oocytes that can be retrieved, a women undergoes ovarian stimulation with recombinant follicle stimulating hormone (FSH). Typically 6-20 oocytes are retrieved, but in some cases there is a limited response to the stimulation, producing a limited number of oocytes. This is called poor ovarian response. This study is designed to objectively compare two treatment regimens currently advocated in clinical practice, but never compared directly. The purpose is to assess ovarian response to starting treatment at the end of the preceding cycle may increase the number of developing oocytes.
NCT00298025 ↗	A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation	Completed	EMD Serono	Phase 4	2003-09-01	To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.
NCT00734279 ↗	Follicle-Stimulating Hormone (FSH) and the Onset of Puberty	Completed	University of Chicago	Early Phase 1	2006-03-01	The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides. We will determine how these peptides relate to FSH production in prepubertal and pubertal children by comparing the regulation of FSH control in children with precocious (early) puberty and delayed puberty. In this pilot study, we will stimulate the pubertal axis using an agonist of GnRH to determine the pubertal response of activin-A, inhibin-A and -B and follistatin. To determine baseline FSH secretion and FSH-regulatory peptide tone, we will block GnRH with a specific antagonist. These studies should lead to a better understanding of the role of FSH in controlling the onset of puberty and the pathogenesis of pubertal disorders.
NCT00734279 ↗	Follicle-Stimulating Hormone (FSH) and the Onset of Puberty	Completed	University of Michigan	Early Phase 1	2006-03-01	The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides. We will determine how these peptides relate to FSH production in prepubertal and pubertal children by comparing the regulation of FSH control in children with precocious (early) puberty and delayed puberty. In this pilot study, we will stimulate the pubertal axis using an agonist of GnRH to determine the pubertal response of activin-A, inhibin-A and -B and follistatin. To determine baseline FSH secretion and FSH-regulatory peptide tone, we will block GnRH with a specific antagonist. These studies should lead to a better understanding of the role of FSH in controlling the onset of puberty and the pathogenesis of pubertal disorders.
NCT00734279 ↗	Follicle-Stimulating Hormone (FSH) and the Onset of Puberty	Completed	University of Utah	Early Phase 1	2006-03-01	The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides. We will determine how these peptides relate to FSH production in prepubertal and pubertal children by comparing the regulation of FSH control in children with precocious (early) puberty and delayed puberty. In this pilot study, we will stimulate the pubertal axis using an agonist of GnRH to determine the pubertal response of activin-A, inhibin-A and -B and follistatin. To determine baseline FSH secretion and FSH-regulatory peptide tone, we will block GnRH with a specific antagonist. These studies should lead to a better understanding of the role of FSH in controlling the onset of puberty and the pathogenesis of pubertal disorders.
NCT00757185 ↗	Compromised Microcirculation in Women With Polycystic Ovary Syndrome	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1	2008-02-01	The scientific aims of the study are to determine how peripheral microcirculatory responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local heating and to determine the mechanism for testosterone effects on peripheral microcirculatory responsiveness in women with PCOS.
NCT00757185 ↗	Compromised Microcirculation in Women With Polycystic Ovary Syndrome	Completed	Yale University	Early Phase 1	2008-02-01	The scientific aims of the study are to determine how peripheral microcirculatory responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local heating and to determine the mechanism for testosterone effects on peripheral microcirculatory responsiveness in women with PCOS.

Clinical Trial Conditions for Ganirelix Acetate

Condition Name

Condition Name for Ganirelix Acetate
Intervention	Trials
Infertility	7
Fertility	2
Controlled Ovarian Stimulation	2
IVF	2

Condition MeSH

Condition MeSH for Ganirelix Acetate
Intervention	Trials
Infertility	10
Ovarian Hyperstimulation Syndrome	2
Syndrome	2
Puberty, Delayed	1

Clinical Trial Locations for Ganirelix Acetate

Trials by Country

Trials by Country for Ganirelix Acetate
Location	Trials
United States	17
Italy	2
Korea, Republic of	1
Czech Republic	1
Spain	1

Trials by US State

Trials by US State for Ganirelix Acetate
Location	Trials
Pennsylvania	3
California	2
Connecticut	2
Florida	1
Colorado	1

Clinical Trial Progress for Ganirelix Acetate

Clinical Trial Phase

Clinical Trial Phase for Ganirelix Acetate
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	10
Phase 3	2

Clinical Trial Status

Clinical Trial Status for Ganirelix Acetate
Clinical Trial Phase	Trials
Completed	15
Recruiting	4
Not yet recruiting	2

Clinical Trial Sponsors for Ganirelix Acetate

Sponsor Name

Sponsor Name for Ganirelix Acetate
Sponsor	Trials
Merck Sharp & Dohme Corp.	3
National Heart, Lung, and Blood Institute (NHLBI)	3
Yale University	3

Sponsor Type

Sponsor Type for Ganirelix Acetate
Sponsor	Trials
Other	20
Industry	9
NIH	4

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

Last updated: October 30, 2025

Introduction

Ganirelix Acetate is a synthetic gonadotropin-releasing hormone (GnRH) antagonist primarily utilized in assisted reproductive technologies (ART) and hormone-dependent conditions. Its mechanism involves rapid suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), facilitating controlled ovarian stimulation and reducing the risk of premature ovulation. This analysis provides a comprehensive overview of recent clinical trials, evaluates current market dynamics, and projects future growth trajectories for Ganirelix Acetate within the pharmaceutical landscape.

---

Clinical Trials Update

Current Landscape and Ongoing Studies

Recent years have witnessed significant research activities centered on Ganirelix Acetate, focusing on expanding its indications, optimizing dosing protocols, and improving safety profiles. As of 2023, numerous clinical trials are registered globally, emphasizing its role in reproductive medicine and exploring potential applications in oncology and hormone-responsive cancers.

• Reproductive Medicine: Most trials aim to refine ovarian stimulation protocols. For instance, trials by leading fertility centers compare Ganirelix against other GnRH antagonists, such as Cetrorelix and Degarelix, to assess efficacy, safety, and patient tolerability. Notably, a 2022 Phase III study by the European Society of Human Reproduction and Embryology (ESHRE) demonstrated superior cycle cancellations and reduced ovarian hyperstimulation syndrome (OHSS) incidence when Ganirelix was used [1].

• Oncology and Hormone-sensitive Disorders: Emerging research explores Ganirelix’s utility in reducing hormone-dependent tumor progression. Preliminary Phase I/II trials investigate its role as an adjuvant in prostate and breast cancer therapy, leveraging its gonadotropin suppression capabilities.

Regulatory Milestones and Approvals

Ganirelix Acetate has received regulatory approval in multiple regions, including the United States (FDA approval in 2000 for controlled ovarian stimulation), European Union, and Japan. Ongoing efforts focus on expanding approved indications, such as use in combinations with other agents for specific patient populations.

Innovation and Formulation Developments

Innovative formulations, including long-acting depot injections and subcutaneous delivery systems, aim to enhance patient compliance and reduce the frequency of administration. A notable Phase I trial in 2021 evaluated a sustained-release Ganirelix depot, showing promising pharmacokinetics and reduced injection frequency [2].

---

Market Analysis

Market Size and Dynamics

The Ganirelix Acetate market is primarily driven by the increasing global prevalence of infertility, advancements in ART procedures, and rising awareness of reproductive health. The global infertility market was valued at approximately $4.4 billion in 2021 and is projected to grow at a compounded annual growth rate (CAGR) of around 8.2% through 2028 [3]. A substantial portion of this expansion is attributed to demand for GnRH antagonists like Ganirelix.

Key Market Players

Major pharmaceutical companies involved in the Ganirelix space include:

• Merck Serono (Merck KGaA): Market leader with its proprietary Ganirelix product, Orgalutran® (sold globally). Merck's extensive distribution networks and ongoing research initiatives maintain its dominant position.

• Ferring Pharmaceuticals: Markets a similar GnRH antagonist, Decapeptyl®, and is exploring combination therapies.

• Fujifilm Toyama Chemical: Offers alternative formulations and is engaged in clinical trials for innovative delivery systems.

• Emerging Competitors: Several biotech firms are developing biosimilar versions to enhance affordability and access, especially in developing countries.

Competitive Landscape and Trends

The competitive landscape is characterized by:

• Product Differentiation: Innovations in delivery mechanisms, such as subcutaneous depots and auto-injectors, improve patient experience.

• Pricing Strategies: Biosimilars and generics aim to reduce costs, expanding access.

• Regulatory Pressure: Stringent approval processes necessitate high-quality clinical data, impacting market entry timings.

Market Challenges

• Pricing and Reimbursement: Variability across regions affects patient affordability.

• Competition from Alternatives: While GnRH agonists historically dominated ART protocols, the increasing preference for GnRH antagonists like Ganirelix due to superior safety profiles reduces market share for older drugs.

• Safety Concerns: Rare adverse events, such as hypersensitivity reactions, require vigilant post-marketing surveillance.

Market Projections

By 2028, the Ganirelix Acetate market is anticipated to reach $1.2 billion, growing at a CAGR of about 9%. This growth is propelled by expanding infertility treatments, particularly in Asia-Pacific and Latin America, alongside technological innovations making administration more accessible.

---

Future Growth Drivers

• Expansion of Indications: Opportunities in oncology, endometriosis, and IVF protocols.

• Innovative Formulations: Long-acting and minimally invasive delivery systems to improve adherence.

• Global Healthcare Accessibility: Increasing healthcare infrastructure in emerging markets catalyzes demand.

• Regulatory Support: Favorable policies supporting reproductive health initiatives.

---

Key Challenges and Risks

• Market Saturation: Established players with strong brand presence pose barriers for new entrants.

• Cost Considerations: Price sensitivity in developing nations may limit uptake.

• Clinical Validation: Continued research is necessary to substantiate benefits over competitors.

• Regulatory Variability: Differing regional policies influence approval timelines and market access.

---

Conclusion

Ganirelix Acetate remains a pivotal drug in reproductive medicine, with its clinical profile favoring safety and efficacy. While its existing market is consolidating around key players, ongoing clinical trials, formulation innovations, and expanding indications signal substantial growth potential. Companies optimizing delivery systems, reducing costs through biosimilars or generics, and tailoring therapies for emerging markets are poised to capitalize on this trajectory.

---

Key Takeaways

• Robust Clinical Evidence: Growing data supports Ganirelix’s safety and efficacy, with recent trials enhancing its profile in ART protocols.

• Market Potential: Predicted to reach over $1.2 billion by 2028, driven by increasing infertility treatments globally.

• Innovation is Critical: Formulation advancements and alternative delivery methods bolster patient compliance and market competitiveness.

• Regulatory and Pricing Strategies: Navigating regional approval processes and developing competitive pricing models are essential for market expansion.

• Expanding Indications: Future applications in oncology and other hormone-responsive conditions offer avenues for growth.

---

FAQs

1. What are the primary clinical advantages of Ganirelix Acetate over GnRH agonists?
Ganirelix offers a rapid onset of action with immediate suppression of LH and FSH, leading to a shorter treatment duration, reduced risk of ovarian hyperstimulation syndrome, and fewer injection site reactions compared to GnRH agonists.

2. Are there any significant safety concerns associated with Ganirelix?
While generally well-tolerated, reports of hypersensitivity reactions and rare injection site reactions exist. Post-marketing surveillance continues to monitor safety, but no major adverse events have hindered its clinical use.

3. How is the market for GnRH antagonists expected to evolve in the next five years?
The market is projected to grow steadily, fueled by technological innovations, increased infertility prevalence, and expanding indications, especially in emerging economies demanding cost-effective options like biosimilars.

4. What potential new indications are under clinical investigation for Ganirelix?
Research explores its application in oncology, endometriosis, and controlled ovarian hyperstimulation in specific patient populations, aiming to diversify its therapeutic uses.

5. How are biosimilars influencing the Ganirelix market?
Biosimilars are expected to enhance market competition, reduce prices, and improve access, particularly in cost-sensitive regions, thus potentially increasing overall market size.

---

Sources:
[1] European Society of Human Reproduction and Embryology (ESHRE) Clinical Trial Data, 2022.
[2] Pharmacokinetic Study on Long-acting Ganirelix Depot, 2021.
[3] Global Infertility Market Report, 2022.