CLINICAL TRIALS PROFILE FOR DONEPEZIL HYDROCHLORIDE

All Clinical Trials for DONEPEZIL HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000173 ↗	Memory Impairment Study (Mild Cognitive Impairment Study)	Completed	Alzheimer's Disease Cooperative Study (ADCS)	Phase 3	1999-03-01	The National Institute on Aging (NIA) is launching a nationwide treatment study targeting individuals with mild cognitive impairment (MCI), a condition characterized by a memory deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from both dementia and normal age-related changes in memory. Accurate and early evaluation and treatment of MCI individuals might prevent further cognitive decline, including development of Alzheimer's disease (AD). The Memory Impairment Study is the first such AD prevention clinical trial carried out by NIH, and will be conducted at 65-80 medical research institutions located in the United States and Canada. This study will test the usefulness of two drugs to slow or stop the conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an investigational agent approved by the Food and Drug Administration for another use. Vitamin E (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study to delay important dementia milestones, such as patients' institutionalization or progression to severe dementia, by about seven months.
NCT00000173 ↗	Memory Impairment Study (Mild Cognitive Impairment Study)	Completed	National Institute on Aging (NIA)	Phase 3	1999-03-01	The National Institute on Aging (NIA) is launching a nationwide treatment study targeting individuals with mild cognitive impairment (MCI), a condition characterized by a memory deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from both dementia and normal age-related changes in memory. Accurate and early evaluation and treatment of MCI individuals might prevent further cognitive decline, including development of Alzheimer's disease (AD). The Memory Impairment Study is the first such AD prevention clinical trial carried out by NIH, and will be conducted at 65-80 medical research institutions located in the United States and Canada. This study will test the usefulness of two drugs to slow or stop the conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an investigational agent approved by the Food and Drug Administration for another use. Vitamin E (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study to delay important dementia milestones, such as patients' institutionalization or progression to severe dementia, by about seven months.
NCT00004807 ↗	Study of the Pathogenesis of Rett Syndrome	Completed	Johns Hopkins University	N/A	1995-01-01	OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.
NCT00004807 ↗	Study of the Pathogenesis of Rett Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	1995-01-01	OBJECTIVES: I. Extend current knowledge of the phenotype and natural history of Rett syndrome (RS). II. Continue the search for a cytogenetic and/or DNA marker. III. Study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. IV. Identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.

Clinical Trial Conditions for DONEPEZIL HYDROCHLORIDE

Condition Name

Condition Name for DONEPEZIL HYDROCHLORIDE
Intervention	Trials
Alzheimer's Disease	87
Alzheimer Disease	46
Healthy	21
Dementia	18

Condition MeSH

Condition MeSH for DONEPEZIL HYDROCHLORIDE
Intervention	Trials
Alzheimer Disease	163
Dementia	51
Cognitive Dysfunction	37
Cognition Disorders	27

Clinical Trial Locations for DONEPEZIL HYDROCHLORIDE

Trials by Country

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Trials by Country for DONEPEZIL HYDROCHLORIDE
Location	Trials
United States	783
Japan	171
Canada	96
Germany	67
Korea, Republic of	57

Trials by US State

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Trials by US State for DONEPEZIL HYDROCHLORIDE
Location	Trials
California	54
Florida	51
New York	43
Texas	40
Arizona	36

Clinical Trial Progress for DONEPEZIL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DONEPEZIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	71
Phase 3	51
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for DONEPEZIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	213
Terminated	37
Unknown status	23

Clinical Trial Sponsors for DONEPEZIL HYDROCHLORIDE

Sponsor Name

Sponsor Name for DONEPEZIL HYDROCHLORIDE
Sponsor	Trials
Pfizer	31
Eisai Inc.	24
Eisai Co., Ltd.	11

Sponsor Type

Sponsor Type for DONEPEZIL HYDROCHLORIDE
Sponsor	Trials
Other	233
Industry	229
NIH	38

Donepezil Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Donepezil hydrochloride, a cholinesterase inhibitor, is a widely used medication for the treatment of Alzheimer's disease. Here, we will delve into the latest updates on clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Long-Term Efficacy and Safety

Clinical trials have consistently demonstrated the efficacy and safety of donepezil. A multicenter, open-label, phase 3 extension study showed that long-term use of donepezil (up to 144 weeks) maintained significant improvements in cognition and global function in patients with Alzheimer's disease. The study, which followed patients from two initial double-blind, placebo-controlled trials, indicated that donepezil treatment could be sustained without significant adverse effects, with most patients tolerating the 10 mg/day dosage[1].

Recent and Ongoing Trials

Donepezil is being explored for various indications beyond Alzheimer's disease. Recent Phase 1 studies compared the pharmacokinetics of donepezil patches versus oral formulations in healthy adults, leading to FDA approval for the patches in 2022. These patches deliver 5 or 10 mg of the drug daily and have been shown to cause fewer gastrointestinal and nervous system side effects compared to oral forms[5].

Ongoing trials are investigating the use of donepezil in traumatic brain injury, glycemic control in Type 2 diabetes, wound healing, cognitive problems due to chemotherapy or surgery, and chemotherapy-induced peripheral neuropathy, among other conditions[5].

Market Analysis

Current Market Size and Growth

The global donepezil market is experiencing significant growth driven by several key factors. As of 2023, the market was valued at approximately $0.9 billion and is projected to reach $1.1 billion by 2033, growing at a CAGR of 1.9%[3].

Another report indicates that the market size was $1.241 billion in 2023 and is expected to reach $1.8225 billion by 2030, with a CAGR of 5.5% during the forecast period[2].

Drivers of Market Growth

The increasing prevalence of Alzheimer's disease, particularly among the aging population, is a major driver of the donepezil market. Advances in R&D activities and government initiatives to improve healthcare access and reimbursement policies also contribute to market growth[2][3].

Market Segments and Distribution

The donepezil market is segmented by dosage strength (5 mg, 10 mg, and 23 mg), route of administration (oral and transdermal), and distribution channels (hospital pharmacies, drug stores, retail pharmacies, and online providers). The 5 mg segment is particularly significant due to its common use in managing mild to moderate Alzheimer's disease, offering a balance between efficacy and side effects[3].

Key Players

Major players in the donepezil market include Eisai, Pfizer, Teva, Novartis, Apotex, Dr. Reddy's Laboratories, Sun Pharmaceutical, Hansoh Pharma, Cipla, and others. These companies are driving innovation through strategic marketing initiatives and R&D investments[2].

Market Projections

Future Growth Opportunities

The donepezil market is expected to continue growing, driven by the increasing demand for Alzheimer's disease treatments. Emerging markets offer significant opportunities for expansion, as healthcare infrastructure and access to treatments improve in these regions[3].

Challenges and Restraints

Despite the growth potential, the market faces challenges such as side effects associated with donepezil, which may restrict its adoption. However, the development of new dosage forms, such as transdermal patches, is helping to mitigate these issues by reducing side effects[3][5].

Combination Therapies and Future Trends

Combination with Other Drugs

The launch of Namzaric (donepezil + memantine) in 2016 has shown steady sales growth and is expected to continue, with peak sales forecasted at $574.1 million in 2025. This combination therapy highlights the trend towards using multiple drugs in combination to manage Alzheimer's disease more effectively[4].

Future Clinical Trials

Future clinical trials are likely to focus on the combinatory effects of drugs rather than seeking a single cure for Alzheimer's disease. There will also be an increased emphasis on enrolling preclinical individuals and using advanced imaging and genetic tests to identify patients earlier[4].

Key Takeaways

• Clinical Efficacy: Donepezil has demonstrated long-term efficacy and safety in treating Alzheimer's disease.
• Market Growth: The global donepezil market is growing, driven by the increasing prevalence of Alzheimer's disease, R&D activities, and government initiatives.
• Market Size: The market was valued at $0.9 billion in 2023 and is projected to reach $1.1 billion by 2033.
• Key Players: Major pharmaceutical companies are driving innovation and market growth.
• Future Trends: Combination therapies and new dosage forms, such as transdermal patches, are expected to shape the future of the donepezil market.

FAQs

Q: What are the primary drivers of the donepezil market growth?

The primary drivers include the increasing prevalence of Alzheimer's disease, rise in R&D activities, and increase in government initiatives.

Q: What are the common side effects associated with donepezil?

Common side effects include headache, itching or irritation at the application site (for patches), muscle spasms, constipation, diarrhea, and dizziness.

Q: What new dosage forms of donepezil have been developed?

Recent developments include transdermal patches that deliver 5 or 10 mg of donepezil daily, which have been shown to cause fewer side effects compared to oral forms.

Q: Which companies are major players in the donepezil market?

Major players include Eisai, Pfizer, Teva, Novartis, Apotex, Dr. Reddy's Laboratories, and others.

Q: What is the projected market size of donepezil by 2030?

The market is projected to reach $1.8225 billion by 2030, growing at a CAGR of 5.5% from 2023 to 2030[2].

Sources

1. JAMA Neurology: "Open-Label, Multicenter, Phase 3 Extension Study of the Safety and Efficacy of Donepezil in Patients with Alzheimer Disease".
2. Valuates Reports: "Global Donepezil Drug Market Research Report, Industry Forecast Analysis".
3. EINPresswire: "Donepezil Market to Reach $1.1 Billion, Globally, by 2033 at 1.9% CAGR: Allied Market Research".
4. Drug Development: "MARKET BRIEF - Alzheimer's Disease Market Report (2016-2026)".
5. ALZFORUM: "Donepezil".