Lecanemab

Highest phase reached
Approved
www.ebi.ac.uk
Drug type
Antibody
www.ebi.ac.uk
First approval year
2023
www.ebi.ac.uk

First approval year
2023
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
Lecanemab
www.ebi.ac.uk

  • leqembi
  • Leqembi

  • ban 2401
  • Ban 2401
  • BAN-2401
  • ban2401
  • BAN2401
  • lecanemab
  • Lecanemab
  • lecanemab [INN]
  • LECANEMAB [JAN]
  • Lecanemab [MI]
  • LECANEMAB [USAN]
  • Lecanemab [WHO-DD]
  • lecanemab inn
  • lecanemab irmb
  • Lecanemab irmb
  • Lecanemab irmb [WHO-DD]
  • lecanemab irmb who dd
  • Lecanemab IV
  • lecanemab jan
  • lecanemab mi
  • lecanemab usan
  • lecanemab who dd
  • Lecanemab-irmb
  • leqembi
  • Leqembi

ATC classification codes
  • N06DX04
Sources for recorded values
www.ebi.ac.uk
CAS registry numbers
  • 1260393-98-3
ChEMBL ID
CHEMBL3833321
www.ebi.ac.uk
FDA ingredient codes (UNII)
  • 12PYH0FTU9

  • 2626142
  • 2626143

Applicant
EISAI INC
Approval date
6 Jan 2023
Application number
BLA761269

Status
Authorised
Status date
15 Apr 2025
Authorisation date
15 Apr 2025
Approved indications
Leqembi 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 Alzheimer’s disease) who are apolipoprotein E 4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology (see section 4.4).
Product number
EMEA/H/C/005966
Authorisation holder
Eisai GmbH
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
7
First in class
No
Fast track
Yes
Breakthrough designation
Yes
Orphan designation
No
Priority review
Yes
Orphan exclusivity
No
Accelerated approval
Yes
Availability
Prescription only
Boxed warning
Yes

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

Administration routes

  • Parenteral

  • Action
    Binding
    Action type
    Binding
    Target
    amyloid β
    Gene symbol
    amyloid β
    Median affinity
    8.7
    Affinity units
    pKd
  • Mechanism
    Amyloid-beta A4 protein inhibitor
    Action type
    Inhibitor
    Target
    Amyloid-beta precursor protein
    Protein identifier
    P05067

Open Targets mechanisms

  • Mechanism
    Amyloid-beta A4 protein inhibitor
    Action type
    Inhibitor
    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_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
  • Condition identifier
    MONDO_0005180

Warnings

  • Warning
    Black Box Warning
    Effect
    carcinogenicity

Open Targets warnings

  • Warning
    Black Box Warning
    Effect
    carcinogenicity
    Country
    United States

  • Event
    amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
    Reports
    14
    Reporting signal score
    141.877
  • Event
    amyloid related imaging abnormality-oedema/effusion
    Reports
    15
    Reporting signal score
    157.514
  • Event
    brain fog
    Reports
    2
    Reporting signal score
    12.5204
  • Event
    cerebral microhaemorrhage
    Reports
    4
    Reporting signal score
    28.8317
  • Event
    cerebral sulcal prominence
    Reports
    1
    Reporting signal score
    10.3699
  • Event
    infusion related reaction
    Reports
    5
    Reporting signal score
    12.1958
  • Event
    superficial siderosis of central nervous system
    Reports
    2
    Reporting signal score
    16.3628

Dose
10 mg/kg
Route
Intravenous
How often
Every 2 weeks

  • Diluted in 250 mL of 0.9% Sodium Chloride Injection, USP
  • Infuse over approximately one hour

Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Natural product
No

  • Component
    Heavy chain
    Type
    Protein
    Sequence
    EVQLVESGGGLVQPGGSLRLSCSASGFTFSSFGMHWVRQAPGKGLEWVAYISSGSSTIYYGDTVKGRFTISRDNAKNSLFLQMSSLRAEDTAVYYCAREGGYYYGRSYYTMDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
  • Component
    Light chain
    Type
    Protein
    Sequence
    DVVMTQSPLSLPVTPGAPASISCRSSQSIVHSNGNTYLEWYLQKPGQSPKLLIYKVSNRFSGVPDRFSGSGSGTDFTLRISRVEAEDVGIYYCFQGSHVPPTFGPGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
  • Component
    Glycosylation sites (N)
    Sequence
    Asn-304 $ Asn-304''''
  • Component
    Glycosylation sites (N)
    Sequence
    Asn-304 $ Asn-304''
  • Component
    Disulfide bridges
    Sequence
    22-96 $ 22''-96'' $ 23'-93' $ 23'''-93''' $ 139'-199' $ 139'''-199''' $ 151-207 $ 151''-207'' $ 219'-227 $ 219'''-227'' $ 233-233'' $ 236-236'' $ 268-328 $ 268''-328'' $ 374-432 $ 374''-432''

  • 62856-212
  • 62856-215
  • 62856-220
  • 62856-222

Related records

Trials (22)

Approved for (2)

Targets (1)