The Alzheimer’s Disease Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

“Alzheimer’s Disease Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Alzheimer’s Disease Market.

Some of the key takeaways from the Alzheimer’s Disease Pipeline Report:

• Companies across the globe are diligently working toward developing novel Alzheimer’s Disease treatment therapies with a considerable amount of success over the years.

• Alzheimer’s Disease companies working in the treatment market are GliaPharm, Galimedix, Oligomerix, Inc, Artery Therapeutics, Inc., Longeveron Inc., INmune Bio, Treeway B.V., ACADIA Pharmaceuticals, Annovis Bio, Neurodon, Sangamo Therapeutics, NKGen Biotech, Asceneuron, TrueBinding, Alector, Cognition Therapeutics, Anavex Life Sciences, Eisai Co Ltd, Cassava Sciences, Inc., Karuna Therapeutics, BioVie, and others, are developing therapies for the Alzheimer’s Disease treatment

• Emerging Alzheimer’s Disease therapies in the different phases of clinical trials are- GP-199, GAL-201, OLX 07010, CS-6253, Lomecel-B, Pegipanermin, TQ001, ACP-2024, Buntanetap, NRDN-201, ST-501, SNK 01, ASN51, TB 006, AL002, CT-1812, Blarcamesine, E 2814, Simufilam, KarXT, NE3107, and others are expected to have a significant impact on the Alzheimer’s Disease market in the coming years.

• On Aug. 29, 2025 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™, pronounced “I Click”) for maintenance dosing. LEQEMBI IQLIK is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of LEQEMBI (lecanemab-irmb) intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.

• In July 2025, Cognition Therapeutics’ investigational dementia treatment demonstrated up to a 129% reduction in the rate of cognitive decline among patients with mild Alzheimer’s disease in a Phase II trial. The Phase II SHINE study (NCT03507790), evaluating zervimesine in Alzheimer’s patients, revealed that those with less advanced brain pathology—measured by lower levels of the blood biomarker p-tau217—experienced significant slowing of cognitive deterioration. Within this subgroup, approximately half of the participants had mild Alzheimer’s disease, while the other half were classified as having moderate Alzheimer’s disease.

• In July 2025, Roche’s Alzheimer’s disease therapy demonstrated sustained benefits in a long-term extension study, showing positive outcomes after 28 weeks of treatment. In the high-dose group of the ongoing Phase Ib/IIa Brainshuttle AD trial (NCT04639050), trontinemab successfully lowered amyloid levels below the 24-centiloid positivity threshold in 91% of patients, with 72% reaching deep clearance below 11 centiloids. Additionally, the study reported early and notable reductions in Alzheimer’s disease biomarkers, including total tau, phosphorylated tau (pTau)181, pTau217, and neurogranin, as measured in both CSF and plasma.

• In July 2025, INmune Bio’s stock dropped over 50% after its TNF inhibitor failed to show efficacy in Alzheimer’s patients in a Phase II trial. The MINDFuL study (NCT05318976) tested XPro (pegipanermin), a selective soluble TNF inhibitor, in early Alzheimer’s patients with inflammatory biomarkers. While no overall benefit was observed at the six-month mark in the intent-to-treat group, patients with two or more inflammation biomarkers showed a modest 0.27-point improvement on the Early Mild Alzheimer’s Cognitive Composite (EMACC) and a -0.20 change in pTau217 blood levels. Inmune Bio suggests this subgroup might benefit from XPro.

• In June 2025, The UAB Brain Aging and Memory Clinic, which opened in spring 2024, ushers in a new chapter of care for Alzheimer’s disease and memory disorders in Alabama and the surrounding region. This facility has played a key role in supporting clinical trials, strengthening UAB’s position as a leading site for testing the latest generation of anti-Alzheimer therapies.

• In May 2025, Nuravax Inc. received a USD 3 million grant from the National Institutes of Health (NIH) to advance Duvax, the first dual-target Alzheimer’s vaccine, into human clinical trials.

• In April 2025, Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has awarded Fast Track designation to BIIB080, an experimental antisense oligonucleotide (ASO) therapy targeting tau, for treating Alzheimer’s disease. This designation aims to accelerate the development and review process of investigational drugs addressing serious diseases with unmet medical needs.

• In March 2025, Acumen Pharmaceuticals completed enrollment for its multi-center, double-blind Phase II ALTITUDE-AD trial evaluating the humanized monoclonal antibody sabirnetug (ACU193) in patients with early Alzheimer’s disease. Sabirnetug is noted as the first antibody to selectively target amyloid beta oligomers (AβOs), a toxic form of amyloid beta implicated in the early stages of Alzheimer’s. The ALTITUDE-AD trial, initiated last year, is a randomized, placebo-controlled study that has enrolled 542 participants across Canada, the EU, the US, and the UK.

• In February 2025, AUS University has initiated a prevention trial to study Eli Lilly’s investigational drug remternetug in young adults, aiming to halt the progression of Alzheimer’s disease. Meanwhile, Washington University School of Medicine has announced the enrollment of the first participants in its Alzheimer’s disease DIAN-TU-002 primary prevention trial (NCT06647498). This study plans to recruit 240 individuals from families carrying mutations in one of three key genes linked to Alzheimer’s, who have a family history placing them at risk of developing the disease in their 30s, with some participants as young as 18 years old.

• In February 2025, NKGen Biotech, Inc. announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to troculeucel, an ex vivo expanded autologous NK cell therapy, for the treatment of moderate Alzheimer’s disease (AD).

• In October 2024, Hoth Therapeutics, Inc. reported that it has been awarded a US patent for its innovative Alzheimer’s therapy, HT-ALZ.

Alzheimer’s Disease Overview

Alzheimer’s disease is a progressive neurodegenerative disorder that primarily affects memory, thinking, and behavior. It is the most common cause of dementia, gradually worsening over time and interfering with daily activities. The disease is characterized by the buildup of abnormal proteins in the brain, such as amyloid plaques and tau tangles, leading to nerve cell damage and loss of brain function. Common symptoms include memory loss, confusion, difficulty in problem-solving, language issues, and personality changes. Although there is no cure, available treatments can help manage symptoms and slow disease progression.

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Emerging Alzheimer’s Disease Drugs Under Different Phases of Clinical Development Include:

• GP-199 : GliaPharm

• GAL-201: Galimedix

• OLX 07010: Oligomerix, Inc

• CS-6253: Artery Therapeutics, Inc.

• Lomecel-B: Longeveron Inc.

• Pegipanermin: INmune Bio

• TQ001: Treeway B.V.

• ACP-2024: ACADIA Pharmaceuticals

• Buntanetap: Annovis Bio

• NRDN-201: Neurodon

• ST-501: Sangamo Therapeutics

• SNK 01: NKGen Biotech

• ASN51: Asceneuron

• TB 006: TrueBinding

• AL002: Alector

• CT-1812: Cognition Therapeutics

• Blarcamesine: Anavex Life Sciences

• E 2814: Eisai Co Ltd

• Simufilam: Cassava Sciences, Inc.

• KarXT: Karuna Therapeutics

• NE3107: BioVie

Alzheimer’s disease Emerging Drugs:

This Alzheimer’s disease pipeline report provides an in-depth review of multiple drug candidates across various stages of clinical development, including Phase III, II, II/III, I, preclinical, and discovery stages. It also offers insights into clinical trial data, detailed pharmacological mechanisms, as well as key agreements and collaborations.

Buntanetap: Annovis Bio

Buntanetap is a small, orally available molecule that targets neurodegeneration by inhibiting the translation of neurotoxic aggregating proteins and thereby impeding the toxic cascade. This improves axonal transport, synaptic transmission, and reduces neuroinflammation, ultimately restoring the health of nerve cells and brain function. By normalizing these pathways, buntanetap has the potential to reverse neurodegeneration and improve quality of life for patients.

Currently, the drug is in the Phase III stage of its development for the treatment of Alzheimer’s disease (AD).

AR1001: AriBio Co., Ltd.

AR1001, developed by the South Korean biopharmaceutical company Aribio Co., is an investigational oral PDE5 inhibitor for Alzheimer’s disease. Preclinical studies have shown its neuroprotective properties by preventing neuron apoptosis, restoring synaptic plasticity, and reducing hyperphosphorylated tau proteins. Demonstrating superior blood–brain barrier penetration and being tenfold more potent than sildenafil, AR1001 is currently in Phase III development as a potential disease-modifying therapy for Alzheimer’s.

AGB101: AgeneBio

AGB101 is a proprietary extended-release formulation of Levetiracetam, an FDA-approved anti-epileptic, being studied for Mild Cognitive Impairment (MCI) caused by Alzheimer’s disease (AD). Administered once daily at nearly one-twelfth the typical epilepsy dose, it targets hippocampal overactivity by inhibiting the synaptic protein SV2A. The approach aims to reduce hippocampal hyperactivity in early AD, potentially slowing tau pathology and disease progression. AGB101 is currently in Phase II/III clinical development for Alzheimer’s disease.

AMX0035: Amylyx Pharmaceuticals Inc

AMX0035 is an investigational oral therapy combining sodium phenylbutyrate (PB) and taurursodiol (TURSO) in a fixed dose. It aims to reduce neuronal death via dual mechanisms: PB alleviates endoplasmic reticulum (ER) stress by upregulating DJ-1, while TUDCA improves mitochondrial function by stabilizing membranes and raising the apoptotic threshold. By targeting ER stress and mitochondrial dysfunction—two interconnected drivers of neurodegeneration—AMX0035 is designed to slow disease progression. Preclinical studies suggest it enhances cell survival and function, with synergistic effects beyond the individual agents. The drug is currently in Phase II development for Alzheimer’s disease.

IVL3003: Inventage Lab., Inc.

IVL3003 is an investigational therapy under development for Alzheimer’s disease (AD), aimed at addressing critical pathological processes linked to the condition. Though its precise mechanism of action (MoA) has not yet been publicly revealed, the candidate is believed to hold potential for neuroprotective and disease-modifying benefits. As part of a new generation of innovative approaches for neurodegenerative disorders, IVL3003 represents ongoing efforts to tackle unmet needs in AD treatment. Currently, the drug is in early-stage clinical evaluation, specifically Phase I/II trials, for Alzheimer’s disease.

BHV-8000: Biohaven Pharmaceuticals

BHV-8000 is an innovative, first-in-class oral therapy that selectively inhibits both TYK2 and JAK1 while effectively penetrating the brain. These pathways play key roles in immune and inflammatory signaling, and their dual inhibition helps suppress Th17 cell formation, Type I IFN signaling, and overall inflammation. By limiting the pro-inflammatory activity of microglia, astrocytes, and infiltrating T-lymphocytes, BHV-8000 aims to disrupt the cycle of neuroinflammation. The candidate is currently being assessed in Phase I clinical trials for the treatment of Alzheimer’s disease.

Alzheimer’s Disease 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

Alzheimer’s Disease Molecule Type

Alzheimer’s Disease Products have been categorized under various Molecule types, such as

• Monoclonal antibody

• Small molecule

• Peptide

Alzheimer’s Disease Pipeline Therapeutics Assessment

• Alzheimer’s Disease Assessment by Product Type

• Alzheimer’s Disease By Stage and Product Type

• Alzheimer’s Disease Assessment by Route of Administration

• Alzheimer’s Disease By Stage and Route of Administration

• Alzheimer’s Disease Assessment by Molecule Type

• Alzheimer’s Disease by Stage and Molecule Type

DelveInsight’s Alzheimer’s Disease 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)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Alzheimer’s Disease product details are provided in the report. Download the Alzheimer’s Disease pipeline report to learn more about the emerging Alzheimer’s Disease therapies

Some of the key companies in the Alzheimer’s Disease Therapeutics Market include:

Key companies developing therapies for Alzheimer’s Disease are – AbbVie, Inc., Teva Pharmaceuticals Ltd., Eisai Co., Ltd., Janssen Pharmaceuticals, Inc., Johnson & Johnson, Novartis AG, Zydus Lifesciences Ltd (CADILA), Sun Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd, Aurobindo Pharma Ltd, Amneal Pharmaceuticals Inc., Macleods Pharmaceuticals Ltd., Viatris Inc., Lupin Ltd, Cipla Ltd., Torrent Pharmaceuticals Ltd., Unichem laboratories ltd, Lannett Inc., and others.

Alzheimer’s Disease Pipeline Analysis:

The Alzheimer’s Disease pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of 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 Alzheimer’s Disease Treatment.

• Alzheimer’s Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• 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 Alzheimer’s Disease market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Alzheimer’s Disease drugs and therapies

Alzheimer’s Disease Pipeline Market Drivers

• Increase in prevalence of Alzheimer’s Disease (AD), rising geriatric population are some of the important factors that are fueling the Alzheimer’s Disease Market.

Alzheimer’s Disease Pipeline Market Barriers

• However, clinical trials are more complicated, costly, and slower than trials for other diseases. Lack of clear diagnosis and other factors are creating obstacles in the Alzheimer’s Disease Market growth.

Scope of Alzheimer’s Disease Pipeline Drug Insight

• Coverage: Global

• Key Alzheimer’s Disease Companies: GliaPharm, Galimedix, Oligomerix, Inc, Artery Therapeutics, Inc., Longeveron Inc., INmune Bio, Treeway B.V., ACADIA Pharmaceuticals, Annovis Bio, Neurodon, Sangamo Therapeutics, NKGen Biotech, Asceneuron, TrueBinding, Alector, Cognition Therapeutics, Anavex Life Sciences, Eisai Co Ltd, Cassava Sciences, Inc., Karuna Therapeutics, BioVie, and others

• Key Alzheimer’s Disease Therapies: GP-199, GAL-201, OLX 07010, CS-6253, Lomecel-B, Pegipanermin, TQ001, ACP-2024, Buntanetap, NRDN-201, ST-501, SNK 01, ASN51, TB 006, AL002, CT-1812, Blarcamesine, E 2814, Simufilam, KarXT, NE3107, and others

• Alzheimer’s Disease Therapeutic Assessment: Alzheimer’s Disease current marketed and Alzheimer’s Disease emerging therapies

• Alzheimer’s Disease Market Dynamics: Alzheimer’s Disease market drivers and Alzheimer’s Disease market barriers

Request for Sample PDF Report for Alzheimer’s Disease Pipeline Assessment and clinical trials

Table of Contents

1. Alzheimer’s Disease Report Introduction

2. Alzheimer’s Disease Executive Summary

3. Alzheimer’s Disease Overview

4. Alzheimer’s Disease- Analytical Perspective In-depth Commercial Assessment

5. Alzheimer’s Disease Pipeline Therapeutics

6. Alzheimer’s Disease Late Stage Products (Phase II/III)

7. Alzheimer’s Disease Mid Stage Products (Phase II)

8. Alzheimer’s Disease Early Stage Products (Phase I)

9. Alzheimer’s Disease Preclinical Stage Products

10. Alzheimer’s Disease Therapeutics Assessment

11. Alzheimer’s Disease Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Alzheimer’s Disease Key Companies

14. Alzheimer’s Disease Key Products

15. Alzheimer’s Disease Unmet Needs

16 . Alzheimer’s Disease Market Drivers and Barriers

17. Alzheimer’s Disease Future Perspectives and Conclusion

18. Alzheimer’s Disease Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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