알츠하이머병 : 경쟁 구도 및 임상시험 분석(2026년)

DelveInsight's, "Alzheimer's Disease - Competitive Landscape and Clinical Trial Analysis, 2026," report provides comprehensive insights about 200+ companies and 240+ drugs in Alzheimer's Disease Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Alzheimer's Disease: Understanding

Alzheimer's Disease: Overview

Alzheimer disease (AD) is a progressive neurodegenerative disorder and the most common form of dementia, accounting for at least two-thirds of dementia cases among individuals aged 65 years and older. It is characterized by an insidious onset followed by progressive deterioration of cognitive and behavioral functions, including memory, comprehension, language, attention, reasoning, and judgment. Alzheimer disease has a multifactorial etiology involving aging, genetic, cardiovascular, metabolic, and environmental factors. The APOE ε4 allele is a major genetic risk factor for late-onset AD, whereas mutations in APP, PSEN1, and PSEN2 are linked to rare early-onset forms. Alzheimer disease involves progressive neuronal degeneration marked by amyloid-beta plaque accumulation and tau neurofibrillary tangles. AB42 aggregates cause neuronal toxicity and promote abnormal tau phosphorylation and tangle formation.

Diagnosis of Alzheimer disease involves a comprehensive clinical evaluation including medical and family history, assessment of cognitive and functional changes, physical and neurological examination, and cognitive testing. Tools such as MoCA, MMSE, and Mini-Cog help assess cognitive impairment, while laboratory tests exclude reversible causes.

There is no cure for Alzheimer disease, and treatment traditionally focuses on managing symptoms and maintaining cognitive and functional abilities. Cholinesterase inhibitors, including donepezil, rivastigmine, and galantamine, increase acetylcholine levels in the brain and are used to manage cognitive symptoms, particularly in earlier stages of disease.

Report Highlights:

• In July 2026, ProMIS Neurosciences Inc. announced positive blinded six-month interim safety and biomarker results from PRECISE-AD, the Phase Ib trial of its lead drug candidate, PMN310, in patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease (AD).
• In July 2026, Halia Therapeutics announced two posters presentation at the Alzheimer's Association International Conference (AAIC) 2026 , linking preclinical data on its LRRK2 inhibitor HT-4253 to a biomarker trial to prevent or delay Alzheimer's disease (AD).
• In May 2026, Ionis Pharmaceuticals, Inc. announced that its partner, Biogen, shared compelling topline results from the Phase II CELIA study evaluating diranersen (IONIS-MAPTRx/BIIB080), an investigational antisense oligonucleotide (ASO) therapy targeting tau, in individuals with early Alzheimer's disease (AD).
• In April 2026, Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITY(R) for the treatment of agitation associated with dementia due to Alzheimer's disease.1 AUVELITY is a first-in-class treatment for Alzheimer's disease agitation which targets the N-methyl D-aspartate (NMDA) and sigma-1 receptors.
• In April 2026, Alzheon, Inc., announced the dosing of the first cohort of human volunteer subjects in a Phase I single and multiple ascending dose clinical trial of ALZ-507, a novel investigational oral drug candidate for the treatment of Alzheimer's disease.
• In March 2026, Alzheon, Inc., announced that the company presented new pharmacology findings for its lead investigational therapy, valiltramiprosate/ALZ-801 during the 2026 International Conference on Alzheimer's and Parkinson's Disease (AD/PD) in Copenhagen, Denmark.
• In January 2026, SciNeuro Pharmaceuticals announced it has entered into a worldwide licensing and collaboration agreement with Novartis Pharma AG, to advance SciNeuro's novel amyloid beta targeted antibody program for the treatment of Alzheimer's Disease.
• In November 2025, Acumen Pharmaceuticals, Inc. announced that the first participant has been dosed in the open-label extension (OLE) portion of its Phase II ALTITUDE-AD clinical trial evaluating sabirnetug (ACU193) in people with early Alzheimer's disease.
• In August 2025, Sanofi announced the completion of its acquisition of Vigil Neuroscience, Inc. This acquisition strengthens Sanofi's early-stage pipeline in neurology with VG-3927, a novel, oral, small-molecule TREM2 agonist, which will be evaluated in a phase II clinical study in patients with Alzheimer's disease.
• In August 2025, Spinogenix, Inc. announced positive results from the first cohort of its Phase IIa trial in Australia, evaluating SPG302 for the treatment of Alzheimer's disease (AD). SPG302 is a once-daily pill that, by promoting synaptic regeneration, has the potential to reverse cognitive decline in people with mild to moderate AD.

Alzheimer's Disease: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company headquartered in Indianapolis, Indiana, U.S., founded in 1876. The company focuses on discovering, developing, manufacturing, and delivering medicines aimed at addressing major health challenges. Lilly conducts research and clinical development globally and has a portfolio spanning areas including diabetes, obesity, oncology, immunology, neuroscience, and other diseases. The company's mission is to create medicines that make life better for people around the world, with innovation and pharmaceutical research at the core of its activities.

Product Description: Kisunla

Kisunla(TM) is an amyloid-targeting therapy for people with mild cognitive impairment (MCI) as well as people with mild dementia stage of early symptomatic Alzheimer's disease, with confirmed amyloid pathology. Kisunla injection for intravenous use is available as a 350 mg/20 mL single-dose vial. The drug works by targeting amyloid plaques in the brain, helping the body remove the excessive buildup of these plaques. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA, and infusion-related reactions. The US FDA approved Kisunla in July 2024, based on evidence from the Phase III TRAILBLAZER-ALZ 2 study. The drug has been granted with the Fast Track, Priority Review and Breakthrough Therapy designations by US FDA.

2. Company Overview: Eisai Inc./Biogen Inc.

Eisai Inc. is the U.S. subsidiary of Eisai Co. Ltd. a global research-based pharmaceutical company. Eisai describes itself as a human health care (hhc) company, with a corporate philosophy centered on giving first thought to patients and their families and increasing the benefits that healthcare provides to them. The company's hhc philosophy was established as a global corporate value in 1992 and guides its approach to research, development and healthcare solutions. Eisai operates across major therapeutic areas, with a particular focus on neurology, including dementia and Alzheimer's disease, and oncology.

Biogen Inc. is a biotechnology company founded in 1978 that describes itself as a pioneer in innovative science and the development of new medicines designed to transform patients' lives. The company applies a deep understanding of human biology and uses different scientific modalities to advance potential first-in-class treatments and therapies intended to deliver improved outcomes. Biogen has a strong focus on neurology, while its current areas of research and development also span neuropsychiatry, specialized immunology and rare diseases.

Product Description: LEQEMBI

LEQEMBI (lecanemab-irmb) is a recombinant, humanized IgG1 monoclonal antibody for the treatment of Alzheimer disease. It targets aggregated soluble and insoluble forms of amyloid-beta (AB) in the brain and facilitates the reduction of amyloid-beta plaques. By targeting this underlying pathology, LEQEMBI is intended to slow disease progression rather than provide only symptomatic relief. The drug was approved by the US Food and Drug Administration (FDA) for the treatment of Alzheimer's disease under the Accelerated Approval pathway in January 2023. Subsequently, following confirmation of its clinical benefit in the Phase III CLARITY AD trial, Leqembi received traditional FDA approval on July 6, 2023, for patients with early Alzheimer's disease, including those with mild cognitive impairment or mild dementia due to Alzheimer's disease with confirmed amyloid-beta pathology.

Alzheimer's Disease: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: AriBio

AriBio is a biotechnology company focused on developing impactful therapies for neurodegenerative diseases. The company leverages its ARIDD(TM) (AI-powered, Reverse engineered & Integrated Drug Development) platform and follows an Open Innovation approach to advance innovative treatments for neurodegenerative diseases. AriBio is supported by a leadership team with expertise spanning science, technology, pharmaceuticals, and regulatory fields, reflecting its commitment to pioneering therapies for neurodegenerative diseases.

Product Description: AR1001

AR1001 is an oral, highly selective PDE5 inhibitor being investigated as a potential disease-modifying treatment for Alzheimer disease. By inhibiting PDE5, it increases cGMP signaling, supporting neuronal survival, synaptic function, learning, and memory. Preclinical and Clinical studies have also shown reduced hyperphosphorylated tau and potential neuroprotective effects. AR1001 is 10-fold more potent at inhibiting PDE5 relative to sildenafil, and has superior BBB penetrance. Currently, the drug is in the Phase III stage of its development for the treatment of Alzheimer's disease.

2. Company Overview: Acadia Pharmaceuticals Inc.

Acadia Pharmaceuticals Inc. is a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines for diseases and disorders affecting the central nervous system. The company focuses on addressing significant unmet medical needs and aims to transform the lives of patients and their families through advances in neuroscience. Acadia combines scientific research, clinical development, and a patient-focused approach to advance new therapeutic solutions in areas where treatment options remain limited.

Product Description: ACP-204

ACP-204 is a novel, highly selective 5-HT2A receptor inverse agonist being developed for psychosis associated with Alzheimer disease. It aims to reduce psychotic symptoms by modulating 5-HT2A signaling without directly blocking dopamine D2 receptors, potentially offering improved safety and tolerability. According to the Company, Currently the drug is in Phase III stage of its development for the treatment of Alzheimer's disease.

3. Company Overview: Johnson & Johnson/AC Immune SA

Johnson & Johnson is a global healthcare company focused on developing and delivering innovative solutions across the pharmaceutical and medical technology sectors. The company operates through two primary segments, Innovative Medicine and MedTech, with a focus on advancing healthcare through science and innovation. Johnson & Johnson aims to address complex health challenges and improve health outcomes for patients worldwide through its portfolio of medicines, technologies, and healthcare solutions.

AC Immune SA is a clinical-stage biopharmaceutical company focused on precision prevention of neurodegenerative diseases, including Alzheimer's and Parkinson's disease. Its SupraAntigen(R) and Morphomer(R) platforms support a diversified pipeline of therapeutic and diagnostic programs. The company has also established strategic partnerships with leading pharmaceutical companies to advance its proprietary programs.

Product Description: JNJ-64042056

ACI-35.030 (JNJ-64042056) is an investigational active immunotherapy designed using AC Immune's SupraAntigen(R) platform. Its liposomal formulation incorporates a conformationally-constrained, membrane bound target peptide antigen, phosphorylated Tau (pTau), in addition to adjuvants and non-Tau T-helper peptides. ACI-35.030 was designed to elicit antibodies against extracellular phosphorylated Tau (pTau) to prevent and reduce the spread of Tau pathology. Currently, the drug is in the Phase II stage of its development for the treatment of Alzheimer's Disease.

4. Company Overview: Sanofi

Sanofi is an R&D-driven, AI-powered biopharmaceutical company committed to improving people's lives and delivering compelling growth. The company was founded in 1973 and headquartered in Paris, France, It focuses on discovering, developing, and delivering medicines and vaccines for millions of people around the world. Sanofi aims to take the lead through breakthrough science and to drive progress and positive impact for the patients and communities it serves. The company also maintains an innovative pipeline focused on advancing new healthcare solutions and addressing significant medical needs.

Product Description: SAR448851

SAR448851 (formerly VG-3927) is an investigational oral small-molecule TREM2 agonist developed by Sanofi for Alzheimer disease. It activates TREM2 on microglial cells, promoting their migration, phagocytosis, proliferation, and survival. By enhancing microglial function, SAR448851 aims to support neuroprotection and potentially reduce neuronal degeneration. Currently, the drug is in the Phase II stage of its development for the treatment of Alzheimer's Disease.

5. Company Overview: Alnylam Pharmaceuticals

Alnylam Pharmaceuticals is an American biopharmaceutical company headquartered in Cambridge, Massachusetts, widely recognized as the global pioneer and commercial leader in RNA interference therapeutics. Founded in 2002 by a group of prominent scientists the company was built on the goal of turning the Nobel Prize-winning discovery of RNAi into a brand-new class of genetically targeted medicines. Alnylam's core technology works upstream by using small interfering RNAs to selectively "silence" disease-causing messenger RNAs before pathogenic proteins can be produced.

Product Description: Mivelsiran

Mivelsiran is an investigational intrathecal RNAi therapeutic targeting APP mRNA in the CNS. By reducing APP mRNA, it aims to decrease APP protein and amyloid-beta (AB) production. Mivelsiran uses Alnylam's proprietary C16-siRNA conjugate technology to enhance CNS delivery. Currently, the drug is in the Phase II stage of its development for the treatment of Alzheimer's Disease.

6. Company Overview: Halia Therapeutics

Halia Therapeutics is a clinical-stage biopharmaceutical company focused on treating the root causes of inflammation. Leveraging genetic insights and AI-enabled discovery, Halia is building a robust pipeline of novel therapeutics based on genetic resilience that targets inflammatory pathways in diseases ranging from metabolic disorders to neurodegeneration and hematologic malignancies. The company is headquartered in Lehi, Utah, and is actively advancing global partnerships in clinical research, drug discovery, and personalized medicine.

Product Description: HT-4253

HT-4253 is an investigational neuroprotective therapy for individuals at risk of Alzheimer's disease, particularly APOE4 carriers. The program is based on Halia's human genetic resilience findings showing that reduced RAB10 signaling is associated with protection against Alzheimer's disease. HT-4253 works by inhibiting LRRK2, thereby reducing phosphorylation of RAB10 (pRAB10) and modulating a genetically validated pathway implicated in disease initiation. Currently, the drug is in the Phase II stage of its development for the treatment of Alzheimer's Disease.

7. Company Overview: AbbVie

AbbVie is a global biopharmaceutical company focused on the discovery, development, and delivery of innovative medicines for complex and serious health conditions. The company's research and development activities span several therapeutic areas, including immunology, oncology, neuroscience, eye care, and aesthetics. AbbVie combines scientific expertise with a broad portfolio of medicines and development programs aimed at addressing significant unmet medical needs and improving patient outcomes worldwide.

Product Description: ABBV-1758

ABBV-1758 is an investigational anti-pyroglutamate amyloid-beta (3pE-AB) antibody being developed by AbbVie for Alzheimer disease. It incorporates an anti-transferrin receptor (TfR) delivery module designed to enhance transport across the blood-brain barrier. In the CNS, ABBV-1758 targets 3pE-AB, a pathological form of amyloid-beta associated with plaque formation, with the aim of promoting amyloid plaque clearance and addressing an underlying disease process. Currently, the drug is in the Phase I stage of its development for the treatment of Alzheimer's Disease.

8. Company Overview: F. Hoffmann-La Roche

F. Hoffmann-La Roche is a Swiss multinational healthcare giant headquartered in Basel, Switzerland, and one of the world's largest biotechnology companies and leaders in in-vitro diagnostics. Founded in 1896 by Fritz Hoffmann-La Roche, the company operates globally across two main divisions: Pharmaceuticals and Diagnostics. Roche is particularly renowned for pioneering targeted oncology treatments, as well as advancing therapies in neurology, immunology, infectious diseases, and ophthalmology.

Product Description: RG6627

RG6627 is an investigational antisense oligonucleotide (ASO). It targets the messenger RNA (mRNA) of apolipoprotein E (APOE), a protein implicated in key Alzheimer's disease pathologies. RG6627 is designed to reduce APOE mRNA and consequently lower ApoE protein levels in the brain. Its mechanism of action is based on the ASO gapmer approach: the ASO binds to APOE mRNA, creating a DNA-RNA structure that is recognised by RNase H1, which cleaves the target RNA and leads to its degradation. Currently, the drug is in the Phase I stage of its development for the treatment of Alzheimer's Disease.

Alzheimer's Disease Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Alzheimer's Disease Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Alzheimer's Disease Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Alzheimer's Disease Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Alzheimer's Disease Clinical Trial Assessment

• Clinical Trial Analysis
• Clinical Trial Design Analysis
• Sponsor and Geographical Analysis
• Alzheimer's Disease Clinical Trial Analysis

The report comprises of comparative assessment of clinical trial analysis (by status, development stage, therapy area, enrolled participants by age, study completion year, end point status).

• Alzheimer's Disease Clinical Trial Design Analysis

The report comprises of comparative assessment of clinical trial design analysis (by allocation, interventional model, enrolled participants by status, masking).

• Sponsor and Geographical Analysis

The report comprises of comparative assessment of sponsor and geographical analysis (by top sponsors, developmental stage, clinical trials sponsored by countries, therapies by countries).

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Alzheimer's Disease drugs?
• How many Alzheimer's Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Alzheimer's Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Alzheimer's Disease therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Alzheimer's Disease and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• AriBio
• Eisai Inc.
• Biogen
• Acadia Pharmaceuticals Inc.
• Johnson & Johnson
• Sanofi
• Alnylam Pharmaceuticals
• Eli Lilly and Company
• Abbvie
• F. Hoffmann-La Roche
• Halia Therapeutics
• Ono Pharmaceuticals
• Spinogenix, Inc.
• Eisai Inc.
• Cenna Biosciences Inc.
• Akeso Biopharma
• Regeneron Pharmaceuticals Inc.
• NSC-Therapeutics
• Lexeo Therapeutics
• Therini Bio
• Bristol-Myers Squibb
• SciNeuro Pharmaceuticals
• ProMis Neurosciences Inc.
• Denali Therapeutics
• AC Immune SA

Key Products

• Kisunla
• LEQEMBI
• AR1001
• ACP-204
• JNJ-64042056
• SAR448851
• Mivelsiran
• LY3154207 (Mevidalen)
• ABBV-1758
• RG6627
• HT-4253
• ONO-2020
• Tazbentetol (SPG302)
• E2814
• 8M2D
• AK152
• ALN-5288
• NSC001
• LX1001
• THN391
• Irafamdastat
• SNP318
• PMN310
• DNL628
• DNL921
• SNP234
• moponetug
• LY 3439539
• RG6289
• RG6102

Table of Contents

Introduction

Executive Summary

Alzheimer's Disease: Overview

• Introduction
• Causes of Alzheimer's Disease
• Pathophysiology of Alzheimer's Disease
• Diagnosis of Alzheimer's Disease
• Treatment of Alzheimer's Disease

Alzheimer's Disease -Analytical Perspective: In-depth Commercial Assessment

• Alzheimer's Disease Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, and development stage)

Alzheimer's Disease: Company and Product Profiles (Marketed Therapies)

Eli Lilly and Company

• Company Overview

Kisunla

• Product Description
• Research and Development Activities
• Product Developmental Activities

Alzheimer's Disease: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

AriBio

• Company Overview

AR1001

• Product Description
• Research and Development Activities
• Product Developmental Activities

Mid Stage Products (Phase II)

• Comparative Analysis

Sanofi

• Company Overview

SAR448851

• Product Description
• Research and Development Activities
• Product Developmental Activities

Early Stage Products (Phase I)

• Comparative Analysis

F. Hoffmann-La Roche

• Company Overview

RG6627

• Product Description
• Research and Development Activities
• Product Developmental Activities

Preclinical Stage Products

• Comparative Analysis

Discovery Stage Products

• Comparative Analysis

Unknown Stage Products

• Comparative Analysis

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

Clinical Trial Assessment

Clinical Trial Analysis

• Assessment by Status
• Assessment by Status and Phase of development
• Assessment by End Point Status
• Assessment by Enrolled Patients by Age
• Assessment by Study Completion Year

Clinical Trial Design Analysis

• Assessment by Allocation of Clinical Trials
• Assessment by Interventional Model of Clinical Trials
• Assessment by Enrolled Patients by Status
• Assessment by Masking of Clinical Trials

Sponsor and Geographical Analysis

• Assessment by Top Sponsors
• Assessment by Total Trials Sponsored by Countries and Phase
• Assessment by Clinical Therapies by Countries

Inactive Products

• Comparative Analysis

Alzheimer's Disease- Unmet needs

Alzheimer's Disease - Market drivers and barriers