Goserelin
Zoladex (goserelin) is a protein pharmaceutical. Goserelin was first approved as Zoladex on 1989-12-29. The pharmaceutical is active against gonadotropin-releasing hormone receptor.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Zoladex
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Goserelin acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZOLADEX | TerSera Therapeutics | N-019726 RX | 1989-12-29 | 1 products, RLD, RS |
| ZOLADEX | TerSera Therapeutics | N-020578 RX | 1996-01-11 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zoladex | New Drug Application | 2023-03-24 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9202 | Goserelin acetate implant, per 3.6 mg |
| S9560 | Home injectable therapy; hormonal therapy (e.g.; leuprolide, goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem |
Clinical
Clinical Trials
377 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 | 24 | 86 | 63 | 11 | 24 | 195 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 9 | 62 | 53 | 4 | 12 | 136 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | 10 | — | 1 | 1 | 13 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | 5 | 5 | 10 |
| Infertility | D007246 | HP_0000789 | — | — | — | 3 | 1 | 2 | 6 |
| Leiomyoma | D007889 | HP_0000131 | D25 | — | — | 1 | 2 | 2 | 5 |
| Myofibroma | D047708 | — | — | — | — | — | 2 | 2 | 4 |
| Muscular atrophy | D009133 | HP_0003202 | — | — | — | 1 | 1 | — | 2 |
| Atrophy | D001284 | — | — | — | — | — | 1 | — | 1 |
| X-linked bulbo-spinal atrophy | D055534 | Orphanet_139557 | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 4 | 16 | 7 | — | 1 | 25 |
| Carcinoma | D002277 | — | C80.0 | 1 | 6 | 3 | — | 1 | 11 |
| Male breast neoplasms | D018567 | — | — | 2 | 1 | 5 | — | 2 | 10 |
| Neoplasms | D009369 | — | C80 | — | 5 | 3 | — | 1 | 9 |
| Recurrence | D012008 | — | — | — | 3 | 3 | — | 1 | 7 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 3 | 2 | — | — | 4 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | 1 | — | 1 | 2 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | 1 | — | 1 | 2 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | — | — | 1 | — | — | 1 |
| Drug therapy | D004358 | — | — | — | 1 | 1 | — | — | 1 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | 1 | 6 | — | — | 2 | 9 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | — | 3 | — | — | — | 3 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | 1 | — | — | 1 | 3 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | 1 | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 3 | — | — | — | 3 |
| Fallopian tube neoplasms | D005185 | — | — | — | 2 | — | — | — | 2 |
| Azoospermia | D053713 | EFO_0000279 | N46.0 | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Lobular carcinoma | D018275 | EFO_0000570 | — | — | 1 | — | — | — | 1 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | — | 1 | — | — | — | 1 |
Show 13 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | HP_0000855 | — | 1 | — | — | — | 1 | 2 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | — | — | — | — | 1 |
| Uterine hemorrhage | D014592 | — | — | 1 | — | — | — | — | 1 |
| Metrorrhagia | D008796 | HP_0100608 | N92.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | — | — | — | 1 | 1 |
| Nerve degeneration | D009410 | HP_0002180 | — | — | — | — | — | 1 | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
| Psychotic disorders | D011618 | — | F20.81 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 1 | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 1 | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Resistance training | D055070 | — | — | — | — | — | — | 1 | 1 |
Show 14 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Goserelin |
| INN | goserelin |
| Description | Goserelin is an organic molecular entity. |
| Classification | Protein |
| Drug class | prehormones or hormone-release stimulating peptides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 65807-02-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201247 |
| ChEBI ID | — |
| PubChem CID | 5311128 |
| DrugBank | DB00014 |
| UNII ID | 0F65R8P09N (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
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Zoladex – AstraZeneca
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Estimated US medical usage
Goserelin
Total medical expenditures per year (USD, in millions)
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,125 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,907 adverse events reported
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