Dementia Associated With Alzheimer’s Disease Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Dementia Associated With Alzheimer's Disease Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Dementia Associated With Alzheimer’s Disease Pipeline Insight 2025” report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Dementia Associated With Alzheimer’s Disease pipeline landscape. It covers the Dementia Associated With Alzheimer’s Disease pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Dementia Associated With Alzheimer’s Disease 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 Dementia Associated With Alzheimer’s Disease Pipeline Report

  • In March 2025, Karuna Therapeutics announced a phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer’s Disease (AD) with moderate to severe psychosis related to AD.
  • In March 2025, BioXcel Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has closed the inspection of a single site in its TRANQUILITY II Phase 3 trial under 21 C.F.R.20.64(d)(3) and released the Establishment Inspection Report.
  • DelveInsight’s Dementia Associated With Alzheimer’s Disease pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Dementia Associated With Alzheimer’s Disease treatment.
  • The leading Dementia Associated With Alzheimer’s Disease Companies such as BioVie, Karuna Therapeutics, Cassava Sciences, Inc., Cognition Therapeutics, Alector, TrueBinding, KeyMed Biosciences, Alzinova, AriBio Co., Ltd., Eli Lilly & Co., AbbVie Inc., Allyx Therapeutics, Inc., Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd and others.
  • Promising Dementia Associated With Alzheimer’s Disease Pipeline Therapies such as ITI-1284, Brexpiprazole, KarXT, Quetiapine Fumarate, DMB-I (Dimebon), Rifaximin SSD 40 mg IR tablet, OPC-34712, and others.

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Dementia Associated With Alzheimer’s Disease Emerging Drugs Profile

  • 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.

  • KarXT: Karuna Therapeutics

KarXT, a combination of xanomeline and trospium, is an investigational treatment developed by Karuna Therapeutics, primarily aimed at addressing psychosis associated with Alzheimer’s disease (AD) and schizophrenia. KarXT functions as a muscarinic receptor agonist, specifically targeting the M1 and M4 muscarinic acetylcholine receptors. Xanomeline activates these receptors, which are crucial for cognitive processes such as learning and memory. Trospium, on the other hand, is included to mitigate peripheral side effects associated with xanomeline, such as nausea and vomiting, by preventing its action on muscarinic receptors outside the brain. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Dementia Associated With Alzheimer’s Disease.

  • Simufilam: Cassava Sciences

Simufilam (formerly known as PTI-125) is an investigational drug being developed by Cassava Sciences. It targets an altered form of filamin A (FLNA), a protein implicated in the disease’s pathology. Unlike traditional Alzheimer’s treatments that focus on clearing amyloid plaques, simufilam works by stabilizing FLNA, thereby potentially reducing neuroinflammation and cognitive decline associated with the disease. Currently, the drug is in the Phase III stage of development to treat Dementia Associated With Alzheimer’s Disease.

  • CT-1812: 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.

  • CM383: KeyMed Biosciences

CM383 is an investigational drug being developed for the treatment of Alzheimer’s disease. It is a small molecule designed to target the underlying mechanisms of the disease, specifically by modulating the immune response and reducing neuroinflammation, which are key factors in Alzheimer’s pathology. CM383 works by targeting the immune system’s response to amyloid-beta plaques, which are characteristic of Alzheimer’s disease. It aims to enhance the brain’s ability to clear these plaques and improve neuronal health. This approach is distinct from many traditional Alzheimer’s treatments that primarily focus on amyloid plaque reduction or cholinergic modulation. Currently, the drug is in the Phase I stage of development to treat Alzheimer’s-disease.

The Dementia Associated With Alzheimer’s Disease Pipeline Report Provides Insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Dementia Associated With 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 Dementia Associated With Alzheimer’s Disease Treatment.
  • Dementia Associated With Alzheimer’s Disease Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Dementia Associated With Alzheimer’s Disease Drugs under development 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 Dementia Associated With Alzheimer’s Disease market

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Dementia Associated With Alzheimer’s Disease Companies

BioVie, Karuna Therapeutics, Cassava Sciences, Inc., Cognition Therapeutics, Alector, TrueBinding, KeyMed Biosciences, Alzinova, AriBio Co., Ltd., Eli Lilly & Co., AbbVie Inc., Allyx Therapeutics, Inc., Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd and others.

Dementia Associated With 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

  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical

Dementia Associated With Alzheimer’s Disease Products have been categorized under various Molecule types such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

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Scope of the Dementia Associated With Alzheimer’s Disease Pipeline Report

  • Coverage- Global
  • Dementia Associated With Alzheimer’s Disease Companies- BioVie, Karuna Therapeutics, Cassava Sciences, Inc., Cognition Therapeutics, Alector, TrueBinding, KeyMed Biosciences, Alzinova, AriBio Co., Ltd., Eli Lilly & Co., AbbVie Inc., Allyx Therapeutics, Inc., Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd and others.
  • Dementia Associated With Alzheimer’s Disease Pipeline Therapies- ITI-1284, Brexpiprazole, KarXT, Quetiapine Fumarate, DMB-I (Dimebon), Rifaximin SSD 40 mg IR tablet, OPC-34712, and others.
  • Dementia Associated With Alzheimer’s Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Dementia Associated With Alzheimer’s Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Dementia Associated With Alzheimer’s Disease Pipeline on our website @ Dementia Associated With Alzheimer’s Disease Emerging Drugs and Companies

Table of Content

  1. Introduction
  2. Dementia Associated With Alzheimer’s Disease Executive Summary
  3. Dementia Associated With Alzheimer’s Disease Overview
  4. Dementia Associated With Alzheimer’s Disease Pipeline Therapeutics
  5. Dementia Associated With Alzheimer’s Disease Therapeutic Assessment
  6. Dementia Associated With Alzheimer’s Disease– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. NE3107: BioVie
  9. Mid Stage Products (Phase II)
  10. CT-1812: Cognition Therapeutics
  11. Early Stage Products (Phase I)
  12. CM383: KeyMed Biosciences
  13. Preclinical and Discovery Stage Products
  14. Drug name: Company name
  15. Inactive Products
  16. Dementia Associated With Alzheimer’s Disease Key Companies
  17. Dementia Associated With Alzheimer’s Disease Key Products
  18. Dementia Associated With Alzheimer’s Disease- Unmet Needs
  19. Dementia Associated With Alzheimer’s Disease- Market Drivers and Barriers
  20. Dementia Associated With Alzheimer’s Disease- Future Perspectives and Conclusion
  21. Dementia Associated With Alzheimer’s Disease Analyst Views
  22. Dementia Associated With Alzheimer’s Disease Key Companies
  23. Appendix

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