Delving into the Latest Updates on Lecanemab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-amyloid beta protofibril antibody, Immunoglobulin G1, anti-(human beta-amyloid protofibril) (human-mus musculus monoclonal BAN2401 heavy chain), disulfide with human-mus musculus monoclonal BAN2401 light chain, dimer, lecanemab-irmb

+ [7]

Target

APP

Action

inhibitors

Mechanism

APP inhibitors(Beta amyloid A4 protein inhibitors)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersOther Diseases

Active Indication

Dementia due to Alzheimer's disease (disorder)Mild cognitive disorderAlzheimer Disease+ [2]

Inactive Indication-

Originator Organization

BioArctic AB

Active Organization

Biogen, Inc.

Eisai, Inc.Eisai GmbH

+ [4]

Inactive Organization-

License Organization

Biogen, Inc.

Eisai Co., Ltd.

Shanghai Pharmaceuticals Holding Co., Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (06 Jan 2023),

Alzheimer Disease

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Innovative Licensing and Access Pathway (United Kingdom), Priority Review (Japan), Priority Review (China)

Login to view timeline

Structure/Sequence

Sequence Code 315606586L

Source: *****

Sequence Code 315606587H

Source: *****

Alzheimer's disease (AD) manifests itself in cognitive decline, impaired ability to perform daily life, and a variety of behavioral and psychiatric symptoms, seriously endangering the health of the elderly. The prevalence and disability rates of AD in China remain high, and the lack of effective treatment options has brought a heavy burden to patients and their families. Early intervention is regarded as an effective strategy to improve clinical symptoms, delay disease progression and maintain current quality of life. The humanized monoclonal antibody lencanemab (Lecanemab) was approved by the U.S. FDA in July 2023 for the treatment of mild cognitive impairment or mild dementia caused by AD, and was officially approved in January 2024 in China. Lencanemab highly targets soluble and insoluble neurotoxic β-amyloid (Aβ) proteins, reducing pathogenic Aβ plaque deposition and preventing its formation in the brains of AD patients, thus reducing neurotoxicity and improving patients' cognitive functions. In addition, lencanumab may also play a neuroprotective role by modulating synaptic plasticity and regulating neural network activity in brain neurons. However, there is a lack of clinical studies to prove this mechanism. In this study, we will enroll consecutive patients with early AD treated with lencanemab infusion as well as those receiving conventional anti-dementia therapy, and comprehensively assess the effects and intrinsic molecular mechanisms of lencanemab on synaptic function and neural networks using magnetic resonance imaging, molecular imaging positron emission tomography (PET), neuropsychological assessment, and analysis of blood cerebrospinal fluid samples.

Start Date10 Mar 2025

Sponsor / Collaborator

Xuanwu Hospital Capital Medical University

[+11]

NCT05999084

/ RecruitingNot ApplicableIIT

Georgia Memory Net Center for Medicare and Medicaid Services Registry for Anti-Amyloid Monoclonal Antibody Coverage with Evidence Development

The purpose of this registry is to compile information on patients who are receiving FDA-approved anti-amyloid mAbs in the course of their clinic visits in the Emory Cognitive Neurology Clinic and in Georgia Memory Net Memory Assessment Clinics.

Start Date06 Mar 2025

Sponsor / Collaborator

Emory University

[+1]

NCT06602258

/ Active, not recruitingPhase 2

A Phase 2, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Study to Evaluate Safety, Tolerability, and Biomarker Efficacy of E2814 With Concurrent Lecanemab Treatment in Subjects With Early Alzheimer's Disease

The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 18 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer's disease (AD).

Start Date30 Sep 2024

Sponsor / Collaborator

Eisai, Inc.

100 Clinical Results associated with Lecanemab

Login to view more data

100 Translational Medicine associated with Lecanemab

Login to view more data

100 Patents (Medical) associated with Lecanemab

Login to view more data

460

Literatures (Medical) associated with Lecanemab

01 Feb 2026·Neural Regeneration Research

Recent advances in immunotherapy targeting amyloid-beta and tauopathies in Alzheimer’s disease

Article

Author: Guo, Wanshu ; Sha, Sha ; Ren, Lina ; Qu, Le ; Li, Ying ; Cao, Yunpeng ; Xing, Xiaona ; Wang, Yan

Alzheimer’s disease, a devastating neurodegenerative disorder, is characterized by progressive cognitive decline, primarily due to amyloid-beta protein deposition and tau protein phosphorylation. Effectively reducing the cytotoxicity of amyloid-beta42 aggregates and tau oligomers may help slow the progression of Alzheimer’s disease. Conventional drugs, such as donepezil, can only alleviate symptoms and are not able to prevent the underlying pathological processes or cognitive decline. Currently, active and passive immunotherapies targeting amyloid-beta and tau have shown some efficacy in mice with asymptomatic Alzheimer’s disease and other transgenic animal models, attracting considerable attention. However, the clinical application of these immunotherapies demonstrated only limited efficacy before the discovery of lecanemab and donanemab. This review first discusses the advancements in the pathogenesis of Alzheimer’s disease and active and passive immunotherapies targeting amyloid-beta and tau proteins. Furthermore, it reviews the advantages and disadvantages of various immunotherapies and considers their future prospects. Although some antibodies have shown promise in patients with mild Alzheimer’s disease, substantial clinical data are still lacking to validate their effectiveness in individuals with moderate Alzheimer’s disease.

01 Feb 2026·Neural Regeneration Research

Insights into the transcriptomic heterogeneity of brain endothelial cells in normal aging and Alzheimer’s disease

Article

Author: Hoi, Maggie Pui Man ; Lei, Chon Lok ; Yue, Qian ; Wan, Huaibin ; Zhang, Zaijun ; Li, Shang

Drug development for Alzheimer’s disease is extremely challenging, as demonstrated by the repeated failures of amyloid-β-targeted therapeutics and the controversies surrounding the amyloid-β cascade hypothesis. More recently, advances in the development of Lecanemab, an anti-amyloid-β monoclonal antibody, have shown positive results in reducing brain A burden and slowing cognitive decline in patients with early-stage Alzheimer’s disease in the Phase III clinical trial (Clarity Alzheimer’s disease). Despite these promising results, side effects such as amyloid-related imaging abnormalities (ARIA) may limit its usage. ARIA can manifest as ARIA-E (cerebral edema or effusions) and ARIA-H (microhemorrhages or superficial siderosis) and is thought to be caused by increased vascular permeability due to inflammatory responses, leading to leakages of blood products and protein-rich fluid into brain parenchyma. Endothelial dysfunction is an early pathological feature of Alzheimer’s disease, and the blood–brain barrier becomes increasingly leaky as the disease progresses. In addition, APOE4, the strongest genetic risk factor for Alzheimer’s disease, is associated with higher vascular amyloid burden, increased ARIA incidence, and accelerated blood–brain barrier disruptions. These interconnected vascular abnormalities highlight the importance of vascular contributions to the pathophysiology of Alzheimer’s disease. Here, we will closely examine recent research evaluating the heterogeneity of brain endothelial cells in the microvasculature of different brain regions and their relationships with Alzheimer’s disease progression.

01 Sep 2025·Value in Health Regional Issues

Evaluating the Cost-Effectiveness of Pharmacological Therapy in Alzheimer Disease in Brazil

Article

Author: Moriguti, Julio Cesar ; Pereira, Leonardo Regis Leira ; Price, Price Udo ; Heggie, Robert

OBJECTIVES:

Alzheimer disease (AD) is a worsening neurodegenerative disorder and the leading cause of dementia, accounting for 60% to 70% of cases. It contributes significantly to disability, caregiver reliance, and is the eighth leading cause of death. AD is one of the most expensive diseases to treat, creating an economic burden for the healthcare system and families of patients. Dementia care costs in Brazil are projected to reach $49.2 billion by 2030, $63.5 billion by 2040, and $77.3 billion by 2050. This study evaluated the cost-effectiveness of acetylcholinesterase inhibitors (standard of care [SoC]) in slowing disease progression compared with no pharmacological therapy (best supportive care [BSC]), lecanemab, and donanemab in mild AD patients.

METHODS:

We developed a decision-analytic model to simulate AD progression, using cost and health utility data specific to Brazil, supplemented with data from the literature when necessary. The model covers a 20-year horizon from both the Brazilian national healthcare system and societal perspectives. Costs and quality-adjusted life years (QALYs) were discounted at 3.5% per year to reflect their present value. Costs in local currencies were converted to US dollars (US$) and inflation-adjusted to 2024 values.

RESULTS:

In the base-case analysis from the healthcare perspective, SoC was more clinically effective than BSC with a cost per QALY of $5211. For lecanemab versus SoC, the cost per QALY gained was $2 098 225, whereas donanemab versus lecanemab was $1 460 400.

CONCLUSIONS:

The SoC is a cost-effective pharmacological intervention for AD, offering the lowest cost per QALY gains over a 20-year period.

1,178

News (Medical) associated with Lecanemab

19 Jun 2025

·firstwordpharma.com

NICE reaffirms negative stance on Alzheimer's therapies Kisunla, Leqembi

The UK's National Institute for Health and Care Excellence (NICE) has again ruled that the benefits offered by two recently approved amyloid plaque-targeting therapies for Alzheimer's disease are too small to justify their additional cost to the NHS. The latest draft guidance, issued Thursday, reaffirms earlier decisions on Eli Lilly's Kisunla (donanemab) and Eisai's Leqembi (lecanemab), and comes ahead of a final ruling next month."We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments, including providing an additional opportunity for new evidence to be submitted," remarked Helen Knight, director of medicines evaluation at NICE.Kisunla and Leqembi have been shown in clinical trials to delay progression from mild to moderate Alzheimer's by four to six months. "The committee accepted that any slowing of the disease getting worse would be meaningful for people with mild cognitive impairment or mild dementia caused by Alzheimer's disease," Knight noted.Displacing other services"However, the committee concluded the small benefits…shown in the clinical trials and the lack of long-term evidence of effectiveness, together with the substantial resources the NHS would need to commit to the treatments means if they were approved they could displace other essential treatments and services that deliver significant benefits to patients," Knight added.While both Lilly and Eisai have put forward confidential pricing agreements for Kisunla and Leqembi, NHS England published a briefing paper last year suggesting the cost of providing the drugs on the NHS could be £500 million ($671 million) to £1 billion ($1.3 billion) per year. Around 50% to 60% of this would relate to the price of the therapies, with the remaining amount spent on patient assessment, diagnosis and administering the treatments.As such, the final draft guidance concludes that neither drug can be recommended on the NHS for treating mild cognitive impairment or mild dementia caused by Alzheimer's disease. System failures?Both Lilly and Eisai said that they will appeal NICE's decision, blaming the negative decision on wider NHS failings. Nick Burgin, president of global value and access at Eisai, said the health service "is not ready" for the challenge of tackling Alzheimer's disease, noting that flaws in the evaluation process meant that Leqembi would have been rejected even if it was provided to the NHS for free."If the system can't deliver scientific firsts to NHS patients, it is broken," added Chris Stokes, Lilly's general manager of UK and Northern Europe.

19 Jun 2025

·pharma.economictimes.indiatimes.com

Lilly to appeal after UK agency opposes reimbursement for Alzheimer's drug

Bengaluru: Eli Lilly said on Thursday it would appeal against a UK agency's recommendation to not reimburse the cost of Alzheimer's drug Kisunla , blocking access for patients seeking treatment under the country's state-run health service. The U.S.-based drugmaker plans to appeal on the grounds that the National Institute for Health and Care Excellence's ( NICE ) recommendation was unreasonable based on the evidence the company, clinical experts and patient groups have submitted. Kisunla was approved in the UK last year to treat mild cognitive impairment and mild dementia caused by Alzheimer's disease. NICE, which determines the cost-effectiveness of treatments paid for by public funds, had at the time deemed Lilly's drug too expensive for wide use. Leqembi, a rival drug from Eisai and Biogen , was also deemed too costly for UK's state-run health service in August last year. NICE's reimbursement recommendation marks another hurdle for Lilly's drug, after the EU medicines regulator in March rejected Kisunla saying the treatment's ability to slow cognitive decline was not significant enough to outweigh the risk of serious brain swelling in patients. Both Kisunla and Leqembi are designed to clear sticky clumps of a protein called amyloid beta in the brain, believed to be a hallmark of Alzheimer's. They entered the market after decades of failed attempts to combat the mind-wasting disease. Adoption of the drugs has been slow in the United States due to the complexities involved with their use, such as the need for extra diagnostic tests and regular brain scans to monitor for potentially serious side effects. (Reporting by Sriparna Roy in Bengaluru; Editing by Devika Syamnath)

Drug Approval

13 Jun 2025

·www.prnewswire.com

BioArctic to initiate next cohorts in exidavnemab Phase 2a study after positive safety review

STOCKHOLM, June 13, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced today that the interim safety review of the clinical Phase 2a study EXIST showed exidavnemab to be safe and well-tolerated, whereby the second dose cohorts will now be initiated. The EXIST study evaluates exidavnemab, a drug candidate being developed as a treatment for Parkinson's disease and Multiple System Atrophy (MSA). The first cohort in the ongoing clinical Phase 2a study EXIST evaluated a lower dose of exidavnemab compared to placebo in patients with Parkinson's disease. An interim safety review showed that exidavnemab was safe and well tolerated. The positive outcome will result in the initiation of two further cohorts, to evaluate a higher dose of exidavnemab in comparison with placebo in patients with Parkinson's disease as well as MSA. "Exidavnemab is BioArctic's second disease modifying treatment for severe brain diseases, building on a similar scientific approach as Leqembi®. Both originate from our antibody platform, selectively targeting aggregated, toxic misfolded proteins. I am pleased that the interim safety review of our phase 2a study EXIST of exidavnemab showed a good safety and tolerability profile as expected, supporting progression into higher doses in both Parkinson's disease and MSA," says Gunilla Osswald, CEO at BioArctic. The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blinded, placebo-controlled study to evaluate the safety and tolerability of exidavnemab and its pharmacokinetic profile. In addition, a broad range of biomarkers will be evaluated in plasma, cerebrospinal fluid (CSF), and using digital measurements. Exidavnemab is being developed as a novel disease-modifying treatment for synucleinopathies such as Parkinson's disease and MSA. Exidavnemab is a monoclonal antibody (mAb) that selectively targets pathological alpha-synuclein aggregates, while sparing the physiological forms. Aggregated alpha-synuclein damages nerve cells, and by selectively binding and removing these aggregates, exidavnemab is intended to preserve nerve cell function and slow the disease. There is a large unmet medical need for slowing disease progression in diseases such as Parkinson's disease and MSA. Exidavnemab has recently been granted orphan drug designation (ODD) in the US and a positive opinion regarding orphan medicinal product designation (OD) in the EU for the treatment of MSA. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval. This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on June 13, 2025, at 08:00 CET. For further information, please contact: Oskar Bosson, VP Communications and Investor Relations E-mail: mailto:[email protected] Telephone: +46 70 410 71 80 About Exidavnemab Exidavnemab is a monoclonal antibody drug candidate that is designed to selectively target and eliminate pathological alpha-synuclein aggregates, while sparing the physiological forms. Aggregates of alpha-synuclein participate in neurodegenerative disorders including Parkinson's disease and Multiple System Atrophy (MSA). The goal is to develop a disease modifying treatment that stops or slow down the progression of alpha-synucleinopathies e.g. Parkinson's disease and MSA. BioArctic's phase 2a study EXIST with exidavnemab is ongoing since 2024. EXIST is an important step towards a proof-of-concept study focusing on the efficacy of the drug candidate. Exidavnemab has been granted orphan drug designation (ODD) in the US and a positive opinion regarding orphan medicinal product designation (OD) in the EU for the treatment of Multiple System Atrophy (MSA). About BioArctic AB BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company is the originator of Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with Eisai. BioArctic has a broad research portfolio within Alzheimer's disease, Parkinson's disease, ALS and enzyme deficiency diseases. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which improves the transport of drugs into the brain. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For more information, please visit . This information was brought to you by Cision . The following files are available for download: SOURCE BioArctic WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Orphan DrugClinical Result

100 Deals associated with Lecanemab

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lecanemab	-	DB14580

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Dementia due to Alzheimer's disease (disorder)	United Kingdom	Eisai Europe Ltd.	22 Aug 2024
Mild cognitive disorder	United Kingdom	Eisai Co., Ltd.	22 Aug 2024
Alzheimer Disease	United States	Eisai, Inc.	06 Jan 2023

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 1	Japan	Eisai Co., Ltd.	01 Sep 2013
Brain Injuries, Traumatic	Preclinical	United States	BioArctic AB	15 Nov 2023
Down Syndrome	Preclinical	United States	BioArctic AB	15 Nov 2023

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


S23.002 (AAN2025)	Not Applicable	Mild cognitive disorder \| Dementia due to Alzheimer's disease (disorder) CSF \| Amyvid PET \| Apolipoprotein E genotyping	5	Lecanemab (Leqembi)	zuxzfwkoji(ifircsuskd) = uihavpyvvx ueqavpofiv (ugwolcdvaz )	Positive	07 Apr 2025
P1-3.017 (AAN2025)	Not Applicable	Status Epilepticus Maintenance ApoE4 carrier	1	Lecanemab	indmucoitw(cwhevlcend) = ARIA may cause headaches, visual disturbances, confusion, and dizziness nyzssxfkno (ttsuchwure ) View more	-	07 Apr 2025
P12-3.019 (AAN2025)	Not Applicable	-	-	Lecanemab	muyiqqetxi(xlkzbkvcmx) = aaphzbxuge nzarxfnilg (anqmkkfvuo, 91.1)	-	07 Apr 2025
NCT03887455 (Clarity AD, PRNewswire) Manual	Phase 3	Alzheimer Disease	1,795	lecanemab	vsfiqkzgta(qnvcsmxiem) = ijvwcncbdt baqqavailq (invbgfvmkf ) View more	Positive	30 Jul 2024
				Placebo	vsfiqkzgta(qnvcsmxiem) = esmzqrwsoj baqqavailq (invbgfvmkf )
NCT03887455 (Clarity AD, Pubmed) Manual	Phase 3	Alzheimer Disease ApoE e4 carriers \| ApoE ε4 homozygous participants	3,407	Lecanemab 10 mg/kg biweekly	yqrzzrcswp(dxnbgblbjj) = lwehgjfeek vsxkepiqff (jqgorvqqlk ) View more	Positive	10 May 2024
				placebo (Core Study)	damgbwrcfc(hgbwytsges) = jvgfwpympz tijgtgbqcf (tswvfrrkfh )
NCT03887455 (Clarity AD, AAN2024)	Phase 3	Alzheimer Disease amyloid PET centiloid levels	-	Lecanemab 10 mg/kg biweekly	ftejcfcjlf(xlcivwbbbr) = fkygzvjfim fcgeasboaw (yalgarvemu )	Positive	09 Apr 2024
				Placebo	ftejcfcjlf(xlcivwbbbr) = qnwtyddldg fcgeasboaw (yalgarvemu )
NCT03887455 (Clarity AD, PRNewswire \| NEWS \| Corporate Publications) Manual	Phase 3	Alzheimer Disease	898	LEQEMBI (SC)	uuthgxfstx(hwrwqzwqxf) = dguwlxsybc pgaoumkurc (hspxdjnfuf, 2.27) View more	Positive	25 Oct 2023
				LEQEMBI (IV)	uuthgxfstx(hwrwqzwqxf) = ztlvnygfgi pgaoumkurc (hspxdjnfuf, 1.14) View more
NCT01767311 (FDA) Manual	Phase 2	Alzheimer Disease ApoE ε4	315	LEQEMBI 10 mg/kg	tbajtrgzlk(czckyzkdns) = rmxaiuiuyd alyedanoqr (zmxfwlmtvm, -3.91 to -0.72) View more	Positive	06 Jan 2023
				placebo	ldoqhplczf(leswnaqfip) = blzptxmcbb fjlptpkdsd (nwurgazddl ) View more
NCT03887455 (Clarity AD, FDA) Manual	Phase 3	Alzheimer Disease ApoE ε4	1,464	LEQEMBI 10 mg/kg	ktvaxuumcu(fekbvfhycc) = ccjtylduvi bckmhbavyb (mhmltiskyd ) Met View more	Positive	06 Jan 2023
				Placebo	ktvaxuumcu(fekbvfhycc) = ddxuoiiujs bckmhbavyb (mhmltiskyd ) Met View more
NCT03887455 (Clarity AD, Pubmed) Manual	Phase 3	Alzheimer Disease	1,795	Lecanemab	fxhxtbwkii(mgsrdwmehe) = wbfhufzqvz eijyrrxyjs (wdiucpkqqp ) View more	Positive	05 Jan 2023
				Placebo	fxhxtbwkii(mgsrdwmehe) = wbpberrvqy eijyrrxyjs (wdiucpkqqp )

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.

Lecanemab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation