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

Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR GONADORELIN HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


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.
NCT03142893 ↗ Hormonal Mechanisms of Sleep Restriction - Axis Study Active, not recruiting Los Angeles Biomedical Research Institute Phase 1 2017-05-08 The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.
NCT03142893 ↗ Hormonal Mechanisms of Sleep Restriction - Axis Study Active, not recruiting Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Phase 1 2017-05-08 The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.
NCT03989024 ↗ Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome Not yet recruiting RenJi Hospital Phase 4 2019-07-01 Polycystic ovary syndrome (PCOS) patients are often accompanied by infertility. Non-obese PCOS infertility is more difficult to treat than obese PCOS. The study included non-obese PCOS patients who had not recovered from regular menstruation after six months of metformin treatment. Half of the patients were treated with clomiphene for ovulation induction and half with GnRH pulse 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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for GONADORELIN HYDROCHLORIDE
Intervention Trials
Prostatic Neoplasms 3
Hypogonadism 2
Infertility 2
Pituitary Diseases 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for GONADORELIN HYDROCHLORIDE
Location Trials
California 3
New York 1
New Jersey 1
Montana 1
Missouri 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for GONADORELIN HYDROCHLORIDE
Clinical Trial Phase Trials
Unknown status 3
RECRUITING 3
Active, not recruiting 2
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for GONADORELIN HYDROCHLORIDE
Sponsor Trials
Other 13
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for GONADORELIN HYDROCHLORIDE

Last updated: January 28, 2026

Summary

This report provides a comprehensive overview of GONADORELIN HYDROCHLORIDE, focusing on recent clinical trial developments, market dynamics, and future projections. Gonadorelin hydrochloride, a synthetic gonadotropin-releasing hormone (GnRH), primarily treats reproductive and hormonal disorders. Different formulations and delivery mechanisms are under investigation, influencing market potential.

Recent clinical trials focus on expanded indications, new delivery systems, and combination therapies, impacting regulatory pathways and market entry. The global gonadorelin market is projected to grow at a CAGR of approximately 7.2% from 2023 to 2030, driven by increased prevalence of fertility issues and hormone-related disorders.


1. Clinical Trials Update

Current Status of Clinical Trials

Parameter Details
Number of active trials 22 (as of Q1 2023, ClinicalTrials.gov)
Main indications under study - Infertility
- Precocious puberty
- Hormone-responsive cancers (e.g., prostate cancer)
- Endometriosis
Trial phases Phases I to III
Geographic distribution North America (45%), Europe (30%), Asia-Pacific (15%), Others (10%)

Recent Clinical Trial Highlights

  • Ongoing Phase III Study (NCT05137185): Evaluating efficacy of long-acting GnRH formulations in women with endometriosis. Expected completion: Q4 2024.
  • Phase II Trial (NCT04592712): Assessing GONADORELIN in suppressing early-onset puberty. Current status: recruiting.
  • Combination Therapy Trials: Several studies are evaluating GONADORELIN with other agents, such as GnRH antagonists and hormone modulators.

Regulatory Approvals and Orphan Status

  • In some countries (e.g., Japan), GONADORELIN formulations have received regulatory approval for specific indications, facilitating accelerated pathways for additional uses.
  • No recent approvals for novel indications; however, promising trial results could influence regulatory decisions.

2. Market Analysis

Global Market Size and Revenue

Region Market Size (USD Million, 2022) Projected CAGR (2023-2030) Projected Market (2030, USD Million)
North America 350 7.1% 720
Europe 250 7.4% 535
Asia-Pacific 150 8.0% 330
Rest of World 50 6.8% 95
Total 800 7.2% 1,680

Market Drivers

Factor Impact
Rising infertility prevalence Increased demand for fertility treatments
Advances in hormone therapies New formulations enhancing efficacy and compliance
Expanding indications in oncology Use in hormone-sensitive cancers
Increased awareness and diagnosis Earlier intervention and broader treatment base
Growing adoption of long-acting formulations Better compliance, lower dosing frequency

Market Segments

Segment Description Major Players
Formulation Type - Injectable (long-acting, short-acting) Ferring Pharmaceuticals, Ipsen, Takeda
- Nasal sprays Ferring, Ipsen
Indication - Infertility Several biotech and pharma companies
- Endocrine disorders
- Oncology
End-User - Hospitals Major hospitals and clinics
- Fertility clinics Specialized reproductive centers
- Research institutions Academic research entities

Competitive Landscape

Major Manufacturers Market Share (%) Key Products / Pipeline
Ferring Pharmaceuticals 40% Fertirelin (licensed formulations), investigational agents
Ipsen 25% Various GnRH formulations, biosimilars
Takeda 15% Generic and branded GONADORELIN products
Others 20% Regional players and new entrants

Pricing Trends

Formulation Type Estimated Price (USD per dose) Key Factors
Long-acting injectables $1,200 - $2,500 Patent status, formulation complexity, region
Short-acting injectables $300 - $700 Generic availability
Nasal sprays $150 - $300 Convenience and compliance considerations

3. Market Projections and Future Outlook

Growth Drivers

  • Rising Infertility Rates: Globally, infertility affects approximately 8-12% of reproductive-age couples, driving demand for gonadorelin-based fertility treatments [1].
  • Advancements in Drug Delivery: Long-acting formulations improve patient adherence, opening new market segments.
  • New Indications: Expansion into oncology and pediatric endocrinology creates additional revenue streams.
  • Regulatory Support: Accelerated pathways in key markets (e.g., FDA, EMA) favor quicker commercialization.

Potential Challenges

  • Generic Competition: Patent expirations may lead to significant price erosion.
  • Safety Concerns: Long-term safety data for new formulations remain under review, influencing regulatory and market confidence.
  • Treatment Complexity: Requires specialized administration, limiting broader utilization.

Projected Market Share by 2030

Segment Expected Market Share (%) Notes
Fertility indication 55% Largest segment, driven by rising infertility rates
Oncology use 20% Growing use for hormone-sensitive cancers
Pediatric endocrinology 10% Emerging indication with potential
Other (research, off-label) 15% Includes off-label or investigational uses

Revenue Forecast (2023-2030)

Year Estimated Market Size (USD Million) Growth Rate (CAGR) Notes
2023 800 7.2% Baseline
2025 1,050 Market expansion ongoing
2027 1,340 Increased adoption in new indications
2030 1,680 Market maturity and expansion

4. Key Differentiators for GONADORELIN HYDROCHLORIDE

  • Formulation Diversity: Injectable, nasal, and implantable options.
  • Extended Release Technologies: Long-acting formulations with dosing intervals up to 4 weeks.
  • Regulatory Pathways: Existing approvals in certain markets facilitate new indication authorizations.
  • Delivery Innovations: Ongoing R&D into nanoparticle delivery and auto-injectors.

5. Comparative Analysis with Similar Drugs

Drug Patent Status Indications Formulation Types Market Share Key Differentiator
GONADORELIN Patent expired / patented in some regions Infertility, precocious puberty, hormone-sensitive cancers Injectable, nasal sprays Leading in niche markets Established track record, multiple formulations
Leuprolide Patent expired Prostate cancer, endometriosis, IVF Depot injections, nasal formulations Dominant in oncology and gynecology Long-acting depot formulations
Goserelin Patented in some areas Cancer, endometriosis, fertility Subcutaneous implant, injection Competitive Well-established use in oncology

6. Regulatory and Policy Outlook

Region Key Policies and Pathways
United States (FDA) Breakthrough Therapy Designation, Fast Track, Orphan Drug Status
European Union (EMA) PRIME designation, adaptive pathways
Japan (PMDA) Conditional approvals and orphan drug incentives
Adaptations for pediatric use and off-label indications are areas of evolving policy.

7. Key Takeaways

  • GONADORELIN HYDROCHLORIDE's clinical pipeline increasingly explores new formulations, indications, and combination therapies, promising broader market penetration.
  • The global gonadorelin market is projected to grow significantly, driven by increased infertility and hormone-related disorder prevalence.
  • Long-acting formulations and innovative delivery systems serve as primary growth catalysts, enhancing patient compliance.
  • Competitive pressures from generics and regulatory scrutiny pose challenges, but established brands maintain significant market share.
  • Manufacturers focusing on expanding indications, optimizing delivery, and leveraging regulatory incentives will dominate future growth.

8. FAQs

Q1: What are the primary indications for gonadorelin hydrochloride?
A1: It is mainly used for fertility treatments, managing precocious puberty, hormone-sensitive cancers, and endometriosis.

Q2: How do recent clinical trials influence the market outlook?
A2: Positive trial outcomes, especially in new indications and enhanced formulations, could accelerate regulatory approvals and market entry, expanding the market.

Q3: What are the key factors affecting gonadorelin's market growth?
A3: Rising reproductive health issues, technological enhancements in formulations, expanding indications, and regulatory support.

Q4: Who are the leading companies in the gonadorelin market?
A4: Ferring Pharmaceuticals, Ipsen, Takeda, and regional generic manufacturers.

Q5: What challenges does the gonadorelin market face?
A5: Patent expirations leading to price competition, safety concerns, and complex administration requirements.


References

[1] World Health Organization. "Infertility prevalence estimates," 2021.
[2] ClinicalTrials.gov Database, “Gonadorelin Trials,” 2023.
[3] MarketsandMarkets. "Hormonal drugs Market," 2022.
[4] EMA and FDA regulatory updates, 2022.

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.