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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/06 | Phase 2 | Not yet recruiting | |||
2025/01/23 | Phase 2 | Recruiting | |||
2024/12/11 | Phase 2 | Recruiting | |||
2024/09/13 | Phase 2 | Not yet recruiting | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | ||
2024/07/15 | Not Applicable | Completed | Shanghai East Hospital | ||
2024/03/29 | Phase 3 | Completed | |||
2024/02/23 | Phase 3 | Recruiting | |||
2023/08/23 | Phase 2 | Recruiting | |||
2023/04/28 | Phase 1 | Not yet recruiting | |||
2023/04/03 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| DirectRx | 72189-294 | ORAL | 5 mg in 1 1 | 11/11/2021 | |
| Bryant Ranch Prepack | 63629-2511 | ORAL | 10 mg in 1 1 | 12/15/2020 | |
| Rebel Distributors Corp | 21695-169 | ORAL | 10 mg in 1 1 | 12/22/2009 | |
| Allergan, Inc. | 0456-3205 | ORAL | 5 mg in 1 1 | 7/26/2023 | |
| Direct_Rx | 72189-538 | ORAL | 10 mg in 1 1 | 2/29/2024 | |
| Bryant Ranch Prepack | 71335-1899 | ORAL | 10 mg in 1 1 | 12/22/2021 | |
| Allergan, Inc. | 0456-1228 | ORAL | 28 mg in 1 1 | 11/9/2023 | |
| Major Pharmaceuticals | 0904-6505 | ORAL | 5 mg in 1 1 | 4/27/2018 | |
| Chartwell RX, LLC | 62135-943 | ORAL | 2 mg in 1 mL | 10/12/2023 | |
| Major Pharmaceuticals | 0904-6506 | ORAL | 10 mg in 1 1 | 4/27/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Withdrawn | 4/21/2013 | ||
Authorised | 5/15/2002 | ||
Authorised | 4/21/2013 | ||
Authorised | 6/12/2013 | ||
Authorised | 12/3/2013 | ||
Authorised | 5/17/2002 | ||
Authorised | 11/22/2012 | ||
Authorised | 4/28/2013 | ||
Authorised | 4/22/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AVANTEN FILM-COATED TABLETS 10MG | SIN15599P | TABLET, FILM COATED | 10.0mg | 12/18/2018 | |
| EBIXA TABLET 10 mg | SIN12315P | TABLET, FILM COATED | 10 mg | 6/11/2003 | |
| MEMANTINHYDROCHLORID STADA FILM-COATED TABLET 10MG | SIN15489P | TABLET, FILM COATED | 10mg | 5/21/2018 | |
| MEMANTINE MEVON FILM-COATED TABLETS 10 MG | SIN15300P | TABLET, FILM COATED | 10 mg | 7/18/2017 | |
| ADMENTA 10 FILM COATED TABLET 10 mg | SIN15609P | TABLET, FILM COATED | 10.000 mg | 1/9/2019 | |
| COGNIMET FILM-COATED TABLET 10MG | SIN16928P | TABLET, FILM COATED | 10.00 mg | 1/16/2024 | |
| MARIXINO FILM-COATED TABLETS 10 MG | SIN15120P | TABLET, FILM COATED | 10.00mg | 11/28/2016 | |
| NEMDATINE FILM COATED TABLET 10MG | SIN14801P | TABLET, FILM COATED | 10.00 mg | 7/6/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20217137 | 化学药品 | 胶囊剂 | 12/21/2021 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20247053 | 化学药品 | 胶囊剂 | 3/21/2024 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20234079 | 化学药品 | 胶囊剂 | 8/29/2023 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20243597 | 化学药品 | 胶囊剂 | 4/24/2024 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20223151 | 化学药品 | 胶囊剂 | 3/22/2022 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20213938 | 化学药品 | 胶囊剂 | 12/14/2021 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20223042 | 化学药品 | 胶囊剂 | 1/30/2022 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20213267 | 化学药品 | 胶囊剂 | 4/13/2021 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20223152 | 化学药品 | 胶囊剂 | 3/22/2022 | |
| Memantine Hydrochloride Sustained-release Capsules | 国药准字H20223150 | 化学药品 | 胶囊剂 | 3/22/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MEMANTINE SANDOZ TABLET 10MG | N/A | N/A | N/A | 9/8/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MEMANTINE-LAPL memantine hydrochloride 5mg film-coated tablet blister pack | 168412 | Medicine | A | 11/17/2011 | |
| MEMANTINE-LAPL memantine hydrochloride 20mg film-coated tablet blister pack | 168415 | Medicine | A | 11/17/2011 | |
| MEMANTINE GENERICHEALTH memantine hydrochloride 15mg film-coated tablet blister pack | 168426 | Medicine | A | 11/17/2011 | |
| Memantine Hydrochloride 20 mg bulk | 280145 | Medicine | A | 9/9/2016 | |
| APO-MEMANTINE memantine hydrochloride 20mg film-coated tablet blister pack | 207782 | Medicine | A | 4/24/2014 | |
| MEMANTINE RANBAXY memantine hydrochloride 10 mg tablet blister pack | 201740 | Medicine | A | 11/28/2013 | |
| MEMANXA memantine hydrochloride 10 mg tablet blister pack | 152754 | Medicine | A | 11/17/2009 | |
| MEMANXA memantine hydrochloride 10 mg tablet bottle | 152753 | Medicine | A | 11/17/2009 | |
| MEMANTINE-LAPL memantine hydrochloride 15mg film-coated tablet blister pack | 168414 | Medicine | A | 11/17/2011 | |
| APO-MEMANTINE memantine hydrochloride 10mg tablet blister pack | 159582 | Medicine | A | 1/29/2010 |
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