Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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)

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
Injection site pain	987.24	24.01	426	8145	173273	90446603
Underdose	944.44	24.01	303	8268	53714	90566162
Accidental underdose	636.79	24.01	107	8464	984	90618892
Injection site erythema	343.33	24.01	173	8398	98329	90521547
Injection site pruritus	320.18	24.01	137	8434	53697	90566179
Injection site reaction	283.98	24.01	149	8422	91931	90527945
Injection site urticaria	253.39	24.01	86	8485	17925	90601951
Injection site swelling	228.67	24.01	112	8459	59727	90560149
Migraine	204.32	24.01	158	8413	190234	90429642
Injection site haemorrhage	188.00	24.01	78	8493	28240	90591636
Incorrect dose administered	183.28	24.01	106	8465	78824	90541052
Injection site rash	155.11	24.01	65	8506	24108	90595768
Injection site mass	133.73	24.01	57	8514	22033	90597843
Product dose omission issue	132.47	24.01	150	8421	291537	90328339
Therapeutic response shortened	131.80	24.01	57	8514	22822	90597054
Drug dose omission by device	95.23	24.01	36	8535	10195	90609681
Headache	87.08	24.01	226	8345	862520	89757356
Incorrect dose administered by device	83.01	24.01	28	8543	5709	90614167
Injection site bruising	82.57	24.01	55	8516	52252	90567624
Constipation	63.62	24.01	103	8468	280292	90339584
Injection site warmth	55.72	24.01	29	8542	17486	90602390
Wrong technique in product usage process	45.21	24.01	44	8527	71527	90548349
Device difficult to use	44.53	24.01	25	8546	17500	90602376
Product administered at inappropriate site	43.73	24.01	16	8555	4135	90615741
Injury associated with device	42.60	24.01	16	8555	4448	90615428
Product dispensing error	40.99	24.01	21	8550	12252	90607624
Incorrect product formulation administered	40.64	24.01	8	8563	186	90619690
Drug ineffective	38.33	24.01	242	8329	1384056	89235820
Product storage error	36.12	24.01	23	8548	20218	90599658
Alopecia	35.43	24.01	115	8456	494956	90124920
Injection site irritation	34.66	24.01	15	8556	6000	90613876
Illness	31.82	24.01	39	8532	81930	90537946
Weight increased	31.63	24.01	99	8472	417828	90202048
Urticaria	30.34	24.01	81	8490	312653	90307223
Infusion related reaction	28.77	24.01	3	8568	416777	90203099
Accidental exposure to product	28.55	24.01	27	8544	42339	90577537
Feeling abnormal	26.99	24.01	53	8518	167182	90452694
Pruritus	26.29	24.01	111	8460	541414	90078462
Injection site discolouration	25.61	24.01	14	8557	9306	90610570
Injection site discomfort	25.31	24.01	12	8559	5928	90613948
Arthropathy	24.36	24.01	3	8568	366239	90253637
Product administration interrupted	24.31	24.01	15	8556	12477	90607399

FDA Adverse Event Reporting System (Male)

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	248.54	38.40	60	872	16606	42603797
Injection site pain	114.46	38.40	44	888	57754	42562649
Accidental underdose	75.33	38.40	13	919	658	42619745
Injection site erythema	56.91	38.40	20	912	20175	42600228
Migraine	56.05	38.40	21	911	25393	42595010
Headache	55.73	38.40	44	888	239325	42381078
Incorrect dose administered by device	41.23	38.40	10	922	2746	42617657
Therapeutic response shortened	40.37	38.40	14	918	13540	42606863

FDA Adverse Event Reporting System (Geriatric)

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
Injection site pain	551.74	26.57	237	5361	177685	110406016
Accidental underdose	439.10	26.57	73	5525	1232	110582469
Underdose	393.15	26.57	140	5458	63414	110520287
Injection site pruritus	204.33	26.57	82	5516	51176	110532525
Injection site erythema	203.82	26.57	98	5500	94078	110489623
Migraine	151.30	26.57	99	5499	171553	110412148
Injection site haemorrhage	146.11	26.57	57	5541	32971	110550730
Incorrect dose administered by device	141.15	26.57	38	5560	6776	110576925
Injection site urticaria	125.68	26.57	43	5555	17172	110566529
Injection site reaction	118.67	26.57	67	5531	89003	110494698
Injection site swelling	108.94	26.57	56	5542	61734	110521967
Drug dose omission by device	97.21	26.57	34	5564	14482	110569219
Incorrect dose administered	96.65	26.57	62	5536	103579	110480122
Injection site mass	93.24	26.57	38	5560	24575	110559126
Injection site rash	88.18	26.57	36	5562	23383	110560318
Wrong technique in product usage process	66.32	26.57	46	5552	87302	110496399
Headache	65.43	26.57	140	5458	882237	109701464
Injection site bruising	61.37	26.57	36	5562	51227	110532474
Device difficult to use	57.71	26.57	25	5573	18780	110564921
Product dose omission issue	53.08	26.57	73	5525	321709	110261992
Accidental exposure to product	37.14	26.57	26	5572	49982	110533719
Alopecia	35.47	26.57	65	5533	364688	110219013
Injection site warmth	31.29	26.57	16	5582	17389	110566312
Injection site irritation	30.92	26.57	11	5587	4913	110578788
Pruritus	28.64	26.57	79	5519	581481	110002220
Injury associated with device	28.30	26.57	10	5588	4379	110579322
Therapeutic response shortened	28.28	26.57	18	5580	29565	110554136

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N02CD02	NERVOUS SYSTEM ANALGESICS ANTIMIGRAINE PREPARATIONS Calcitonin gene-related peptide (CGRP) antagonists
MeSH PA	D000077221	Calcitonin Gene-Related Peptide Receptor Antagonists
MeSH PA	D000700	Analgesics
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents
CHEBI has role	CHEBI:35480	analgesic
CHEBI has role	CHEBI:67079	anti-inflammatory agent

Related Drugs by ATC class:

N02CD Calcitonin gene-related peptide (CGRP) antagonists 7 drugs

atogepant eptinezumab erenumab fremanezumab rimegepant ubrogepant zavegepant

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:

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

External reference:

ID	Source
55KHL3P693	UNII
4037908	VANDF
4037909	VANDF
C4694273	UMLSCUI
CHEBI:755804	CHEBI
CHEMBL3707328	ChEMBL_ID
DB14042	DRUGBANK_ID
D10936	KEGG_DRUG
10277	INN_ID
C000628360	MESH_SUPPLEMENTAL_RECORD_UI
8967	IUPHAR_LIGAND_ID
C000605816	MESH_SUPPLEMENTAL_RECORD_UI
782371005	SNOMEDCT_US
782419003	SNOMEDCT_US
291703	MMSL
35092	MMSL
35093	MMSL
d08941	MMSL
017757	NDDF
2058846	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
EMGALITY	HUMAN PRESCRIPTION DRUG LABEL	1	0002-1436	INJECTION, SOLUTION	120 mg	SUBCUTANEOUS	BLA	30 sections
EMGALITY	HUMAN PRESCRIPTION DRUG LABEL	1	0002-2377	INJECTION, SOLUTION	120 mg	SUBCUTANEOUS	BLA	30 sections
EMGALITY	HUMAN PRESCRIPTION DRUG LABEL	1	0002-3115	INJECTION, SOLUTION	100 mg	SUBCUTANEOUS	BLA	30 sections

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galcanezumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: