Alzheimer's disease Pipeline

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.

 

Geography Covered

• Global coverage

 

Alzheimer’s disease: Understanding

Alzheimer’s disease: Overview

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder that primarily affects memory, cognition, and behavior. It is the most common cause of dementia, accounting for 60–80% of cases worldwide. AD is characterized by gradual neuronal loss, particularly in the hippocampus and cerebral cortex, leading to cognitive decline and impaired daily functioning. Although aging is the most significant risk factor, genetic predisposition (such as APOE4 mutations), lifestyle factors, and cardiovascular health also contribute to its development.

 

The signs and symptoms of Alzheimer’s disease begin with mild memory loss and difficulty in recalling recent events or conversations. As the disease progresses, individuals experience confusion, disorientation, impaired judgment, difficulty completing familiar tasks, and changes in mood or personality. In later stages, severe memory loss, difficulty recognizing loved ones, loss of motor skills, and an inability to communicate or perform basic activities of daily living occur. Behavioral symptoms, such as agitation, depression, and paranoia, are also common.

 

Pathophysiologically, Alzheimer’s disease is associated with the accumulation of β-amyloid plaques and neurofibrillary tangles composed of hyperphosphorylated tau protein. These abnormal protein aggregates disrupt neuronal communication, trigger inflammation, and lead to synaptic dysfunction and neuronal death. Oxidative stress, mitochondrial dysfunction, and cholinergic system deficits further contribute to disease progression. The loss of acetylcholine, a neurotransmitter essential for learning and memory, plays a crucial role in cognitive decline.

 

Diagnosis of Alzheimer’s disease is primarily clinical, based on cognitive assessments and patient history. Standardized tests such as the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) help evaluate cognitive impairment. Imaging techniques like magnetic resonance imaging (MRI) and positron emission tomography (PET) scans assess brain atrophy and amyloid deposition. Biomarkers, including cerebrospinal fluid (CSF) levels of β-amyloid and tau, are also used for early diagnosis and differentiation from other dementias.

 

Treatment for Alzheimer’s disease aims to manage symptoms and slow progression, as there is currently no cure. Cholinesterase inhibitors (e.g., donepezil, rivastigmine) and N-methyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine) help improve cognitive function and memory. Recently, monoclonal antibodies targeting β-amyloid, such as aducanumab and lecanemab, have been approved for early-stage AD to reduce amyloid burden. Lifestyle modifications, cognitive therapy, and caregiver support play essential roles in managing the disease and improving quality of life.

 

"Alzheimer’s disease- Pipeline Insight, 2025" report by DelveInsight 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, II/III 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 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: AgeneBio

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: Amylyx Pharmaceuticals Inc

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: Inventage Lab., Inc.

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: Biohaven Pharmaceuticals

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.

Further product details are provided in the report……..

 

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. 200+ 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.

 

Phases

DelveInsight’s report covers around 220+ 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 

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

 

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

 

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?