goserelin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
pituitary hormone-release stimulating peptides	1327	65807-02-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: goserelin Decapeptide I zoladex goserelin acetate	A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer. Molecular weight: 1269.43 Formula: C59H84N18O14 CLOGP: -5.05 LIPINSKI: 3 HAC: 32 HDO: 18 TPSA: 493.39 ALOGS: -4.48 ROTB: 33

Molecule

Description

Molfile Inchi Smiles

Synonyms:

goserelin
Decapeptide I
zoladex
goserelin acetate

A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.

Molecular weight: 1269.43
Formula: C59H84N18O14
CLOGP: -5.05
LIPINSKI: 3
HAC: 32
HDO: 18
TPSA: 493.39
ALOGS: -4.48
ROTB: 33

Drug dosage:

Dose	Unit	Route
0.13	mg	implant

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	20 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.04 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
Dec. 29, 1989	FDA	ASTRAZENECA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	844.23	19.42	359	9896	81762	63397005
Metastases to bone	813.91	19.42	246	10009	20773	63457994
Metastases to liver	665.75	19.42	217	10038	23422	63455345
Neutropenia	350.09	19.42	261	9994	174744	63304023
Neoplasm progression	195.32	19.42	102	10153	36326	63442441
PIK3CA-activated mutation	172.99	19.42	39	10216	1020	63477747
Metastases to lung	172.07	19.42	68	10187	12682	63466085
Metastases to lymph nodes	155.43	19.42	56	10199	8102	63470665
Tumour marker increased	137.58	19.42	45	10210	4870	63473897
Bone lesion	137.43	19.42	47	10208	5834	63472933

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Osteonecrosis of jaw	288.37	15.33	129	10266	17760	34928776
Prostatic specific antigen increased	240.18	15.33	107	10288	14573	34931963
Metastases to bone	220.97	15.33	95	10300	11875	34934661
Malignant neoplasm progression	167.72	15.33	166	10229	87880	34858656
Prostate cancer metastatic	144.23	15.33	57	10338	5746	34940790
Hot flush	110.16	15.33	68	10327	17998	34928538
Interstitial lung disease	104.12	15.33	112	10283	65170	34881366
Osteonecrosis	103.58	15.33	61	10334	14829	34931707
Prostate cancer	79.49	15.33	77	10318	39572	34906964
Malignant spinal cord compression	60.24	15.33	13	10382	144	34946392

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Metastases to bone	652.24	14.96	230	16450	24197	79703511
Malignant neoplasm progression	517.49	14.96	333	16347	135657	79592051
Metastases to liver	377.38	14.96	161	16519	28153	79699555
Osteonecrosis of jaw	250.39	14.96	139	16541	43087	79684621
Neutropenia	213.68	14.96	281	16399	287429	79440279
Prostatic specific antigen increased	175.40	14.96	70	16610	10316	79717392
Hot flush	152.64	14.96	111	16569	54766	79672942
Metastases to lymph nodes	148.00	14.96	62	16618	10335	79717373
Prostate cancer metastatic	123.29	14.96	42	16638	3965	79723743
Metastases to lung	112.24	14.96	61	16619	18102	79709606

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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Source	Code	Description
ATC	L02AE03	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONES AND RELATED AGENTS Gonadotropin releasing hormone analogues
FDA EPC	N0000175655	Gonadotropin Releasing Hormone Receptor Agonist
FDA MoA	N0000175654	Gonadotropin Releasing Hormone Receptor Agonists
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D018931	Antineoplastic Agents, Hormonal

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Endometriosis	indication	129103003
Hormone receptor positive malignant neoplasm of breast	indication	417181009
Advanced Prostatic Carcinoma	indication
Endometrial Ablation Adjunct	indication
Urinary tract obstruction	contraindication	7163005	DOID:5200
Hypercholesterolemia	contraindication	13644009
Hypertensive disorder	contraindication	38341003	DOID:10763
Hypercalcemia	contraindication	66931009	DOID:12678
Diabetes mellitus	contraindication	73211009	DOID:9351
Hyperglycemia	contraindication	80394007	DOID:4195

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.85	acidic
pKa2	9.65	acidic
pKa3	11.9	acidic
pKa4	12.55	acidic
pKa5	13.03	acidic
pKa6	13.27	acidic
pKa7	13.43	acidic
pKa8	10.75	Basic
pKa9	6.69	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Gonadotropin-releasing hormone receptor	GPCR	P30968	GNRHR_HUMAN	AGONIST				CHEMBL	CHEMBL
Lutropin-choriogonadotropic hormone receptor	GPCR	P22888	LSHR_HUMAN					WOMBAT-PK

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External reference:

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ID	Source
003532	NDDF
006407	NDDF
008308	NDDF
008309	NDDF
0F65R8P09N	UNII
108771008	SNOMEDCT_US
108773006	SNOMEDCT_US
126138002	SNOMEDCT_US
145781-92-6	SECONDARY_CAS_RN
1550	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ZOLADEX	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3466	IMPLANT	3.60 mg	SUBCUTANEOUS	NDA	26 sections
ZOLADEX	HUMAN PRESCRIPTION DRUG LABEL	1	70720-950	IMPLANT	3.60 mg	SUBCUTANEOUS	NDA	27 sections
ZOLADEX	HUMAN PRESCRIPTION DRUG LABEL	1	70720-950	IMPLANT	3.60 mg	SUBCUTANEOUS	NDA	27 sections
ZOLADEX	HUMAN PRESCRIPTION DRUG LABEL	1	70720-950	IMPLANT	3.60 mg	SUBCUTANEOUS	NDA	27 sections
ZOLADEX	HUMAN PRESCRIPTION DRUG LABEL	1	70720-951	IMPLANT	10.80 mg	SUBCUTANEOUS	NDA	26 sections
ZOLADEX	HUMAN PRESCRIPTION DRUG LABEL	1	70720-951	IMPLANT	10.80 mg	SUBCUTANEOUS	NDA	26 sections

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