Donanemab

Highest phase reached
Approved
www.ebi.ac.uk
Drug type
Antibody
www.ebi.ac.uk

Listing at source
Listed
Highest phase reached
Approved
www.ebi.ac.uk

Drug type
Antibody
www.ebi.ac.uk
Drug name
Donanemab
www.ebi.ac.uk

  • kisunla
  • Kisunla

  • donanemab
  • Donanemab
  • donanemab [INN]
  • Donanemab [MI]
  • DONANEMAB [USAN]
  • Donanemab [WHO-DD]
  • donanemab azbt
  • Donanemab azbt [WHO-DD]
  • donanemab azbt who dd
  • donanemab inn
  • donanemab mi
  • donanemab usan
  • donanemab who dd
  • Donanemab-azbt
  • immunoglobulin g1 anti human pyroglutamyl aβ 3 x peptide human clone ly3002813 γ1 chain disulfide with human clone ly3002813 κ chain dimer
  • Immunoglobulin G1, anti-(human pyroglutamyl Aβ (3-x) peptide)(human clone LY3002813 γ1-chain), disulfide with human clone LY3002813 κ-chain, dimer
  • kisunla
  • Kisunla
  • ly 3002813
  • LY 3002813
  • LY-3002813
  • ly3002813
  • LY3002813

ATC classification codes
  • N06DX05
Sources for recorded values
www.ebi.ac.uk
CAS registry numbers
  • 1931944-80-7
ChEMBL ID
CHEMBL4297245
www.ebi.ac.uk
FDA ingredient codes (UNII)
  • 1ADB65P1KK

  • 2687965
  • 2687966

Applicant
ELI LILLY CO
Approval date
2 Jul 2024
Application number
BLA761248

Status
Authorised
Status date
24 Sept 2025
Authorisation date
24 Sept 2025
Approved indications
Donanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early symptomatic Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers with confirmed amyloid pathology (see section 4.4).
Product number
EMEA/H/C/006024
Authorisation holder
Eli Lilly Nederland B.V.
Priority medicines scheme
No
Generic
No
Biosimilar
No
Generic medicines
0
Biosimilar medicines
0
Advanced therapy
No
Conditional approval
No
Additional monitoring
Yes
Accelerated assessment
No
Exceptional circumstances
No

Therapeutic areas

  • Alzheimer Disease
  • Cognitive Dysfunction
European medicines record
www.ema.europa.eu

Patents
0
Designations
5
First in class
No
Fast track
Yes
Breakthrough designation
Yes
Orphan designation
No
Priority review
Yes
Orphan exclusivity
No
Accelerated approval
No
Availability
Prescription only

Pharmacology name
donanemab
Type
Antibody
Drug name stem
-mab
Approval recorded by Guide to Pharmacology
Yes

Administration routes

  • Parenteral

Mechanisms of action

  • Mechanism
    Amyloid-beta A4 protein disrupting agent
    Action type
    DISRUPTING_AGENT
    Target
    Amyloid-beta precursor protein
    Protein identifier
    P05067

Open Targets mechanisms

  • Mechanism
    Amyloid-beta A4 protein disrupting agent
    Action type
    DISRUPTING AGENT
    Target
    Amyloid-beta precursor protein

  • Condition
    Dementia
    Highest recorded phase
    4
    Condition identifier
    HP:0000726
    Subject identifier
    D003704
  • Condition
    Alzheimer Disease
    Highest recorded phase
    4
    Condition identifier
    MONDO:0004975
    Subject identifier
    D000544

  • Condition identifier
    HP_0001268
    Highest recorded phase
    2
  • Condition identifier
    HP_0100543
  • Condition identifier
    HP_0100543
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0001627
  • Condition identifier
    MONDO_0001627
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0004975
  • Condition identifier
    MONDO_0004975
    Highest recorded phase
    4

Dose
350 mg, 700 mg, 1,050 mg, 1,400 mg
Route
Intravenous
How often
Every 4 weeks

  • Administer over approximately 30 minutes
  • Dilute prior to administration with 0.9% sodium chloride injection
  • Inspection for particulate matter and discoloration prior to administration
  • Observe patient post-infusion for at least 30 minutes

Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Natural product
No

  • Component
    Disulfide bridges location
    Sequence
    22-96$22''-96''$23'-93'$23'''-93'''$139'-199'$139'''-199'''$142-198$142''-198''$218-219'$218''-219'''$224-224''$227-227''$259-319$259''-319''$365-423$365''-423''
  • Component
    Heavy chain
    Type
    Protein
    Sequence
    QVQLVQSGAEVKKPGSSVKVSCKASGYDFTRYYINWVRQAPGQGLEWMGWINPGSGNTKYNEKFKGRVTITADESTSTAYMELSSLRSEDTAVYYCAREGITVYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
  • Component
    Glycosylation sites (N)
    Sequence
    Asn295 $ Asn295''
  • Component
    Disulfide bridges
    Sequence
    22-96 $ 22''-96'' $ 23'-93' $ 23'''-93''' $ 139'-199' $ 139'''-199''' $ 142-198 $ 142''-198'' $ 218-219' $ 218''-219''' $ 224-224'' $ 227-227'' $ 259-319 $ 259''-319'' $ 365-423 $ 365''-423''
  • Component
    Light chain
    Type
    Protein
    Sequence
    DIVMTQTPLSLSVTPGQPASISCKSSQSLLYSRGKTYLNWLLQKPGQSPQLLIYAVSKLDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCVQGTHYPFTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

  • 0002-9401

Related records

Trials (18)

Approved for (2)

Targets (1)