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Last Updated: January 10, 2025

CLINICAL TRIALS PROFILE FOR GONADORELIN HYDROCHLORIDE


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All Clinical Trials for gonadorelin hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01907009 ↗ A PHASEII STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT)OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (MEL-CAP). Unknown status Barts & The London NHS Trust Phase 2/Phase 3 2013-01-01 The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients. Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer. Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles. 39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive. Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs: MELPHALAN and LENOGRASTIM for 3 cycles alternately.
NCT02349347 ↗ A PHASEII STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT)OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (MEL-CAP). Unknown status Barts & The London NHS Trust Phase 2/Phase 3 2013-01-01 The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients. Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer. Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles. 39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive. Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs: MELPHALAN and LENOGRASTIM for 3 cycles alternately.
NCT02349347 ↗ A PHASEII STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT)OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (MEL-CAP). Unknown status Queen Mary University of London Phase 2/Phase 3 2013-01-01 The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients. Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer. Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles. 39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive. Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs: MELPHALAN and LENOGRASTIM for 3 cycles alternately.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for gonadorelin hydrochloride

Condition Name

2220-0.200.20.40.60.811.21.41.61.822.2Sleep RestrictionCastrate Resistant Prostate CancerHypogonadotropic Hypogonadism[disabled in preview]
Condition Name for gonadorelin hydrochloride
Intervention Trials
Sleep Restriction 2
Castrate Resistant Prostate Cancer 2
Hypogonadotropic Hypogonadism 2
[disabled in preview] 0
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Condition MeSH

321000.511.522.53Prostatic NeoplasmsHypogonadismPolycystic Ovary Syndrome[disabled in preview]
Condition MeSH for gonadorelin hydrochloride
Intervention Trials
Prostatic Neoplasms 3
Hypogonadism 2
Polycystic Ovary Syndrome 1
[disabled in preview] 0
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Clinical Trial Locations for gonadorelin hydrochloride

Trials by Country

+
Trials by Country for gonadorelin hydrochloride
Location Trials
United States 22
China 3
United Kingdom 2
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Trials by US State

+
Trials by US State for gonadorelin hydrochloride
Location Trials
California 3
Wisconsin 1
West Virginia 1
South Carolina 1
Pennsylvania 1
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Clinical Trial Progress for gonadorelin hydrochloride

Clinical Trial Phase

25.0%50.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 4Phase 2/Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for gonadorelin hydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 2
Phase 2 1
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Clinical Trial Status

42.9%28.6%28.6%000.511.522.53Unknown statusActive, not recruitingRecruiting[disabled in preview]
Clinical Trial Status for gonadorelin hydrochloride
Clinical Trial Phase Trials
Unknown status 3
Active, not recruiting 2
Recruiting 2
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Clinical Trial Sponsors for gonadorelin hydrochloride

Sponsor Name

trials000111112222Los Angeles Biomedical Research InstituteLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterBarts & The London NHS Trust[disabled in preview]
Sponsor Name for gonadorelin hydrochloride
Sponsor Trials
Los Angeles Biomedical Research Institute 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 2
Barts & The London NHS Trust 2
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Sponsor Type

91.7%8.3%0-10123456789101112OtherNIH[disabled in preview]
Sponsor Type for gonadorelin hydrochloride
Sponsor Trials
Other 11
NIH 1
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Gonadorelin hydrochloride Market Analysis and Financial Projection

Gonadorelin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Gonadorelin hydrochloride, a synthetic analogue of the naturally occurring gonadotropin-releasing hormone (GnRH), plays a crucial role in various medical and veterinary applications. This article delves into the current state of clinical trials, market analysis, and future projections for gonadorelin hydrochloride.

Clinical Trials and Applications

Veterinary Use

In the veterinary sector, gonadorelin hydrochloride is used to enhance reproductive outcomes. A recent study focused on the effect of a high dose (200 μg) of gonadorelin hydrochloride compared to the standard dose (100 μg) in lactating Holstein cows. The study aimed to determine if the higher dose would increase ovulatory response and pregnancies per artificial insemination (AI). The results indicated that cows receiving the higher dose had a higher ovulatory response and greater circulating progesterone concentrations, leading to higher pregnancy rates per AI[1].

Human Use

In human medicine, gonadorelin is used in various applications, including assisted reproductive technologies, treatment of delayed puberty, and management of hypogonadism. Clinical trials have explored its efficacy in these areas. For instance, gonadorelin is used to induce ovulation in women and spermatogenesis in men undergoing fertility treatments[5].

Adverse Events and Safety

A disproportionality analysis of adverse events associated with GnRH analogs, including gonadorelin, highlighted the importance of continuous monitoring. The study used data from the FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) to identify potential new adverse event signals. Common adverse events included cardiac failure, diabetes mellitus, liver disorder, and suicidal ideation, emphasizing the need for careful clinical monitoring[4].

Market Analysis

Market Size and Growth

The gonadorelin market has experienced significant growth in recent years and is projected to continue this trend. The market size is anticipated to expand substantially from 2023 to 2031, driven by factors such as improved diagnostic methods, advancements in healthcare infrastructure, and an aging population[2][5].

Segmentation

The market is segmented based on type (injectable, implant), application (veterinary, human), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The veterinary segment is notable for its use in enhancing reproductive outcomes in livestock, while the human segment is driven by applications in fertility treatments and hormonal disorders[2][5].

Key Drivers

  • Growing Knowledge and Diagnosis: Improved diagnostic methods and increasing awareness of hormonal abnormalities are driving the demand for gonadorelin therapy.
  • Improvements in Healthcare Infrastructure: Enhanced access to diagnosis and treatment, particularly in emerging economies, is expanding the market.
  • Aging Population: The rising incidence of age-related hormonal illnesses such as menopause and andropause is increasing the demand for gonadorelin.
  • Technological Advancements: New formulations, delivery systems, and more potent forms of gonadorelin are expected to boost market growth[5].

Challenges

  • Strict Regulatory Requirements: The approval process for new gonadorelin products is stringent, which can impede market expansion.
  • Exorbitant Treatment Cost: High treatment costs can limit access, especially in underdeveloped regions.
  • Side Effects and Safety Issues: Adverse events and safety concerns can affect market demand.
  • Restricted Therapeutic Indications: The specialized therapeutic indications of gonadorelin may limit its market potential compared to drugs with broader applications[5].

Market Projections

Forecast Period

From 2024 to 2030, the gonadorelin market is expected to grow significantly. This growth will be fueled by ongoing clinical research, technological advancements, and increasing healthcare spending. The market is anticipated to reach substantial value, driven by the expanding demand for gonadorelin in both veterinary and human healthcare sectors[5].

Geographical Outlook

The market will see significant growth in various regions, including North America, Europe, and the Asia-Pacific. Emerging economies, particularly in the Asia-Pacific region, are expected to contribute significantly to the market's expansion due to improvements in healthcare infrastructure and increasing awareness of hormonal disorders[2][5].

Competitive Landscape

The market is competitive, with several key players such as Ferring, Xuchang Shangke Chemical, Bachem, Aspen Oss, and Merck. These companies are focusing on product innovation, price strategies, and expanding their market presence through various distribution channels, including hospitals, clinics, retail pharmacies, and online pharmacies[5].

Key Players and Distribution Channels

Key Players

Major players in the gonadorelin market include Ferring, Xuchang Shangke Chemical, Bachem, Aspen Oss, Shenzhen JYMed Technology, Toronto Research Chemicals, LKT Laboratories, Hemmo Pharmaceutical, Angle BioPharma, and Merck. These companies are driving innovation and market expansion through their products and strategies[5].

Distribution Channels

Gonadorelin products are primarily distributed through hospitals and clinics, where they are administered under medical supervision. Retail pharmacies and online pharmacies also play a role, subject to regulatory requirements. The diversity in distribution channels ensures broader access to gonadorelin treatments[5].

Key Takeaways

  • Clinical Trials: Ongoing clinical trials are exploring the efficacy and safety of gonadorelin hydrochloride in various applications.
  • Market Growth: The market is projected to grow significantly from 2023 to 2031, driven by improved diagnostics, healthcare infrastructure, and an aging population.
  • Segmentation: The market is segmented by type, application, and geography, with key drivers including growing knowledge, improvements in healthcare, and technological advancements.
  • Challenges: Regulatory requirements, treatment costs, side effects, and restricted therapeutic indications are key challenges.
  • Geographical Outlook: Significant growth is expected in North America, Europe, and the Asia-Pacific region.
  • Competitive Landscape: The market is competitive with several key players focusing on innovation and market expansion.

FAQs

What is gonadorelin hydrochloride used for in veterinary medicine?

Gonadorelin hydrochloride is used in veterinary medicine to enhance reproductive outcomes, particularly to increase ovulatory response and pregnancies per artificial insemination in lactating cows.

What are the common adverse events associated with gonadorelin hydrochloride?

Common adverse events include cardiac failure, diabetes mellitus, liver disorder, and suicidal ideation, highlighting the need for continuous clinical monitoring.

Which regions are expected to drive the growth of the gonadorelin market?

The Asia-Pacific region, along with North America and Europe, is expected to drive significant growth in the gonadorelin market due to improvements in healthcare infrastructure and increasing awareness of hormonal disorders.

Who are the key players in the gonadorelin market?

Key players include Ferring, Xuchang Shangke Chemical, Bachem, Aspen Oss, Shenzhen JYMed Technology, Toronto Research Chemicals, LKT Laboratories, Hemmo Pharmaceutical, Angle BioPharma, and Merck.

What are the main distribution channels for gonadorelin products?

Gonadorelin products are primarily distributed through hospitals and clinics, with additional distribution through retail pharmacies and online pharmacies subject to regulatory requirements.

Sources

  1. Journal of Dairy Science: "Effect of using 200 μg of gonadorelin at the first gonadotropin treatment of the breeding-Ovsynch protocol on ovulatory response and pregnancies per artificial insemination in lactating Holstein cows."
  2. Market Research Intellect: "Gonadorelin Sales Market Size, Scope And Forecast Report."
  3. University of Maryland, Baltimore: "Gonadorelin acetate - University of Maryland, Baltimore."
  4. Frontiers in Pharmacology: "A disproportionality analysis of adverse events caused by GnRHas from the FAERS and JADER databases."
  5. Verified Market Research: "In-Depth Industry Outlook: Gonadorelin Market Size, Forecast."

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