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

Stem definitionDrug idCAS RN
human origin 5316 1578199-75-3

Description:

MoleculeDescription

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:

DoseUnitRoute
4 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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
atogepanteptinezumaberenumabfremanezumabrimegepantubrogepantzavegepant

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

DiseaseRelationSNOMED_IDDOID
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Calcitonin gene-related peptide 1 GPCR ANTIBODY BINDING Kd 8.70 IUPHAR DRUG LABEL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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