Alzheimer's Disease Clinical Trials 2025: EMA, PDMA, FDA Approvals, Treatment Market, Medication, Therapies, MOA, ROA and Companies by DelveInsight

(Albany, USA) DelveInsight's 'Alzheimer's disease Pipeline Insight 2025' report provides comprehensive global coverage of pipeline Alzheimer's disease therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Alzheimer's disease pipeline domain.

For Alzheimer's disease emerging drugs, the Alzheimer's disease pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

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 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 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 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 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
• 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.

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Alzheimer's Disease Overview
Alzheimer's disease (AD) is a neurodegenerative disorder that leads to the progressive decline of brain cells and is the primary cause of dementia, characterized by impairments in thinking and the ability to perform daily activities independently. AD is considered a multifactorial condition, with two main hypotheses for its cause: the cholinergic hypothesis and the amyloid hypothesis. Several risk factors, including advancing age, genetics, head injuries, vascular diseases, infections, and environmental influences, contribute to the disease.

In Alzheimer's Disease, there are two main types of neuropathological changes that provide evidence of disease progression: (1) positive lesions, caused by the accumulation of neurofibrillary tangles, amyloid plaques, dystrophic neurites, neuropil threads, and other deposits in the brain, and (2) negative lesions, which result from large-scale atrophy due to the loss of neurons, neuropil, and synapses. Other factors like neuroinflammation, oxidative stress, and damage to cholinergic neurons also contribute to neurodegeneration.

The symptoms of Alzheimer's disease vary depending on the stage of progression. AD is typically categorized into three stages: preclinical (presymptomatic), mild, and dementia stage, based on the extent of cognitive impairment. Unlike the DSM-5 classification, these stages focus on the severity of cognitive decline. Early signs often include short-term memory loss, particularly affecting episodic memory, with long-term memory relatively preserved. This is followed by difficulties with problem-solving, judgment, executive functions, and a lack of motivation, leading to challenges in multitasking and abstract thinking. In the early stages, impairments in executive functioning can range from subtle to more pronounced. As the disease progresses, language difficulties and impairments in visuospatial skills emerge, along with neuropsychiatric symptoms such as apathy, social withdrawal, disinhibition, agitation, psychosis, and wandering. Later stages may involve motor difficulties like dyspraxia, olfactory dysfunction, sleep disturbances, and extrapyramidal motor signs such as dystonia, akathisia, and parkinsonian symptoms. In the final stage, patients may lose primitive reflexes, experience incontinence, and become entirely dependent on caregivers.
Treatments for Alzheimer's disease focus on alleviating symptoms, helping patients maintain comfort, dignity, and independence for as long as possible. Cholinesterase inhibitors, such as galantamine, rivastigmine, and donepezil, are commonly prescribed to manage mild to moderate Alzheimer's symptoms. These medications may help reduce or control cognitive and behavioral issues.

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Alzheimer's disease Treatment Analysis: Drug Profile
AR1001: AriBio Co., Ltd.
AR1001 is a selective inhibitor of phosphodiesterase 5. This new pyrrolo-pyrimidinone was first developed for treatment of erectile dysfunction in South Korea, and is now being tested for Alzheimer's Disease. Its maker claims AR1001 to be 10-fold more potent at inhibiting PDE5, and better at entering the brain, than approved PDE5 inhibitors, including sildenafil.
The rationale for using PDE5 inhibitors in AD stems from animal studies, where these compounds enhance memory and learning by increasing the intracellular messenger cGMP, and also possibly by improving blood supply to the brain. Several PDE5 inhibitors have been reported to curtail amyloid production, and to lessen neuroinflammation and learning and memory deficits in mouse models of AD. Currently the drug is in Phase III stage of Clinical trial evaluation for the treatment of Alzheimer's disease.

NE3107: BioVie
NE3107 is an orally available small molecule with potential anti-inflammatory and insulin-sensitizing properties that can cross the blood-brain barrier. It was originally developed by NeurMedix and acquired by BioVie in April. The experimental molecule works by blocking the activation of two major regulators of inflammatory pathways: extracellular signal regulated kinase (ERK) and nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB). NFκB is activated by amyloid beta and tau - two proteins that form toxic clumps that contribute to Alzheimer's - and by the pro-inflammatory molecules that it stimulates, leading to chronic inflammation. NE3107 was found to have no immunosuppressive effects and to block ERK- and NF-κB-induced inflammation without suppressing their functions involved in maintaining overall balance, such as insulin signaling and nerve cell growth and survival. Currently, the drug is in phase III stage of development for the treatment of Alzheimer Disease.

LY3372689: Eli Lilly & Co.
LY3372689 is an orally active O-GlcNAcase (OGA) enzyme inhibitor. O-GlcNAcylation, i.e., addition of N-acetylglucosamine to serine and threonine residues, is a post-translational modification that regulates the function of many proteins. In particular, N-GlcNAcylation of tau reduces its propensity to form toxic aggregates. OGA catalyzes removal of O-GlcNAc. OGA inhibitors promote tau glycosylation, prevent aggregation, and appear to stabilize tau in a soluble, nonpathogenic form. LY3372689 can be used for tauopathies research, including Alzheimer's disease. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of Alzheimer's disease.
CT1812: Cognition Therapeutics
Cognition Therapeutics isdeveloping CT1812, an oral, brain-penetrant, small molecule therapeutic, which has been shown to protect neurons and synapses by preventing the binding of toxic oligomers. CT1812 acts as a neuroprotective agent both by shielding neurons and synapses from oligomer binding and by preventing oligomers from attaching to synapses in the first place. CT1812 may help mitigate the neurotoxic effects, slowing cognitive decline and progression of Alzheimer's disease. Currently, the drug is in the Phase II stage of development to treat Alzheimer's-disease.

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Key Alzheimer's disease Therapies and Companies
• 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

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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

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: Late-Stage Products (Phase III)
8. Alzheimer's disease Pipeline: Mid-Stage Products (Phase II)
9. Alzheimer's disease Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

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About DelveInsight
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