Gonadorelin - PharmaKB

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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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
urogenital diseases	D000091642
endocrine system diseases	D004700
signs and symptoms pathological conditions	D013568

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Drug Products

FDA

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New Drug Application (NDA)

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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EMA

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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

Agency Specific

FDA

EMA

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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

1506 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	56	217	132	24	72	471
Infertility	D007246	EFO_0000545	—	12	31	43	85	112	272
Breast neoplasms	D001943	EFO_0003869	C50	12	94	68	5	28	202
Endometriosis	D004715	EFO_0001065	N80	3	17	15	11	24	67
Female infertility	D007247	EFO_0008560	N97	6	11	14	15	26	65
Polycystic ovary syndrome	D011085	EFO_0000660	E28.2	6	2	4	10	22	43
Hypogonadism	D007006	—	E23.0	9	6	1	2	23	41
Fertilization in vitro	D005307	—	—	1	2	4	19	10	35
Ovarian hyperstimulation syndrome	D016471	—	—	2	3	2	14	15	35
Precocious puberty	D011629	—	E22.8	1	2	13	6	13	35

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Adenocarcinoma	D000230	—	—	8	35	10	—	3	49
Triple negative breast neoplasms	D064726	—	—	2	13	5	—	1	20
Male breast neoplasms	D018567	—	—	4	5	9	—	2	18
Healthy volunteers/patients	—	—	—	7	7	2	—	6	16
Neoplasm metastasis	D009362	EFO_0009708	—	2	5	6	—	2	14
Hypersensitivity	D006967	EFO_0003785	T78.40	—	7	2	—	5	14
Pregnancy rate	D018873	—	—	—	1	1	—	6	7
Endometrial neoplasms	D016889	EFO_0004230	—	—	5	4	—	1	7
Osteoporosis	D010024	EFO_0003882	M81.0	—	—	2	—	4	6
Lymphoma	D008223	—	C85.9	—	3	3	—	1	5

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Salivary gland neoplasms	D012468	EFO_0003826	D11	—	8	—	—	1	9
Mood disorders	D019964	EFO_0004247	F30-F39	1	2	—	—	4	7
Hyperandrogenism	D017588	—	—	1	1	—	—	4	6
Ovarian neoplasms	D010051	EFO_0003893	C56	1	5	—	—	—	5
Hodgkin disease	D006689	—	C81	—	3	—	—	1	4
Postpartum depression	D019052	EFO_0007453	F53.0	—	2	—	—	2	4
Helping behavior	D006379	—	—	1	2	—	—	1	3
Non-hodgkin lymphoma	D008228	—	C85.9	—	3	—	—	—	3
Multiple myeloma	D009101	—	C90.0	—	3	—	—	—	3
Endocrine system diseases	D004700	EFO_0001379	E34.9	—	2	—	—	1	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Delayed puberty	D011628	—	E30.0	2	—	—	—	2	4
Transgenes	D019076	—	—	1	—	—	—	1	2
Premenstrual syndrome	D011293	—	N94.3	1	—	—	—	1	2
Overweight	D050177	—	E66.3	1	—	—	—	—	1
Cocaine-related disorders	D019970	—	F14	1	—	—	—	—	1
Hiv	D006678	—	O98.7	1	—	—	—	—	1
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	1	—	—	—	—	1
Antibiotic prophylaxis	D019072	—	—	1	—	—	—	—	1
Therapeutic equivalency	D013810	—	—	1	—	—	—	—	1
Cerebral arterial diseases	D002539	EFO_1000859	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	—	—	—	2	2
Congenital abnormalities	D000013	EFO_0003915	Q89.9	—	—	—	—	2	2
Vascular stiffness	D059289	—	—	—	—	—	—	2	2
Transsexualism	D014189	—	F64.0	—	—	—	—	2	2
Gender identity	D005783	—	—	—	—	—	—	2	2
Ultrasonography	D014463	—	—	—	—	—	—	2	2
Eunuchism	D005058	EFO_0007266	E29.1	—	—	—	—	2	2
Premature birth	D047928	EFO_0003917	O60	—	—	—	—	2	2
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	—	—	—	—	1	1
Premature cardiac complexes	D005117	—	I49.40	—	—	—	—	1	1

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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