CLINICAL TRIALS PROFILE FOR GONADORELIN HYDROCHLORIDE

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.

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

Condition MeSH

Condition MeSH for gonadorelin hydrochloride
Intervention	Trials
Prostatic Neoplasms	3
Infertility	2
Hypogonadism	2

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

Trials by US State

Trials by US State for gonadorelin hydrochloride
Location	Trials
California	3
Georgia	1
District of Columbia	1
Arizona	1
Colorado	1

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

Clinical Trial Status

Clinical Trial Status for gonadorelin hydrochloride
Clinical Trial Phase	Trials
RECRUITING	3
Unknown status	3
Active, not recruiting	2

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

Sponsor Type

Sponsor Type for gonadorelin hydrochloride
Sponsor	Trials
Other	13
NIH	1

Last updated: July 27, 2026

Gonadorelin Hydrochloride Clinical Trials Update, Market Analysis, and Revenue Projection (2026–2036)

Executive summary

Public information on gonadorelin hydrochloride clinical development is sparse and fragmented by indication, dose regimen, and data-holder. Market exposure is anchored in legacy use of gonadotropin-releasing hormone (GnRH) therapy (idiopathic hypogonadotropic hypogonadism and infertility-related indications historically using pulsatile or timed gonadorelin administration). Current commercial trajectory depends on (1) whether marketed products retain steady pricing/volume in their core geographies, (2) competitive pressure from alternative GnRH analogs and gonadotropin regimens, and (3) regulatory and patent status by country. Without a drug-specific Orange Book / patent estate, FDA approvals-by-NDA/BLA mapping, and verified trial registry snapshots, a complete, auditable projection for 2026–2036 cannot be produced in a manner suitable for R&D, licensing, or litigation decisions.

What clinical trials exist for gonadorelin hydrochloride, and what is the latest status?

No complete, authoritative, drug-substance-level “latest trials” dataset is available in the current context to support a reliable update by study phase (Phase 1/2/3), enrollment status, completion dates, or endpoints for gonadorelin hydrochloride across geographies.

Which indications are most commonly studied (historically)

Gonadorelin hydrochloride is used in clinical practice as a GnRH agonist with pulsatile administration in selected reproductive endocrine disorders. Typical historical study endpoints include LH/FSH axis restoration, ovulation induction response metrics, and endocrine biomarker normalization. A precise, current clinical-trials update by endpoint cannot be compiled from the available material.

What endpoints would matter for an R&D update

For decision-grade development, trials typically report:

• LH and FSH pulsatility and magnitude after dosing
• Time to ovulation and pregnancy rate (infertility indications)
• Testosterone or estradiol recovery (hypogonadotropic hypogonadism)
• Safety signals: headache, injection site reactions, and gonadotropin-related adverse events

Is gonadorelin hydrochloride approved by the FDA, and what is its regulatory status?

A complete regulatory status mapping (NDA numbers, labeling indications, dosage forms, and any exclusivity flags) cannot be produced from the information available in this context.

What you would need to validate for market entry or competition

Decision-critical regulatory elements include:

• Approved dosage forms and strengths (injectable vs other)
• Indication-specific labeling scope
• Status of any risk evaluation and mitigation strategy (REMS), if applicable
• Whether any ANDA/505(b)(2) pathways cite the reference listed drug

What patents protect gonadorelin hydrochloride, and when do they expire?

A complete patent estate assessment requires verified patent numbers, assignees, claims scope (composition, formulation, method-of-use), and jurisdiction-specific expiration. That information is not available in this context, so a full protection and expiration timeline cannot be issued.

What patent categories typically appear for GnRH products

For GnRH therapies, estates often split into:

• Composition of matter (active ingredient salt or specific polymorphs)
• Formulation patents (concentration, stabilizers, delivery device)
• Method-of-use patents (pulsatile dosing schedules, patient subpopulations)
• Device or pump-related claims (if sustained/pulsatile systems are integral)

How big is the market for gonadorelin hydrochloride, and where is revenue concentrated?

A quantitative market sizing and geography split cannot be produced from the information available in this context.

What typically drives demand

Demand drivers for GnRH therapy products include:

• Urology and reproductive endocrinology prescribing patterns
• Use in infertility workups and hypogonadism management
• Availability of alternative therapies (gonadotropins, other GnRH agonists/antagonists)
• Health-system formularies and procurement pricing

Who are the competitors to gonadorelin hydrochloride in reproductive endocrinology?

A verified competitive landscape requires current marketed alternatives by indication and geography plus their regulatory and pricing posture. That level of mapping cannot be produced from the available context.

Most relevant comparator classes

Common therapeutic substitutes include:

• Gonadotropins (FSH/LH preparations or hMG)
• Other GnRH agonists with different pharmacokinetics (including depot formulations)
• GnRH antagonists (where used in fertility protocols)

What is the clinical and commercial development outlook for gonadorelin hydrochloride?

A development outlook and market projection require:

• Current trial readouts or ongoing studies by indication
• Regulatory pathway and approval probability
• Pricing and reimbursement conditions None of these are available in a decision-grade, auditable way in the current context.

Revenue projection: base case, upside, and downside (2026–2036)

A 2026–2036 revenue projection cannot be generated without inputs that are not present here, including: (1) current unit sales and pricing, (2) approved indication and volume durability, (3) competitive entry timing, and (4) IP/regulatory events by geography.

Key Takeaways

• A decision-grade clinical trials update and 2026–2036 market projection for gonadorelin hydrochloride cannot be produced from the available information in this context.
• Market exposure for gonadorelin hydrochloride depends on approved labeling durability, competitive substitution by GnRH alternatives and gonadotropin regimens, and country-specific regulatory and patent status.
• A complete update for R&D, licensing, or litigation use requires verified data sources for trial registries, FDA approvals/Orange Book entries, and jurisdictional patent estates, mapped to the specific marketed product(s).

FAQs

1. What is gonadorelin hydrochloride used for in clinical practice?
2. How does gonadorelin hydrochloride compare with GnRH agonists and antagonists for fertility protocols?
3. What dosing regimens are typically used with gonadorelin in hypogonadotropic hypogonadism?
4. Are there generic or 505(b)(2) alternatives for gonadorelin hydrochloride in the US?
5. What clinical endpoints matter most for new gonadorelin hydrochloride trials?

References

No sources were cited because no verifiable, drug-specific clinical, regulatory, patent, or market data are available in the provided context.