Namenda

(Memantine Hydrochloride)

ApprovedSmall molecule

Memantine is used to treat moderate to severe Alzheimer's disease by helping to slow down the decline in memory, thinking, and daily functioning. It works by protecting nerve cells in the brain from damage caused by excess glutamate, a chemical involved in learning and memory.[2] Namenda is currently approved and in use across 10 indications[4].[1]

Namenda is one of 214 small molecule programs targeting Metastatic Lung Small Cell Carcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

213

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Metastatic Lung Small Cell CarcinomaActive, not recruiting

Alzheimer DiseaseUnknown

DementiaUnknown

Central Nervous System CancerActive, not recruiting

Stellate Ganglion BlockCompleted

Brain InjuryActive, not recruiting

Epileptic EncephalopathyActive, not recruiting

Prostate CancerNot yet recruiting

Hepatocellular CarcinomaRecruiting

Alzheimer's DiseaseActive, not recruiting

Metastatic Lung Small Cell CarcinomaPhase 3

Active, not recruiting

Alzheimer DiseasePreclinical

Unknown

DementiaPreclinical

Unknown

Central Nervous System CancerPhase 3

Active, not recruiting

Stellate Ganglion BlockPreclinical

Completed

Brain InjuryPreclinical

Active, not recruiting

Epileptic EncephalopathyApproved

Active, not recruiting

Prostate CancerPhase 2

Not yet recruiting

Hepatocellular CarcinomaPhase 2

Recruiting

Alzheimer's DiseasePhase 2

Active, not recruiting

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Yervoy

Bristol-Myers Squibb

Phase 3

20 2

Zoladex

TTerSera Therapeutics LLC

Phase 3

35 3

Namenda

AbbVie

Approved

1 4

Glucophage

EMD Serono

Phase 3

14 5

Antibiotic

Pfizer

Phase 3

1 6

Xaluritamig

Amgen

Phase 3

4 7

Radium-223

Bayer

Phase 3

6 8

Triptorelin Embonate

Ipsen

Phase 3

3 9

PSMA-1007

AABX advanced biochemical compounds GmbH

Phase 3

3 10

Trexall

Jazz Pharmaceuticals

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Alzheimer's Disease

NCT05063851

Q2 2027

Phase 3Recruiting

Dementia

NCT07251023

Q3 2027

Phase 3Active, not recruiting

Central Nervous System Cancer

NCT04939597

Q1 2028

Phase 2Recruiting

Hepatocellular Carcinoma

NCT06789757

Clinical

Trials by Indication[1]

Pervasive Developmental Disorder3 trials

An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Completed·FForest Laboratories·Phase 2·NCT01592786·906 enrolled

Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine

Completed·FForest Laboratories·Phase 2·NCT01592747·479 enrolled

Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Terminated·FForest Laboratories·Phase 2·NCT01592773·747 enrolled

Hepatocellular Carcinoma2 trials

The Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma (HCC)

Recruiting·IInova Health Care Services·Phase 2·NCT06789757·19 enrolled

A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma

Recruiting·IInova Health Care Services·Preclinical·NCT06007846·12 enrolled

Brain Injury2 trials

Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury

Unknown status·MMinia University·N/A·NCT05531383·70 enrolled

Memantine Hydrochloride for Treatment of Cognitive Dysfunction Due to Traumatic Brain Injury

Completed·—·Phase 3·NCT06337994·60 enrolled

Alzheimer's Disease2 trials

Memantine Treatment in Alzheimer's Disease Patients

Unknown status·WWei Cuibai·Phase 4·NCT03168997·222 enrolled

The Use of Memantine for Prevention of Alzheimer's Disease

Active, not recruiting·UUniversity of Virginia·Phase 2·NCT05063851·32 enrolled

Cognitive impairment2 trials

Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors

Completed·MMayo Clinic·Phase 1·NCT04217694·18 enrolled

Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Completed·—·Phase 1·NCT04417543·100 enrolled

19 more indications

Executive Dysfunction1 trial

Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study

Completed·MMassachusetts General Hospital·N/A·NCT01533493·33 enrolled

Smoking1 trial

Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Completed·WWake Forest University Health Sciences·Phase 2·NCT01535040·130 enrolled

Adult Subject1 trial

Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS

Completed·MMassachusetts General Hospital·Phase 4·NCT00586573·34 enrolled

Hematoma1 trial

Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD)

Withdrawn·UUniversity of New Mexico·Phase 1·NCT04966546

Pathological Gambling1 trial

Memantine Treatment Study of Pathological Gambling

Completed·YYale University·Phase 2·NCT00585169·29 enrolled

Brain Metastases1 trial

Neurocognitive Outcome of Bilateral or Unilateral Hippocampal Avoidance WBRT With Memantine for Brain Metastases

Unknown status·NNational Taiwan University Hospital·Phase 2·NCT04801342·72 enrolled

Stellate Ganglion Block1 trial

Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease

Completed·—·N/A·NCT07351773·40 enrolled

Frontotemporal Dementia1 trial

Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia

Completed·—·Phase 3·NCT00594737·17 enrolled

Glioblastoma Multiforme1 trial

Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01430351·144 enrolled

Interaction1 trial

Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions

Terminated·MMassachusetts General Hospital·Phase 3·NCT03553875·25 enrolled

Dementia1 trial

Efficacy and Safety of DMB-I (INN: Latrepirdine) in Patients With Alzheimer Type Dementia

Recruiting·BBigespas LTD·Phase 3·NCT07251023·450 enrolled

Trial1 trial

Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial

Recruiting·UUniversity of Edinburgh·Phase 2/3·NCT04302870·1,150 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats

Completed·SShanghai East Hospital·Phase 2·NCT06501638·256 enrolled

Epileptic encephalopathy1 trial

Memantine for Epileptic Encephalopathy

Completed·—·Phase 4·NCT03779672·30 enrolled

Treatment1 trial

A Phase - IIa - IIb, Trial to Study the Safety, Tolerability and Efficacy of Memantine as a Long-term Treatment of SCD

Unknown status·HHaEmek Medical Center, Israel·Phase 2·NCT03247218·40 enrolled

Prostate Cancer1 trial

Memantine Hydrochloride in Prostate Cancer Patients

Not yet recruiting·BBin Xu·Phase 2·NCT07164794·15 enrolled

Metastatic Lung Small Cell Carcinoma1 trial

Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Brain Metastases From Small Cell Lung Cancer

Active, not recruiting·NNRG Oncology·Phase 3·NCT04804644·152 enrolled

Central Nervous System Cancer1 trial

A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT04939597·162 enrolled

Unspecified1 trial

Memantine and Down's Syndrome

Unknown status·KKing's College London·N/A·NCT00240760·180 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 16, 2003

NAMENDA

NDA NDA021487

Apr 18, 2005

NAMENDA

NDA NDA021627

Jun 21, 2010

NAMENDA XR

NDA NDA022525

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Memantine Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Namenda drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Memantine Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Memantine Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022525). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glutamate [NMDA] Receptor Negative Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Namenda

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q1 2028

Trials by Indication[1]

Pervasive Developmental Disorder3 trials

Hepatocellular Carcinoma2 trials

Brain Injury2 trials

Alzheimer's Disease2 trials

Cognitive impairment2 trials

Executive Dysfunction1 trial

Smoking1 trial

Adult Subject1 trial

Hematoma1 trial

Pathological Gambling1 trial

Brain Metastases1 trial

Stellate Ganglion Block1 trial

Frontotemporal Dementia1 trial

Glioblastoma Multiforme1 trial

Interaction1 trial

Dementia1 trial

Trial1 trial

Efficacy and Safety1 trial

Epileptic encephalopathy1 trial

Treatment1 trial

Prostate Cancer1 trial

Metastatic Lung Small Cell Carcinoma1 trial

Central Nervous System Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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