Alzheimer's drugs · FDA record

FDA regulatory record

Alzheimer's drugs at the FDA

Every Alzheimer's drug the FDA has approved, what its label says it is for, and where it stands. Then the anti-amyloid antibodies in depth: what each decision rested on, what the label requires and what FDA asked for next, in the agency's own words.

FDA-approved Alzheimer's drugs
17
Anti-amyloid antibodies
3
Anti-amyloid decisions traced
7
Applications pending
Not publishedby FDA · see below

The record is FDA documents only. This page does not assess whether any drug works. All 7 decisions have a complete record loaded.

Approval timeline

  • FDA application approved
  • Since discontinued
  • Anti-amyloid approval
  • Refused (complete response)
  • On the market
Range
1995200020052010201520202025Checked Sep 24, 2026Treatment of dementia of the Alzheimer’s type Aricept Exelon Razadyne Namenda Namzaric Adlarity Zunveyl Treatment of Alzheimer’s disease Leqembi Kisunla Leqembi Iqlik Brain imaging (PET): amyloid and tau Amyvid Vizamyl Neuraceq Tauvid Agitation associated with dementia due to Alzheimer’s disease Rexulti No current FDA label Cognex Aduhelm

Hover a mark for its application or decision; select a row for the drug's full record.

Anti-amyloid decisions: did the agency hold its position?

All positions →
AduhelmJun 7, 2021LeqembiJan 6, 2023donanemabJan 18, 2023LeqembiJul 6, 2023KisunlaJul 2, 2024Leqembi IqlikAug 29, 2025Leqembi IqlikJul 13, 2026
SurrogateOriginConsistent—Consistent———
Effect sizeOriginConditional—ConsistentConsistent——
ARIAOriginDepartsConsistent—DepartsConsistentConsistentConsistentConsistent
DataOriginConditionalConsistentConsistentConsistentConsistent——
ConfirmatoryOriginConsistent—Consistent———

Pending applications

Not published by FDA. FDA does not disclose applications under review; one appears here once FDA makes it public.

Latest committee meeting notice: , Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establi…

Last checked .

Advisory committee votes

yes no uncertain or abstain

Decided without a committee vote

Every FDA-approved Alzheimer's drug

DrugWhat the label says it is forFirst approvedStatusFDA applicationsGeneric applications
Treatment of dementia of the Alzheimer’s type 7
Ariceptdonepezil hydrochlorideEisai Inc ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type.FDA label, effective  ↗ Marketed
  • NDA 20690 tablet · · Prescription
  • NDA 21719 solution · · Discontinued
  • NDA 21720 tablet, orally disintegrating · · Discontinued
  • NDA 22568 tablet · · Prescription
 48
Exelonrivastigmine tartrate + rivastigmineNovartis, Sandoz EXELON PATCH is an acetylcholinesterase inhibitor indicated for treatment of: • Mild, moderate, and severe dementia of the Alzheimer’s type (AD).FDA label, effective  ↗FDA class: Cholinesterase Inhibitor Marketed
  • NDA 20823 capsule · · Discontinued
  • NDA 21025 solution · · Discontinued
  • NDA 22083 film, extended release · · Prescription
 11
Razadynegalantamine hydrobromideJanssen Pharms Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.No current Razadyne label · label of a same-ingredient generic (Galantamine Hydrobromide, Bryant Ranch Prepack), effective  ↗ Discontinued
  • NDA 21169 tablet · · Discontinued
  • NDA 21224 solution · · Discontinued
  • NDA 21615 capsule, extended release · · Discontinued
 22
Namendamemantine hydrochlorideAbbvie, Allergan Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.FDA label, effective  ↗ Discontinued
  • NDA 21487 tablet · · Discontinued
  • NDA 21627 solution · · Discontinued
  • NDA 22525 capsule, extended release · · Discontinued
 44
Namzaricdonepezil hydrochloride; memantine hydrochlorideAbbvie NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.FDA label, effective  ↗ Marketed
  • NDA 206439 capsule, extended release · · Prescription
 4
Adlaritydonepezil hydrochlorideCorium Donepezil hydrochloride tablets are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type.No current Adlarity label · label of a same-ingredient generic (Donepezil Hydrochloride, Cardinal Health 107, Llc), effective  ↗ Discontinued 48
Zunveylbenzgalantamine gluconateAlpha Cognition ZUNVEYL is indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults.FDA label, effective  ↗ Marketed
  • NDA 218549 tablet, delayed release · · Prescription
 0
Treatment of Alzheimer’s disease 3
Leqembilecanemab-irmbEisai IncIn depth ↓ LEQEMBI is indicated for the treatment of Alzheimer’s disease.FDA label, effective  ↗FDA class: Amyloid Beta-directed Antibody Marketed
  • BLA 761269 injectable · · Prescription
 0
Kisunladonanemab-azbtEli Lilly CoIn depth ↓ KISUNLA TM is indicated for the treatment of Alzheimer's disease.FDA label, effective  ↗ Marketed
  • BLA 761248 injectable · · Prescription
 0
Leqembi Iqliklecanemab-irmbEisai IncIn depth ↓ LEQEMBI is indicated for the treatment of Alzheimer’s disease.FDA label, effective  ↗FDA class: Amyloid Beta-directed Antibody Marketed
  • BLA 761375 injectable · · Prescription
 0
Brain imaging (PET): amyloid and tau 4
Amyvidflorbetapir f-18Avid Radiopharms Inc AMYVID is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: … Evaluation of Alzheimer's disease (AD) and other causes of cognitive declineFDA label, effective  ↗FDA class: Radioactive Diagnostic Agent Marketed
  • NDA 202008 solution · · Discontinued, Prescription
 0
Vizamylflutemetamol f-18Ge Healthcare VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: … Evaluation of Alzheimer's disease (AD) and other causes of cognitive declineFDA label, effective  ↗FDA class: Radioactive Diagnostic Agent Marketed
  • NDA 203137 injectable · · Discontinued, Prescription
 0
Neuraceqflorbetaben f-18Lantheus NEURACEQ is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: … Evaluation of Alzheimer’s disease (AD) and other causes of cognitive declineFDA label, effective  ↗FDA class: Radioactive Diagnostic Agent Marketed
  • NDA 204677 solution · · Prescription
 0
Tauvidflortaucipir f-18Avid Radiopharms Inc TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).FDA label, effective  ↗ Marketed
  • NDA 212123 solution · · Discontinued, Prescription
 0
Agitation associated with dementia due to Alzheimer’s disease 1
RexultibrexpiprazoleOtsuka REXULTI is indicated for: … Treatment of agitation associated with dementia due to Alzheimer's diseaseFDA label, effective  ↗FDA class: Atypical Antipsychotic Marketed 16
No current FDA label 2
Cognextacrine hydrochlorideShionogi Inc [no current label on openFDA] Discontinued
  • NDA 20070 capsule · · Discontinued
 0
Aduhelmaducanumab-avwaBiogen IncIn depth ↓ [no current label on openFDA] Marketed
  • BLA 761178 injectable · · Prescription
 0

Every brand-name (NDA or BLA) drug whose current FDA label names Alzheimer's disease in its indication, plus discontinued brands of the same ingredients. Class, indication and label date come from openFDA's drug labels; applications, sponsors, approval dates, marketing status and the count of generic (ANDA) applications come from the Drugs@FDA database. “First approved” is the brand's first application, which can predate its Alzheimer's indication. “Marketed” means at least one of its products is not listed as discontinued. Fetched .

Anti-amyloid antibodies, in depth

The newest class, and the one FDA has argued over most: every decision since 2021, what it rested on, and the agency's own words on ARIA.

Aduhelm

aducanumab · Biogen Inc.

  • AduhelmBLA 761178Approved Accelerated approval, Withdrawal: not in the FDA record · checked

FDA decisions

  1. Approved Aduhelm, accelerated approvalBasis: Reduction in amyloid beta plaques

ARIA · the agency’s positions

  1. Origin Aduhelm The incidence of ARIA-E was higher in apolipoprotein E ε4 (ApoE ε4) carriers than in ApoE ε4 non-carriers (42% and 20%, respectively).Prescribing information (label), p. 5 ↗
  2. Origin Aduhelm Obtain brain MRIs prior to the 7th infusion (first dose of 10 mg/kg) and 12th infusion (sixth dose of 10 mg/kg) of ADUHELM to evaluate for the presence of asymptomatic ARIA.Prescribing information (label), p. 6 ↗
Every ARIA position, all drugs →

Leqembi · Leqembi Iqlik

lecanemab · Eisai Inc.

FDA decisions

  1. Approved Leqembi, accelerated approvalBasis: Reduction in amyloid beta plaques
  2. Approved Leqembi, traditional approvalBasis: Study 301 (CLARITY AD): CDR-SB at 18 months
  3. Approved Leqembi Iqlik, subcutaneous maintenance dosingBasis: Subcutaneous maintenance dosing after 18 months
  4. Approved Leqembi Iqlik, subcutaneous initiation dosingBasis: Subcutaneous starting dose, 500 mg weekly

ARIA · where it started or changed, and where it stands

  1. Departs Leqembi Consider testing for ApoE ε4 status to inform the risk of developing ARIA when deciding to initiate treatment with LEQEMBI.Prescribing information (label), p. 5 ↗
  2. Departs Leqembi Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.Prescribing information (label), p. 2 ↗
  3. Consistent Leqembi Iqlik Patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers.Prescribing information (label), p. 3 ↗
Every ARIA position, all drugs →

Kisunla

donanemab · Eli Lilly and Company

  • KisunlaBLA 761248Approved Traditional approval,

FDA decisions

  1. Refused donanemab, complete responseBasis: Safety database insufficient for long-term safety
  2. Approved Kisunla, traditional approvalBasis: Studies AACI and AACG (clinical efficacy)

ARIA · the agency’s positions

  1. Consistent Kisunla The incidence of ARIA in AACI was higher in ApoE ε4 homozygotes (55% on donanemab vs. 22% on placebo) than in heterozygotes (36% on donanemab vs 13% on placebo) and noncarriers (25% on donanemab vs 12% on placebo).Summary review, p. 6 ↗
Every ARIA position, all drugs →

Decision timeline

DateDrugDecisionPathwayBasisAdvisory committeeConfirmatory
Aduhelm (aducanumab)Biogen Inc. Approved Accelerated approval Reduction in amyloid beta plaques Advisory committee, Q8: 0 yes · 10 no · 1 uncertain PMR 3971-1: randomized, controlled trialTrial completion 08/2029
Leqembi (lecanemab)Eisai Inc. Approved Accelerated approval Reduction in amyloid beta plaques Not referredApproval letter, p. 3 PMR 4384-1: randomized, controlled trialTrial completion 09/2022
donanemabEli Lilly and Company Refused Complete response Safety database insufficient for long-term safety Not mentionedin the complete response letter Not applicable
Leqembi (lecanemab)Eisai Inc. Approved Traditional approval Study 301 (CLARITY AD): CDR-SB at 18 months Advisory committee, Q2: 6 yes · 0 no · 0 abstain PMR 4384-1 fulfilled (Study 301)
Kisunla (donanemab)Eli Lilly and Company Approved Traditional approval Studies AACI and AACG (clinical efficacy) Advisory committee, Q2: 11 yes · 0 no · 0 abstain PMC 4605-3: randomized trial of maintenance dosing
Leqembi Iqlik (lecanemab)Eisai Approved Subcutaneous maintenance dosing Subcutaneous maintenance dosing after 18 months Not referredApproval letter, p. 2 PMR 4871-1: registry study, via Leqembi's PMR 4497-1
Leqembi Iqlik (lecanemab)Eisai Inc. Approved Subcutaneous initiation dosing Subcutaneous starting dose, 500 mg weekly Not mentionedin the supplement approval letter Noneno postmarketing requirement in the letter

Five regulatory questions, traced across every decision

Pending

FDA does not publish which applications it is reviewing.

So this page cannot list pending applications, and it does not claim there are none. An application appears here only once FDA itself makes it public. These are the sources the record watches:

Most recent committee meeting notice: , Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application 761248, for Donanemab Solution for Intravenous Infusion. No meeting has been announced since the last decision in this record ().

Last checked .

Alzheimer's products that are not drugs with an Alzheimer's indication on openFDA (for example, devices). Listed only: no entry.