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Alzheimer's Disease Drug Development Pipeline: 2025-A Surge in Innovation as 110+ Biopharma Leaders Drive the Future of Alzheimer's Disease Therapies | DelveInsight
Alzheimer's Disease Drug Development Pipeline
The fight against Alzheimer's disease is gaining momentum. In its newly released "Alzheimer's disease (AD) - Pipeline Insight, 2025" report, DelveInsight showcases how global pharmaceutical and biotechnology players are transforming the Alzheimer's disease market with groundbreaking therapies.
With more than 120 pipeline candidates under development and a growing number of regulatory designations, the Alzheimer's disease drug development pipeline is more vibrant than ever. This surge includes disease-modifying therapies, amyloid and tau-targeting antibodies, neuroprotective agents, and next-gen diagnostics aimed at improving early detection and intervention.
Key Takeaways from the Alzheimer's Disease Pipeline Report
• DelveInsight's Alzheimer's disease pipeline analysis depicts a robust space with 110+ active players working to develop 120+ pipeline drugs for Alzheimer's disease treatment.
• The leading Alzheimer's disease companies include AriBio, Eli Lilly, Cognition Therapeutics, AbbVie, Allyx Therapeutics, Cassava Sciences, BioVie, Novo Nordisk, Alector, Longeveron, Cognition Therapeutics, TrueBinding, VT BIO, Luye Pharma Group, Lexeo Therapeutics, Merck Sharp & Dohme LLC, Regeneration Biomedical, Alnylam Pharmaceuticals, Sinotau Pharmaceutical Group, Eisai, Shanghai Hengrui Pharmaceutical, and others are evaluating their lead assets to improve the Alzheimer's disease treatment landscape.
• Key Alzheimer's disease pipeline therapies in various stages of development include AR1001, LY3372689, CT1812, ABBV-916, ALX-001, Simufilam, Remternetug, NE3107, Semaglutide, AL002, Lomecel-B, CT1812, TB006, LY3372689, ABBV-552, SHR-1707, LX1001, MK-1167, RB-ADSC, ALN-APP, XTR006, E2814, VT301, and others.
• In April 2025, Biogen announced that the FDA granted Fast Track designation to BIIB080, its investigational antisense oligonucleotide therapy targeting tau, for the treatment of Alzheimer's disease, aiming to accelerate development for this high-need area.
• In March 2025, BioXcel Therapeutics announced that the FDA has closed its inspection of a site involved in the Phase III TRANQUILITY II trial for the acute treatment of agitation in Alzheimer's dementia, issuing an Establishment Inspection Report under 21 CFR 20.64(d)(3).
• In March 2025, Axsome Therapeutics announced it received formal pre-NDA meeting minutes from the FDA, supporting a planned sNDA submission for AXS-05 for the treatment of agitation associated with Alzheimer's disease.
• In February 2025, NKGen Biotech, Inc., a clinical-stage biotechnology company with a market cap of $17 million, received Fast Track designation from the FDA for its investigational drug, troculeucel, aimed at treating moderate Alzheimer's disease.
• In January 2025, Beckman Coulter Diagnostics announced that the FDA granted Breakthrough Device Designation to its Access p‐Tau217/β-Amyloid 1-42 plasma ratio blood test, designed to help healthcare providers identify patients with amyloid pathology linked to Alzheimer's disease.
• In January 2025, Eisai Co., Ltd. and Biogen Inc. announced that the FDA approved the Supplemental Biologics License Application (sBLA) for lecanemab-irmb (LEQEMBI) with once every four weeks IV maintenance dosing for the treatment of Alzheimer's disease.
Stay informed on these critical clinical milestones - access recent Alzheimer's pipeline breakthroughs here: https://www.delveinsight.com/report-store/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
Alzheimer's Disease Overview
Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia, marked by memory loss, cognitive decline, and loss of independence. The condition is multifactorial, with key pathological features including amyloid plaques, neurofibrillary tangles, brain atrophy, and cholinergic neuron damage. Risk factors include aging, genetics, vascular issues, head injuries, and environmental triggers.
AD progresses through preclinical, mild cognitive impairment, and dementia stages. Early symptoms include short-term memory loss, followed by impaired judgment, executive dysfunction, language issues, and neuropsychiatric symptoms like agitation and apathy. Advanced stages lead to full dependence.
While there is no cure, current Alzheimer's disease drugs like donepezil, rivastigmine, and galantamine help manage mild to moderate symptoms. The Alzheimer's disease drug development pipeline: 2025 is expanding rapidly, with therapies targeting tau, amyloid, inflammation, and more, offering new hope in the Alzheimer's disease market.
Explore the market transformation with disease-modifying therapies - get a sample of the report now: https://www.delveinsight.com/report-store/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
Alzheimer's Disease Treatment Analysis: Drug Profile
AR1001: AriBio Co., Ltd.
AR1001 is a potent, brain-penetrant phosphodiesterase 5 (PDE5) inhibitor initially developed for erectile dysfunction in South Korea. Now repurposed for Alzheimer's disease treatment, AR1001 is reportedly 10 times more effective than approved PDE5 inhibitors like sildenafil. The therapeutic rationale lies in PDE5 inhibitors' ability to enhance memory and learning through elevated cGMP levels, improved cerebral blood flow, and reduced amyloid buildup and neuroinflammation. AR1001 is currently in Phase III clinical trials for Alzheimer's disease.
NE3107: BioVie
NE3107 is an oral small molecule with anti-inflammatory and insulin-sensitizing capabilities, designed to cross the blood-brain barrier. It targets inflammatory regulators ERK and NF-κB, both implicated in Alzheimer's pathology through their activation by amyloid beta, tau, and cytokines. NE3107 blocks inflammation without suppressing essential cellular functions like insulin signaling and neuroprotection. Currently, it is in Phase III development for the treatment of Alzheimer's disease.
LY3372689: Eli Lilly & Co.
LY3372689 is an oral O-GlcNAcase (OGA) inhibitor being studied for Alzheimer's disease. OGA enzymes remove O-GlcNAc modifications on proteins; inhibiting OGA enhances tau glycosylation, reducing its aggregation into toxic forms. By promoting a more stable, nonpathogenic tau, LY3372689 shows potential in targeting tau-driven neurodegeneration. It is currently in Phase II clinical trials for Alzheimer's disease therapy.
Key Alzheimer's Disease Therapies and Companies
• LY3372689: Eli Lilly & Co.
• CT1812: Cognition Therapeutics
• ABBV-916: AbbVie Inc.
• ALX-001: Allyx Therapeutics, Inc.
• Masitinib (AB1010): AB Science
• Valiltramiprosate (ALZ-801): Alzheon Inc.
• Mirodenafil (AR1001): AriBio Co., Ltd.
• Levetiracetam (AGB101): AgeneBio, Inc.
• Blarcamesine (ANAVEX2-73): Anavex Life Sciences Corp.
• Buntanetap (ANVS401 or posiphen): Annovis Bio, Inc.
• Tricaprilin (CER0001): Cerecin
• Bezisterim (NE3107): BioVie
• Simufilam (PTI-125): Cassava Sciences
• Semaglutide (NN6535): Novo Nordisk
• Remternetug (LY3372993): Eli Lilly
• Piromelatine (Neu-P11): Neurim Pharmaceuticals
• Masupirdine (SUVN-502): Suven Life Sciences
• KarXT (Trospium Chloride/Xanomeline): Bristol Myers Squibb/Karuna Therapeutics
• T3D-959: T3D Therapeutics, Inc.
• LX 1001: Lexeo Therapeutics
• AXS-05 (Bupropion/Dextromethorphan): Axsome Therapeutics, Inc.
• ABvac40: Araclon Biotech S.L.
• E2814: Eisai Co., Ltd.
• Hydromethylthionine Mesylate (HMTM)/TRx0237: TauRx Therapeutics
• TB006: TrueBinding, Inc.
• ACI-35.030/JNJ-2056: AC Immune SA/Johnson & Johnson
• Allogeneic MSC/Lomecel-B: Longeveron Inc.
• Pepinemab: Vaccinex Inc.
• IGC-AD1: IGC Pharma LLC
See which companies are leading the Alzheimer's race - download the latest competitive pipeline landscape now: https://www.delveinsight.com/report-store/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
Alzheimer's Disease Therapeutics Assessment
The report provides detailed segmentation of therapies by:
• Stage of Development: Discovery, Preclinical, Phase I, II, III.
• Therapy Type: Mono, Combination, Mono/Combination.
• Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy.
• Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical.
It also offers a comprehensive analysis of discontinued/inactive assets, licensing trends, strategic collaborations, and evolving commercial models.
Scope of the Alzheimer's Disease Pipeline Report
• Coverage: Global
• Key Alzheimer's Disease Companies: AriBio, Eli Lilly, Cognition Therapeutics, AbbVie, Allyx Therapeutics, Cassava Sciences, BioVie, Novo Nordisk, Alector, Longeveron, Cognition Therapeutics, TrueBinding, VT BIO, Luye Pharma Group, Lexeo Therapeutics, Merck Sharp & Dohme LLC, Regeneration Biomedical, Alnylam Pharmaceuticals, Sinotau Pharmaceutical Group, Eisai, Shanghai Hengrui Pharmaceutical, and others.
• Key Alzheimer's Disease Pipeline Therapies: AR1001, LY3372689, CT1812, ABBV-916, ALX-001, Simufilam, Remternetug, NE3107, Semaglutide, AL002, Lomecel-B, CT1812, TB006, LY3372689, ABBV-552, SHR-1707, LX1001, MK-1167, RB-ADSC, ALN-APP, XTR006, E2814, VT301, and others.
Dive deeper into the mechanism of action, product strategy, and unmet needs shaping Alzheimer's research: https://www.delveinsight.com/report-store/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
Table of Contents
1. Introduction
2. Executive Summary
3. Alzheimer's Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Alzheimer's Disease Pipeline Therapeutics
6. Alzheimer's Disease Pipeline: Late-Stage Products (Phase III)
7. Alzheimer's Disease Pipeline: Mid-Stage Products (Phase II)
8. Alzheimer's Disease Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix
About the Report
The Alzheimer's Disease Drug Development Pipeline: 2025 is part of DelveInsight's series of pipeline intelligence reports. It delivers a comprehensive view of drug candidates' clinical, scientific, and commercial status targeting Alzheimer's disease.
Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.
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