Overview
Initially approved by the FDA in 2013, memantine is an N-methyl-D-aspartate (NMDA) receptor antagonist used in the management of Alzheimer's Disease (AD). It is different from many other Alzheimer's Disease medications, as it works by a different mechanism than the cholinesterase enzyme inhibitors normally employed in the management of Alzheimer's disease . Memantine blocks the effects of glutamate, a neurotransmitter in the brain that leads to neuronal excitability and excessive stimulation in Alzheimer's Disease . In 2010, it was estimated that 36 million people worldwide live with Alzheimer's Disease. In 2013, this number increased to 44 million. Almost doubling every 20 years, the prevalence of Alzheimer's Disease is predicted to reach 66 million by 2030 and to 115 million by 2050 . In December 2013, the G8 dementia summit concluded that dementia should be considered a global priority with the objective of developing a cure or a disease-modifying therapy by the year 2025 .
Indication
Memantine is used to manage moderate to severe Alzheimer's dementia . A more recent systemic review and meta-analysis indicates that memantine is beneficial as a first line drug for the treatment of Alzheimer's dementia. Cholinesterase inhibitors may be added to memantine for further beneficial effects on behavioral symptoms and other symptoms of dementia .
Associated Conditions
- Alzheimer's Disease (AD)
- Moderate to Severe Alzheimer's Disease
- Mild Vascular dementia
- Moderate Alzheimer's Type Dementia
- Moderate Vascular dementia
- Severe Alzheimer's Type Dementia
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/12/03 | Phase 2 | Completed | Forest Laboratories | ||
2013/10/30 | Phase 3 | Completed | |||
2013/08/14 | Phase 4 | Completed | |||
2013/07/17 | Phase 4 | Completed | |||
2013/06/13 | Phase 2 | Completed | |||
2013/05/08 | Phase 4 | UNKNOWN | |||
2013/05/01 | Not Applicable | Withdrawn | |||
2012/12/06 | Phase 2 | Completed | |||
2012/09/03 | Phase 2 | Completed | |||
2012/08/02 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-2512 | ORAL | 10 mg in 1 1 | 12/15/2020 | |
| NorthStar RxLLC | 72603-119 | ORAL | 10 mg in 1 1 | 12/26/2023 | |
| Apotex Corp. | 60505-6162 | ORAL | 2 mg in 1 mL | 12/14/2023 | |
| Vitruvias Therapeutics, Inc. | 69680-164 | ORAL | 28 mg in 1 1 | 12/26/2023 | |
| American Health Packaging | 60687-184 | ORAL | 10 mg in 1 1 | 2/19/2024 | |
| Sun Pharmaceutical Industries, Inc. | 47335-322 | ORAL | 10 mg in 1 1 | 10/5/2023 | |
| Zydus Lifesciences Limited | 70771-1119 | ORAL | 5 mg in 1 1 | 11/5/2022 | |
| Wockhardt USA LLC. | 64679-122 | ORAL | 10 mg in 1 1 | 12/19/2017 | |
| Rising Pharma Holdings, Inc. | 16571-852 | ORAL | 7 mg in 1 1 | 4/19/2025 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-011 | ORAL | 10 mg in 1 1 | 11/15/2017 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Memantine Hydrochloride Oral Solution | 国药准字H20183420 | 化学药品 | 口服溶液剂 | 11/27/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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