How many clinical trials are studying Memantine?

5 recruiting trials in our tracked data involve Memantine.

What conditions is Memantine being studied for?

In our tracked recruiting trials, Memantine is being studied in trials for Alzheimer's disease, Breast Cancer, Breast Cancer Stage I.

Memantine: clinical trials recruiting now

Q: Is Memantine FDA-approved?

Yes. According to the FDA drug label available through openFDA, Memantine is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Memantine appears in the FDA drug-label database. Marketed as Memantine hydrochloride.

FDA-approved use

Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablets are an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. (1)

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study. — Lupin Pharmaceuticals Inc.	Class II (FDA: may cause temporary or reversible harm)	Terminated	2020-02-12
Failed Dissolution Specifications — The Harvard Drug Group LLC	Class II (FDA: may cause temporary or reversible harm)	Ongoing	2026-03-24
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing. — The Harvard Drug Group	Class III (FDA: unlikely to cause harm)	Terminated	2020-04-24
Failed Dissolution Specifications: High out of specification result observed at stability studies. — The Harvard Drug Group	Class III (FDA: unlikely to cause harm)	Terminated	2019-12-13
Failed Dissolution Specifications: High out of specification result observed at stability studies. — Lupin Pharmaceuticals Inc.	Class III (FDA: unlikely to cause harm)	Terminated	2019-12-10

FDA label via openFDA

Phase breakdown

Early Phase 1 1 Phase 1 2 Phase 2 3

Conditions being studied

Condition	Trials
Alzheimer's disease	1
Breast Cancer	1
Breast Cancer Stage I	1
Breast Cancer Stage II	1
Breast Cancer Stage III	1
Cognitive Change	1
Cognitive Decline	1
Cognitive Impairment	1
Depression	1
Epilepsy	1
Glioblastoma	1
Locally Advanced Breast Cancer	1
Major Depression	1
Negative Symptoms With Primary Psychotic Disorder	1
Osteoporosis	1

Recruiting trials involving Memantine

Add-on MEmaNtine to Dopamine Modulation to Improve Negative Symptoms at First Psychosis
NCT04789915 · Phase: Phase 1 · Ages: 18 Years to 45 Years · Sex: All (male and female) · 1 location
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
NCT06041789 · Phase: Phase 2 · Ages: 50 Years and older · Sex: All (male and female) · 2 locations
Glutamate Inhibitors in Glioblastoma
NCT05664464 · Phase: Phase 1, Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
NCT06727773 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Female · 1 location
Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression
NCT07560878 · Phase: Early Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Memantine FDA-approved?

Yes, marketed as Memantine hydrochloride.

How many recruiting trials involve Memantine?

5 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.