memantine
Trade name: namenda
Approved
Oct 16, 2003
NAMENDA (marketed under the brands Namenda among others) is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Persistent activation of central nervous system N-methyl-D-aspartate (NMDA) receptors by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer’s disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity uncompetitive (open-channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels. There is no evidence that memantine prevents or slows neurodegeneration in patients with Alzheimer’s disease. Memantine showed low to negligible affinity for GABA, benzodiazepine, dopamine, adrenergic, histamine and glycine receptors and for voltage-dependent Ca2+, Na+ or K+ channels. Memantine also showed antagonistic effects at the 5HT3 receptor with a potency similar to that for the NMDA receptor and blocked nicotinic acetylcholine receptors with one-sixth to one-tenth the potency. In vitro studies have shown that memantine does not affect the reversible inhibition of acetylcholinesterase by donepezil, galantamine, or tacrine. — NCATS
Clinical trial activity
229 trials · 212 clinical orgs · 50 marketing orgs
Earliest trial started Dec 1, 1996 (NCT00000867)
Timeline
1990s
2000s
- Oct 16, 2003
Forest Laboratories — Earliest FDA Approval
- Oct 16, 2003
Allergan — NDA Secondary Org
- Oct 16, 2003
AbbVie — NDA Secondary Org
- Oct 16, 2003
Forest Laboratories — NDA Organization
- Apr 18, 2005
GlaxoSmithKline — NDA Secondary Org
2010s
- Apr 14, 2010
Dr. Reddy's Laboratories — Marketing Organization
- May 5, 2010
Sun Pharmaceuticals — Marketing Organization
- Oct 25, 2011
Teva — Marketing Organization
- Mar 12, 2012
Orbion Pharms — Marketing Organization
- Mar 12, 2012
Orchid Pharma — Marketing Organization
- Jan 30, 2015
Mylan — Marketing Organization
- Apr 10, 2015
Amneal Pharmaceuticals — Marketing Organization
- Apr 10, 2015
Lupin — Marketing Organization
- Jul 31, 2015
Upsher-Smith Laboratories — Marketing Organization
- Sep 4, 2015
Wockhardt — Marketing Organization
- Sep 4, 2015
Celltrion — Marketing Organization
- Oct 13, 2015
Alembic — Marketing Organization
- Oct 13, 2015
Aurobindo Pharma — Marketing Organization
- Oct 13, 2015
Jubilant Innovation Ltd. — Marketing Organization
- Oct 13, 2015
Lannett Company, Inc. — Marketing Organization
- Oct 13, 2015
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Oct 13, 2015
Torrent Pharmaceuticals Limited — Marketing Organization
- Oct 13, 2015
Unichem — Marketing Organization
- Oct 13, 2015
Neogen — Marketing Organization
- Nov 17, 2015
Puracap Pharmaceutical — Marketing Organization
- Nov 30, 2015
Ajanta Pharma Ltd — Marketing Organization
- Dec 7, 2015
Sciegen Pharmaceticals — Marketing Organization
- Sep 28, 2016
Rising Pharmaceuticals — Marketing Organization
- Nov 22, 2016
Apotex — Marketing Organization
- May 23, 2017
Strides Pharma Science — Marketing Organization
- Jun 9, 2017
Anchen Pharmaceuticals, Inc — Marketing Organization
- Jun 9, 2017
Endo Pharmaceuticals — Marketing Organization
- Jun 9, 2017
Bristol-Myers Squibb — Marketing Organization
- Jul 10, 2017
Cadila Healthcare — Marketing Organization
- Aug 3, 2017
Zydus Discovery DMCC — Marketing Organization
- May 7, 2018
Allied Pharmaceutical Services — Marketing Organization
- May 7, 2018
Shijiazhuang Pharma Group (CSPC) — Marketing Organization
- May 7, 2018
Renata — Marketing Organization
- May 7, 2018
ACME Laboratories — Marketing Organization
- Jul 11, 2018
Chartwell Pharmaceuticals — Marketing Organization
2020s
- Feb 28, 2020
Ani Pharmaceuticals — Marketing Organization
- Feb 28, 2020
Hikma — Marketing Organization
- Apr 3, 2020
Yiling Pharmaceutical Inc. — Marketing Organization
- Apr 3, 2020
Menovo — Marketing Organization
- Aug 31, 2020
Seton Pharm — Marketing Organization
- Aug 31, 2020
Saptalis Pharmaceuticals — Marketing Organization
- Dec 11, 2020
Polygen Pharmaceuticals — Marketing Organization
- Apr 2, 2021
Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization
- Aug 11, 2022
Novast Labs — Marketing Organization
- Sep 26, 2022
Hetero Labs Ltd — Marketing Organization
- Oct 11, 2022
LP Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Acute Febrile Encephalopathy · Phase 4
- Affect · Phase 4
- AIDS Dementia Complex · Phase 2
- Alcohol Drinking · Phase 3
- Alcohol-Induced Disorders · Phase 2
- Alcoholism · Phase 4
- Alzheimer Disease · Phase 4
- Amphetamine-Related Disorders · Phase 2/Phase 3
- Amyotrophic Lateral Sclerosis · Phase 2/Phase 3
- Anemia, Sickle Cell · Phase 2
- Anxiety Disorders · Phase 3
- Aphasia · Phase 4
- Asperger Syndrome · Phase 2
- Attention Deficit Disorder with Hyperactivity · Phase 4
- Autism Spectrum Disorder · Phase 4
- Autistic Disorder · Phase 3
- Binge-Eating Disorder · Phase 4
- Bipolar Disorder · Phase 4
- Brain Concussion · Phase 2/Phase 3
- Brain Diseases · Phase 2
- Brain Injuries, Traumatic · Phase 4
- Brain Neoplasms · Phase 3
- Breast Neoplasms · Phase 3
- Cancer Pain · Phase 2/Phase 3
- Carcinoma, Hepatocellular · Phase 2/Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Renal Cell · Phase 3
- Central Nervous System Diseases · Phase 1
- Central Nervous System Neoplasms · Early Phase 1
- Central Nervous System Stimulants · Phase 1/Phase 2
- Cocaine-Related Disorders · Phase 2
- Cognition Disorders · Phase 3
- Cognitive Dysfunction · Phase 3
- Colorectal Neoplasms · Phase 2
- Complex Regional Pain Syndromes · Phase 4
- Compulsive Behavior · Phase 2
- Craniopharyngioma · Phase 2
- Delirium · Phase 4
- Dementia · Phase 4
- Dementia, Vascular · Phase 3
- Depression · Phase 4
- Depressive Disorder · Phase 4
- Dermatology · Phase 2/Phase 3
- Disability Evaluation · Phase 3
- Disruptive, Impulse Control, and Conduct Disorders · Phase 2
- Down Syndrome · Phase 4
- Drug Evaluation · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Drug Therapy · Phase 2/Phase 3
- Ependymoma · Phase 2
- Epilepsy · Phase 1
- Essential Tremor · Phase 4
- Fibromyalgia · Phase 3
- Fibrosis · Phase 2/Phase 3
- Fragile X Syndrome · Early Phase 1
- Frontotemporal Dementia · Phase 4
- Frontotemporal Lobar Degeneration · Phase 4
- Gait Disorders, Neurologic · Phase 4
- Gambling · Phase 2
- General Surgery · Phase 4
- Glaucoma, Open-Angle · Phase 3
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Gliosarcoma · Phase 1
- Growth and Development · Phase 2
- Healthy Volunteers · Phase 4
- Hematoma, Subdural, Chronic · Early Phase 1
- Heroin Dependence · Phase 2/Phase 3
- HIV Infections · Phase 2
- Huntington Disease · Phase 4
- Intellectual Disability · Phase 2
- Ischemic Stroke · Phase 3
- Lewy Body Disease · Phase 4
- Lung Neoplasms · Phase 3
- Lupus Erythematosus, Systemic · Phase 2
- Major Depressive Disorder · Phase 2/Phase 3
- Melanoma · Phase 3
- Memantine · Phase 3
- Memory Disorders · Phase 4
- Migraine Disorders · Phase 3
- Multiple Sclerosis · Phase 4
- Muscle Weakness · Early Phase 1
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 3
- Neoplasms, Germ Cell and Embryonal · Phase 2
- Nervous System Neoplasms · Phase 3
- Neuralgia · Phase 3
- Nystagmus, Pathologic · Phase 4
- Obesity · Phase 1
- Obsessive-Compulsive Disorder · Phase 3
- Opioid-Related Disorders · Phase 2/Phase 3
- Orthostatic Intolerance · Phase 1/Phase 2
- Pain · Phase 4
- Parkinson Disease · Phase 4
- Pharmacokinetics · Phase 2
- Physiological Effects of Drugs · Phase 4
- Postoperative Pain · Phase 4
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Psychophysiologic Disorders · Phase 3
- Psychotic Disorders · Phase 4
- Pulmonary Arterial Hypertension · Phase 1
- Radiation · Phase 2
- Safety · Phase 4
- Schizophrenia · Phase 4
- Signs and Symptoms · Phase 1
- Small Cell Lung Carcinoma · Phase 3
- Stomach Diseases · Early Phase 1
- Stress Disorders, Post-Traumatic · Phase 4
- Stroke · Phase 4
- Substance-Related Disorders · Phase 3
- Tachycardia · Phase 1/Phase 2
- Tension-Type Headache · Phase 3
- Therapeutics · Phase 4
- Tobacco Use Disorder · Phase 2
- Trichotillomania · Phase 2/Phase 3
Mechanism of action
- Glutamate [NMDA] receptorNEGATIVE ALLOSTERIC MODULATOR
Glutamate [NMDA] receptor negative allosteric modulator
- Glutamate receptor ionotropic, NMDA 1 (GRIN1) ↗
- Glutamate receptor ionotropic, NMDA 2A (GRIN2A) ↗
- Glutamate receptor ionotropic, NMDA 2B (GRIN2B) ↗
- Glutamate receptor ionotropic, NMDA 2D (GRIN2D) ↗
- Glutamate receptor ionotropic, NMDA 3B (GRIN3B) ↗
- Glutamate receptor ionotropic, NMDA 2C (GRIN2C) ↗
- Glutamate receptor ionotropic, NMDA 3A (GRIN3A) ↗
- Glutamate (NMDA) receptor subunit zeta 1
- Glutamate [NMDA] receptor subunit epsilon 1
- Glutamate [NMDA] receptor subunit epsilon 2
- Glutamate [NMDA] receptor subunit 3A
- Glutamate [NMDA] receptor subunit epsilon 4
- Glutamate [NMDA] receptor subunit epsilon 3
- Glutamate NMDA receptor; GRIN1/GRIN2B
- Glutamate NMDA receptor; GRIN1/GRIN2A
- Ionotropic glutamate receptor NMDA 1/2C
- Ionotropic glutamate receptor NMDA 1/2D
- Glutamate NMDA receptor; GRIN1/GRIN2A/GRIN2B
- Glutamate receptor ionotropic, NMDA 1/2C/3B
Combination products
namzaric
with donepezil
Approval history
- approvedOct 16, 2003
Chemistry & pharmacology
SMILES
CC12CC3CC(C)(C1)CC(N)(C3)C2- Mol. weight
- 179.31 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL807 ↗
- WikipediaMemantine ↗
- NCATSW8O17SJF3T ↗
- ChEMBLCHEMBL1699 ↗
Also known as
- 1,3-dimethyl-5-adamantanamine
- 1,3-dimethyl-5-adamantanamine
- 1-amino-3,5-dimethyladamantane
- 1-amino-3,5-dimethyladamantane
- 3,5-dimethyl-1-adamantanamine
- 3,5-dimethyl-1-adamantanamine
- 3,5-dimethyl-1-aminoadamantane
- 3,5-dimethyl-1-aminoadamantane
- 3,5-dimethyltricyclo(3.3.1.1(3,7))decan-1-amine
- 3,5-dimethyltricyclo(3.3.1.1(3,7))decan-1-amine
- akatinol
- akatinol
- alzantin
- ebixa
- ebixa
- ebixa
- marixino
- maruxa
- memantina
- memantina
- memantina
- memantine
- memantine
- memantine
- memantine
- memantine
- memantine
- memantine
- memantine
- memantine
- memantine
- memantine
- memantine hcl
- memantine hcl
- memantine hcl
- memantine hydrochloride
- memantine hydrochloride
- memantine hydrochloride
- memantine hydrochloride
- memantine hydrochloride
- memantine hydrochloride
- memantine hydrochloride / donepezil hydrochloride
- memantinol
- memantinum
- memantinum
- memnatine
- namenda
- namenda
- namenda
- namenda
- namenda xr
- namenda xr
- nemdatine
- nemdatine
- nemdatine
- valios
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07139834 | Phase 1 | Jan 31, 2026 | Columbia University |
| NCT07248228 | Phase 2 | Dec 31, 2025 | Case Western Reserve University |
| NCT07164794 | Phase 2 | Nov 30, 2025 | Southeast University, The First People's Hospital of Lianyungang |
| NCT06914310 | Phase 2/Phase 3 (Phase 3) | Mar 25, 2025 | Mansoura University |
| NCT06789757 | Phase 2 | Feb 25, 2025 | Inova Health System |
| NCT06727773 | Phase 2 | Dec 31, 2024 | National Institute on Aging (NIA), University of North Carolina at Chapel Hill |
| NCT06679387 | Phase 2 | Oct 30, 2024 | Ain Shams University |
| NCT06594172 | Phase 2 | Sep 10, 2024 | Fujian Medical University, Guangzhou Medical University, Shantou University, Southern Medical University |
| NCT06501638 | N/A | Jul 7, 2024 | Huazhong University of Science and Technology |
| NCT06153238 | Phase 1 | Feb 28, 2024 | Sandoz |
| NCT06159790 | Phase 3 | Feb 28, 2024 | Sandoz |
| NCT06275035 | Phase 3 | Feb 22, 2024 | Tata Memorial Hospital |
| NCT06337994 | Phase 3 | Jan 1, 2024 | Assiut University |
| NCT05834231 | Phase 1/Phase 2 (Phase 2) | Aug 31, 2023 | Mansoura University |
| NCT06007846 | Phase 2/Phase 3 (Phase 3) | Jul 31, 2023 | Inova Health System |
| NCT05796752 | Phase 2/Phase 3 (Phase 3) | Jun 1, 2023 | University of Chicago |
| NCT05660863 | Phase 1 | Jun 1, 2023 | Guangzhou Magpie Pharmaceuticals Co., Ltd. |
| NCT05664464 | Phase 1/Phase 2 (Phase 2) | Jan 31, 2023 | Swiss National Science Foundation, University of Zurich |
| NCT05418049 | Early Phase 1 (Phase 1) | Sep 1, 2022 | National Institutes of Health (NIH), University of Cincinnati |
| NCT05430867 | Phase 4 | Jul 1, 2022 | Jiao Tong University |
Organizations
Research & Development (212)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Forest Laboratories | For profit | 43 | 11 | 4 | 2004 |
| Lundbeck | For profit | 18 | 7 | 5 | 2003 |
| Harvard University | Academic/Hospital | 11 | 8 | 4 | 2005 |
| Columbia University | Academic/Hospital | 9 | 8 | 3 | 2002 |
| National Cancer Institute (NCI) | Government | 8 | 1 | 3 | 2008 |
| Merz | For profit | 7 | 5 | 3 | 2007 |
| National Cheng Kung University | Academic/Hospital | 7 | 7 | 2 | 2009 |
| National Institute on Drug Abuse (NIDA) | Government | 7 | 0 | 4 | 2003 |
| Stanford University | Academic/Hospital | 5 | 4 | 3 | 2004 |
| University of California, San Diego | Academic/Hospital | 5 | 5 | 3 | 2008 |
| University of London | Academic/Hospital | 5 | 2 | 4 | 2005 |
| Allergan | For profit | 4 | 3 | 2 | 1999 |
| Government of Taiwan | Government | 4 | 0 | 2 | 2009 |
| Mclean Hospital | Academic/Hospital | 4 | 3 | 4 | 2006 |
| National Institutes of Health (NIH) | Government | 4 | 0 | 3 | 1997 |
| NRG Oncology | Academic/Hospital | 4 | 3 | 1 | 2008 |
| The University of Texas, Dallas | Academic/Hospital | 4 | 3 | 2 | 2004 |
| Yale University | Academic/Hospital | 4 | 4 | 2 | 2006 |
| Case Western Reserve University | Academic/Hospital | 3 | 3 | 2 | 2005 |
| Department of Veteran Affairs | Government | 3 | 3 | 2 | 2005 |
Marketing (61)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACME Laboratories | For profit | MKTG | May 7, 2018 |
| AbbVie | For profit | NDA2 | Oct 16, 2003 |
| Ajanta Pharma Ltd | For profit | MKTG | Nov 30, 2015 |
| Alembic | For profit | MKTG | Oct 13, 2015 |
| Alembic | For profit | SYN | Oct 13, 2015 |
| Allergan | For profit | NDA2 | Oct 16, 2003 |
| Allergan | For profit | SYN | Oct 16, 2003 |
| Allied Pharmaceutical Services | For profit | MKTG | May 7, 2018 |
| Amneal Pharmaceuticals | For profit | MKTG | Apr 10, 2015 |
| Anchen Pharmaceuticals, Inc | For profit | MKTG | Jun 9, 2017 |
| Ani Pharmaceuticals | For profit | MKTG | Feb 28, 2020 |
| Ani Pharmaceuticals | For profit | SYN | Feb 28, 2020 |
| Apotex | For profit | MKTG | Nov 22, 2016 |
| Apotex | For profit | SYN | Nov 22, 2016 |
| Aurobindo Pharma | For profit | MKTG | Oct 13, 2015 |
| Bristol-Myers Squibb | For profit | MKTG | Jun 9, 2017 |
| Cadila Healthcare | For profit | MKTG | Jul 10, 2017 |
| Celltrion | For profit | MKTG | Sep 4, 2015 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 11, 2018 |
| Chartwell Pharmaceuticals | For profit | SYN | Oct 13, 2015 |
| Dr. Reddy's Laboratories | For profit | MKTG | Apr 14, 2010 |
| Endo Pharmaceuticals | For profit | MKTG | Jun 9, 2017 |
| Forest Laboratories | For profit | NDA | Oct 16, 2003 |
| GlaxoSmithKline | For profit | NDA2 | Apr 18, 2005 |
| Hetero Labs Ltd | For profit | MKTG | Sep 26, 2022 |
| Hikma | For profit | MKTG | Feb 28, 2020 |
| Hikma | For profit | SYN | Feb 28, 2020 |
| Jubilant Innovation Ltd. | For profit | MKTG | Oct 13, 2015 |
| LP Pharmaceuticals | For profit | MKTG | Oct 11, 2022 |
| Lannett Company, Inc. | For profit | MKTG | Oct 13, 2015 |
| Lupin | For profit | MKTG | Apr 10, 2015 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Oct 13, 2015 |
| Menovo | For profit | MKTG | Apr 3, 2020 |
| Mylan | For profit | MKTG | Jan 30, 2015 |
| Mylan | For profit | SYN | Jan 30, 2015 |
| Neogen | For profit | MKTG | Oct 13, 2015 |
| Novast Labs | For profit | MKTG | Aug 11, 2022 |
| Orbion Pharms | For profit | MKTG | Mar 12, 2012 |
| Orchid Pharma | For profit | MKTG | Mar 12, 2012 |
| Polygen Pharmaceuticals | For profit | MKTG | Dec 11, 2020 |
| Puracap Pharmaceutical | For profit | MKTG | Nov 17, 2015 |
| Renata | For profit | MKTG | May 7, 2018 |
| Rising Pharmaceuticals | For profit | SYN | Jan 30, 2015 |
| Rising Pharmaceuticals | For profit | MKTG | Sep 28, 2016 |
| Saptalis Pharmaceuticals | For profit | MKTG | Aug 31, 2020 |
| Sciegen Pharmaceticals | For profit | MKTG | Dec 7, 2015 |
| Seton Pharm | For profit | MKTG | Aug 31, 2020 |
| Shijiazhuang Pharma Group (CSPC) | For profit | MKTG | May 7, 2018 |
| Strides Pharma Science | For profit | MKTG | May 23, 2017 |
| Sun Pharmaceuticals | For profit | MKTG | May 5, 2010 |
| Sun Pharmaceuticals | For profit | SYN | May 5, 2010 |
| Teva | For profit | MKTG | Oct 25, 2011 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Oct 13, 2015 |
| Unichem | For profit | MKTG | Oct 13, 2015 |
| Unichem | For profit | SYN | Oct 13, 2015 |
| Upsher-Smith Laboratories | For profit | MKTG | Jul 31, 2015 |
| Wockhardt | For profit | MKTG | Sep 4, 2015 |
| Yichang Humanwell Pharmaceutical Co.,Ltd | For profit | MKTG | Apr 2, 2021 |
| Yiling Pharmaceutical Inc. | For profit | MKTG | Apr 3, 2020 |
| Zydus Discovery DMCC | For profit | MKTG | Aug 3, 2017 |
| Zydus Discovery DMCC | For profit | SYN | Jul 10, 2017 |