Alzheimer's-disease - Pipeline Insight, 2025

This “Alzheimer’s-disease - Pipeline Insight, 2025” report provides comprehensive insights about 110+ companies and 120+ 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.

Alzheimer’s-disease: Understanding

Alzheimer’s-disease: Overview

Alzheimer’s disease (AD) is a disorder that causes degeneration of the cells in the brain and it is the main cause of dementia, which is characterized by a decline in thinking and independence in personal daily activities. AD is considered a multifactorial disease: two main hypotheses were proposed as a cause for AD, cholinergic and amyloid hypotheses. Additionally, several risk factors such as increasing age, genetic factors, head injuries, vascular diseases, infections, and environmental factors play a role in the disease.

There are two types of neuropathological changes in AD which provide evidence about disease progress and symptoms and include: (1) positive lesions (due to accumulation), which are characterized by the accumulation of neurofibrillary tangles, amyloid plaques, dystrophic neurites, neuropil threads, and other deposits found in the brains of AD patients. In addition to (2) negative lesions (due to losses), that are characterized by large atrophy due to a neural, neuropil, and synaptic loss. Besides, other factors can cause neurodegeneration such as neuroinflammation, oxidative stress, and injury of cholinergic neurons.

Symptoms of Alzheimer's disease depend on the stage of the disease. Alzheimer's disease is classified into preclinical or presymptomatic, mild, and dementia-stage depending on the degree of cognitive impairment. These stages are different from the DSM-5 classification of Alzheimer's disease. The initial and most common presenting symptom is episodic short-term memory loss with relative sparing of long-term memory and can be elicited in most patients even when not the presenting symptom. Short-term memory impairment is followed by impairment in problem-solving, judgment, executive functioning, lack of motivation and disorganization, leading to problems with multitasking and abstract thinking. In the early stages, impairment in executive functioning ranges from subtle to significant. This is followed by language disorder and impairment of visuospatial skills. Neuropsychiatric symptoms like apathy, social withdrawal, disinhibition, agitation, psychosis, and wandering are also common in the mid to late stages. Difficulty performing learned motor tasks (dyspraxia), olfactory dysfunction, sleep disturbances, extrapyramidal motor signs like dystonia, akathisia, and parkinsonian symptoms occur late in the disease. This is followed by primitive reflexes, incontinence, and total dependence on caregivers.

Treating the symptoms of Alzheimer’s can help provide people with comfort, dignity, and independence for a longer period of time and also assist their caregivers. Galantamine, rivastigmine, and donepezil are cholinesterase inhibitors that are prescribed for mild to moderate Alzheimer’s symptoms. These drugs may help reduce or control some cognitive and behavioral symptoms.

'Alzheimer’s-disease- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Alzheimer’s-disease pipeline landscape is provided which includes the disease overview and Alzheimer’s-disease treatment guidelines. The assessment part of the report embraces, in depth Alzheimer’s-disease commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Alzheimer’s-disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Alzheimer’s-disease R&D. The therapies under development are focused on novel approaches to treat/improve Alzheimer’s-disease.

Alzheimer’s-disease Emerging Drugs Chapters

This segment of the Alzheimer’s-disease report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Alzheimer’s-disease Emerging Drugs

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.

ABBV-916: AbbVie Inc.

ABBV-916 anti-AβpE3 (N-terminal truncated, pyroglutamate-modified at amino acid position 3, amyloid beta) is a monoclonal antibody being investigated for the treatment of Alzheimer’s Disease. The drug candidate is administered through intravenous route as an infusion. Currently, the drug is in the Phase II stage of development to treat Alzheimer’s-disease.

ALX-001: Allyx Therapeutics, Inc.

ALX-001 (previously BMS-984923) is a silent allosteric modulator of mGluR5, a first-in-class compound that selectively blocks the pathogenic activation of the receptor while preserving the physiological glutamate signaling that is required for normal cognition. ALX-001 has a wide therapeutic window that can saturate receptor binding while avoiding on-target toxicity observed with negative allosteric modulators. Currently, the drug is in the Phase I stage of development to treat Alzheimer’s disease.

Alzheimer’s-disease: Therapeutic Assessment

This segment of the report provides insights about the different Alzheimer’s-disease drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Alzheimer’s-disease

• There are approx. 110+ key companies which are developing the therapies for Alzheimer’s-disease. The companies which have their Alzheimer’s-disease drug candidates in the most advanced stage, i.e. Phase III include, AriBio Co., Ltd. and BioVie.

Phases

The report covers around 120+ products under different phases of clinical development like

• 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

Route of Administration

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

Molecule Type

Products have been categorized under various Molecule types such as

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

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Alzheimer’s-disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Alzheimer’s-disease therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Alzheimer’s-disease drugs.

Alzheimer’s-disease Report Insights

• Alzheimer’s-disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Alzheimer’s-disease Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Alzheimer’s-disease drugs?
• How many Alzheimer’s-disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Alzheimer’s-disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Alzheimer’s-disease therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Alzheimer’s-disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• AriBio Co., Ltd.

Eli Lilly & Co.

Cognition Therapeutics

• AbbVie Inc.

Allyx Therapeutics, Inc.

Cassava Sciences

• BioVie Inc.

Novo Nordisk

• Alector Inc.

Longeveron Inc.

Cognition Therapeutics

• TrueBinding, Inc.

VT BIO

• Luye Pharma Group Ltd.

Lexeo Therapeutics

• Merck Sharp & Dohme LLC
• Regeneration Biomedical
• Alnylam Pharmaceuticals
• Sinotau Pharmaceutical Group
• Eisai Inc.

Shanghai Hengrui Pharmaceutical Co., Ltd.

Key Products

• 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

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