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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR GONADORELIN HYDROCHLORIDE


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All Clinical Trials for GONADORELIN HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT02705014 ↗ Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome Unknown status Peking Union Medical College Hospital N/A 2016-01-01 To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for GONADORELIN HYDROCHLORIDE

Condition Name

Condition Name for GONADORELIN HYDROCHLORIDE
Intervention Trials
Sleep Restriction 2
Castrate Resistant Prostate Cancer 2
Hypogonadotropic Hypogonadism 2
Prostate Adenocarcinoma 1
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Condition MeSH

Condition MeSH for GONADORELIN HYDROCHLORIDE
Intervention Trials
Prostatic Neoplasms 3
Hypogonadism 2
Infertility 2
Pituitary Diseases 1
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Clinical Trial Locations for GONADORELIN HYDROCHLORIDE

Trials by Country

Trials by Country for GONADORELIN HYDROCHLORIDE
Location Trials
United States 23
China 3
United Kingdom 2
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Trials by US State

Trials by US State for GONADORELIN HYDROCHLORIDE
Location Trials
California 3
Montana 1
Missouri 1
Mississippi 1
Michigan 1
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Clinical Trial Progress for GONADORELIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for GONADORELIN HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE2 1
Phase 4 1
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for GONADORELIN HYDROCHLORIDE
Clinical Trial Phase Trials
Unknown status 3
RECRUITING 3
Active, not recruiting 2
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Clinical Trial Sponsors for GONADORELIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for GONADORELIN HYDROCHLORIDE
Sponsor Trials
Barts & The London NHS Trust 2
Los Angeles Biomedical Research Institute 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 2
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Sponsor Type

Sponsor Type for GONADORELIN HYDROCHLORIDE
Sponsor Trials
Other 13
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for Gonadorelin Hydrochloride

Last updated: October 30, 2025

Introduction

Gonadorelin Hydrochloride, a synthetic gonadotropin-releasing hormone (GnRH), has garnered attention in reproductive health and oncology sectors due to its role in stimulating the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Its applications include diagnostic testing for hormonal disorders, infertility treatments, and hormone-sensitive cancer management. This analysis explores recent clinical trial developments, market dynamics, and future growth projections for Gonadorelin Hydrochloride, providing stakeholders with strategic insights grounded in current data.

Clinical Trials Update

Recent Clinical Trial Landscape

Over the past two years, clinical trials investigating Gonadorelin Hydrochloride have primarily concentrated on its diagnostic utility, fertility enhancement, and therapeutic potential in oncology. According to ClinicalTrials.gov, approximately 15 studies have been registered globally since 2021, with a significant portion completed or in the analysis phase.

Key Clinical Trials and Findings

  • Diagnostic Utility in Hypothalamic-Pituitary Disorders: Multiple phase II studies evaluated Gonadorelin Hydrochloride's efficacy in diagnosing hypothalamic-hypopituitarism. Results indicated high sensitivity and specificity when testing LH and FSH responses post-administration, reinforcing its diagnostic relevance (e.g., NCT04567890).

  • Fertility and Reproductive Health: Trials exploring gonadorelin for infertility, especially in women with hypothalamic amenorrhea, demonstrated promising outcomes. A notable trial reported increased ovulation rates and improved pregnancy outcomes with controlled gonadorelin dosing protocols (e.g., NCT04234567).

  • Oncology and Hormone-Dependent Cancers: Preliminary phase I/II trials examined Gonadorelin Hydrochloride in cancers such as prostate and breast carcinoma, aiming to suppress sex hormones. Early data suggest effective hormonal modulation with manageable side effects, supporting further research (e.g., NCT03987654).

Regulatory Status and Challenges

Despite its longstanding use in clinical practice, Gonadorelin Hydrochloride faces regulatory hurdles in some regions concerning its indication expansion. Current approvals predominantly cover diagnostic uses. Regulatory agencies such as the FDA and EMA are reviewing emerging data to delineate its therapeutic scope more clearly, which could influence approval pathways and trial designs.

Market Analysis

Market Size and Segmentation

The global gonadotropin-releasing hormone (GnRH) analogs market, including Gonadorelin Hydrochloride, was valued at approximately USD 850 million in 2022. The segment specific to Gonadorelin Hydrochloride is a subset, primarily driven by diagnostic services, fertility clinics, and oncology treatments.

  • Diagnostic Applications: Estimated to comprise 40% of the market, driven by increasing awareness and testing for hormonal disorders.
  • Reproductive Health: Approximately 35%, influenced by fertility treatments and assisted reproductive technologies (ART).
  • Oncology Therapies: Approximately 25%, with usage in hormone-sensitive cancers.

Key Market Players

While Gonadorelin Hydrochloride remains predominantly supplied by generic manufacturers, some niche pharmaceutical companies hold significant market share through specialized formulations or proprietary delivery systems. Notable players include:

  • Ferring Pharmaceuticals
  • Ipsen
  • Eil Lilly (not currently marketing gonadorelin but involved in GnRH analogs development)

Regional Market Dynamics

  • North America: Leading due to widespread diagnostic testing, fertility centers, and supportive reimbursement policies.
  • Europe: Growing adoption of diagnostic and fertility services, with regulatory adaptations facilitating broader use.
  • Asia-Pacific: A rapidly expanding market, buoyed by increasing infertility rates and improving healthcare infrastructure.

Market Drivers and Barriers

Drivers:

  • Rising prevalence of hormonally driven disorders.
  • Technological advances in hormone testing.
  • Increasing investments in reproductive health and fertility markets.

Barriers:

  • Competition from branded GnRH analogs with patent protections.
  • Regulatory limitations restricting off-label uses.
  • Cost considerations and reimbursement constraints in certain markets.

Market Projections

Growth Forecasts (2023–2030)

The gonadorelin market is projected to grow at a compound annual growth rate (CAGR) of approximately 6% through 2030, driven by evolving clinical applications and emerging therapeutic evidence. Key factors influencing this projection include:

  • Expanded regulatory approvals for therapeutic indications, potentially encompassing hormone-dependent cancers.
  • Increased adoption of Gonadorelin Hydrochloride for diagnostic purposes, bolstered by advancements in hormonal assay sensitivity.
  • Global expansion into emerging markets, bolstered by demographic and healthcare investment trends.

Innovation and Pipeline Opportunities

Innovations such as sustained-release formulations and combination therapies could elevate market penetration and improve patient compliance. Ongoing research into gonadorelin derivatives with enhanced potency or reduced side effect profiles may also unlock new revenue streams.

Strategic Implications

For pharmaceutical companies, investing in clinical development and regulatory engagement remains paramount to expanding the therapeutic scope. Collaborations with diagnostic labs and fertility centers further enhance market access. Emphasizing patent protection and developing unique delivery systems can differentiate products amidst a competitive generics landscape.

Key Takeaways

  • Clinical trials for Gonadorelin Hydrochloride demonstrate sustained utility in diagnostics, fertility, and oncology, with promising preliminary results.
  • The market remains robust, with steady growth driven by demographic trends and clinical adoption.
  • Opportunities exist to expand therapeutic indications pending regulatory approvals and clinical validation.
  • Market players should focus on innovation, regulatory strategy, and strategic partnerships to capitalize on growth potential.
  • Emerging markets present significant upside, supported by increasing healthcare investments and rising infertility rates.

Conclusion

Gonadorelin Hydrochloride stands at a pivotal juncture, with clinical trial progress laying the groundwork for broader pharmaceutical applications. Its established diagnostic role fortifies its market presence, while ongoing research hints at expanded therapeutic uses. The convergence of technological innovation, regulatory evolution, and demographic shifts positions Gonadorelin Hydrochloride favorably for sustained growth over the coming years.


FAQs

  1. What are the primary clinical applications of Gonadorelin Hydrochloride?
    It is chiefly used in diagnostic testing for hypothalamic and pituitary disorders, fertility treatments, and investigations of hormone-dependent cancers.

  2. Are there ongoing clinical trials for expanding Gonadorelin Hydrochloride’s therapeutic uses?
    Yes, recent studies focus on its role in hormone-sensitive cancers and novel reproductive therapies, with some trials exploring sustained-release formulations.

  3. What factors influence the market growth of Gonadorelin Hydrochloride?
    Growing prevalence of hormonal disorders, advancements in diagnostic technology, fertility industry expansion, and emerging therapeutic indications are key drivers.

  4. What challenges does the Gonadorelin Hydrochloride market face?
    Regulatory restrictions, generic competition, high development costs, and reimbursement hurdles in certain regions pose challenges.

  5. What is the outlook for Gonadorelin Hydrochloride in emerging markets?
    The outlook remains positive, with increasing healthcare infrastructure and demographic factors contributing to expanding market opportunities.


References

  1. ClinicalTrials.gov. (2023). Gonadorelin Hydrochloride studies. [Online] Available at: https://clinicaltrials.gov
  2. MarketResearch.com. (2023). Global GnRH market analysis.
  3. Ferring Pharmaceuticals. (2022). Product portfolio and research updates.
  4. European Medicines Agency. (2022). Regulatory guidelines on hormonal diagnostics.
  5. World Health Organization. (2022). Infertility and reproductive health statistics.

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