Product Description
Gonadorelin is a medicine that is the same as gonadotropin-releasing hormone (GnRH) that is naturally released from the hypothalamus gland. GnRH causes the pituitary gland to release other hormones (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]). LH and FSH control development in children and fertility in adults. (Sourced from: https://www.mayoclinic.org/drugs-supplements/gonadorelin-intravenous-route-injection-route/description/drg-20067426)
Mechanisms of Action: GnRH Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Intravenous, Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Austria | Bangladesh | Canada | Chile | Czech | Dominican Republic | France | Germany | Greece | Hong Kong | India | Ireland | Italy | Korea | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Poland | Slovenia | South Africa | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Merck KGaA
Company Location: GERMANY HRB 6164 I8
Company CEO: Belen Garijo
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, Czech Republic, France, Germany, Italy, Korea, Netherlands, Russia, Spain, Switzerland, Turkey, United Kingdom, United States
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Adenocarcinoma|Prostate Cancer
Phase 2: Ovarian Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| BOUQUET | P2 |
Active, not recruiting |
Ovarian Cancer |
2028-02-28 |
2% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| GUIDANCE | P3 |
Recruiting |
Adenocarcinoma|Prostate Cancer |
2026-11-11 |
2025-03-18 |
Primary Endpoints |
|
| RADIODOSE | P1 |
Recruiting |
Prostate Cancer |
2028-11-24 |
50% |
2025-08-08 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| NEPC Study | P1 |
Recruiting |
Prostate Cancer |
2027-06-23 |
50% |
2025-11-01 |
|
| MCC-21139 | P2 |
Active, not recruiting |
Prostate Cancer |
2027-07-15 |
2% |
2024-07-24 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| PREDICT-RT* | P3 |
Active, not recruiting |
Adenocarcinoma|Prostate Cancer |
2033-12-31 |
2025-09-12 |
Primary Endpoints |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
10/20/2025 |
News Article |
The results of the EMPRESS study show the activity of giredestrant in reducing tumor proliferation in ER+/HER2- breast cancer at early stages without the need for ovarian function suppression |
|
10/17/2025 |
News Article |
Novartis Kisqali® 5-year NATALEE data demonstrate 28% reduction in risk of recurrence in the broadest early breast cancer patient population |
|
10/07/2025 |
News Article |
Knight Therapeutics Announces Relaunch of ORGOVYX® in Canada |
|
10/07/2025 |
News Article |
Knight Therapeutics Announces Relaunch of MYFEMBREE® in Canada |