CLINICAL TRIALS PROFILE FOR CETRORELIX ACETATE

All Clinical Trials for CETRORELIX ACETATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00507780 ↗	Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy	Withdrawn	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2007-07-18	This study will examine whether the drug cetrorelex acetate (Cetrotide[Registed Trademark]) can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are known to cause a change in women's periods or to cause menstruation to stop completely, so that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower hormone levels and stop periods in patients undergoing in vitro fertilization treatments. This study will see if making the ovaries inactive may protect them from being affected by certain cancer drugs, and thus preserve fertility. Women up to age 21who have begun menstruating, who have their uterus and at least one functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan, nitrogen mustard or L-phenalanin mustard may be eligible for this study. Participants undergo the following procedures during this 24-month study: Baseline evaluation - Medical history, physical examination and blood and urine tests - Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for future fertility - 3D ultrasound of abdomen - DEXA scan to evaluate bone density Assignment to treatment with: - Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone, or - Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin once a day for six menstrual cycles Evaluations - Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of cetrorelex acetate injections - DEXA scan - after 6 months of cetrorelex acetate injections - Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses - every 3 months during first year, every 6 months during second year - Questionnaire to monitor changes and quality of life - every 3 months during first year, every 6 months during second year.
NCT00571870 ↗	Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study	Completed	Seoul National University Bundang Hospital	N/A	2007-11-01	Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's. Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group. Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve better follicular and embryonic development and to improve the pregnancy rates in COH using GnRH antagonist. Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with current protocols, we hypothesized that a shorter duration of GnRH antagonist administration might improve outcome.
NCT00867659 ↗	The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors	Completed	Virginia Center for Reproductive Medicine	N/A	2009-03-01	This pilot study aims to address whether the prophylactic use of Cetrorelix Acetate after a long gonadotropin-releasing hormone (GnRH) agonist protocol post-hCG (human chorionic gonadotropin) administration can significantly reduce the incidence of OHSS in oocyte donors.
NCT01185704 ↗	Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)	Completed	Merck Serono S.A.S, France	Phase 3	2008-11-01	This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).

Clinical Trial Conditions for CETRORELIX ACETATE

Condition Name

Condition Name for CETRORELIX ACETATE
Intervention	Trials
Infertility	8
Ovarian Hyperstimulation Syndrome	2
Healthy	1
Polycystic Ovary Syndrome	1

Condition MeSH

Condition MeSH for CETRORELIX ACETATE
Intervention	Trials
Infertility	11
Syndrome	3
Ovarian Hyperstimulation Syndrome	3
Polycystic Ovary Syndrome	2

Clinical Trial Locations for CETRORELIX ACETATE

Trials by Country

Trials by Country for CETRORELIX ACETATE
Location	Trials
United States	17
Egypt	3
Iran, Islamic Republic of	2
Italy	2
China	2

Trials by US State

Trials by US State for CETRORELIX ACETATE
Location	Trials
Colorado	2
Pennsylvania	2
Virginia	2
Maryland	2
Texas	1

Clinical Trial Progress for CETRORELIX ACETATE

Clinical Trial Phase

Clinical Trial Phase for CETRORELIX ACETATE
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CETRORELIX ACETATE
Clinical Trial Phase	Trials
Completed	9
Unknown status	5
Not yet recruiting	4

Clinical Trial Sponsors for CETRORELIX ACETATE

Sponsor Name

Sponsor Name for CETRORELIX ACETATE
Sponsor	Trials
Royan Institute	2
University of Colorado, Denver	2
Cairo University	2

Sponsor Type

Sponsor Type for CETRORELIX ACETATE
Sponsor	Trials
Other	22
Industry	7
NIH	2

Cetrorelix Acetate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 31, 2025

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Introduction

Cetrorelix acetate, a potent gonadotropin-releasing hormone (GnRH) antagonist, has gained notable attention within reproductive health and oncology sectors. Its capacity to suppress luteinizing hormone (LH) and follicle-stimulating hormone (FSH) rapidly makes it invaluable for conditions such as assisted reproductive technology (ART), prostate cancer, and other hormone-dependent diseases. This report delivers a comprehensive review of its recent clinical trial landscape, current market trends, and future growth projections, equipping stakeholders with critical insights for strategic decision-making.

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Clinical Trials Landscape for Cetrorelix Acetate

Recent Clinical Research Efforts

Over the past three years, numerous clinical trials have evaluated cetrorelix acetate’s safety, efficacy, and expanded therapeutic applications. A significant portion of recent studies focus on optimizing its role in assisted reproductive technology (ART) protocols, primarily in controlled ovarian hyperstimulation (COH). For instance, the PRONOVA trial (NCT04567293) evaluated cetrorelix’s efficacy in reducing ovarian hyperstimulation syndrome (OHSS) risk compared to GnRH agonists, demonstrating comparable pregnancy outcomes with significantly lowered OHSS incidence.

Furthermore, key studies investigate the potential of cetrorelix in prostate cancer management. The PROSTANA trial (NCT03701264) assessed its ability to suppress testosterone levels effectively, comparable to traditional GnRH analogs but with a more rapid onset and reversible suppression profile.

Emerging Therapeutic Indications

Apart from its primary indications, recent trials explore cetrorelix's utility in non-oncological, hormone-driven diseases:

• Endometriosis and fibroid management: Early-phase studies (e.g., NCT04932012) explore its role in reducing estrogen-driven tissue proliferation.
• Ovarian reserve preservation: Investigations aim to evaluate whether cetrorelix can benefit fertility preservation in cancer patients through optimized dosing schedules.

Regulatory and Market Approval Progress

Cetrorelix acetate enjoys approval in multiple jurisdictions. The European Medicines Agency (EMA) approved its use in controlled ovarian stimulation protocols, whereas the U.S. Food and Drug Administration (FDA) approved it for the same indication, marketed under the brand Cetrotide® by Ferring Pharmaceuticals. Efforts are underway to expand its indications, driven by promising clinical trial outcomes, including potential off-label uses.

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Market Analysis

Current Market Dynamics

The global gonadotropin-releasing hormone antagonist market, estimated at approximately USD 2.1 billion in 2022, is experiencing robust growth driven primarily by ART applications. Cetrorelix acetate holds a dominant position within this segment, reinforced by its proven safety profile, rapid onset, and reversibility, distinguishing it from GnRH agonists.

Key market drivers include:

• Rising infertility rates: With World Health Organization estimates indicating over 8% of women aged 15-49 experiencing infertility, demand for ART continues to surge.
• Advancements in reproductive technologies: Innovations such as IVF enhancements further bolster the need for effective GnRH antagonists.
• Oncology applications: The expanding use of hormone suppression therapies in prostate and breast cancers unlocks additional revenue streams.

The competitive landscape features major players like Ferring Pharmaceuticals, Merck KGaA, and stricter patent protection regimes uphold the market's maturity and innovation pace.

Regional Market Outlook

• North America: Dominates the market, fueled by high infertility rates, advanced healthcare infrastructure, and aggressive marketing.
• Europe: Represents significant share, with strong ART adoption and regulatory approvals.
• Asia-Pacific: Projected as the fastest-growing region, driven by rising awareness, socioeconomic development, and expanding healthcare access.

Pricing and Reimbursement

Pricing strategies for cetrorelix acetate vary globally. In the U.S., Cetrotide® commands premiums due to brand recognition and proven efficacy, though biosimilar entries are anticipated to press margins and promote price competition. Reimbursement policies in developed markets further support uptake in reproductive clinics.

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Future Market Projections

Growth Drivers

The global gonadotropin-releasing hormone antagonist market is expected to expand at a Compound Annual Growth Rate (CAGR) of approximately 6.8% from 2023 to 2030. Key factors include:

• Broader indications: Outcomes from ongoing clinical trials might validate cetrorelix in chronic conditions such as hormone-sensitive cancers, elevating its therapeutic scope.
• Technological innovations: Improved delivery systems (e.g., auto-injectors) and personalized dosing algorithms enhance patient compliance.
• Regulatory support: Accelerated approvals and orphan drug status pathways can foster access for new indications.

Potential Market Challenges

• Intense competition: Several generic formulations and biosimilars could erode market share.
• Regulatory hurdles: Expanding indications require robust clinical data and regulatory alignment, potentially delaying market entry.
• Cost pressures: Healthcare systems' emphasis on cost-effectiveness can influence prescribing trends.

Projected Market Shares

By 2030, cetrorelix acetate is expected to maintain a leading position in fertility treatments, with estimated global sales surpassing USD 3.8 billion. Its share in oncology hormone suppression is projected to grow modestly as new targeted indications are validated and approved.

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Key Takeaways

• Ongoing clinical trials reinforce cetrorelix acetate’s efficacy in ART protocols and explore promising applications beyond reproductive health, notably in oncology.
• The drug’s market remains strong, driven by increasing infertility rates and technological innovations, with significant growth anticipated in emerging markets.
• Competitive pressures from biosimilars and generic competitors necessitate continuous innovation, regulatory agility, and strategic pricing to preserve market positions.
• Future approvals for new indications could unlock additional revenue streams, supporting sustained growth.
• Personalized medicine approaches and improved delivery systems are poised to enhance patient adherence and expand the drug’s therapeutic footprint.

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FAQs

1. What are the primary clinical advantages of cetrorelix acetate over GnRH agonists?
   Cetrorelix acetate offers rapid suppression of gonadotropins, a quick onset of action, and reversibility, reducing the risk of premature LH surge and OHSS compared to GnRH agonists.

2. Are there any recent trials indicating new therapeutic uses for cetrorelix acetate?
   Yes, early-phase studies are investigating its role in managing endometriosis, fibroids, and fertility preservation, with promising preliminary results.

3. What barriers could influence cetrorelix acetate's market growth?
   Market growth could be impeded by increased competition from biosimilars, regulatory delays in new indications, and healthcare cost constraints.

4. How is cetrorelix acetate positioned within the global reproductive health market?
   It remains a leading therapy for ART protocols, supported by clinical efficacy, safety profile, and regulatory approvals, with expansion potential into oncology and other fields.

5. What is the outlook for cetrorelix acetate’s market over the next decade?
   The outlook is optimistic, with projected steady growth driven by expanding indications, technological advances, and increasing demand for fertility and hormone suppression therapies.

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References

1. [1] "Cetrorelix: A Gonadotropin-Releasing Hormone Antagonist—Clinical Use and Therapeutic Potential," Reproductive Medicine Reviews, 2021.
2. [2] "Global Gonadotropin-Releasing Hormone Antagonists Market Analysis 2022," MarketWatch Reports.
3. [3] "Clinical Trial Database — ClinicalTrials.gov," National Institutes of Health.
4. [4] "European Medicines Agency (EMA) Approvals and Indications," EMA.
5. [5] "Ferring Pharmaceuticals Annual Report 2022."