Data updated: May 26, 2026
NAMENDA (memantine hydrochloride)
CNS
Approved 2003-10-16
2
Indications
--
Phase 3 Trials
22
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2003-10-16
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
NAMENDA Approval History
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 2003 to 2018
May 2016 SUPPL
Mfg · Manufacturing (CMC)
Mar 2016 SUPPL
Mfg · Manufacturing (CMC)
Apr 2015 SUPPL
Mfg
Jul 2014 SUPPL
Mfg
Nov 2013 SUPPL
Mfg
Mar 2013 SUPPL
Mfg
What NAMENDA Treats
2 FDA approvalsOriginally approved for its first indication in 2003 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04804644 | NRG-CC009 NCI-2020-11651, NRG-CC009 | Ph 3 | recruiting | Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability |
| NCT03553875 | 2018P001082 | Ph 3 | terminated | Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions |
| NCT04939597 | ACCL2031 NCI-2020-07502, ACCL2031 | Ph 3 | active not recruiting | A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor |
| NCT07164794 | 2025ZDSYLL297-P01 | Ph 2 | not yet recruiting | Memantine Hydrochloride in Prostate Cancer Patients |
| NCT06789757 (HCC) | INOVA-2023-74 | Ph 2 | recruiting | The Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma (HCC) |
| NCT06007846 | U23-01-4957 | Ph 2, Ph 3 | recruiting | A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer |
| NCT01430351 | 2011-0374 NCI-2011-03038, 2011-0374 | Ph 1 | terminated | Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy |
| NCT06337994 | AUH-Neurol-TBI_2024 | Ph 3 | completed | Memantine Hydrochloride for Treatment of Cognitive Dysfunction Due to Traumatic Brain Injury |
| NCT01535040 results posted | IRB00020412 U10CA081851, REBACCCWFU 99311 | Ph 2 | completed | Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking |
| NCT04417543 | Memantine in epilepsy | Ph 1 | completed | Effect of Memantine on Cognitive Impairment in Patients With Epilepsy |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
NAMENDA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.