Alzheimer's Disease Pipeline Drugs Landscape Report 2025: MOA Analysis, R&D Progress, Clinical Trial Pipeline, and Strategic Market Evolution

DelveInsight's, "Alzheimer's Disease Pipeline Insight 2025" report provides comprehensive insights about 200+ companies and 220+ pipeline drugs in Alzheimer's disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Alzheimer's Disease Pipeline Report

* On 20 November 2025, Hoffmann-La Roche conducted a clinical trial is recruiting people who either are at risk of AD - have build-up of beta-amyloid, but have no clinical symptoms, or with a diagnosis of mild cognitive impairment. People can take part if they have a certain level of plaques (beta-amyloid) in the brain, shown by a positron emission tomography (PET) scan, a medical imaging technique in which tracers are injected to visualize specific pathological processes in the brain. People who take part in this clinical trial (participants) will be given RO7269162 OR placebo for up to about 1 and a half years.
* On 20 November 2025, Eli Lilly and Company announced a study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo.
* On 14 November 2025, GlaxoSmithKline initiated a study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.
* On 13 November 2025, Eisai Inc. announced a 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).
* On 12 November 2025, Bristol-Myers Squibb conducted a Phase 3 study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 1).
* DelveInsight's Alzheimer's Disease Pipeline report depicts a robust space with 200+ active players working to develop 220+ pipeline therapies for Alzheimer's Disease treatment.
* The leading Alzheimer's Disease Companies such as Anavex Life Sciences Corp., TauRx Therapeutics Ltd, BioVie Inc., AriBio Co., Ltd., Novo Nordisk A/S, AgeneBio, Neurim Pharmaceuticals, Eisai Inc., T3D Therapeutics, Merck Sharp & Dohme, Shanghai Hengrui Pharmaceutical, NeuroSense Therapeutics, Pharmazz, Johnson & Johnson Innovative Medicine, NKGen Biotech, LEXEO Therapeutics, Inventage Lab, Neumora Therapeutics, Takeda, Perha Pharmaceuticals, Luye Pharma Group Ltd., Eli Lilly and Company, Prothena, Therabest Korea, Neurotez, TRIMTECH Therapeutics, Lexeo Therapeutics and others.
* /Promising Alzheimer's Disease Pipeline Therapies such as SAR110894, Donepezil, Aricept, INM-176, Wujia Yizhi granules, CPC-201, ENA713, memantine ER, Gantenerumab, Solanezumab, Florbetapir F18, ITI-1284 and others.

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The Alzheimer's Disease Pipeline Report provides a disease overview, pipeline scenario, and therapeutic assessment of the key pipeline therapies in this domain. The Alzheimer's Disease Pipeline Report also highlights the unmet needs with respect to the Alzheimer's Disease.

Alzheimer's Disease Overview

Alzheimer's disease (AD) is a progressive neurodegenerative disorder that primarily affects memory, cognition, and behavior. It is the most common cause of dementia, accounting for 60-80% of cases worldwide. AD is characterized by gradual neuronal loss, particularly in the hippocampus and cerebral cortex, leading to cognitive decline and impaired daily functioning. Although aging is the most significant risk factor, genetic predisposition (such as APOE4 mutations), lifestyle factors, and cardiovascular health also contribute to its development.

Alzheimer's Disease Emerging Drugs Profile

* AR1001: AriBio Co., Ltd.

AR1001 is a PDE5 inhibitor being developed as an investigational oral agent for the treatment of Alzheimer's disease. Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity, demonstrating multiple mechanisms of action for disease modifying effects that may ameliorate the course of AD. AR1001 has also demonstrated robust reduction of Hyperphosphorylated Tau proteins in pre-clinical models as well as in a Phase II trial. It is being developed by the South Korean biopharmaceutical company, Aribio Co. 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.

* AGB101: AgeneBio

AGB101 is a proprietary extended-release formulation of Levetiracetam, an FDA-approved anti-epileptic. AGB101 is being evaluated for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) as a once-daily dose that is given to patients at approximately one-twelfth of the dose most commonly prescribed for epilepsy. AGB101 is being investigated for the treatment of hippocampal overactivity and to assess its ability to control progression to Alzheimer's dementia. AGB101's mechanism of action is inhibition of the synaptic protein SV2A. The rationale for AGB101's use in MCI stems from suggestions that tamping down hippocampal neuron hyperactivity in people in the early stages of AD dementia may prevent the spread of tau pathology and disease progression. Currently, the drug is in the Phase II/III stage of its development for the treatment of Alzheimer's Disease.

* AMX0035: Amylyx Pharmaceuticals Inc

AMX0035 is an investigational, oral, fixed-dose combination of sodium Phenylbutyrate (PB) and Taurursodiol (TURSO). This combination therapy is designed to reduce neuronal death through two mechanisms: sodium phenylbutyrate decreases Endoplasmic Reticulum (ER) stress (by upregulating the master chaperone regulator DJ-1) and TUDCA mitigates mitochondrial dysfunction (by incorporating into the mitochondrial membrane and increasing apoptotic threshold). AMX0035 is designed to slow or mitigate neurodegeneration by targeting endoplasmic reticulum (ER) stress and mitochondrial dysfunction, two connected central pathways that lead to cell death and neurodegeneration. Preclinical studies have provided evidence that AMX0035 may reduce cell death and improve cellular function, also supporting the synergistic effect of AMX0035 compared to individual compounds. . Currently, the drug is in the Phase II stage of its development for the treatment of Alzheimer's disease.

* IVL3003: Inventage Lab., Inc.

IVL3003 is an investigational therapeutic candidate being developed for the treatment of Alzheimer's disease (AD). It is designed to target key pathological processes associated with AD, potentially offering neuroprotective and disease-modifying effects. While the exact mechanism of action (MoA) has not been publicly disclosed, IVL3003 is part of a new wave of innovative approaches aiming to address unmet needs in neurodegenerative disorders. The compound is currently in early-stage clinical development. Its progression highlights continued efforts to develop effective therapies for cognitive decline and neurodegeneration in AD. Currently, the drug is in the Phase I/II stage of its development for the treatment of Alzheimer's disease (AD).

* BHV-8000: Biohaven Pharmaceuticals

BHV-8000 is a first-in-class, oral, brain-penetrant, dual TYK2/JAK1 selective inhibitor. The TYK2 and JAK1 signal transduction pathways mediate highly complementary immune and inflammatory signalling events. Dual inhibition of TYK2 and JAK1 can effectively block Th17 cell generation, Type I IFN signaling, and inflammation. By reducing the inflammatory impacts of microglia, astrocytes, and infiltrating T-lymphocytes, BHV-8000 breaks the cycle of neuroinflammation. The drug is currently in Phase I stage of clinical trial evaluation for the treatment of Alzheimer's disease.

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The Alzheimer's Disease Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Alzheimer's Disease with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Alzheimer's Disease Treatment.
* Alzheimer's Disease Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Alzheimer's Disease Drugs development pipeline based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Alzheimer's Disease market

Alzheimer's Disease Companies

Anavex Life Sciences Corp., TauRx Therapeutics Ltd, BioVie Inc., AriBio Co., Ltd., Novo Nordisk A/S, AgeneBio, Neurim Pharmaceuticals, Eisai Inc., T3D Therapeutics, Merck Sharp & Dohme, Shanghai Hengrui Pharmaceutical, NeuroSense Therapeutics, Pharmazz, Johnson & Johnson Innovative Medicine, NKGen Biotech, LEXEO Therapeutics, Inventage Lab, Neumora Therapeutics, Takeda, Perha Pharmaceuticals, Luye Pharma Group Ltd., Eli Lilly and Company, Prothena, Therabest Korea, Neurotez, TRIMTECH Therapeutics, Lexeo Therapeutics and others

Alzheimer's disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Intravenous
* Subcutaneous
* Oral
* Intramuscular

Alzheimer's Disease Products have been categorized under various Molecule types such as

* Monoclonal antibody
* Small molecule
* Peptide

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Scope of the Alzheimer's Disease Pipeline Report

* Coverage- Global
* Alzheimer's Disease Companies- Anavex Life Sciences Corp., TauRx Therapeutics Ltd, BioVie Inc., AriBio Co., Ltd., Novo Nordisk A/S, AgeneBio, Neurim Pharmaceuticals, Eisai Inc., T3D Therapeutics, Merck Sharp & Dohme, Shanghai Hengrui Pharmaceutical, NeuroSense Therapeutics, Pharmazz, Johnson & Johnson Innovative Medicine, NKGen Biotech, LEXEO Therapeutics, Inventage Lab, Neumora Therapeutics, Takeda, Perha Pharmaceuticals, Luye Pharma Group Ltd., Eli Lilly and Company, Prothena, Therabest Korea, Neurotez, TRIMTECH Therapeutics, Lexeo Therapeutics and others.
* Alzheimer's Disease Pipeline Therapies- SAR110894, Donepezil, Aricept, INM-176, Wujia Yizhi granules, CPC-201, ENA713, memantine ER, Gantenerumab, Solanezumab, Florbetapir F18, ITI-1284 and others.
* Alzheimer's Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Alzheimer's Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Executive Summary
* Alzheimer's disease: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Alzheimer's disease- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* AR1001: AriBio Co., Ltd.
* Mid Stage Products (Phase II/III)
* AGB101: AgeneBio
* Early Stage Products (Phase I/II)
* IVL3003: Inventage Lab., Inc.
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Inactive Products
* Alzheimer's disease Key Companies
* Alzheimer's disease Key Products
* Alzheimer's disease- Unmet Needs
* Alzheimer's disease- Market Drivers and Barriers
* Alzheimer's disease- Future Perspectives and Conclusion
* Alzheimer's disease Analyst Views
* Alzheimer's disease Key Companies
* Appendix

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