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Last update 27 Feb 2026

Donepezil Hydrochloride

Last update 27 Feb 2026

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

+ [47]

Target

ACHE

Action

inhibitors

Mechanism

AChE inhibitors(Acetylcholinesterase inhibitors)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic DiseaseOther Diseases

Active Indication

Lewy Body DiseaseAlzheimer DiseaseDementia+ [1]

Inactive Indication

Advanced cancerAttention Deficit DisorderCadasil+ [14]

Originator Organization

Eisai Co., Ltd.

Active Organization

Chongqing Ruien Pharmaceutical Co., Ltd.

Sandoz Pty Ltd.

MYUNGMOON Pharm Co., Ltd.

+ [11]

Inactive Organization

Pfizer Inc.Eisai Ltd. (Canada)

Teikoku Pharma USA, Inc.

+ [10]

License Organization

Inventage Lab, Inc.

ICURE PHARM INC

Lotus Pharmaceutical Co., Ltd.

+ [9]

Drug Highest PhaseApproved

First Approval Date

United States (25 Nov 1996),

Alzheimer Disease

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC24H30ClNO3

InChIKeyXWAIAVWHZJNZQQ-UHFFFAOYSA-N

CAS Registry120011-70-3

438

Clinical Trials associated with Donepezil Hydrochloride

TCTR20251117014

/ Not yet recruitingPhase 3IIT

Treatment outcome and quality of life in patients with permanent post-stroke non-fluent aphasia treated by donepezil: A randomized clinical study

Start Date01 Jan 2026

Sponsor / Collaborator-

ChiCTR2500112761

/ Not yet recruitingNot ApplicableIIT

A Clinical Study on the Analgesic Efficacy of a Single Preoperative Dose of Anrekenfen in Patients Undergoing Ambulatory Laparoscopic Abdominal Surgery

Start Date01 Dec 2025

Sponsor / Collaborator

Jining Medical College Affiliated Hospital

NCT07208344

/ RecruitingEarly Phase 1IIT

A Randomized Double-blind Clinical Study on the Use of Umbilical Cord Blood as an Adjuvant Therapy to Improve Cognitive Function in Alzheimer's Disease and Its Mechanism of Action

This study is a single-center, prospective, double-blind, randomized controlled clinical trial (RCT).
Employing a parallel-group design, the trial plans to enroll 30 clinically diagnosed AD patients, who will be randomly assigned via a computerized randomization tool into three equal groups: low-dose, high-dose, and control (10 patients per group).
The blinded clinical trial consists of three phases:
**Screening Phase**: All enrolled patients must provide fully informed consent and meet inclusion criteria while avoiding exclusion criteria. Baseline assessments will be recorded, and single-cell omics samples will be collected. Patients may voluntarily opt for cerebrospinal fluid (CSF) sampling.
The umbilical cord blood (UCB) used clinically is sourced from the Shandong Cord Blood Hematopoietic Stem Cell Bank. Following erythrocyte and granulocyte depletion via lymphocyte separation and density gradient centrifugation, the UCB is purified to reduce immunogenicity and undergoes genetic screening to exclude the APOE4 risk allele.
**Treatment Phase**: In addition to standard care, patients will receive intravenous infusions at weekly intervals for four sessions. A fifth infusion will be administered one month after the fourth. The low-dose group receives 1×10⁸ UCB-derived mononuclear cells (UCB-MNCs) per infusion, the high-dose group receives 3×10⁸ UCB-MNCs, and the control group receives an equivalent volume of saline placebo.
All clinically administered UCB-MNCs undergo genetic screening to exclude the APOE4 risk allele.
**Follow-up Phase**:
Assessments will be conducted at 30 days (1 month), 60 days (2 months), 90 days (3 months), and 180 days (6 months) post-initial infusion, including:
1. CDR-SB scale scoring;
2. Total and subdomain scores of the Activities of Daily Living (ADL) scale;
3. Serum inflammatory cytokines (IL-1, IL-2, IL-6, IL-8, IL-10, TNF-α), AD biomarkers (P-tau181, P-tau217), and other relevant markers;
4. Single-cell omics sample collection;
5. Optional CSF sampling per patient preference.
After database lock, unblinding will occur for subsequent analysis.

Start Date31 Jul 2025

Sponsor / Collaborator

Anhui Provincial Hospital

[+1]

100 Clinical Results associated with Donepezil Hydrochloride

100 Translational Medicine associated with Donepezil Hydrochloride

100 Patents (Medical) associated with Donepezil Hydrochloride

6,206

Literatures (Medical) associated with Donepezil Hydrochloride

31 Dec 2026·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

From bench to brain: novel thieno-oxazine hybrids as potent pleiotropic anti-Alzheimer’s agents with in vivo / in vitro validation and in silico insights

Article

Author: Fayed, Eman A. ; Almotairi, Reema ; Hamdan, Amira M. ; Hafez, Shaimaa M. ; Hamdan, Ahmed M. E. ; Oudah, Khulood H. ; Ramsis, Triveena M. ; Khedre Mohamed, Ehsan ; Faisal Alzahrani, Shahad ; Ebrahim, Maha A. ; A. A. Najm, Mazin ; Gohar, Nirvana A. ; Albalawi, Najla A. ; Abu-Elfotuh, Karema

Due to their various pharmacological effects, several substituted sulphur heterocycles containing thiophene have recently attracted a great deal of attention. A novel 2,3-diaryl-2,3,5,6,7,8-hexahydro-4H-benzo[4,5]thieno[3,2-e][1,3]oxazin-4-one (9-14) was synthesised starting from cyclohexa[b]thiophene. Compounds 9 and 10 showed the greatest gene expression downregulation of BAX by 75.1% and 79.7%, and upregulation of Bcl-2 gene expression by 8.1 folds for each. It also decreased the level of AChE by 70.2 and 75%; respectively. Compounds 9 and 10 significantly increased Wnt3a levels by 5.8 and 6.6 folds, and β-Catenin levels by 10.1 and 10.5 folds, respectively, compared to donepezil. They significantly downregulated 5-GSK3β gene expression by 77.1%, and 78.7%, respectively. Even though all compounds exhibited potent inhibition of AChE, all synthesised compounds, except for compounds 5 and 11 demonstrated higher selectivity towards BChE (SI < 1). In-silico ADMET calculations as well as molecular docking have been performed for synthetic compounds.

31 Dec 2026·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Design, synthesis and biological evaluation of donepezil-safinamide hybrids as dual AChE and MAO-B inhibitor for Alzheimer’s disease treatment

Article

Author: Yang, Chunyan ; Guo, Yan ; Cao, Zhongcheng ; Wang, Xiaoli ; Zhu, Jiang ; Li, Wei

Alzheimer's disease (AD) still lacks therapies that definitively halt its progression. Dual AChE/MAO-B inhibitors offer a promising strategy to address both symptoms and pathology. Here, we designed and synthesised a series of donepezil-safinamide hybrids. The optimised compound 28c was identified as a potent inhibitor of AChE (IC₅₀ = 1.70 μM) and MAO-B (IC₅₀ = 0.18 μM). Mechanistic studies indicated that 28c acts as a reversible mixed-type inhibitor of AChE and a competitive reversible inhibitor of MAO-B. Molecular docking and molecular dynamic simulations revealed that 28c could strongly and stably bind to MAO-B and AChE mainly through van der Waals interactions. Moreover, compound 28c demonstrated effective blood-brain barrier penetration, exhibited suitable stability in mouse plasma and brain homogenate, and showed a favourable safety profile both in vitro and in vivo. Furthermore, 28c could attenuate AD-related symptoms and exert hippocampal neuroprotection effect in vivo, highlighting its promise as an anti-AD candidate.

01 May 2026·NEUROPHARMACOLOGY

Discovery of a novel IMS48 as a dual inhibitor of acetylcholinesterase and butyrylcholinesterase: In vitro and in vivo study for Alzheimer therapy

Article

Author: Ahmad, Matloob ; Khurshid, Mohsin ; Munir, Samman ; Ashfaq, Usman Ali ; Khan, Imran Ahmad ; Chauhdary, Zunera

Current medications for Alzheimer's disease (AD) provide symptomatic relief only and fail to prevent neurodegeneration, necessitating the development of new therapeutic agents. This study aimed to evaluate benzimidazole (BIM) analogs as potential inhibitors for AD. In vitro screening identified 1-benzyl-3-(2-((3-chlorophenyl)amino)-2-oxoethyl)-1H-benzo[d]imidazole-3-ium chloride (IMS48) as a potent inhibitor of both acetylcholinesterase (AChE) and butyrylcholinesterase (BChE), with IC₅₀ values of 0.31 ± 0.04 μM and 1.85 ± 0.05 μM, respectively, outperforming the standard drug donepezil. In the in vivo study, rats were administered D-gal (300 mg/kg) and AlCl₃ (150 mg/kg) orally for three weeks to induce AD-like symptoms. Concurrently, IMS48 was administered at doses of 0.75 mg/kg and 1.5 mg/kg for 21 days. Donepezil (DON) was used as a positive control to evaluate the therapeutic efficacy of the IMS8 compound. IMS48 treatment significantly reversed behavioral alterations and improved learning ability. Histopathological analysis demonstrated that IMS48 effectively inhibited neuronal death and neurofibrillary tangles in the brain tissue. Furthermore, IMS48 restored the altered antioxidant enzyme levels (p < 0.001), reducing malondialdehyde (MDA) concentration and enhancing superoxide dismutase (SOD), glutathione (GSH), and catalase (CAT) concentrations. IMS48 also downregulated the gene expression of AChE (1.56 ± 0.10-fold and 1.71 ± 1.76-fold), APP (1.96 ± 0.17-fold and 3.39 ± 0.139-fold), BACE1 (1.92 ± 0.10-fold and 2.59 ± 0.04-fold), TNFα (2.16 ± 0.21-fold and 3.35 ± 0.17-fold), IL-1α (1.86 ± 0.236-fold and 2.56 ± 0.15-fold), and IL-1β (1.58 ± 1.82-fold and 2.32 ± 0.13-fold), associated with AD pathology and neuroinflammation. Overall, these findings highlight the neuroprotective potential of IMS48 in enhancing cognitive function and mitigating neurodegeneration in AD.

115

News (Medical) associated with Donepezil Hydrochloride

25 Feb 2026

·www.businesswire.com

Alpha Cognition Announces First Patient Enrolled in BEACON Real-World Effectiveness Study

VANCOUVER, British Columbia & GRAPEVINE, Texas--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) (“Alpha Cognition,” “ACI,” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for neurodegenerative diseases, today announced the enrollment of the first patient in BEACON, a Phase 4 real world effectiveness study, to assess the impact of ZUNVEYL® in the Long-Term Care (LTC) setting. The BEACON study is designed to assess the real-world impact of ZUNVEYL on cognition, neuropsychiatric symptoms, safety, and tolerability in patients with Alzheimer’s disease residing in nursing homes. By generating data in routine clinical practice, the study aims to complement findings from earlier clinical trials and provide practice-relevant evidence in a care setting with significant unmet need that will further support the Company’s commercialization efforts. “Enrollment of first patient in the BEACON study represents a significant milestone for Alpha Cognition,” said Kurt Grady, Alpha Cognition’s Vice President of Medical Affairs. “This study is designed to generate real-world clinical evidence in the nursing home environment, where the need for effective and well-tolerated therapies is particularly high. If positive, these data have the potential to further strengthen the clinical foundation for ZUNVEYL and support our ongoing commercial launch by providing meaningful insights for healthcare providers, patients, and caregivers.” BEACON is a post-approval study expected to enroll approximately 200 patients across multiple clinical sites. The study will collect efficacy data and monitor adverse events throughout the study period, contributing to ongoing post-market evaluation and informing real-world clinical use of ZUNVEYL in the long-term care population. Alpha Cognition expects to report topline results in the fourth quarter of 2026, following completion of enrollment and patient follow-up. 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. This news release includes forward-looking statements within the meaning of applicable United States and Canadian 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 with the anticipated results of the BEACON study and the potential for such results to further strengthen the clinical foundation for ZUNVEYL and support its ongoing commercial launch, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. 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, including bridge funding, 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 Annual Report on Form 10-K as filed with the SEC on May 31, 2025 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.

Phase 2Phase 3

18 Feb 2026

·www.alphacognition.com

Alpha Cognition Announces Issuance of Additional U.S. Patent Covering ZUNVEYL® Dosing Regimens

VANCOUVER, B.C. and GRAPEVINE, TX — February 18, 2026 — Alpha Cognition Inc. (NASDAQ: ACOG) (“Alpha Cognition,” “ACI,” or the “Company”), a biopharmaceutical company focused on developing novel therapies for debilitating neurodegenerative disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent Application No. 12,551,491, entitled “Dosage Regimens for Benzgalantamine.” The issued patent includes claims covering methods of orally administering benzgalantamine for the treatment of mild to moderate Alzheimer’s disease using specific dosing regimens. The patent is expected to provide U.S. patent protection through July 2045 and represents an important addition to the Company’s intellectual property portfolio supporting ZUNVEYL, Alpha Cognition’s FDA-approved therapy for mild to moderate Alzheimer’s disease. “This newly issued patent meaningfully strengthens the intellectual property protection surrounding ZUNVEYL by covering clinically relevant dosing regimens for oral administration,” said Michael McFadden, Chief Executive Officer of Alpha Cognition. “These method-of-use claims extend and reinforce our existing patent portfolio, supporting ZUNVEYL’s long-term differentiation and enhancing its commercial value in the U.S. market.” The issuance of this patent further advances Alpha Cognition’s long-term intellectual property strategy by protecting key methods of administering benzgalantamine and extending exclusivity beyond existing patent coverage. The Company believes this patent underscores the innovative nature of its benzgalantamine research and supports durable market protection for ZUNVEYL. About Alpha Cognition Inc. Alpha Cognition Inc. is a pre-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. This news release includes forward-looking statements within the meaning of applicable United States and Canadian 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 Company’s expectation that the additional U.S. patent will provide U.S. patent protection through July 2045 and supporting ZUNVEYL’s long-term differentiation and enhancing its commercial value and protecting key methods of administering benzgalantamine, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. 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, including bridge funding, 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 Annual Report on Form 10-K as filed with the SEC on March 31, 2025 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. For further information: Investor Relations LifeSci Advisors, PJ Kelleher pkelleher@lifesciadvisors.com

Drug ApprovalPatent Expiration

18 Feb 2026

·www.biospace.com

Alpha Cognition Announces Issuance of Additional U.S. Patent Covering ZUNVEYL ® Dosing Regimens

VANCOUVER, British Columbia & GRAPEVINE, Texas--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) (“Alpha Cognition,” “ACI,” or the “Company”), a biopharmaceutical company focused on developing novel therapies for debilitating neurodegenerative disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent Application No. 12,551,491, entitled “Dosage Regimens for Benzgalantamine.” The issued patent includes claims covering methods of orally administering benzgalantamine for the treatment of mild to moderate Alzheimer’s disease using specific dosing regimens. The patent is expected to provide U.S. patent protection through July 2045 and represents an important addition to the Company’s intellectual property portfolio supporting ZUNVEYL, Alpha Cognition’s FDA-approved therapy for mild to moderate Alzheimer’s disease. “This newly issued patent meaningfully strengthens the intellectual property protection surrounding ZUNVEYL by covering clinically relevant dosing regimens for oral administration,” said Michael McFadden, Chief Executive Officer of Alpha Cognition. “These method-of-use claims extend and reinforce our existing patent portfolio, supporting ZUNVEYL’s long-term differentiation and enhancing its commercial value in the U.S. market.” The issuance of this patent further advances Alpha Cognition’s long-term intellectual property strategy by protecting key methods of administering benzgalantamine and extending exclusivity beyond existing patent coverage. The Company believes this patent underscores the innovative nature of its benzgalantamine research and supports durable market protection for ZUNVEYL. About Alpha Cognition Inc. Alpha Cognition Inc. is a pre-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. This news release includes forward-looking statements within the meaning of applicable United States and Canadian 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 Company’s expectation that the additional U.S. patent will provide U.S. patent protection through July 2045 and supporting ZUNVEYL’s long-term differentiation and enhancing its commercial value and protecting key methods of administering benzgalantamine, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. 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, including bridge funding, 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 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 Annual Report on Form 10-K as filed with the SEC on March 31, 2025 and available at . 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. Contacts Investor Relations LifeSci Advisors, PJ Kelleher pkelleher@lifesciadvisors.com

Drug ApprovalPatent Expiration

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	United States	Corium LLC	11 Mar 2022
Lewy Body Disease	Japan	Eisai Co., Ltd.	19 Sep 2014
Alzheimer Disease	United States	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	United States	Pfizer Inc.	01 Sep 2008
Cognitive Dysfunction	Phase 3	United States	Eisai, Inc.	01 Sep 2008
Down Syndrome	Phase 3	United States	Eisai, Inc.	01 Sep 2008
Down Syndrome	Phase 3	United States	Pfizer Inc.	01 Sep 2008
Attention Deficit Disorder	Phase 3	United Kingdom	Eisai Co., Ltd.	30 Apr 2008
Neoplasms	Phase 3	United Kingdom	Eisai Co., Ltd.	30 Apr 2008
Cerebrovascular Disorders	Phase 3	Canada	Eisai, Inc.	01 May 2004
Advanced cancer	Phase 3	United States	Pfizer Inc.	01 Nov 2003
Sedation	Phase 3	United States	Pfizer Inc.	01 Nov 2003
Dementia, Vascular	Phase 3	United States	Eisai, Inc.	01 Mar 2003

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)	aczapahnaj(jcfflmtchv) = djudaexpbh jrywbaxzth (bymcvwpepm, 3.19) View more	-	10 Feb 2025
				Measurement of serum level of anti-dementia drug+Memantine+Donepezil (Intervention Arm)	aczapahnaj(jcfflmtchv) = rtiryenxze jrywbaxzth (bymcvwpepm, 3.56) View more
NCT04730635 (MK-0000-413, CTgov)	Phase 1	Alzheimer Disease \| Mild cognitive disorder	44	Donepezil (Donepezil)	mhlrnvovwr(ucubtjgvyt) = grxoawuoug ddfebxddwo (albpromwex, 0.078) View more	-	28 Oct 2024
				Placebo (Placebo)	mhlrnvovwr(ucubtjgvyt) = tbrvnqwvhz ddfebxddwo (albpromwex, 0.091) View more
NCT04617782 (CTgov)	Phase 1	-	60	Donepezil (Treatment A 5 mg TDS)	bljioqfbrs(lyitjiukmg) = mpelnjmzkf cpgytmjuct (tiwhauyohr, 9.1) View more	-	19 Sep 2024
				Donepezil (Treatment B 10 mg TDS)	bljioqfbrs(lyitjiukmg) = dryvujrjxd cpgytmjuct (tiwhauyohr, 19.9) View more
NCT02487082 (CTgov)	Phase 2	Autism Spectrum Disorder	12	Placebo+Melatonin+Donepezil (Group A)	rdhnfmhcut(hadmmkoajw) = faxwrllmmj acpgvngure (xwocrbfmaa, fvsnytxhmt - gzmbtmbkjv) View more	-	06 Jun 2024
				Placebo+Melatonin+Donepezil (Group B)	rdhnfmhcut(hadmmkoajw) = uibsflwkyf acpgvngure (xwocrbfmaa, mlcerobiie - eqobtbrgbn) View more
NCT02345213 (Pubmed)	Phase 4	Lewy Body Disease	160	多奈哌齐	zzlgproduk(fthrbvylkb): difference = 1.4 (95% CI, 0.42 - 2.30), P-Value = 0.004 View more	Positive	04 Mar 2024
				安慰剂
NCT02822573 (Remember, CTgov)	Phase 3	Cognitive Dysfunction \| Breast Cancer \| Invasive Mammary Carcinoma	276	Donepezil 5 mg (Donepezil)	fsoifhzdxd(ljlaewkhkc) = jjnhsfgrmh bdqufrpxrd (bklekjegsq, gcuwmxpncf - cefggiacxx) View more	-	13 Sep 2023
				Placebo (Placebo)	fsoifhzdxd(ljlaewkhkc) = usuuibjhxz bdqufrpxrd (bklekjegsq, anlyhtmdhr - ofillembqf) View more
NCT04617782 (Pubmed \| J Alzheimers Dis)	Phase 1	-	60	10-mg/d Corplex™ donepezil transdermal delivery system	vkcgeljxcu(xcyafvyfys) = oral donepezil was associated with higher incidence of gastrointestinal AEs (14.5% versus 53.6%) pdhnoxefmj (ewqmdpaayq ) View more	-	25 Oct 2022
				5-mg/d Corplex™ donepezil transdermal delivery system
NCT04617782 (ANA2022)	Phase 1	-	60	Donepezil TDS 10mg/d	wzncflbywz(pyuhpsfggu) = azmvwidddh stpdnhundb (xkivelubht, 100.5 - 117.4) View more	Positive	14 Sep 2022
				Donepezil TDS 5mg/d	wzncflbywz(pyuhpsfggu) = jifegjsbjh stpdnhundb (xkivelubht, 97.6 - 113.6) View more
NCT04617782 (ANA2022)	Phase 1	-	-	Once-weekly 5-mg/d donepezil TDS	ijbwdfesur(fqmhapvivp) = 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 wsozetmzkk (yvhpsaalef )	-	14 Sep 2022
				Once-weekly 10-mg/d donepezil TDS
NCT00477659 (CTgov)	Phase 4	Alzheimer Disease	14	Donepezil hydrochloride	llkdgjlqzv(dbkoefuhjb) = fxzhypgcep eublqjanuo (pxilhzyqgl, 17.23) View more	-	10 Nov 2021

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