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NCT00507780 ↗	Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy	Withdrawn	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2007-07-18	This study will examine whether the drug cetrorelex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.

Clinical Trial Conditions for CETRORELIX ACETATE

Condition Name

Condition Name for CETRORELIX ACETATE
Intervention	Trials
Infertility	9
Ovarian Hyperstimulation Syndrome	2
Infertility, Female	1

Condition MeSH

Condition MeSH for CETRORELIX ACETATE
Intervention	Trials
Infertility	12
Ovarian Hyperstimulation Syndrome	3
Syndrome	3

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
Indiana	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-Trial Status, Market Position, and Forward Projections

Last updated: May 1, 2026

What is cetrorelix acetate and where is it used clinically?

Cetrorelix acetate is a gonadotropin-releasing hormone (GnRH) antagonist used to prevent premature luteinizing hormone (LH) surges in controlled ovarian hyperstimulation (COH) for infertility treatment. It is a mature, established product used in fertility clinics for cycle management rather than a late-stage, high-risk development program.

What is the current clinical-trials landscape?

No current, clearly attributable late-stage (Phase 3/registrational) clinical program for cetrorelix acetate is identifiable from the information provided in this request. The drug’s development history is consistent with an already-approved, marketed product, and the available “clinical trials update” in the public domain typically centers on:

• Formulation or device-administration variations
• Comparative regimen studies (timing, injection schedules) in COH
• Post-marketing safety and operational endpoints

Because this prompt does not include a trial identifier set (e.g., NCT numbers) or a source list to anchor a complete, accurate trial status snapshot, a full and correct “trial-by-trial” update cannot be produced under the operating constraints.

What markets does cetrorelix acetate serve and how is it positioned?

Cetrorelix acetate competes within the GnRH antagonist segment for infertility COH, a category that also includes other antagonists (notably ganirelix in historical markets). Positioning is driven by:

• Clinic protocol integration (COH pathways and stimulation regimens)
• Supply reliability and injection convenience
• Local pricing and reimbursement frameworks
• Brand vs generic availability in each jurisdiction

From a business lens, cetrorelix is not a new-entrant growth story in the way an investigational asset is. Its market behavior tracks:

• Volume of assisted reproductive technology (ART) cycles
• Uptake of antagonist protocols versus agonist protocols
• Competitive pricing dynamics and biosimilar/generic penetration (where applicable)
• Country-level fertility services demand and reimbursement intensity

What do the likely demand drivers indicate for 2025 to 2030?

A defensible projection for cetrorelix acetate must be tied to the ART market and COH regimen share. The major demand drivers are structural:

• ART cycle growth in markets with expanding fertility care access
• Continued preference shift toward GnRH antagonist regimens in many clinical settings due to protocol flexibility and reduced risk of premature LH surge-related complications
• Stable replacement needs as cetrorelix is used per treatment cycle (consumption-linked demand)

Given the absence of product-level sales history in the prompt and the absence of trial identifiers, the only rigorous projections that can be produced under strict accuracy constraints are directional scenario projections tied to macro demand rather than single-asset revenue forecasts.

Scenario framework (cycle-linked demand, not trial-linked growth)

• Base-case: Cetoreli x acetate revenue grows in line with ART cycle volumes, with modest share stability or gradual share adjustments within antagonist protocols.
• Upside: Faster adoption of antagonist COH protocols in additional geographies plus improved clinic retention for antagonist workflows.
• Downside: Competitive substitution (price pressure from alternatives, especially generic availability where regulatory/market conditions allow) and reimbursement tightening.

These scenarios are operationally useful, but they do not produce numerical market-size or revenue targets without sales/market-trajectory inputs.

What are the key competitive and commercial constraints?

Cetrorelix acetate competes in a space with predictable commercial constraints:

Protocol substitution risk

• If clinics standardize to another antagonist in a region based on price, supply, or clinician familiarity, cetrorelix can face share compression.

Pricing and reimbursement pressure

• Fertility care reimbursement rules vary widely by country and can change the net purchasing decision even when clinical protocols remain stable.

Supply chain reliability

• Injection drug supply can materially impact clinic ordering and continuity, especially during localized disruptions.

What is the actionable outlook for R&D and investing decisions?

For R&D teams, cetrorelix acetate is most relevant in:

• Lifecycle management (formulation, dosing convenience, administration route refinements)
• Comparative protocol research and real-world evidence generation aligned with clinic uptake
• Patent and exclusivity strategy around formulation and method-of-use claims (where still available)

For investors and business planning, the asset should be modeled as:

• A consumption-driven, mature product
• Subject to incremental growth from ART demand and regimen share
• Exposed to price competition and substitution within the antagonist class

Key Takeaways

• Cetrorelix acetate is an established GnRH antagonist used in infertility COH to prevent premature LH surges.
• A complete, trial-by-trial clinical trials update cannot be produced from the information included in this request.
• Market growth is most plausibly driven by ART cycle volume growth and ongoing regimen preference for GnRH antagonists.
• Forward projections should be framed as cycle-linked demand scenarios, with attention to protocol substitution and pricing pressure rather than trial-driven step-changes.

FAQs

1. Is cetrorelix acetate currently under Phase 3 development for a new indication?
   The prompt does not provide trial identifiers or endpoints to confirm any active registrational study, so a Phase 3 status call cannot be made.

2. What is the main clinical role of cetrorelix acetate in fertility treatment?
   It prevents premature LH surge in controlled ovarian hyperstimulation.

3. What most influences cetrorelix acetate demand in the real world?
   ART cycle volumes and the share of COH protocols using GnRH antagonists.

4. How does competition typically affect cetrorelix acetate pricing and share?
   Substitution to other antagonists and generic or branded alternatives can pressure net pricing.

5. What is the most practical way to model cetrorelix acetate market growth?
   Use a cycle-linked demand model tied to ART market growth and antagonist-protocol share rather than expecting trial-driven inflection.

References

[1] Cetrorelix acetate prescribing information and regulatory labels (product-specific).