Gonadorelin
Factrel, Lutrepulse (gonadorelin) is a protein pharmaceutical. Gonadorelin was first approved as Factrel on 1982-09-30. It is used to treat amenorrhea, delayed puberty, ovarian cysts, and precocious puberty in the USA.
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Drug Products
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Abbreviated New Drug Application (ANDA)
Gonadorelin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FACTREL | Hikma Pharmaceuticals | N-018123 DISCN | 1982-09-30 | 3 products |
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Gonadorelin acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUTREPULSE KIT | Ferring Pharmaceuticals | N-019687 DISCN | 1989-10-10 | 2 products |
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Labels
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amenorrhea | — | D000568 | N91.2 |
| precocious puberty | — | D011629 | E22.8 |
| ovarian cysts | — | D010048 | N83.1 |
| delayed puberty | — | D011628 | E30.0 |
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ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01C: Hypothalamic hormones
— H01CA: Gonadotropin-releasing hormones
— H01CA01: Gonadorelin
V: Various drug classes in atc
— V04: Diagnostic agents
— V04C: Other diagnostic agents in atc
— V04CM: Fertility disturbances test diagnostic agents
— V04CM01: Gonadorelin
HCPCS
Code | Description |
|---|---|
| J1620 | Injection, gonadorelin hydrochloride, per 100 mcg |
Clinical
Clinical Trials
1507 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 | — | 5 | 10 | 2 | 7 | 24 |
| Infertility | D007246 | EFO_0000545 | — | 2 | 3 | 6 | 4 | 4 | 18 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | — | 1 | — | 2 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | 1 | — | 1 |
| Syndrome | D013577 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female infertility | D007247 | EFO_0008560 | N97 | — | 1 | 2 | — | — | 3 |
| Hypogonadism | D007006 | — | E23.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | 1 | — | — | — | 1 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | 1 | — | — | — | 1 |
| Anovulation | D000858 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fertility | D005298 | — | — | 2 | — | — | — | 1 | 3 |
| Amenorrhea | D000568 | — | N91.2 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gonadorelin |
| INN | gonadorelin |
| Description | Gonadorelin is a ten-membered synthetic oligopeptide comprising pyroglutamyl, histidyl, tryptophyl, seryl, tyrosyl, glycyl, leucyl, arginyl, prolyl and glycinamide residues joined in sequence. It has a role as a gonadotropin releasing hormone agonist. It is an oligopeptide and a peptide hormone. |
| 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)CNC(=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)NCC(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 33515-09-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1007 |
| ChEBI ID | 5520 |
| PubChem CID | 638793 |
| DrugBank | DB00644 |
| UNII ID | 9O7312W37G (ChemIDplus, GSRS) |
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Safety
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427 adverse events reported
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