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Last update 15 Feb 2025

Donepezil Hydrochloride

Last update 15 Feb 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryDonepezil, a minuscule molecular compound, functions as an acetylcholinesterase inhibitor, indicating that it hinders the degradation of acetylcholine, a neurotransmitter in the brain, and provides assistance in enhancing cognitive function. Patients in mild, moderate, and severe stages of Alzheimer's Disease receive this drug as a therapeutic agent. Initially authorized in November 1996 by Eisai, a pharmaceutical establishment situated in Japan, it has now expanded to a worldwide availability. Although Donepezil Hydrochloride does not hold the cure for Alzheimer's Disease, it does assist in controlling some of the symptoms associated with the disease, such as memory loss, confusion, and other cognitive impairments. As a crucial medication for those existing with Alzheimer's Disease, it can amplify their quality of life and curtail the progression of the disease.

Drug Type

Small molecule drug

Synonyms

ARIPEZIL, BNAG, Domepezil

+ [45]

Target

ACHE

Mechanism

AChE inhibitors(Acetylcholinesterase inhibitors)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic DiseaseOther Diseases

Active Indication

DementiaLewy Body DiseaseAlzheimer Disease+ [1]

Inactive Indication

Advanced cancerAttention Deficit DisorderCadasil+ [11]

Originator Organization

Eisai Co., Ltd.

Active Organization

Aulbio Co., Ltd.Startup

Shanxi HCXF Pharmaceutical Co., Ltd.

McGill University

+ [12]

Inactive Organization

Pfizer Inc.

Teikoku Pharma USA, Inc.Teva Pharmaceuticals USA, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

US (25 Nov 1996),

Alzheimer Disease

RegulationPriority Review (CN)

Structure/Sequence

Molecular FormulaC24H30ClNO3

InChIKeyXWAIAVWHZJNZQQ-UHFFFAOYSA-N

CAS Registry120011-70-3

360

Clinical Trials associated with Donepezil Hydrochloride

NCT06041789

/ RecruitingPhase 2IIT

Effect of Acetylcholinesterase Inhibitors on Bone Metabolism and Fracture Risk Factors Among Older Adults With Mild to Moderate Alzheimer's Disease

People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. The purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality.
Participants in this study will have a bone density test and have blood samples collected at the baseline study visit. Participants will then be randomly assigned to donepezil or matching placebo to be taken daily by mouth for 12 months. Blood samples will be collected at 6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will also complete questionnaires at each study visit.

Start Date03 Feb 2025

Sponsor / Collaborator

Duke University

[+1]

NCT06774261

/ Not yet recruitingPhase 1IIT

A Phase 1b Dose Range Finding Study of Phenserine Compared to Donepezil in Participants With Early or Mild Alzheimer's Disease

The goal of this clinical trial is to evaluate if phenserine can treat early or mild Alzheimer's Disease (AD) by comparing it to donepezil. This study will include participants with early or mild Alzheimer's Disease, and the main questions it aims to answer are:
How does phenserine affect exosome biomarkers of cell death compared to donepezil? What is the safety and tolerability profile of phenserine at ascending oral doses compared to donepezil? Researchers will compare participants receiving phenserine to those receiving donepezil to see if phenserine produces better pharmacodynamic outcomes and if it is safe and well-tolerated.
Participants will:
Be randomized to receive either oral phenserine or oral donepezil for a treatment duration of 8 weeks.
Undergo oral dose escalation based on tolerability. Complete regular follow-up visits every two weeks to assess pharmacodynamic, pharmacokinetic, and safety measures.

Start Date01 Feb 2025

Sponsor / Collaborator

Helse Stavanger HF

[+4]

NL-OMON57117

/ SuspendedNot ApplicableIIT

Randomized, double-blind, placebo-controlled, 2-way crossover study to characterize pharmacological reversal of biperiden-induced cognitive effects by donepezil in healthy elderly subjects - Biperiden challenge reversed by donepezil

Start Date06 Jan 2025

Sponsor / Collaborator

Centre for Human Drug Research

100 Clinical Results associated with Donepezil Hydrochloride

100 Translational Medicine associated with Donepezil Hydrochloride

100 Patents (Medical) associated with Donepezil Hydrochloride

7,292

Literatures (Medical) associated with Donepezil Hydrochloride

01 Jun 2025·IBRO Neuroscience Reports

Neuroprotective effects of empagliflozin against scopolamine-induced memory impairment and oxidative stress in rats

Article

Author: Hosseini, Mir-Jamal ; Anoush, Mahdieh ; Rahmati, Fatemeh ; Bijani, Soroush ; Bokaei Hosseini, Zahra ; Taghaddosi, Neda ; Kalantari-Hesari, Ali

Alzheimer's disease (AD) is one of the most common age-related neurodegenerative disorders. The main medicinal theory for the management of AD belongs to the acetyl-cholinesterase-inhibition pathway and NMDA antagonism. Recent investigation proposed memory improvement by sodium-glucose co-transporter 2 (SGLT2) inhibitors which indicated to improve glycemic control in adults with type 2 diabetes mellitus. According to the lack of sufficient evidence about the efficacy of empagliflozin (EMPA) for memory improvement, in comparison with donepezil (DON), the present research was carried out in order to investigate this hypothesis towards scopolamine-induced neurotoxicity on experimental male Wistar rats. The animals divided into two sets, each included 4 groups: The first set of Healthy animals [Control, EMPA (4 or 10 mg/kg), DON (1 mg/kg)]. The second set of rat Alzheimer model, which received 2 mg/kg Scopolamine by intraperitoneal route for 10 days followed by other treatments [AD, AD+ EMPA (4 or 10 mg/kg) and AD+DON]. Normal rats and AD rats, with each group receiving different substances for 8 consecutive days and 24 h after the accomplishment of the drug administrations, the memory functions assessed through Morris water maze (MWM) paradigm. This task was followed by decapitation of rats in order to evaluate the biochemical oxidative stress parameters in brain tissue. Our data indicated that EMPA significantly improved animals' performance in the behavioral test with a significant decrease in oxidative stress and antioxidant imbalance. In addition, EMPA (4 mg/kg) significantly reduced both cellular malondialdehyde and protein carbonyl content while conversely increased the total reduced glutathione content. Besides, the levels of total as well as endogenous antioxidants in the ferric reducing antioxidant power assay reported to be augmented. It seems that EMPA significantly improved both cellular biochemical aspects and memory performance in animal models in accordance with histopathological assessments. Conclusively, 4 mg/kg EMPA demonstrated better results in all aspects that were evaluated during this research.

01 Mar 2025·BEHAVIOURAL BRAIN RESEARCH

Donepezil treatment mitigates cholinergic system alterations, oxidative stress, neuroinflammation and memory impairment induced by branched-chain amino acid administration in rats

Article

Author: Alano, Carolina Giassi ; Streck, Emilio Luiz ; Leipnitz, Guilhian ; Canarim, Rafael Orestes ; Réus, Gislaine Zilli ; Effting, Pauline Souza ; De Pieri, Ellen ; Lemos, Isabela da Silva ; Botelho, Maria Eduarda Mendes ; Machado-de-Ávila, Ricardo Andrez ; Ribeiro, Catharina de Bem

Maple Syrup Urine Disease (MSUD) is an inherited metabolic disorder biochemically characterized by tissue accumulation of leucine, isoleucine, and valine and their derivatives. Patients present with neurological disabilities and treatment is limited. Donepezil, a drug used for neurodegenerative disorders, has been shown to improve memory and counteract oxidative stress and inflammation. In the present study, we investigated whether donepezil administration could improve alterations in the cholinergic system, oxidative stress, inflammation, and behavior changes in rats submitted to a chemical MSUD model based on the administration of branched-chain amino acids (BCAA) leucine, isoleucine, and valine. Our results showed a decrease in short- and long-term memory in the object recognition task in rats submitted to BCAA administration. We also verified an increase in acetylcholinesterase (AChE) activity and a decrease in choline acetyltransferase in the cerebral cortex of the BCAA control group. Increased reactive species production, alterations in the antioxidant defenses, and inflammation were further observed. Additionally, we found that donepezil treatment attenuated alterations in AChE activity, reactive species production, lipids oxidative damage, inflammation, and memory. Our findings contribute to the understanding of the pathophysiology of MSUD and suggest that donepezil is a potential pharmacological treatment for this disorder.

01 Mar 2025·BEHAVIOURAL BRAIN RESEARCH

Standardized extract of Ginkgo biloba induced memory consolidation in female mice with hypofunction of vesicular acetylcholine transporter

Article

Author: da Veiga, Irina Emanuela T ; Medeiros, Gleiciene N ; Soliani, Andressa G ; Cerutti, Suzete M ; Silva, Sofia M S E ; Prado, Carla Máximo ; Muratori, Beatriz G

Basal forebrain cholinergic neurons are pivotal for cholinergic signaling in the neocortex and hippocampal formation, crucially implicated in neurodegenerative diseases like late-onset Alzheimer's disease (LOAD), recognition memory impairments, and decision-making. The acetylcholine transporter (VAChT) is essential for loading acetylcholine into synaptic vesicles. Building on our previous findings showing that Ginkgo biloba extract (EGb) preserves recognition memory, we hypothesized EGb would enhance memory in female mice with varying VAChT reductions. We also explored whether reduced cholinergic signaling induces anxiety-like behavior and whether EGb could alleviate such symptoms. Three-month-old female mice with severe VAChT reduction (knockdown homozygotes; VAChT KD^HOM), moderate reduction (heterozygotes; VAChT KD^HET), and wild-type (WT) mice received the vehicle, 5mg/kg Donepezil, or EGb at doses of 250, 500, and 1000mg/kg for 30 days. Memory assessments included aversive tasks like discriminative avoidance memory and non-aversive tasks like object recognition and location memory. We assessed VAChT protein expression in the hippocampal formation (HF) using Western blotting and quantified VAChT-immunopositive cells (IR⁺) in specific HF subfields (dCA1, dCA3, dDG) using immunohistochemistry. Chronic EGb treatment significantly improved long-term memory in female VAChT KD^HOM mice in object recognition and locations memories in a dose-dependent manner, unlike Donepezil. Enhanced memory was correlated with an increase in VAChT-IR⁺ cells in the dCA1 of VAChT KD^HOM mice. Additionally, EGb reduced VAChT-IR⁺ cells in the dDG of VAChT KD^HET mice, which was associated with decreased anxiety-like behavior. These findings suggest that EGb effectively mitigates deficits caused by cholinergic deficiency in hippocampal-dependent memory consolidation, thereby improving our understanding of its role in modulating long-term memory and hippocampal plasticity.

News (Medical) associated with Donepezil Hydrochloride

08 Jan 2025

·www.businesswire.com

Alpha Cognition Announces a $44 Million Exclusive Licensing Agreement for the Development and Commercialization of ZUNVEYL (benzgalantamine), an FDA-Approved Treatment for Mild-to-Moderate Alzheimer’s Disease, in China

VANCOUVER, British Columbia & DALLAS--( BUSINESS WIRE )--Alpha Cognition, Inc. (Nasdaq: ACOG) (“ACI” or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, and China Medical System Holdings Limited (CMS) (867.HK), a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability in the People’s Republic of China, today announced an exclusive licensing agreement for the development, manufacturing and commercialization of ZUNVEYL (benzgalantamine) in Asia (excluding Japan), Australia and New Zealand. ZUNVEYL is a next generation acetylcholinesterase inhibitor approved in the US for the treatment of mild-to-moderate Alzheimer’s disease. Terms of the agreement total $44 million, which includes $6 million in total upfront payments split into tranches and development and commercial milestone payments. Additionally, ACI is eligible to receive royalties on net sales of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand. CMS will be responsible for the regulatory, development, manufacturing, and commercialization of ZUNVEYL in the licensed territories. “We are excited to partner with CMS to distribute ZUNVEYL, an FDA-approved oral treatment for mild-to-moderate Alzheimer’s disease. The product has significant potential in China and we believe that CMS has the commitment and expertise to manage the complex regulatory and commercial landscape in these territories,” said Michael McFadden, CEO of Alpha Cognition. “With their strong track record of developing and commercializing CNS therapies in China, we believe CMS is the ideal partner to advance ZUNVEY’s regulatory development in a region where 50 million people are estimated to have Alzheimer’s disease.” Alpha Cognition remains on track to launch ZUNVEYL in the United States in Q1 2025. The company will provide a corporate update and present its Launch Strategy on January 28, 2025 at 4pm EST. About CMS CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs. CMS focuses on the global FIC and BIC innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products. CMS deeply engages in several specialty therapeutic fields, such as cardio-cerebrovascular, central nervous system, gastroenterology, dermatology and ophthalmology, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. For more information about CMS, please visit https://web.cms.net.cn/en/home . About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company’s timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company’s planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company’s business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company’s potential growth opportunities in China, the timing and results of the Company’s milestone payments for China, the Company’s regulatory submissions in China, and the potential regulatory approval and commercialization of the Company’s products in China. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at www.sec.gov . These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

License out/inDrug Approval

08 Jan 2025

·www.alphacognition.com

Alpha Cognition Announces a $44 Million Exclusive Licensing Agreement for the Development and Commercialization of ZUNVEYL (benzgalantamine), an FDA-approved treatment for Mild-to-Moderate Alzheimer’s Disease, in China

January 8, 2025 VANCOUVER, B.C. and Dallas, TX. Alpha Cognition, Inc. (Nasdaq: ACOG) (“ACI” or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, and China Medical System Holdings Limited (CMS) (867.HK), a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability in the People’s Republic of China, today announced an exclusive licensing agreement for the development, manufacturing and commercialization of ZUNVEYL (benzgalantamine) in Asia (excluding Japan), Australia and New Zealand. ZUNVEYL is a next generation acetylcholinesterase inhibitor approved in the US for the treatment of mild-to-moderate Alzheimer’s disease. Terms of the agreement total $44 million, which includes $6 million in total upfront payments split into tranches and development and commercial milestone payments. Additionally, ACI is eligible to receive royalties on net sales of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand. CMS will be responsible for the regulatory, development, manufacturing, and commercialization of ZUNVEYL in the licensed territories. “We are excited to partner with CMS to distribute ZUNVEYL, an FDA-approved oral treatment for mild-to-moderate Alzheimer’s disease. The product has significant potential in China and we believe that CMS has the commitment and expertise to manage the complex regulatory and commercial landscape in these territories,” said Michael McFadden, CEO of Alpha Cognition. “With their strong track record of developing and commercializing CNS therapies in China, we believe CMS is the ideal partner to advance ZUNVEY’s regulatory development in a region where 50 million people are estimated to have Alzheimer’s disease.” Alpha Cognition remains on track to launch ZUNVEYL in the United States in Q1 2025. The company will provide a corporate update and present its Launch Strategy on January 28, 2025 at 4pm EST. About CMS CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs. CMS focuses on the global FIC and BIC innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products. CMS deeply engages in several specialty therapeutic fields, such as cardio-cerebrovascular, central nervous system, gastroenterology, dermatology and ophthalmology, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. For more information about CMS, please visit https://web.cms.net.cn/en/home. About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. For further information: Investor Relations IR@alphacognition.com https://www.alphacognition.com/ Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company’s timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company’s planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company’s business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company’s potential growth opportunities in China, the timing and results of the Company’s milestone payments for China, the Company’s regulatory submissions in China, and the potential regulatory approval and commercialization of the Company’s products in China. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at www.sec.gov. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

License out/inDrug Approval

16 Dec 2024

·www.alphacognition.com

Alpha Cognition Announces Partial Exercise of Over-Allotment Option

VANCOUVER, British Columbia and Dallas, TX — December 16, 2024 (BUSINESS WIRE) — Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies for debilitating neurodegenerative disorders, today announced that the underwriters of its underwritten U.S. public offering (the “Offering”) have partially exercised their over-allotment option to purchase an additional 488,506 common shares at the public offering price of US$5.75 per share for an additional US$2.8 million in gross proceeds. After giving effect to the partial exercise of the over-allotment option, the Company sold an aggregate 9,184,159 common shares for gross proceeds of approximately US$52.8 million, before deducting underwriter discounts and other related expenses. The option closing date was December 16, 2024. The common shares began trading on The Nasdaq Capital Market on November 12, 2024, under the ticker symbol “ACOG”. The Company intends to use the proceeds towards the commercialization and launch of ZUNVEYLTM in Alzheimer’s Disease, further research and development of its pipeline product candidates, continued commercial CMC activities (chemistry, manufacturing, and controls), and for working capital and general corporate purposes. Titan Partners Group, a division of American Capital Partners, is acting as Sole Bookrunner for the offering. The securities were sold pursuant to a registration statement on Form S-1 (File No. 333-280196) relating to these securities and a related registration statement on Form S-1 MEF that became effective upon its filing in accordance with Rule 462(b) under the Securities Act of 1933, as amended. The Offering is being made only by means of a prospectus. A copy of the final prospectus related to the Offering may be obtained from Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, or via email at prospectus@titanpartnersgrp.com or telephone at (929) 833-1246. In addition, a copy of the final prospectus relating to the Offering may be obtained via the SEC's website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor (AChEI) for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it improves the function of neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. Benzgalantamine is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential use of proceeds of the Offering. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future. Contacts For further information: Michael McFadden, CEO Tel: 1-858-344-4375 info@alphacognition.com Titan Partners Contact: Tel: (929) 833-1246 info@titanpartnersgrp.com.

Clinical Study

100 Deals associated with Donepezil Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00670	Donepezil Hydrochloride	N06DA02	DB00843

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dementia	US	Corium International, Inc.	11 Mar 2022
Lewy Body Disease	JP	Eisai Co., Ltd.	19 Sep 2014
Alzheimer Disease	US	Eisai, Inc.	25 Nov 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 3	US	Pfizer Inc.	01 Sep 2008
Cognitive Dysfunction	Phase 3	US	Eisai, Inc.	01 Sep 2008
Down Syndrome	Phase 3	US	Pfizer Inc.	01 Sep 2008
Down Syndrome	Phase 3	US	Eisai, Inc.	01 Sep 2008
Attention Deficit Disorder	Phase 3	US	Eisai Co., Ltd.	02 Jul 2008
Attention Deficit Disorder	Phase 3	AR	Eisai Co., Ltd.	02 Jul 2008
Attention Deficit Disorder	Phase 3	AU	Eisai Co., Ltd.	02 Jul 2008
Attention Deficit Disorder	Phase 3	CA	Eisai Co., Ltd.	02 Jul 2008
Attention Deficit Disorder	Phase 3	CL	Eisai Co., Ltd.	02 Jul 2008
Attention Deficit Disorder	Phase 3	FR	Eisai Co., Ltd.	02 Jul 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04117178 (MONANTI, CTgov)	Phase 4	Alzheimer Disease \| Dementia due to Parkinson's disease \| Lewy Body Disease	132	Measurement of serum level of anti-dementia drug (Standard of Care)	zqrnidqqby(hectwvocez) = eoyoaxizry jrlxjrfsml (vdkbnznqjt, iiwwagxhdx - mlxencbcri) View more	-	10 Feb 2025
				Measurement of serum level of anti-dementia drug+memantine+Donepezil (Intervention Arm)	zqrnidqqby(hectwvocez) = adibegszip jrlxjrfsml (vdkbnznqjt, qzwedidwoc - gytoifkuuz) View more
NCT04730635 (MK-0000-413, CTgov)	Phase 1	Alzheimer Disease \| Mild cognitive disorder	44	Donepezil (Donepezil)	lavjvbflxh(abwuhxlscf) = hohcethmga hksixocesq (dnmduubgal, yfijvlljrg - hcfnsotrrp) View more	-	28 Oct 2024
				Placebo (Placebo)	lavjvbflxh(abwuhxlscf) = eoqrroyyro hksixocesq (dnmduubgal, bktgfmamdq - cyrijbatdc) View more
NCT04617782 (CTgov)	Phase 1	-	60	Donepezil (Treatment A 5 mg TDS)	vfytptoxcj(evdguodkcl) = ezqjsqvhuz vdpwecxkxy (hqcnmdjjgz, zvyuxmdujg - erdapgwcnj) View more	-	19 Sep 2024
				Donepezil (Treatment B 10 mg TDS)	vfytptoxcj(evdguodkcl) = lszcbygglz vdpwecxkxy (hqcnmdjjgz, wrfhxeqzqy - ljovopzuyd) View more
NCT02487082 (CTgov)	Phase 2	Autism Spectrum Disorder	12	Placebo+Melatonin+Donepezil (Group A)	digyhuoqqi(bpvjijbhyt) = bdozxnobbc mauqhcazsa (ifvgutkxte, osglxscmfo - qwmxgircpo) View more	-	06 Jun 2024
				Placebo+Melatonin+Donepezil (Group B)	digyhuoqqi(bpvjijbhyt) = rngmyyjrkm mauqhcazsa (ifvgutkxte, szvjroethg - fvptbigllp) View more
NCT02822573 (Remember, CTgov)	Phase 3	Cognitive Dysfunction \| Breast Cancer	276	Donepezil 5 mg (Donepezil)	mioxmhbjbr(hpvyejjjez) = enbmqdegaz hgtycmtboc (zjjslsnpqj, zxhubfcdza - siveqruipz) View more	-	13 Sep 2023
				Placebo (Placebo)	mioxmhbjbr(hpvyejjjez) = prvfnoqeon hgtycmtboc (zjjslsnpqj, qxtxeaoweh - fcdcdixavb) View more
LIFE Study (AAIC2023)	Not Applicable	Alzheimer Disease First line	-	Newly prescribed donepezil	bmsclfvmtx(bdamhrkskd) = rejphjrtno kfezmzkqgh (xefmamsrax )	-	16 Jun 2023
AAIC2022	Not Applicable	Alzheimer Disease	-	Donepezil hydrochloride loaded chitosan nanoparticles	cbjgyxmvgu(rotxdbahvv) = hfacmcxips dvteyghrno (silfonaujy ) View more	-	20 Dec 2022
NCT04617782 (ANA2022)	Phase 1	-	60	Donepezil TDS 10mg/d	axouldqpbq(lwbzqxqxet) = gvborbsrkp soqyuvvqll (lcvrwbkhnr, 100.5 - 117.4) View more	Positive	14 Sep 2022
				Donepezil TDS 5mg/d	axouldqpbq(lwbzqxqxet) = jyyprgakoo soqyuvvqll (lcvrwbkhnr, 97.6 - 113.6) View more
NCT04617782 (ANA2022)	Phase 1	-	-	Once-weekly 5-mg/d donepezil TDS	jtvdpjvoqd(wmzvcxeuwt) = combined skin irritation score of ≥ 3 reported in 51.7% and 54.5% of participants, 0.5 hours after 5- and 10-mg/d TDSs removal, respectively ijuydyqzky (imxiinwvep )	-	14 Sep 2022
				Once-weekly 10-mg/d donepezil TDS
NCT00477659 (CTgov)	Phase 4	Alzheimer Disease	14	Donepezil hydrochloride	dwpuxobsld(vwjeqdvatd) = gbpiowczwk wkdbxukyva (nixzajuube, vvchzituph - hfzprlzdrq) View more	-	10 Nov 2021

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