MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (donepezil hydrochloride)
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is indicated for the treatment of Alzheimer's Disease.
How MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Works
This combination product utilizes two distinct mechanisms to address the symptoms of Alzheimer's disease. Memantine acts as an uncompetitive NMDA receptor antagonist that binds to receptor-operated cation channels to manage the persistent activation of these receptors by glutamate. Donepezil enhances cholinergic function by reversibly inhibiting acetylcholinesterase, the enzyme responsible for the hydrolysis of acetylcholine. This inhibition increases the concentration of acetylcholine in the central nervous system to improve neurotransmission.
Details
- Status
- Prescription
- First Approved
- 2017-01-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
Companies
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Approval History
What MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Treats
1 indicationsMEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alzheimer's Disease
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00688376 results posted | E2020-G000-333 E2020-G000-334, 2007-005435-28 | Ph 3 | completed | Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment |
| NCT01466270 results posted | IRB00019792-1 U10CA081851, REBACCCWFU 97211 | Ph 2 | completed | Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction |
| NCT00369785 results posted | IRB00000551 U10CA081851, REBACCCWFU 91105 | Ph 3 | completed | Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors |
| NCT04013477 | DA5207_ADK_Ia | Ph 1 | completed | Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults |
| NCT02660983 results posted | E2020-K082-418 | Ph 4 | completed | A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease |
| NCT01903824 | C26401/1111 2013-001883-51 | Ph 1 | completed | Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects |
| NCT00695136 results posted | 080154 08-M-0154 | Ph 1, Ph 2 | completed | The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism |
| NCT01506752 | E2020-J081-034 | Ph 1 | completed | A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males |
| NCT01506739 | E2020-J081-033 | Ph 1 | completed | A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males |
| NCT01504503 | 645/09 | Ph 1 | completed | Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition |
| NCT01504516 | 646-09 | Ph 1 | completed | Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is indicated for the treatment of Alzheimer's Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.