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
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Alzheimer’s Disease Emerging Drugs Profile
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 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 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 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 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.
The Alzheimer’s Disease Pipeline Report Provides Insights into
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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
Alzheimer’s Disease Products have been categorized under various Molecule types such as
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Scope of the Alzheimer’s Disease Pipeline Report
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