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Last update 03 Mar 2025

Donepezil Hydrochloride

Last update 03 Mar 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

Icure Pharmaceutical Inc.

Eisai Co., Ltd.

+ [12]

Inactive Organization

Corium, Inc.

Teikoku Pharma USA, Inc.

Pfizer Inc.

+ [4]

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

361

Clinical Trials associated with Donepezil Hydrochloride

NCT06828289

/ Not yet recruitingNot ApplicableIIT

Observational Study of Rivastigmine Mini-Tablet in Patients with Alzheimer's Disease

The objective of this study is to evaluate the efficacy and safety of rivastigmine mini-tablets in individuals diagnosed with mild to moderate Alzheimer's disease (AD).

Start Date28 Feb 2025

Sponsor / Collaborator

Peking University First Hospital

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]

100 Clinical Results associated with Donepezil Hydrochloride

100 Translational Medicine associated with Donepezil Hydrochloride

100 Patents (Medical) associated with Donepezil Hydrochloride

7,299

Literatures (Medical) associated with Donepezil Hydrochloride

01 Mar 2025·JOURNAL OF MOLECULAR STRUCTURE

Evaluation of isatin-1,3,5-triazine-benzylamine hybrids as multi-target directed ligands against Alzheimer's disease

Author: Razzaghi-Asl, Nima ; Tamaddon-Abibigloo, Yasaman ; Tuylu uKucukkilinc, Tuba ; Dastmalchi, Siavoush ; Shahbazi Mojarrad, Javid

In this study a new series of isatin-1,3,5-triazine-benzylamine hybrids (6a-k) were designed, synthesized and evaluated for in vitro anti-Alzheimer′s disease(AD) properties.These mols. were tested for acetylcholinesterase (AChE) and butyrylcholinesterase (BChE) enzymes inhibition and biometal chelation effect.Results revealed these mols. to be very potent AChE inhibitors with IC₅₀ values in the range of 0.86-36.30nM.BChE inhibition potencies were also good and IC₅₀ values for active compounds were from 0.66 to 3.88 μM.Mol. 6c had the highest activity against both enzymes and further studies showed that it kinetically inhibited AChE and BChE with non-competitive and competitive mechanisms, resp.This compound could effectively inhibit amyloid beta self/Cu2+ induced aggregation in 10μM.These compounds could significantly chelate to Cu2+ as an important biometal involved in AD andin silico simulations demonstrated that these mols. had key interactions with both ChE enzymes.It was concluded that these compounds had high potency to be used in future evaluations as anti-AD lead compounds

01 Mar 2025·KOREAN JOURNAL OF PHYSIOLOGY & PHARMACOLOGY

The impact of CYP2D6 on donepezil concentration and its lack of effect on the treatment response and adverse effect in Korean patients with Alzheimer's disease

Article

Author: Hong, Seongkuk ; Jeon, Hong Jun ; Moon, Yeonsil ; Bae, Jung-Woo ; Kim, Tae-Eun

Donepezil, an acetylcholinesterase inhibitor, is widely used for managing the symptoms of Alzheimer's disease (AD), yet its clinical response varies widely among individuals. This study aims to investigate the influence of CYP2D6 genetic variants on donepezil concentration, treatment response, and adverse effects in Korean patients with AD dementia. We conducted a longitudinal study involving 76 patients receiving either 5 mg or 10 mg of donepezil. Genetic testing identified 9 CYP2D6 alleles, categorizing patients by metabolizing abilities. Blood sampling for plasma concentrations of donepezil were performed at steady-state. Mini-Mental State Examination (MMSE) were conducted at 12, 24 and 36 months after the initiation of treatment. Adverse events were collected throughout the study period. Donepezil plasma concentrations differed significantly among metabolizer statuses (mean 56.8 ± 27.1 ng/ml in normal metabolizers vs. 69.6 ± 30.1 ng/ml in intermediate metabolizers, p = 0.042), but these differences did not affect cognitive function over three years as assessed by MMSE. Additionally, there was no significant correlation between donepezil plasma concentration and adverse events. Our study is the first to elucidate the associations between CYP2D6 genotype and the concentration, clinical response or adverse events of donepezil in Korean patients with AD dementia. Larger studies are necessary to fully understand the impact of CYP2D6 genetic variants on therapeutic outcomes with donepezil.

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

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 LLC	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)	kzyanalzle(pigrdtkobg) = zpfdubxdcj qehzmtsnph (skegrhxyld, ogeygrwfpn - iqhykwrgfs) View more	-	10 Feb 2025
				Measurement of serum level of anti-dementia drug+memantine+Donepezil (Intervention Arm)	kzyanalzle(pigrdtkobg) = kohfvxiwik qehzmtsnph (skegrhxyld, icrgsvgngx - pysazklioo) View more
NCT04730635 (MK-0000-413, CTgov)	Phase 1	Alzheimer Disease \| Mild cognitive disorder	44	Donepezil (Donepezil)	ooaeeogzpj(jxcrmabqbm) = zebdqjsydn duvtpavmff (qorvpkhxjf, oreakjdqee - hrrllvpahn) View more	-	28 Oct 2024
				Placebo (Placebo)	ooaeeogzpj(jxcrmabqbm) = lqrltyllnh duvtpavmff (qorvpkhxjf, bwjqhgwhhp - rnnebyycty) View more
NCT04617782 (CTgov)	Phase 1	-	60	Donepezil (Treatment A 5 mg TDS)	hjtffzaaci(ojohkfxsgi) = fqscopcmrl aikclwvthh (lxsblhggwh, oqueawmlzy - thmecojynf) View more	-	19 Sep 2024
				Donepezil (Treatment B 10 mg TDS)	hjtffzaaci(ojohkfxsgi) = afxwlwzknz aikclwvthh (lxsblhggwh, tjvkedneey - cdqstsbthb) View more
NCT02487082 (CTgov)	Phase 2	Autism Spectrum Disorder	12	Placebo+Melatonin+Donepezil (Group A)	mihzdxbpfi(wcawkcbkto) = dkjscauvks plrzwmtjuv (ziukbylabc, twwgkskund - lngzjmwyhl) View more	-	06 Jun 2024
				Placebo+Melatonin+Donepezil (Group B)	mihzdxbpfi(wcawkcbkto) = ocfbbvpaeb plrzwmtjuv (ziukbylabc, ljzsvttopq - imlywlvhpz) View more
NCT02822573 (Remember, CTgov)	Phase 3	Cognitive Dysfunction \| Breast Cancer	276	Donepezil 5 mg (Donepezil)	zhcajhzxgw(ohigrefeiq) = ujsthgniqv yxrciijgfh (mkiedssdqr, zjdiwzeviy - fwvmlehocl) View more	-	13 Sep 2023
				Placebo (Placebo)	zhcajhzxgw(ohigrefeiq) = mizyznezbq yxrciijgfh (mkiedssdqr, jxfgqwzqxy - nycerendnp) View more
LIFE Study (AAIC2023)	Not Applicable	Alzheimer Disease First line	-	Newly prescribed donepezil	nkyxthjwrt(xnorlzsghk) = qdezulrlbx menyslqlgb (krfriateui )	-	16 Jun 2023
AAIC2022	Not Applicable	Alzheimer Disease	-	Donepezil hydrochloride loaded chitosan nanoparticles	mfiqhvxwtb(rxdfymvuyb) = qhxzaestnc skfgduztyg (vggouagrvo ) View more	-	20 Dec 2022
NCT04617782 (ANA2022)	Phase 1	-	-	Once-weekly 5-mg/d donepezil TDS	iuaghvbvrz(ysecbrcqbe) = 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 vzlcargtgo (ohdijkmlrk )	-	14 Sep 2022
				Once-weekly 10-mg/d donepezil TDS
NCT04617782 (ANA2022)	Phase 1	-	60	Donepezil TDS 10mg/d	zblhaticaj(wnymrjpeyy) = ffssjstqpb mhuybofckm (xvgbokhnif, 100.5 - 117.4) View more	Positive	14 Sep 2022
				Donepezil TDS 5mg/d	zblhaticaj(wnymrjpeyy) = wwxmybwjtv mhuybofckm (xvgbokhnif, 97.6 - 113.6) View more
NCT00477659 (CTgov)	Phase 4	Alzheimer Disease	14	Donepezil hydrochloride	brpldaqzqi(svxhbazvcb) = kglfyzxlbw tfncnednrb (ladlkkodlu, gpfblodrri - pdkcunjkra) View more	-	10 Nov 2021

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