Firmagon(degarelix)
Degarelix, Firmagon (degarelix) is a protein pharmaceutical. Degarelix was first approved as Firmagon on 2008-12-24. It is used to treat prostatic neoplasms in the USA. It has been approved in Europe to treat prostatic neoplasms. The pharmaceutical is active against gonadotropin-releasing hormone receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Firmagon
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Degarelix acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FIRMAGON | Ferring Pharmaceuticals | N-022201 RX | 2008-12-24 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| firmagon | New Drug Application | 2024-01-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| prostatic neoplasms | — | D011471 | C61 |
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J9155 | Injection, degarelix, 1 mg |
Clinical
Clinical Trials
170 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 15 | 67 | 35 | 6 | 25 | 137 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | 3 | 1 | 4 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | 3 | — | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 1 | 1 | — | 3 |
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | 2 | — | 1 | — | 3 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | 2 | — | 1 | — | 3 |
| Abdominal obesity | D056128 | — | — | — | — | — | 1 | — | 1 |
| Weight gain | D015430 | — | — | — | — | — | 1 | — | 1 |
| Adiposity | D050154 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 2 | 10 | 5 | — | 2 | 18 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 2 | 3 | 1 | — | — | 6 |
| Infertility | D007246 | EFO_0000545 | — | — | 1 | 1 | — | 2 | 4 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 2 | — | 1 | 3 |
| Ovarian pregnancy | D065172 | — | O00.2 | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | 1 | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | 1 | — | — | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | 1 | — | — | 1 |
| Hot flashes | D019584 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female infertility | D007247 | EFO_0008560 | N97 | — | 1 | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
| Neoadjuvant therapy | D020360 | — | — | — | 1 | — | — | — | 1 |
| Prostatectomy | D011468 | — | — | — | 1 | — | — | — | 1 |
| Ductal carcinoma breast | D018270 | — | — | — | 1 | — | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | — | 1 | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | — | — | 1 | 1 |
| Premature menopause | D008594 | — | E28.31 | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Fertility | D005298 | — | — | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | — | 1 | 1 |
| Vascular stiffness | D059289 | — | — | — | — | — | — | 1 | 1 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 1 | 1 |
| Fertilization in vitro | D005307 | — | — | — | — | — | — | 1 | 1 |
| Ovarian hyperstimulation syndrome | D016471 | — | — | — | — | — | — | 1 | 1 |
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Degarelix |
| INN | degarelix |
| Description | Degarelix is a polypeptide. |
| Classification | Protein |
| Drug class | hormone-release inhibiting peptides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 214766-78-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL415606 |
| ChEBI ID | — |
| PubChem CID | 16136245 |
| DrugBank | DB06699 |
| UNII ID | SX0XJI3A11 (ChemIDplus, GSRS) |
Target
Agency Approved
GNRHR
GNRHR
Organism
Homo sapiens
Gene name
GNRHR
Gene synonyms
GRHR
NCBI Gene ID
Protein name
gonadotropin-releasing hormone receptor
Protein synonyms
gnRH receptor, gnRH-R, gonadotropin-releasing hormone (type 1) receptor 1, leutinizing hormone releasing horomone receptor, leutinizing-releasing hormone receptor, luliberin receptor, type I GnRH receptor
Uniprot ID
Mouse ortholog
Gnrhr (14715)
gonadotropin-releasing hormone receptor (Q61611)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,961 adverse events reported
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