Press release
Alzheimer's Disease Competitive Landscape 2025: Clinical Trial Analysis, Therapies, FDA Approvals, Future Outlook by DelveInsight
Alzheimer's Disease Competitive Landscape
With 110+ active players and over 120 pipeline drugs under development, the Alzheimer's therapeutic domain continues to evolve with rapid advancements in disease-modifying treatments, biomarkers, and neuroprotective agents. The report delivers a 360° analysis by mechanism of action (MOA), route of administration (ROA), molecule type, and stage of development, offering strategic insights for stakeholders in the neurodegenerative disorder space.
Get exclusive insights into 120+ Alzheimer's pipeline drugs & 110+ active players shaping the future of Alzheimer's treatment: https://www.delveinsight.com/report-store/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Key Highlights from DelveInsight's Alzheimer's Disease Pipeline Report
• 110+ active companies and 120+ emerging therapies are being developed for Alzheimer's disease across various stages of clinical trials.
• Top companies advancing their lead assets include:
AB Science, Alzheon Inc., AriBio Co., Ltd., AgeneBio Inc., Anavex Life Sciences Corp., BioVie, Cassava Sciences, Novo Nordisk, Eli Lilly, Eisai, Bristol Myers Squibb, Johnson & Johnson, and Axsome Therapeutics, among others.
• Breakthrough designations and regulatory milestones (2024-2025) are reshaping the global Alzheimer's treatment paradigm.
Recent Regulatory and Clinical Updates (2024-2025)
• In January 2025, Spear Bio Inc. announced that its pTau 217 blood test received Breakthrough Device Designation from the FDA. This designation highlights the test's potential to address the critical unmet need for millions of undiagnosed Alzheimer's patients in the U.S.
• In January 2025, BioArctic AB announced that the U.S. FDA has accepted Eisai's Biologics License Application (BLA) for the Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. Leqembi is indicated for the treatment of Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia, referred to as early AD.
• In Jan 2025, the U.S. FDA granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody, being investigated for the treatment of early Alzheimer's disease in the phase 2b AuTonomy study.
• In January 2025, Axsome Therapeutics announced plans to seek FDA approval for AXS-05 in Alzheimer's disease agitation, despite mixed results in late-phase studies. AXS-05 is a combination of dextromethorphan and bupropion, already approved for treating major depressive disorder.
• In December 2024, Eli Lilly received regulatory approval in China for Kisunla, its anti-amyloid therapy for Alzheimer's disease, marking a significant milestone in the world's second-largest pharmaceutical market.
• In December 2024, Axsome Therapeutics reported that one Phase 3 trial of Auvelity met its primary goal in treating Alzheimer's agitation, while another trial showed numerical improvement but lacked statistical significance. The company aims to provide an alternative to Rexulti, the only FDA-approved drug for Alzheimer's agitation, developed by Lundbeck and Otsuka Pharmaceutical.
• In Oct 2024, Praxis Bioresearch announced that the FDA has approved the IND application for PRX-P4-003, a gut-activated stimulant designed to treat apathy in Alzheimer's Disease. Earlier, a microdose clinical trial in healthy volunteers showed successful activation of the drug after oral administration, which is the planned route for therapy.
• In Oct 2024, a real-world study published in Alzheimer's and Dementia found that Novo Nordisk's semaglutide is associated with a 40% to 70% reduction in the risk of Alzheimer's diagnosis among patients with type 2 diabetes. This follows a July study based on health records from 100 million patients, which also linked the drug to a lower risk of dementia and other neurological disorders.
• In Oct 2024, Eli Lilly's treatment for early Alzheimer's, donanemab (branded as Kisunla), was deemed too expensive for widespread use by the UK's cost-effectiveness body, indicating that patients may not have access despite its approval by the Medicines and Healthcare products Regulatory Agency (MHRA). Kisunla is now the second Alzheimer's treatment approved in the UK, following Leqembi, developed by Eisai and Biogen.
Stay ahead with in-depth analysis of emerging Alzheimer's drugs, clinical trial stages, and key company strategies. Click to explore @ https://www.delveinsight.com/sample-request/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Alzheimer's Disease Overview
Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia globally. It is characterized by cognitive impairment, memory loss, behavioral changes, and a decline in daily functioning due to neuronal death and synaptic dysfunction.
Pathologically, AD is marked by amyloid-beta plaques and neurofibrillary tau tangles, contributing to neuronal atrophy, neuroinflammation, and oxidative stress. Risk factors such as aging, genetics (APOE ε4 allele), vascular diseases, and head injuries increase susceptibility.
The disease is commonly divided into three stages:
• Preclinical (asymptomatic)
• Mild cognitive impairment (MCI)
• Alzheimer's dementia (advanced stage)
Currently, available therapies focus on symptom management, including cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). However, disease-modifying therapies (DMTs) targeting amyloid and tau pathways are the next frontier.
Emerging Alzheimer's Disease Therapies and Clinical Trials
DelveInsight's pipeline analysis identifies several promising late- and mid-stage candidates with unique mechanisms of action:
1. AR1001 (AriBio Co., Ltd.)
A PDE5 inhibitor initially developed for erectile dysfunction, AR1001 enhances cGMP signaling, improving blood flow and memory performance. It demonstrates strong neuroprotective potential by reducing amyloid formation and neuroinflammation. Currently in Phase III trials.
2. NE3107 (BioVie)
An anti-inflammatory and insulin-sensitizing small molecule, NE3107 targets NF-κB and ERK pathways, crucial in tau and amyloid-induced inflammation. It has shown promising neuroprotective activity and is in Phase III clinical evaluation.
3. LY3372689 (Eli Lilly & Co.)
A novel OGA inhibitor promoting tau glycosylation to prevent aggregation and neurotoxicity. This approach aims to stabilize tau proteins in their soluble, non-pathogenic form. Currently in Phase II development.
4. CT1812 (Cognition Therapeutics)
An oral small molecule that protects neurons by preventing toxic oligomer binding to synapses. The therapy has shown potential to slow cognitive decline and is being evaluated in Phase II studies.
Gain a competitive edge with customized data on Alzheimer's pipeline by MOA, ROA, and molecule type tailored to your business needs @ https://www.delveinsight.com/report-store/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Top Companies in the Alzheimer's Pipeline Landscape
• Eli Lilly and Co.
• Eisai Co., Ltd.
• Novo Nordisk
• BioVie
• Anavex Life Sciences
• Axsome Therapeutics
• Cassava Sciences
• AB Science
• Bristol Myers Squibb
• Karuna Therapeutics
• TauRx Therapeutics
• AC Immune SA
• Longeveron Inc.
• Vaccinex Inc.
• IGC Pharma LLC
These companies are pioneering diverse approaches including small molecules, monoclonal antibodies, peptides, and gene therapies, addressing key pathological targets such as amyloid beta, tau proteins, neuroinflammation, and synaptic dysfunction.
Regulatory Landscape and Market Outlook
The Alzheimer's market is projected to grow exponentially, driven by:
• Accelerating clinical trial activity across North America, Europe, and Asia.
• Increasing regulatory flexibility by the FDA, EMA, and PMDA to expedite disease-modifying drug approvals.
• Expanding biomarker validation for early diagnosis.
• Strategic partnerships between biotech startups and global pharma leaders.
DelveInsight's report further explores market barriers such as high R&D costs, patient recruitment challenges, and pricing pressures, balanced against growth drivers like improved diagnostics, personalized medicine, and AI-integrated neuroimaging.
Key Alzheimer's Pipeline Therapies
• Masitinib (AB1010): AB Science
• Valiltramiprosate (ALZ-801): Alzheon Inc.
• LY3372689: Eli Lilly & Co.
• CT1812: Cognition Therapeutics
• 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 Myeris 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
Each of these assets represents a distinct therapeutic strategy, ranging from amyloid-targeting to neuroinflammation modulation, and neuroregenerative mechanisms.
Gain a competitive edge with customized data on Alzheimer's pipeline by MOA, ROA, and molecule type tailored to your business needs @ https://www.delveinsight.com/report-store/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Alzheimer's Disease Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination
By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
By Route of Administration
• Oral
• Parenteral
• Intravitreal
• Subretinal
• Topical
By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
Scope of the Alzheimer's Disease Pipeline Report
• Coverage: Global
• Key Alzheimer's disease Companies: AB Science, Alzheon Inc., AriBio Co., Ltd., AgeneBio, Inc., Anavex Life Sciences Corp., Annovis Bio, Inc., Cerecin, BioVie, Cassava Sciences, Novo Nordisk, Eli Lilly, Neurim Pharmaceuticals, Suven Life Sciences, Bristol Myers Squibb, Karuna Therapeutics, T3D Therapeutics, Inc., Lexeo Therapeutics, Axsome Therapeutics, Inc., Araclon Biotech S.L., Eisai Co., Ltd., TauRx Therapeutics, TrueBinding, Inc., AC Immune SA, Johnson & Johnson, Longeveron Inc., Vaccinex Inc., IGC Pharma LLC
• Key Alzheimer's disease Pipeline Therapies: Masitinib (AB1010), Valiltramiprosate (ALZ-801), Mirodenafil (AR1001), Levetiracetam (AGB101), Blarcamesine (ANAVEX2-73), Buntanetap (ANVS401 or posiphen), Tricaprilin (CER0001), Bezisterim (NE3107), Simufilam (PTI-125), Semaglutide (NN6535), Remternetug (LY3372993), Piromelatine (Neu-P11), Masupirdine (SUVN-502), KarXT (Trospium Chloride/Xanomeline), T3D-959, LX 1001, AXS-05 (Bupropion/Dextromethorphan), ABvac40, E2814, Hydromethylthionine Mesylate (HMTM)/TRx0237, TB006, ACI-35.030/JNJ-2056, Allogeneic MSC/Lomecel-B, Pepinemab, IGC-AD1
Learn how innovative drugs like AR1001, NE3107 & LY3372689 are advancing toward commercialization. Dive into the full pipeline @ https://www.delveinsight.com/sample-request/alzheimers-disease-ad-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Analyst View
"The Alzheimer's therapeutic landscape is undergoing a paradigm shift from symptom management to disease modification. With over 120 drugs under development, including novel amyloid, tau, and neuroinflammatory targets, the next decade could witness the first generation of truly disease-modifying Alzheimer's therapies," - DelveInsight Analyst Team.
Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679
About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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