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Last update 24 Jan 2025

Donepezil Hydrochloride

Last update 24 Jan 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

Eisai Co., Ltd.

Eisai, Inc.

+ [12]

Inactive Organization

Pfizer Inc.Teva Pharmaceuticals USA, Inc.

Teikoku Pharma 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

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

CTRI/2024/11/076541

/ Not yet recruitingNot ApplicableIIT

Comparing the safety and efficacy of Donepezil,Memantine and fixed drug combination of Donepezil Memantine in dementia patients by using MoCA score - Prospective randomized open label study - nil

Start Date22 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Donepezil Hydrochloride

100 Translational Medicine associated with Donepezil Hydrochloride

100 Patents (Medical) associated with Donepezil Hydrochloride

4,945

Literatures (Medical) associated with Donepezil Hydrochloride

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: Streck, Emilio Luiz ; Alano, Carolina Giassi ; Leipnitz, Guilhian ; Canarim, Rafael Orestes ; Effting, Pauline Souza ; Réus, Gislaine Zilli ; 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·ARCHIVES OF GERONTOLOGY AND GERIATRICS

Patterns, determinants, and outcomes of early use of antidementia drugs: A 6-year multicenter cohort study in Thailand

Article

Author: Winitkulchai, Piyarat ; Na-Ek, Nat ; Mekkhayai, Yaowaret ; Singkham, Noppaket ; Muenpa, Roungtiva ; Onseng, Kittipong ; Wongsalap, Yuttana ; Phatthanasobhon, Sirayut ; Mongkhon, Pajaree ; Rattanachaisit, Watchara ; Chindasu, Pimsai

BACKGROUND:

Evidence on antidementia drugs (ADD) use in developing countries, where accessibility to ADD is challenging, is limited. Our aim was to examine prescribing patterns, factors, and outcomes associated with the early-ADD use (within 3 months from diagnosis) in people with dementia.

METHODS:

A retrospective cohort study included individuals aged ≥ 60 years with dementia from three hospitals in Thailand between 2015 and 2020. Participants were categorized as non-ADD users, early-ADD users, and delayed users. ADD switching and one-year persistence were analyzed. Multivariable logistic regression was used to identify factors associated with early-ADD prescribing and its impact on clinical outcomes, including in-hospital death and hospitalization.

RESULTS:

3,116 patients were included. The ADD prescription rate was 14.31 %, with 79.82 % of those being early-ADD users. Donepezil was the most prescribed (70.18 %). The one-year persistence rate of any ADD was 24.89 %. Factors associated with early-ADD use included the Civil Servant Medical Benefit Scheme, dyslipidemia, and dementia type. Early-ADD use was associated with reduced in-hospital death (adjusted odds ratio [aOR]=0.46, 95 % CI: 0.22-0.96, p = 0.038) and hospitalization (adjusted OR = 0.70 95 % CI: 0.51-0.97, p = 0.034) after controlling for age, sex, and Charlson Comorbidity Index.

CONCLUSION:

ADD prescription rates were relatively low, with a one-year persistence rate of 25 %. Early-ADD use may improve clinical outcomes by reducing hospitalization and in-hospital mortality. These findings provide clinical features of ADD used in real-world settings and highlight the need for adherence to practice standards and strategies to promote ADD persistence among individuals with dementia.

01 Feb 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of novel bicyclic and tricyclic cyclohepta[b]thiophene derivatives as multipotent AChE and BChE inhibitors, in-Vivo and in-Vitro assays, ADMET and molecular docking simulation

Article

Author: Al-Subaie, Faleh Turki ; Fayed, Eman A ; Hamdan, Amira M ; Albalawi, Gharam Saad ; Ramsis, Triveena M ; Hamdan, Ahmed M E ; El-Sebaey, Samiha Ahmed ; Mohamed, Ehsan Khedre ; Albalawi, Tariq Mohammed ; Ebrahim, Maha A ; Abu-Elfotuh, Karema ; El-Sayed Mansour, Reda ; Mohammed, Asmaa A

Alzheimer's disease (AD) is primarily caused by oxidative stress, hyperphosphorylated τ-protein aggregation, and amyloid-β deposition. Changes in dopaminergic and serotoninergic neurotransmitter pathways are linked to certain symptoms of AD. Derivatives of bicyclic and tricyclic cyclohepta[b]thiophene were developed to identify new potential candidates as acetylcholinesterase (AChE) and butyrylcholinesterase (BChE) inhibitors for the treatment of AD. All synthesized compounds exhibited AChE inhibition with IC₅₀ values below 15 μM, while all compounds exhibited BChE inhibition with IC₅₀ values below 25 μM. Compounds 9 and 12 exhibited AChE inhibitory activities with IC₅₀ values of 0.51 μM and 0.55 μM, respectively. Compounds 5 and 9 demonstrated excellent inhibitory activity against BChE with IC₅₀ values of 2.9 μM and 2.48 μM, respectively. Compounds 9, 13, and 14 were found to be the most active in terms of the decrease in the escape latency time, with values comparable to that of Donepezil. Compounds 10, 11, and 12 exhibited promising effects on learning and memory. Compounds 5, 10, 11, and 12 exhibited promising SAP values of 70.67 %, 71.5 %, 74.33 % and 73.83 %, respectively. Other biomarkers were evaluated in rat brains including TAC, MDA, SOD, BDNF, IL-β and TNF-α. Fundamental features of ADMET have been computed in-silico for synthesized compounds. Molecular docking was performed to confirm the binding of the novel compounds to the targets.

News (Medical) associated with Donepezil Hydrochloride

23 Jan 2025

·www.businesswire.com

Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin

BRIDGEWATER, N.J.--( BUSINESS WIRE )--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which references Abbvie’s NAMZARIC ® , and Everolimus 2 mg, 3 mg and 5 mg extended-release capsules, which references Novartis’ AFINITOR DISPERZ ® . In addition, the FDA has granted tentative approval to Amneal’s rifaximin 550 mg oral tablets, which references Bausch Health’s XIFAXAN ® . The FDA approval was tentative as this product is involved in litigation. Memantine/donepezil extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. The product has launched with 180-day exclusivity. Everolimus tablets for oral suspension are indicated for the treatment of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) in adult and pediatric patients aged one year or older. This launch increases the supply of an oncology product that has limited suppliers. Rifaximin 550 mg oral tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. “Amneal’s competitive advantage in the Affordable Medicines business remains our core capabilities to drive innovation at scale across complex categories to expand the breadth and depth of our portfolio,” said Andy Boyer, Executive Vice President, Chief Commercial Officer, Affordable Medicines. “With our 180-day exclusivity on memantine/donepezil, increasing supply for everolimus, and the tentative approval of rifaximin, we are continuing to expand our differentiated portfolio and providing new key therapies for our customers, providers and patients.” The most common adverse reactions with memantine hydrochloride were headache, diarrhea, and dizziness. The most common adverse reactions occurring in patients receiving donepezil include diarrhea, anorexia, vomiting, nausea, and bruising. For complete prescribing information, see package insert available here . The most common adverse reactions with everolimus tablets in patients treated for TSC-Associated SEGA: are stomatitis and respiratory tract infection. For complete prescribing information, see package insert available here . According to IQVIA ® , U.S. annual sales for memantine/donepezil tablets, everolimus tablets and rifaximin tablets for the 12 months ended November 2024 were approximately $88 million, $114 million, and $2.6 billion (for all approved indications of XIFAXAN ® ), respectively. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com . Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Drug Approval

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

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


NCT04730635 (MK-0000-413, CTgov)	Phase 1	Alzheimer Disease \| Mild cognitive disorder	44	Donepezil (Donepezil)	wlcdzqphjg(arftgyjgje) = nmkpcgjhac ejgxtmygor (mdunohokvf, gxwvepwrbm - nvzeyudcxe) View more	-	28 Oct 2024
				Placebo (Placebo)	wlcdzqphjg(arftgyjgje) = ispglagpaz ejgxtmygor (mdunohokvf, sjssscngzp - dharpyydcu) View more
NCT04617782 (CTgov)	Phase 1	-	60	Donepezil (Treatment A 5 mg TDS)	voxtssgtmb(hjtsfsgkjt) = gaxdxaygsp tkaoyusyex (eipuqluaei, cyaonwsonc - emarjiuwzl) View more	-	19 Sep 2024
				Donepezil (Treatment B 10 mg TDS)	voxtssgtmb(hjtsfsgkjt) = zlnmgbgbxw tkaoyusyex (eipuqluaei, ooyhcihdzt - whxgeiyyne) View more
NCT02487082 (CTgov)	Phase 2	Autism Spectrum Disorder	12	Placebo+Melatonin+Donepezil (Group A)	qovhczglkc(dlxjuwcbyi) = ezikwhnuvy kcmhmvggbh (kxskmvmukv, dzjfiaidmq - vbpwqqfbzx) View more	-	06 Jun 2024
				Placebo+Melatonin+Donepezil (Group B)	qovhczglkc(dlxjuwcbyi) = wtncxqagcw kcmhmvggbh (kxskmvmukv, jefqtvypjy - ubgmnxjwcm) View more
NCT02822573 (Remember, CTgov)	Phase 3	Cognitive Dysfunction \| Breast Cancer	276	Donepezil 5 mg (Donepezil)	ixhrregeuc(dygtwlksnm) = ebawsimlvb dwuiujyydr (fienznswhb, gcddtwwupi - xomjyovgzr) View more	-	13 Sep 2023
				Placebo (Placebo)	ixhrregeuc(dygtwlksnm) = bpnqyrdafw dwuiujyydr (fienznswhb, rijzqcbzrg - yxgmkceimk) View more
LIFE Study (AAIC2023)	Not Applicable	Alzheimer Disease First line	-	Newly prescribed donepezil	jebupghrom(fwgfdbhedf) = xhwmafuoms hqiwnhpyzv (qcqqaomcts )	-	16 Jun 2023
AAIC2022	Not Applicable	Alzheimer Disease	-	Donepezil hydrochloride loaded chitosan nanoparticles	cosnbyiean(sqmkirqupm) = csrtsngcxr brrocixxqp (urqfflkfbr ) View more	-	20 Dec 2022
NCT04617782 (ANA2022)	Phase 1	-	60	Donepezil TDS 10mg/d	lzmafddwhs(wwzjcwdxdq) = hcqewqdiax kgeobljnws (ubnnfygogt, 100.5 - 117.4) View more	Positive	14 Sep 2022
				Donepezil TDS 5mg/d	lzmafddwhs(wwzjcwdxdq) = kpuoecpcrp kgeobljnws (ubnnfygogt, 97.6 - 113.6) View more
NCT04617782 (ANA2022)	Phase 1	-	-	Once-weekly 5-mg/d donepezil TDS	cqbneckquf(upeondekvm) = 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 gtbbmojuhz (drxhzawhgs )	-	14 Sep 2022
				Once-weekly 10-mg/d donepezil TDS
NCT00477659 (CTgov)	Phase 4	Alzheimer Disease	14	Donepezil hydrochloride	gowsagakjd(ghtbfzutmw) = yfppcmwaqh aueyjiynat (rzrkrwlerh, qdrvskggdy - cvgwzzvwsf) View more	-	10 Nov 2021

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Donepezil Hydrochloride

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