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Drug ReportsGonadorelin
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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gonadorelin hydrochloride
Tradename
Company
Number
Date
Products
FACTRELHikma PharmaceuticalsN-018123 DISCN1982-09-30
3 products
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Gonadorelin acetate
Tradename
Company
Number
Date
Products
LUTREPULSE KITFerring PharmaceuticalsN-019687 DISCN1989-10-10
2 products
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Labels
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
523 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 neoplasmsD011471—C61219558834207
InfertilityD007246HP_0000789—41614213988
Breast neoplasmsD001943EFO_0003869C50427231962
EndometriosisD004715EFO_0001065N8016621023
HypogonadismD007006HP_0000044E23.054121123
Female infertilityD007247EFO_0008560N9726341122
SyndromeD013577——3123311
Fertilization in vitroD005307————2349
Ovulation inductionD010062———12249
Kallmann syndromeD017436Orphanet_478E23.032—139
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230——2136—121
HypersensitivityD006967HP_0012393T78.40—78—318
NeoplasmsD009369—C80253—212
RecurrenceD012008——133—410
Triple negative breast neoplasmsD064726———45—110
CarcinomaD002277—C80.0251——7
AdenomyosisD062788EFO_1001757N80.0—23—47
Primary ovarian insufficiencyD016649EFO_0004266E28.3131—15
HyperplasiaD006965EFO_0000536——53——5
Endometrial neoplasmsD016889EFO_0004230——42—15
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Premature menopauseD008594HP_0008209E28.3112——13
Male breast neoplasmsD018567———3———3
Ovarian neoplasmsD010051EFO_0003893C56—3———3
Salivary gland neoplasmsD012468EFO_0003826D11—2———2
Ectopic pregnancyD011271—O0011——12
HyperprolactinemiaD006966HP_0000870E22.111———2
Lower urinary tract symptomsD059411EFO_0008008——1——12
FatigueD005221HP_0012378R53.83—2———2
Bone marrow diseasesD001855———1——12
InfectionsD007239EFO_0000544—11———1
Show 17 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TransgenesD019076——1———12
Cocaine-related disordersD019970—F141————1
HivD006678——1————1
Antibiotic prophylaxisD019072——1————1
Cerebral arterial diseasesD002539EFO_1000859—1————1
Menstruation disturbancesD008599HP_0400007N91.51————1
Premenstrual syndromeD011293—N94.31————1
Cohort studiesD015331——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gender dysphoriaD000068116——————44
Pregnancy rateD018873——————22
Insulin resistanceD007333HP_0000855—————22
Gender identityD005783——————22
Premature cardiac complexesD005117—I49.40————11
Wounds and injuriesD014947—T14.8————11
Spinal cord injuriesD013119EFO_1001919—————11
Congenital abnormalitiesD000013EFO_0003915Q89.9————11
Heart disease risk factorsD000082742——————11
Gonadal disordersD006058——————11
Show 29 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGonadorelin
INNgonadorelin
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 classprehormones or hormone-release stimulating peptides
Image (chem structure or protein)Loading
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-ID33515-09-2
RxCUI—
ChEMBL IDCHEMBL1007
ChEBI ID5520
PubChem CID638793
DrugBankDB00644
UNII ID9O7312W37G (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 701 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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326 adverse events reported
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