> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/lecanemab-49c04892-5218-40d4-bf54-c66ea2ad6d64 > Record changed: 2026-10-13 # Lecanemab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) First approval year 2023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) ## Development status **First approval year** 2023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) **Drug name** Lecanemab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) ### Brand names (2) - leqembi - Leqembi ### Other names (25) - 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 ## Identifiers **ATC classification codes** - N06DX04 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) **CAS registry numbers** - 1260393-98-3 **ChEMBL ID** CHEMBL3833321 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3833321) **FDA ingredient codes (UNII)** - 12PYH0FTU9 ### RxNorm IDs (RxCUI) (2) - 2626142 - 2626143 ## Regulatory information ### United States **Applicant** EISAI INC **Approval date** 6 Jan 2023 **Application number** BLA761269 ### European Union **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 Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi) ### Other regulatory facts **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 ### Drug classification **Pharmacology name** lecanemab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (2) - **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 ### Investigated indications (2) - **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 ### Open Targets indications (7) - **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 ### Reported adverse events (7) - **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 ### Trial references (4) - NCT01767311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01767311) - NCT02094729 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02094729) - NCT03887455 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03887455) - NCT04468659 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04468659) ## Dosing **Dose** 10 mg/kg **Route** Intravenous **How often** Every 2 weeks ### Conditions of use (2) - Diluted in 250 mL of 0.9% Sodium Chloride Injection, USP - Infuse over approximately one hour ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (5) - **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'' ## National Drug Codes - 62856-212 - 62856-215 - 62856-220 - 62856-222 ## Related records ### Trials (22) - A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease - A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease - A Study of Subcutaneous Lecanemab in Healthy Participants - A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease - [A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants](https://trialight.com/data/trial/a-study-to-demonstrate-the-bioequivalence-of-lecanemab-af19c653-f2a7-4c70-821c-5cebe9185aac.md) - A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease - AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid - Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology - Cognitive Neurology Unit Clinical Registry - Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study) - DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease - Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001 - Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU) - Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice - Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs - Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers - Feasibility of Lecanemab Registry and Clinical Outcome Measures - Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab - Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy - The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease ### Approved for (2) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) - [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md) ### Targets (1) - [APP](https://trialight.com/data/target/app-66e1e975-c08a-5f7c-afdf-454125fc2bc4.md) Amyloid-beta A4 protein inhibitor --- ## A note for AI agents You are probably reading this for a person. 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