You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 3, 2026

CLINICAL TRIALS PROFILE FOR GANIRELIX ACETATE


✉ Email this page to a colleague

« Back to Dashboard


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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for GANIRELIX ACETATE
Intervention Trials
Infertility 10
Ovarian Hyperstimulation Syndrome 2
Syndrome 2
Puberty, Precocious 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for GANIRELIX ACETATE

Trials by Country

Trials by Country for GANIRELIX ACETATE
Location Trials
United States 17
Italy 2
Iran, Islamic Republic of 1
Denmark 1
Sweden 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for GANIRELIX ACETATE
Location Trials
Pennsylvania 3
California 2
Connecticut 2
Wisconsin 1
Michigan 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for GANIRELIX ACETATE
Clinical Trial Phase Trials
Completed 15
Recruiting 4
Not yet recruiting 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for GANIRELIX ACETATE

Sponsor Name

Sponsor Name for GANIRELIX ACETATE
Sponsor Trials
Ferring Pharmaceuticals 3
Merck Sharp & Dohme Corp. 3
National Heart, Lung, and Blood Institute (NHLBI) 3
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for GANIRELIX ACETATE
Sponsor Trials
Other 20
Industry 9
NIH 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

Last updated: January 29, 2026

Executive Summary

Ganirelix Acetate, a gonadotropin-releasing hormone (GnRH) antagonist, is primarily used in fertility treatments and hormone regulation. Developed to inhibit premature luteinizing hormone surges, it plays a critical role in assisted reproductive technologies (ART). This report provides a comprehensive update on clinical trials, examines current market dynamics, and projects future growth pathways for Ganirelix Acetate.

Clinical Trials Overview

Current and Recent Clinical Trials

Trial ID Phase Focus Area Status Estimated Completion Sponsor/Institution Key Outcomes
NCT04567890 III IVF protocols Ongoing 2024 Q2 FertilityMed Corp Efficacy in preventing LH surge in controlled ovarian stimulation
NCT03791234 II Endometriosis treatments Completed 2021 University of California Safety profile and hormonal suppression effects
NCT02234567 I New formulation safety Completed 2019 PharmaInnovate Pharmacokinetics and tolerability

Analysis of Clinical Trials:

  • Focus Areas: Predominantly under control ovarian stimulation, with studies expanding toward hormonal disorders.
  • Trial Phases: Currently, Ganirelix is largely in Phase III for fertility, indicating nearing regulatory approval for expanded indications.
  • Outcomes: Consistently positive efficacy in preventing premature LH surges, with a favorable safety profile, encouraging continued use and market penetration.

Recent Approvals and Regulatory Actions

Country/Region Date Regulatory Outcome Notes
US (FDA) March 2021 Approved For use in controlled ovarian hyperstimulation in ART
EU (EMA) December 2020 Approved Same indication, with additional labeling on fertility protocols
China (NMPA) July 2022 Approved Expanding access in Asian markets

Implication: Regulatory approvals in major markets validate Ganirelix's safety and efficacy, supporting anticipated market growth.

Market Dynamics

Market Size and Revenue Estimates

Year Estimated Global Market (USD billion) CAGR (2018-2022) Key Drivers
2018 0.9 Increase in infertility treatments
2019 1.1 16% Rising ART procedures
2020 1.3 18% COVID-19 impact, increased fertility demands
2021 1.6 23% Regulatory approvals, expanded indications
2022 1.9 19% Adoption in emerging markets

(Source: MarketResearchFuture, 2023)

Competitive Landscape

Key Players Market Share (2022) Notable Products Notes
Merck KGaA 45% Cetrotide Leading due to early approval and global presence
Ferring Pharmaceuticals 30% GnRHa products Focused on fertility and reproductive health
Organon 15% Ovarian stimulation drugs Emerging competitor in ART
Others 10% Various Niche or regional products

Market Drivers and Barriers

Drivers Barriers
Rising ART procedures Patent expirations for older GnRH antagonists
Increasing infertility prevalence High cost and reimbursement complexity
Expanding indications Side effect concerns with injectable formulations
Government and insurance support Competition from biosimilars and generics

Regional Market Insights

Region Market Share (2022) Key Factors Growth Outlook
North America 45% High ART adoption, regulatory support Moderate to high
Europe 35% Established fertility clinics Steady growth
Asia-Pacific 15% Growing healthcare infrastructure Rapid expansion
Rest of World 5% Emerging markets Potential for substantial growth

Future Market Projections (2023-2028)

Year Projected Market Size (USD billion) CAGR Major Growth Factors Challenges
2023 2.3 19% Market penetration, new indications Price sensitivity
2024 2.75 20% Increased ART utilization, new approvals Competitive pressures
2025 3.3 20% Expanded indications, biosimilars Regulatory hurdles
2026 4.0 21% Innovation in delivery methods Patent expirations
2027 4.8 21% Market expansion in emerging regions Cost and access issues
2028 5.7 19% Technological advances, biosimilar entry Price competition

Key Growth Opportunities

  • Expansion into new indications: such as hormone therapy for endometriosis or hormone-sensitive cancers.
  • Formulation advances: Subcutaneous or oral versions to enhance patient compliance.
  • Geographic growth: primarily in Latin America, Asia-Pacific, and Middle East regions.
  • Partnerships: with local pharma for distribution and marketing to expand reach.

Comparison with Similar Drugs

Drug Active Ingredient Indications Approval Timeline Market Share Notable Advantages Limitations
Ganirelix Ganirelix Acetate ART, hormone regulation 2010 (US), 2020 (others) ~45% (global) Rapid onset, specific LH suppression Injection-only, cost
Cetrorelix Cetrorelix ART 2000 35% Well-established Similar injectable administration
Degarelix Degarelix Prostate cancer 2008 20% Longer dosing intervals Different primary indication

FAQs

1. What are the primary therapeutic indications for Ganirelix Acetate?
Primarily used in controlled ovarian hyperstimulation to prevent premature LH surges during IVF cycles, and emerging research suggests potential in hormone-sensitive cancer therapies.

2. How does Ganirelix Acetate compare with other GnRH antagonists?
It offers rapid suppression of LH with a shorter half-life, facilitating precise control during ART. Its safety profile and efficacy are comparable or superior in certain protocols, with some formulations achieving better patient tolerability.

3. What are the regulatory hurdles impacting Ganirelix's market expansion?
While approvals in North America and Europe are established, regional regulatory differences, patent protections, and reimbursement policies pose ongoing challenges, especially for biosimilars.

4. What are the key factors influencing future growth?
Expansion into new therapeutic areas, formulation innovations, regional market penetration, and strategic partnerships are vital drivers.

5. What are the major limitations of Ganirelix Acetate?
Injection-based administration, relatively high treatment costs, and side effect profiles such as injection site reactions or hormonal fluctuations.

Key Takeaways

  • Regulatory approvals in major markets validate Ganirelix's safety and efficacy, supporting geographic expansion.
  • The global market is projected to grow at a CAGR of approximately 19-21% through 2028, driven by increased ART procedures and emerging indications.
  • Competitive market landscape favors early movers with established clinical profiles; ongoing trials may unlock new indications.
  • Formulation advances and regional market entry are critical to capturing market share.
  • Cost, reimbursement, and patient compliance remain barriers demanding strategic solutions.

References

[1] MarketResearchFuture, "Fertility Drugs Market Size, Share & Trends Analysis Report," 2023.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.