Overview
Degarelix is used for the treatment of advanced prostate cancer. Degarelix is a synthetic peptide derivative drug which binds to gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland and blocks interaction with GnRH. This antagonism reduces luteinising hormone (LH) and follicle-stimulating hormone (FSH) which ultimately causes testosterone suppression. Reduction in testosterone is important in treating men with advanced prostate cancer. Chemically, it is a synthetic linear decapeptide amide with seven unnatural amino acids, five of which are D-amino acids. FDA approved on December 24, 2008.
Indication
Degaralix is used for the management of advanced prostate cancer.
Associated Conditions
- Advanced Prostate Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/03 | Phase 2 | Recruiting | |||
2024/04/23 | Phase 2 | Recruiting | |||
2024/02/28 | Phase 2 | Recruiting | Cancer Research Antwerp | ||
2024/02/20 | Phase 4 | Recruiting | |||
2024/01/23 | Phase 1 | Withdrawn | |||
2023/06/26 | Phase 1 | Active, not recruiting | |||
2023/05/24 | Phase 2 | Not yet recruiting | |||
2023/05/03 | Phase 1 | Recruiting | |||
2023/01/26 | N/A | Completed | |||
2022/11/16 | Phase 1 | Active, not recruiting | Praful Ravi, MB BCHir, MRCP |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/29/2023 | ||
Authorised | 2/17/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FIRMAGON Powder and Solvent for Solution for Injection 80 mg | SIN14351P | INJECTION, POWDER, FOR SOLUTION | 80 mg | 5/13/2013 | |
| FIRMAGON Powder and Solvent for Solution for Injection 120 mg | SIN14350P | INJECTION, POWDER, FOR SOLUTION | 120 mg | 5/13/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Degarelix Acetate for Injection | 国药准字HJ20180054 | 化学药品 | 注射剂 | 3/1/2024 | |
| Degarelix Acetate for Injection | 国药准字HJ20180053 | 化学药品 | 注射剂 | 3/1/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FIRMAGON degarelix (as acetate) composite pack of 80mg powder in vial and solvent for injection in pre-filled syringe | 200047 | Medicine | A | 10/31/2012 | |
| FIRMAGON degarelix (as acetate) composite 120 mg powder in vial and solvent for injection in pre-filled syringe | 200046 | Medicine | A | 10/31/2012 |
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