Alzheimer's Disease Pipeline Insight 2023 (Updated) | Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, and others.

DelveInsight's, "Alzheimer's Disease Pipeline Insights, 2023," report provides comprehensive insights about 150+ companies and 160+ pipeline drugs in Alzheimer's Disease (AD) 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.

In the Alzheimer's Disease Pipeline Report, a detailed description of the drug is given which includes the mechanism of action of the drug, Alzheimer's Disease clinical trials studies, Alzheimer's Disease 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.

Key takeaways from the Alzheimer's Disease Pipeline Report

• DelveInsight's Alzheimer's disease pipeline report depicts a robust space with 150+ active players working to develop 160+ pipeline therapies for Alzheimer's disease treatment.

• The leading Alzheimer's disease Companies includes Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics Inc, and others.

• Promising Alzheimer's disease Pipeline Therapies includes ALZT-OP1, Tricaprilin, Bryostatin-1, INB03, Sumifilam, Neflamapimod, Pegylated exenatide, NLY-02, Masitinib, Atuzaginstat, COR588, Blarcamesine, NDX-1017, Bromocriptine, DNL788, AL002, CMS121, LX1001, TB006, Pepinemab, Posiphen, E2814, RO7126209, IONIS MAPTRx, Brexpiprazole, CT1812, MK-1942, IBC Ab002, ABBV-916, AR1001, ORY-2001, LY3372689, MW150, EX039, SLS-005, Seltorexant, Donanemab, SHR-1707, REM0046127, ALZ-101, VT301, NE3107, PRX005, MK-6240, and others.

• Alzheimer's Disease Companies and academics are working to assess challenges and seek opportunities that could influence Pheochromocytoma R&D. The Alzheimer's Disease pipeline therapies under development are focused on novel approaches to treat/improve Alzheimer's Disease.

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Alzheimer's Disease Overview
Alzheimer's Disease (AD) is a slowly progressive brain disease that begins many years before symptoms emerge. It is the most common cause of dementia, accounting for an estimated 60% to 80% of cases. The hallmark pathologies of Alzheimer's disease are the accumulation of the protein fragment beta‐amyloid (plaques) outside neurons in the brain and twisted strands of the protein tau (tangles) inside neurons. These changes are accompanied by the death of neurons and damage to brain tissue. On the basis of severity, this degenerative disease can be classified as mild, moderate, and severe.

Recent Developmental Activities in the Alzheimer's Disease Treatment Landscape

• In February 2023, Lantheus Holdings, Inc. announced it had acquired Knoxville-based Cerveau Technologies, Inc. ("Cerveau"). Cerveau's asset is MK-6240, a second-generation F 18-labeled positron emission tomography ("PET") imaging agent that targets Tau tangles in Alzheimer's disease.Under the terms of the agreement, Lantheus will pay an upfront payment and potential additional development and commercial milestone payments. Additionally, Lantheus will pay double-digit royalty payments for research revenue and commercial sales.

• In January 2023, Prothena Corporation plc announced positive topline Phase I single ascending dose (SAD) study results for PRX005, a potentially best-in-class investigational tri-epitopic antibody for the treatment of Alzheimer's disease that specifically binds with high affinity to the R1, R2, and R3 repeats within the microtubule binding region (MTBR) of tau and targets both 3R and 4R tau isoforms. The results of the study found all three dose level cohorts of PRX005 to be generally safe and well tolerated, meeting the Phase 1 SAD study primary objective. None of the treatment emergent adverse events (TEAE) were serious. No clinically relevant changes were observed in other safety parameters. PRX005 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints.

• In January 2023, Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted.The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval shortly thereafter. Lilly will continue to work with the FDA to evaluate the fastest pathway to make this potential treatment option widely available to patients.

• In January 2023, Coya Therapeutics, Inc. announced the recent publication of an article entitled "Ex vivo expanded human regulatory T cells modify neuroinflammation in a preclinical model of Alzheimer's Disease" in the peer-reviewed journal Acta Neuropathologica Communications.Furthermore, Treg-treated mice showed a significant reduction in total and plaque-associated microglia as well as reactive astrocytes in the dentate gyrus and frontal cortex versus untreated mice. The reduction in the number of plaque-associated glial cells and suppression of pro-inflammatory signaling pathways within these cells following Treg therapy may attenuate the contribution of these toxic glial cells in AD pathology resulting in mitigation of amyloid burden.

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Alzheimer's Disease Emerging Drugs Profile

• Nilotinib: KeifeRx
Nilotinib, also known as AMN107, a tyrosine kinase inhibitor under investigation as a possible treatment for Alzheimer's Disease. It is an oral Abl tyrosine kinase inhibitor used to treat chronic myeloid leukemia. Nilotinib induces autophagy, leading to death of rapidly dividing cells. In neural degeneration, synuclein misfolds and aggregates as a β-sheet. Multiple observations now suggest propagation of the misfolded protein as a prion, providing a mechanism for the spread of degeneration through the neuraxis. Abl kinase phosphorylates α-synuclein and prevents its degradation. By inhibiting Abl, nilotinib promotes α-synuclein clearance by autophagy. Currently the drug is in Phase III stage of Clinical trial evaluation for the treatment of Alzheimer's disease.

• 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.

• 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.

Alzheimer's Disease Pipeline Therapeutics Assessment
There are approx. 150+ key companies which are developing the therapies for Alzheimer's Disease (AD). The companies which have their Alzheimer's Disease (AD) drug candidates in the most advanced stage, i.e. phase III include, Eisai.

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Scope of the Alzheimer's Disease Pipeline Report

• Coverage- Global

• Alzheimer's Disease Companies- Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics Inc, and others

• Alzheimer's Disease Pipeline Therapies- ALZT-OP1, Tricaprilin, Bryostatin-1, INB03, Sumifilam, Neflamapimod, Pegylated exenatide, NLY-02, Masitinib, Atuzaginstat, COR588, Blarcamesine, NDX-1017, Bromocriptine, DNL788, AL002, CMS121, LX1001, TB006, Pepinemab, Posiphen, E2814, RO7126209, IONIS MAPTRx, Brexpiprazole, CT1812, MK-1942, IBC Ab002, ABBV-916, AR1001, ORY-2001, LY3372689, MW150, EX039, SLS-005, Seltorexant, Donanemab, SHR-1707, REM0046127, ALZ-101, VT301, NE3107, PRX005, MK-6240, and others.

• Alzheimer's Disease Pipeline Segmentation: Product Type, Molecule Type, Mechanism of Action, Route of Administration

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Table of Content
1. Introduction
2. Executive Summary
3. Alzheimer's Disease (AD): Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Alzheimer's Disease (AD) - DelveInsight's Analytical Perspective
7. In-depth Commercial Assessment
8. Alzheimer's Disease (AD) Collaboration Deals
9. Late Stage Products (Phase III)
10. BAN2401: Eisai
11. Mid Stage Products (Phase II)
12. Bryostatin-1: Neurotrope
13. Drug profiles in the detailed report…..
14. Early Stage Products (Phase I)
15. INB03 - INmune Bio
16. Drug profiles in the detailed report…..
17. Pre-clinical and Discovery Stage Products
18. AZT-211: AZTherapies
19. Drug profiles in the detailed report…..
20. Inactive Products
21. Alzheimer's Disease (AD) Key Companies
22. Alzheimer's Disease (AD) Key Products
23. Alzheimer's Disease (AD)- Unmet Needs
24. Alzheimer's Disease (AD)- Market Drivers and Barriers
25. Alzheimer's Disease (AD)- Future Perspectives and Conclusion
26. Alzheimer's Disease (AD) Analyst Views
27. Alzheimer's Disease (AD) Key Companies
28. 28. Appendix

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