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

Stem definition	Drug id	CAS RN
human origin	5316	1578199-75-3

Description:

Molecule	Description
Synonyms: galcanezumab emgality LY2951742 galcanezumab-gnlm	Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

galcanezumab
emgality
LY2951742
galcanezumab-gnlm

Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
4	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Jan. 22, 2021	PMDA	Eli Lilly Japan K.K.
Sept. 27, 2018	FDA	ELI LILLY AND CO

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
Underdose	804.34	28.63	228	5644	27228	63455922
Injection site pain	626.48	28.63	282	5590	129518	63353632
Accidental underdose	342.05	28.63	60	5812	743	63482407
Injection site erythema	332.22	28.63	159	5713	83015	63400135
Injection site reaction	283.60	28.63	128	5744	58396	63424754
Injection site pruritus	278.30	28.63	117	5755	44999	63438151
Injection site urticaria	226.75	28.63	74	5798	13999	63469151
Injection site swelling	214.41	28.63	99	5773	47473	63435677
Migraine	196.77	28.63	121	5751	103225	63379925
Therapeutic response shortened	138.35	28.63	49	5823	11839	63471311

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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
Underdose	190.55	54.95	44	521	13736	34942630
Injection site pain	71.92	54.95	26	539	38979	34917387
Injection site erythema	67.70	54.95	20	545	15879	34940487

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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
Underdose	237.47	32.74	77	3134	33074	79708103
Injection site pain	207.74	32.74	102	3109	129736	79611441
Injection site erythema	202.66	32.74	86	3125	78111	79663066
Injection site pruritus	174.08	32.74	65	3146	42218	79698959
Migraine	137.47	32.74	68	3143	87425	79653752
Accidental underdose	126.53	32.74	23	3188	839	79740338
Injection site reaction	118.10	32.74	53	3158	54732	79686445
Injection site urticaria	100.72	32.74	32	3179	12794	79728383
Injection site swelling	99.66	32.74	45	3166	47087	79694090
Injection site rash	67.97	32.74	26	3185	17928	79723249

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N02CD02	NERVOUS SYSTEM ANALGESICS ANTIMIGRAINE PREPARATIONS Calcitonin gene-related peptide (CGRP) antagonists
MeSH PA	D000700	Analgesics
MeSH PA	D000077221	Calcitonin Gene-Related Peptide Receptor Antagonists
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents

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

Disease	Relation	SNOMED_ID	DOID
Migraine	indication	37796009	DOID:6364

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Calcitonin gene-related peptide 1	GPCR	P06881	CALCA_HUMAN	ANTIBODY BINDING	Kd	8.70		IUPHAR	DRUG LABEL

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External reference:

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ID	Source
017757	NDDF
10277	INN_ID
2058846	RXNORM
291703	MMSL
35092	MMSL
35093	MMSL
4037908	VANDF
4037909	VANDF
55KHL3P693	UNII
782371005	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
EMGALITY	HUMAN PRESCRIPTION DRUG LABEL	1	0002-1436	INJECTION, SOLUTION	120 mg	SUBCUTANEOUS	BLA	29 sections
EMGALITY	HUMAN PRESCRIPTION DRUG LABEL	1	0002-2377	INJECTION, SOLUTION	120 mg	SUBCUTANEOUS	BLA	29 sections
EMGALITY	HUMAN PRESCRIPTION DRUG LABEL	1	0002-3115	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	29 sections

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