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

Stem definitionDrug idCAS RN
monoclonal antibodies 5827 None

Description:

MoleculeDescription

Molfile

Synonyms:

  • donanemab
  • donanemab-azbt
  • kisunla
  • LY3002813
  • N3pG
Donanemab-azbt is a humanized IgG1 monoclonal antibody that targets aggregated forms of amyloid beta (Abeta), including insoluble amyloid plaques. Donanemab-azbt binds to N-terminal pyroglutamate Abeta, a modified form of Abeta found in amyloid plaques.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
July 2, 2024 FDA Eli Lilly
Sept. 24, 2025 EMA Eli Lilly Nederland B.V.
Sept. 24, 2024 PMDA Eli Lilly

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
Amyloid related imaging abnormality-oedema/effusion 387.47 71.11 47 413 897 90627090
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 271.02 71.11 33 427 640 90627347
Amyloid related imaging abnormalities 115.54 71.11 12 448 46 90627941
Infusion related reaction 106.35 71.11 48 412 416732 90211255
Flushing 84.83 71.11 27 433 88464 90539523

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
Infusion related reaction 103.17 69.35 28 169 60778 42560360
Amyloid related imaging abnormality-oedema/effusion 95.29 69.35 13 184 689 42620449
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 86.91 69.35 12 185 693 42620445

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
Amyloid related imaging abnormality-oedema/effusion 381.70 61.11 50 600 1525 110587124
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 345.02 61.11 45 605 1321 110587328
Infusion related reaction 169.77 61.11 68 582 381094 110207555
Flushing 112.07 61.11 36 614 104700 110483949
Amyloid related imaging abnormalities 91.35 61.11 10 640 58 110588591

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06DX05 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTI-DEMENTIA DRUGS
Other anti-dementia drugs

Related Drugs by ATC class:

N06DX Other anti-dementia drugs 3 drugs
aducanumablecanemabmemantine

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

DiseaseRelationSNOMED_IDDOID
Alzheimer's disease indication 26929004 DOID:10652




🐶 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
Amyloid beta A4 protein Membrane other ANTIBODY BINDING Kd 9.09 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEMBL4297245 ChEMBL_ID
C000729112 MESH_SUPPLEMENTAL_RECORD_UI
DB16647 DRUGBANK_ID
4043272 VANDF
4043273 VANDF
C5926272 UMLSCUI
CHEBI:756751 CHEBI
1931944-80-7 SECONDARY_CAS_RN
386964 MMSL
42952 MMSL
d10200 MMSL
019800 NDDF
8357 IUPHAR_LIGAND_ID
10922 INN_ID
2687965 RXNORM
D11500 KEGG_DRUG
1ADB65P1KK UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Kisunla HUMAN PRESCRIPTION DRUG LABEL 1 0002-9401 INJECTION, SOLUTION 17.50 mg INTRAVENOUS BLA 28 sections