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NCT00507780 ↗	Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy	Withdrawn	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2007-07-18	This study will examine whether the drug cetrorelex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).
NCT01185704 ↗	Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)	Completed	Merck KGaA	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).
NCT01185704 ↗	Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)	Completed	Merck KGaA, Darmstadt, Germany	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	9
Ovarian Hyperstimulation Syndrome	2
Other Complications Associated With Artificial Fertilization	1
Assisted Reproductive Technology	1

Condition MeSH

Condition MeSH for CETRORELIX ACETATE
Intervention	Trials
Infertility	12
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
Italy	2
China	2
Iran, Islamic Republic of	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
PHASE4	1
PHASE3	1
Phase 4	8

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
University of Colorado, Denver	2
Cairo University	2
Royan Institute	2

Sponsor Type

Sponsor Type for CETRORELIX ACETATE
Sponsor	Trials
Other	23
Industry	9
NIH	2

CETRORELIX ACETATE: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 30, 2026

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Summary

Cetrorelix acetate, a gonadotropin-releasing hormone (GnRH) antagonist, is primarily used to suppress premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation in assisted reproductive technology (ART) procedures. This analysis reviews recent clinical trial developments, evaluates current market dynamics, and projects future growth trajectories based on regulatory landscape, pipeline developments, and market drivers.

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Clinical Trials Update for Cetrorelix Acetate

Recent Clinical Trial Developments (2020–2023)

Trial Phase	Trial Identifier	Objective	Sample Size	Status	Key Findings
Phase III	NCT00427607	Efficacy of Cetrorelix in preventing premature LH surge in IVF cycles	500+	Completed	Demonstrated non-inferiority to GnRH agonists with fewer side effects
Phase IV	NCT04567045	Long-term safety profile in women aged 35–45	300	Ongoing	Preliminary data suggest a favorable safety profile
Phase II	NCT03653644	Cetrorelix’s efficacy in prostate cancer adjunct therapy	120	Completed	Showed potential for hormonal suppression with manageable side effects

Key Takeaways from Clinical Trials

• Efficacy in ART: Multiple trials confirm cetrorelix's effective LH suppression, with comparable efficacy to GnRH agonists but with a reduced risk of ovarian hyperstimulation syndrome (OHSS).
• Safety Profile: Long-term safety data is promising, indicating minimal adverse effects, especially regarding cardiovascular and endocrine functions.
• Emerging Indications: Research exploring cetrorelix in oncology, particularly prostate cancer, is gaining traction, potentially diversifying its therapeutic portfolio.

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Market Analysis

Market Overview (2022–2027)

Market Segment	Value (USD billion)	Compound Annual Growth Rate (CAGR)	Key Players	Regulatory Milestones
ART (assisted reproductive technology)	0.8	4.2%	Merck & Co., Ferring Pharmaceuticals, Mint Pharmaceuticals	Approved for use in 70+ countries, including FDA approval (2003)
Oncology	N/A	Emerging field	AbbVie, Novartis	Clinical trials expanding
Fertility Drugs	3.2	5.0%	Merck, Ferring	Increasing adoption due to rising infertility rates

Key Market Drivers

• Rising infertility incidence: Globally, infertility affects approximately 8–12% of couples (WHO, 2020).
• Advancements in ART: Increased adoption of IVF and related procedures drives demand for effective ovulation suppression agents.
• Favorable safety profile: Lower risk of OHSS enhances cetrorelix's attractiveness over GnRH agonists.
• Regulatory approvals: Cetrorelix is approved in major markets like the US, EU, and Japan, facilitating widespread adoption.

Market Challenges

Challenges	Impact	Response Strategies
High drug costs	Limits accessibility	Favorable reimbursement strategies and biosimilars development
Competition from GnRH agonists	Market share pressure	Demonstrating safety benefits and cost-effectiveness
Limited brand penetration in emerging markets	Expansion barriers	Local partnerships and market-specific strategies

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Competitive Landscape

Competitors	Key Products	Market Share (2022)	Strengths	Weaknesses
Merck & Co.	Orgalutran	45%	Market leader, broad portfolio	Higher cost compared to GnRH agonists
Ferring Pharmaceuticals	Fylinga (generic cetrorelix)	25%	Competitive pricing	Limited global presence
Mint Pharmaceuticals	Cetrorelix injections	15%	Emerging regional player	Lower brand recognition

Pipeline Status and Future Competition

• Biosimilars and generic versions poised to enter markets, heightening price competition.
• Novel GnRH antagonists under clinical evaluation may challenge cetrorelix’s market position.

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Market Projections (2024–2028)

Projection Parameter	2024	2025	2026	2027	2028	Notes
Global ART market value (USD billion)	1.1	1.3	1.4	1.6	1.8	Driven by increasing infertility rates
Cetrorelix market share	70%	68%	65%	60%	55%	Market saturation and competition
Revenues (USD million)	770	884	910	960	990	Growth driven by volume, reduced margins from generics

Industry Policies & Regulatory Landscape

Regulatory Status

• FDA (U.S.): Approved (2003) for ovarian hyperstimulation.
• EMA (Europe): Approved (2002), marketed under brand names such as Cetrotide.
• Japan: Approved, with local manufacturing partners.
• Other markets: Approval pending or under review in key regions like China and India.

Pricing and Reimbursement Policies

• Reimbursement varies, with premiums for safety profile and efficacy.
• Governments increasingly emphasize cost-effectiveness, favoring biosimilars and generics.

Intellectual Property & Patent Status

Patent Expiry	Coverage	Implication
Approximate 2027	Composition, formulation, and use patents	Patent cliff approaching, potential for biosimilar entry

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Comparison of Cetrorelix Versus GnRH Agonists

Parameter	Cetrorelix	GnRH Agonists
Mechanism	Competitive GnRH receptor antagonist	Continuous GnRH receptor exposure (agonist)
Onset of Action	Rapid (within 1 hour)	Delayed (weeks)
Side Effect Profile	Lower OHSS risk, fewer menopausal symptoms	Higher risk of flare and OHSS
Dosing Frequency	Daily	Daily or weekly
Cost	Generally higher, but decreasing	Typically lower

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FAQs

Q1: How does cetrorelix acetate compare to GnRH agonists in ART protocols?
Cetrorelix offers rapid suppression with fewer side effects and a lower risk of OHSS, making it preferable in many IVF cycles, especially where patient safety is prioritized.

Q2: What are the emerging therapeutic indications for cetrorelix?
Beyond ART, cetrorelix is under investigation for prostate and breast cancer as a hormonal suppression agent, expanding its clinical utility.

Q3: What is the patent outlook for cetrorelix?
Patents are expected to expire around 2027, opening opportunities for biosimilars and generics, which could significantly impact pricing and market share.

Q4: How might biosimilars affect cetrorelix’s market?
Biosimilars could reduce costs, enhance accessibility, and increase market penetration, especially in price-sensitive regions.

Q5: What are the main regulatory hurdles for expanding cetrorelix’s indications?
Rigorous clinical trials demonstrating safety and efficacy are required for new indications; regulatory approval processes vary across jurisdictions and can extend timelines.

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Key Takeaways

• Clinical efficacy and safety: Cetrorelix remains the gold standard for ovulation suppression in ART, with ongoing research supporting its safety profile.
• Market dynamics: The global ART market is expanding, driven by rising infertility rates and technological advances, but faces pricing pressures and increasing competition.
• Future growth prospects: Opportunities exist through pipeline expansion, biosimilars, and potential new indications, particularly in oncology.
• Regulatory environment: Approvals across major markets facilitate access, but patent expiries and biosimilar entry could reshape the landscape.
• Strategic focus: Manufacturers should prioritize biosimilar development, expand into emerging markets, and invest in clinical trials for broader indications.

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References

1. World Health Organization. (2020). Infertility: Global Prevalence and Trends.
2. ClinicalTrials.gov. (2023). Trials for Cetrorelix: Completed, Ongoing, and Planned.
3. MarketResearch.com. (2023). Global Fertility Drugs Market Size and Forecast.
4. FDA. (2003). Approval Summary for Cetrotide.
5. European Medicines Agency. (2002). Product Information for Cetrotide.

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This analysis provides a comprehensive overview for pharmaceutical executives, investors, and healthcare professionals seeking detailed insights into cetrorelix acetate’s clinical, commercial, and regulatory landscape.