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memantine

Phase 4FDA approved

Open-Angle Glaucoma | Small molecule | Ophthalmology |AbbVie Inc.|Trials Updated: Nov 4, 2010

memantine development status

FDA approval on record Oct 16, 2003
Approval holderAbbvie
ApplicationNDA021487
Highest phase Phase 4 run by Florida Atlantic University (NCT00476008)
Phase scored for ABBVPhase 3
Registered trials 10 across 6 sponsors since Aug 2001

Label indication 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 label

memantine target and mechanism

Molecular targetGRIN1, GRIN2A, GRIN2B, GRIN2D, GRIN3B, GRIN2C
Target classNegative Allosteric Modulator
ModalitySmall molecule
ChEMBLCHEMBL807

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment2,298

FDA Designations

No designations recorded

memantine clinical trials

memantine · 2 trials · 1 indication

Phase 3 2
NCT00168350Memantine in Patients With Chronic GlaucomaOpen-Angle Glaucoma
COMPLETED1,179 Analytics
NCT00141882Memantine in Patients With Chronic GlaucomaOpen-Angle Glaucoma
COMPLETED1,119 Analytics
PHASE3COMPLETED
Memantine in Patients With Chronic Glaucoma
Open-Angle GlaucomaUnlock trial analytics
PHASE3COMPLETED
Memantine in Patients With Chronic Glaucoma
Open-Angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression of glaucoma
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
memantineDRUG -
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Eligibility Criteria

Age Range18 Years to 82 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * glaucoma damage on examination of visual field and optic disc * good visual acuity (with glasses if needed)

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Competitive Landscape -Open-Angle Glaucoma 9 trials

Frequently asked questions about memantine

What is memantine used for in open-angle glaucoma?

Memantine is being studied as a treatment for open-angle glaucoma, a chronic eye condition. It is an investigational small molecule in Phase 3 development for this indication. Both completed Phase 3 trials enrolled adults with chronic glaucoma, and the program has not been approved for this use.

What does memantine target?

Memantine targets NMDA receptor subunits, specifically GRIN1, GRIN2A, GRIN2B, GRIN2C, GRIN2D, GRIN3B, and GRIN2D. It acts as a negative allosteric modulator of these receptors. This target class distinguishes its proposed mechanism in glaucoma from its other clinical uses.

Who is developing memantine for open-angle glaucoma?

AbbVie Inc. (ticker ABBV) is the developer associated with memantine in this open-angle glaucoma program. The company is listed as the sponsor of the Phase 3 clinical development effort for this indication.

What phase is memantine in for open-angle glaucoma?

Memantine is in Phase 3 development for open-angle glaucoma. Two Phase 3 trials have been completed, and no active trials are currently listed. It remains an investigational therapy for this indication and is not approved for open-angle glaucoma.

What clinical trials is memantine in for glaucoma?

Two completed Phase 3 trials studied memantine in chronic glaucoma: NCT00168350, which enrolled 1,179 participants, and NCT00141882, which enrolled 1,119 participants. Both were randomized, double-blind studies in adults aged 18 years and older with open-angle glaucoma, totaling 2,298 participants.