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

Stem definitionDrug idCAS RN
humanized origin 5386 1644539-04-7

Description:

MoleculeDescription

Synonyms:

  • eptinezumab
  • eptinezumab-jjmr
  • vyepti
  • ALD403
Eptinezumab-jjmr 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
1.10 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Feb. 21, 2020 FDA Lundbeck Seattle BioPharmaceuticals, Inc.
Jan. 24, 2022 EMA H. LUNDBECK A/S

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
Throat irritation 348.18 35.61 111 3298 48584 90576454
Therapeutic response shortened 196.05 35.61 60 3349 22819 90602219
Drug ineffective 168.53 35.61 230 3179 1384068 89240970
Pruritus 138.81 35.61 133 3276 541392 90083646
Nasal congestion 120.67 35.61 60 3349 83354 90541684
Sneezing 104.24 35.61 40 3369 29829 90595209
Chest discomfort 99.79 35.61 63 3346 138302 90486736
Headache 88.57 35.61 133 3276 862613 89762425
Flushing 75.77 35.61 45 3364 88446 90536592
Nausea 68.87 35.61 137 3272 1110179 89514859
Infusion site extravasation 67.26 35.61 22 3387 10306 90614732
Drug effect less than expected 60.69 35.61 18 3391 6120 90618918
Inappropriate schedule of product administration 52.25 35.61 44 3365 149889 90475149
Rhinorrhoea 50.89 35.61 35 3374 88281 90536757
Throat tightness 47.92 35.61 23 3386 29461 90595577
Anaphylactic reaction 39.69 35.61 30 3379 87494 90537544
Migraine 39.64 35.61 42 3367 190350 90434688

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
Throat irritation 84.65 50.49 21 441 13015 42607858
Drug ineffective 62.70 50.49 52 410 630145 41990728

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
Throat irritation 404.97 38.02 123 3459 53429 110532288
Drug ineffective 242.18 38.02 268 3314 1520272 109065445
Therapeutic response shortened 165.06 38.02 54 3528 29529 110556188
Pruritus 128.17 38.02 123 3459 581437 110004280
Nasal congestion 125.76 38.02 62 3520 98220 110487497
Sneezing 122.24 38.02 44 3538 31940 110553777
Headache 112.80 38.02 140 3442 882237 109703480
Chest discomfort 105.08 38.02 67 3515 173781 110411936
Flushing 74.97 38.02 45 3537 104691 110481026
Nausea 74.20 38.02 138 3444 1235552 109350165
Drug effect less than expected 73.46 38.02 21 3561 7299 110578418
Infusion site extravasation 63.87 38.02 21 3561 11613 110574104
Rhinorrhoea 58.06 38.02 38 3544 102628 110483089
Inappropriate schedule of product administration 54.11 38.02 48 3534 203589 110382128
Cough 41.44 38.02 62 3520 461579 110124138
Throat tightness 39.42 38.02 20 3562 33469 110552248

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N02CD05 NERVOUS SYSTEM
ANALGESICS
ANTIMIGRAINE PREPARATIONS
Calcitonin gene-related peptide (CGRP) antagonists
FDA EPC N0000193952 Calcitonin Gene-related Peptide Antagonist
FDA MoA N0000193953 Calcitonin Gene-related Peptide Antagonists
CHEBI has role CHEBI:35480 analgesic

Related Drugs by ATC class:

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

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

DiseaseRelationSNOMED_IDDOID
Migraine indication 37796009 DOID:6364
Prevention of migraine attacks indication 408381007




🐶 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 BINDING AGENT Kd 10.82 DRUG LABEL DRUG LABEL
Calcitonin gene-related peptide 2 GPCR BINDING AGENT Kd 10.24 DRUG LABEL DRUG LABEL

External reference:

IDSource
8202AY8I7H UNII
4039215 VANDF
4039216 VANDF
C4694272 UMLSCUI
CHEBI:755917 CHEBI
CHEMBL3833320 ChEMBL_ID
DB14040 DRUGBANK_ID
10308 INN_ID
C000628361 MESH_SUPPLEMENTAL_RECORD_UI
D11303 KEGG_DRUG
10694 IUPHAR_LIGAND_ID
870524004 SNOMEDCT_US
871787004 SNOMEDCT_US
331473 MMSL
38196 MMSL
38197 MMSL
d09520 MMSL
018285 NDDF
2282660 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vyepti HUMAN PRESCRIPTION DRUG LABEL 1 67386-130 INJECTION 100 mg INTRAVENOUS BLA 26 sections
Vyepti HUMAN PRESCRIPTION DRUG LABEL 1 67386-130 INJECTION 100 mg INTRAVENOUS BLA 26 sections