Product Description
Leuprorelin (leuprolide acetate) is a gonadotrophin-releasing hormone (GnRH) analogue used to treat a wide range of sex hormone-related disorders including advanced prostatic cancer, endometriosis and precocious puberty. It acts primarily on the anterior pituitary, inducing a transient early rise in gonadotrophin release. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/7533699/)
Mechanisms of Action: GnRH Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Intramuscular,Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Prostate Cancer | Oncology Unspecified | Pain Unspecified | Endometriosis
Known Adverse Events: Hypertension | Pain Unspecified | Respiratory Tract Infections | Musculoskeletal Pain | Migraine Disorders | Depressive Disorder | Breakthrough Pain | Headache | Insomnia | Vaginitis | Asthenia | Constipation | Diarrhea | Hot Flashes | Weight Gain | Injuries/wounds Unspecified
Company: Takeda
Company Location: TOKYO M0 103-8668
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Canada, China, Denmark, Finland, France, Italy, Korea, Netherlands, Poland, Slovakia, Spain, Sweden, United States
Active Clinical Trial Count: 16
Highest Development Phases
Phase 3: Breast Cancer|Prostate Cancer|Puberty, Precocious
Phase 2: Granulosa Cell Tumor
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| REVELUTION-2 | P3 |
Not yet recruiting |
Prostate Cancer |
2029-07-01 |
|
| NCI-2023-06524 | P2 |
Suspended |
Granulosa Cell Tumor |
2027-05-31 |
|
| ASCLEPIuS | P2 |
Active, not recruiting |
Prostate Cancer |
2026-11-01 |
|
| C3431004/MDV3100-13 | P3 |
Unknown Status |
Prostate Cancer |
2026-10-31 |