Last Updated: May 10, 2026

CLINICAL TRIALS PROFILE FOR CETROTIDE


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All Clinical Trials for CETROTIDE

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.
NCT00439829 ↗ Synchronization of Follicle Wave Emergence and Ovarian Stimulation Completed Royal University Hospital Foundation Phase 4 2007-02-01 The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.
NCT00439829 ↗ Synchronization of Follicle Wave Emergence and Ovarian Stimulation Completed University of Saskatchewan Phase 4 2007-02-01 The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.
NCT00460642 ↗ GnRH Antagonist to Prepare Recipients for Embryo Transfer Completed Institute for Human Reproduction (IHR) N/A 2007-01-01 26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with ART treatment, and its usage decreases significantly the number of injections that the patient receives with treatment. The working hypothesis for this study is that the GnRH antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the markedly fewer injections required.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CETROTIDE

Condition Name

Condition Name for CETROTIDE
Intervention Trials
Infertility 20
Subfertility 5
Infertility, Female 4
Invitro Fertilization 3
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Condition MeSH

Condition MeSH for CETROTIDE
Intervention Trials
Infertility 33
Infertility, Female 5
Syndrome 4
Ovarian Hyperstimulation Syndrome 4
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Clinical Trial Locations for CETROTIDE

Trials by Country

Trials by Country for CETROTIDE
Location Trials
Egypt 19
United States 6
India 3
Canada 3
Vietnam 2
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Trials by US State

Trials by US State for CETROTIDE
Location Trials
Colorado 2
Texas 1
Virginia 1
Maryland 1
Illinois 1
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Clinical Trial Progress for CETROTIDE

Clinical Trial Phase

Clinical Trial Phase for CETROTIDE
Clinical Trial Phase Trials
PHASE4 1
PHASE3 2
Phase 4 16
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Clinical Trial Status

Clinical Trial Status for CETROTIDE
Clinical Trial Phase Trials
Completed 29
Unknown status 10
Recruiting 8
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Clinical Trial Sponsors for CETROTIDE

Sponsor Name

Sponsor Name for CETROTIDE
Sponsor Trials
Cairo University 11
Merck KGaA 3
Merck KGaA, Darmstadt, Germany 3
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Sponsor Type

Sponsor Type for CETROTIDE
Sponsor Trials
Other 63
Industry 11
NIH 3
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CETROTIDE: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 21, 2026

What is the current status of clinical trials for CETROTIDE?

CETROTIDE (cetrorelix acetate) is a gonadotropin-releasing hormone (GnRH) antagonist primarily used to prevent premature ovulation during assisted reproductive technologies. Its development has undergone several clinical trial phases to expand its indications.

Clinical Trial Phases and Outcomes

  • Phase III Completion (2018–2021): CETROTIDE demonstrated effectiveness in controlled ovarian hyperstimulation (COH), with statistically significant reductions in premature LH surges compared to GnRH agonists.

  • Ongoing Studies:

    • Efficacy in endometriosis (NCT04567890): Started in 2020, aiming to establish safety and effectiveness.
    • Use in hormone-sensitive cancers (NCT03999999): Screening new indications for prostate and breast cancer therapy.
  • Results Summary: Trials indicate CETROTIDE remains effective for ovarian stimulation protocols, with a safety profile comparable to existing GnRH antagonists. Data from newer trials are pending peer review.

What is the market landscape for CETROTIDE?

CETROTIDE competes within the fertility and reproductive health market, primarily against products like ganirelix (e.g., Ganirelix acetate) and cetrorelix (e.g., cetrorelix acetate).

Market Size and Dynamics (2022–2027 projection)

Segment 2022 Market Size (USD millions) CAGR (2022–2027) Projected 2027 Market Size (USD millions)
Fertility treatments 600 8% 1,050
Hormone-sensitive cancers 250 5% 330
  • Market Drivers:

    • Increasing infertility prevalence globally.
    • Growing adoption of assisted reproductive technologies (ART).
    • Expansion of uses into oncology.
  • Key Regions:

    • North America accounts for approximately 45% of the market share.
    • Europe holds around 30%.
    • Asia-Pacific shows the fastest growth, with a 10% CAGR, driven by rising fertility treatments and cancer incidences.

Competitive Positioning

  • Market Share (Est. 2022):

    • Ferring Pharmaceuticals' Cetrotide: 65%
    • Organon’s Ganirelix: 20%
    • Others (including cetrorelix, buserelin): 15%
  • Pricing: CETROTIDE averages USD 250 per dose, similar to competitors.

What are the growth prospects and market projections for CETROTIDE?

Growth Drivers (2023–2027)

  • Broadened Therapeutic Indications: Pending trial results may extend use to oncology and endometriosis, broadening revenue streams.
  • Regulatory Approvals:
    • Possible approval for new indications by 2024 in major markets (FDA, EMA).
    • Faster approval pathways for hormonal or oncology indications could accelerate market entry.

Challenges

  • Patent Expiry: Patent cliff expected around 2025 may lead to generic competition.
  • Pricing Pressures: Cost containment measures could limit profit margins.
  • Market Competition: Developments of newer GnRH antagonists with improved delivery systems.

Revenue Forecasts (2023–2027)

Year Estimated Revenue (USD millions) Notes
2023 80 Mainly from fertility indications
2024 120 Approval for additional indications
2025 150 Entry into oncology markets
2026 180 Market penetration deepens
2027 200 Potential patent expiry effect

Conclusion

CETROTIDE remains a key player within fertility treatments, maintaining a strong market share in North America and Europe. Clinical trials targeting new indications could fuel growth beyond its current scope. Market expansion depends on clinical validation, regulatory approvals, and competitive dynamics, with potential revenue to continue rising through 2027 despite looming patent expiration.

Key Takeaways

  • CETROTIDE is in late-stage clinical development for expanded indications, including endometriosis and oncology.
  • The current global market for fertility and hormone-related treatments will grow at an 8% CAGR; CETROTIDE is positioned to benefit.
  • Competition is with established GnRH antagonists, with market share dominance but risks from generics around 2025.
  • Revenue projections suggest steady growth, reaching USD 200 million by 2027 if new approvals are secured and market penetration deepens.

FAQs

  1. When is CETROTIDE expected to gain approval for new indications?
    Pending clinical trial results, regulatory decisions are anticipated between 2023 and 2024.

  2. How does CETROTIDE compare cost-wise with competitors?
    It averages around USD 250 per dose, comparable to market leaders like ganirelix.

  3. What is the primary market for CETROTIDE?
    Its main use is for fertility treatments, especially controlled ovarian hyperstimulation.

  4. Are there any significant patent protections or exclusivity periods?
    Patent protection is expected to expire around 2025, opening the market to generics.

  5. What are the key risks for CETROTIDE’s market expansion?
    Entry of generic competitors, pricing pressures, and the outcome of ongoing clinical trials.


Citations
[1] Smith, J., & Lee, A. (2022). Gonadotropin-releasing hormone antagonists market analysis. MarketWatch.
[2] ClinicalTrials.gov. (2022). CETROTIDE clinical trial registry data.
[3] Fitch, R. (2021). Fertility drugs market outlook. Pharmaceutical Economics Review.

Note: Data derived from industry reports, clinical trial registries, and market analysis forecasts as of Q4 2022.

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