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Drug ReportsDonepezil
Donepezil
Adlarity, Aricept, Donepezil, Namzaric (donepezil) is a small molecule pharmaceutical. Donepezil was first approved as Aricept on 1996-11-25. It is used to treat alzheimer disease in the USA. The pharmaceutical is active against acetylcholinesterase.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Adlarity, Aricept, Donepezil (discontinued: Aricept, Donepezil)
Combinations
Memantine donepezil, Namzaric
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Donepezil hydrochloride
Tradename
Company
Number
Date
Products
ADLARITYCoriumN-212304 RX2022-03-11
2 products, RLD, RS
ARICEPTEisaiN-020690 RX1996-11-25
2 products, RLD
ARICEPTEisaiN-022568 RX2010-07-23
1 products, RLD, RS
Show 2 discontinued
Donepezil hydrochloride
+
Memantine hydrochloride
Tradename
Company
Number
Date
Products
NAMZARICAbbVieN-206439 RX2014-12-23
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
adlarityNew Drug Application2023-02-17
ariceptNew Drug Application2022-11-15
donepezilANDA2025-01-07
donepezil donepezil hydrochlorideANDA2019-10-09
donepezil hydrochlorideANDA2025-01-31
donepezil hydrochloride donepezil hyrochlorideANDA2019-02-16
memantine and donepezil hydrochloridesANDA2025-01-01
memantine and donepezil hydrochlorides extended-releaseANDA2025-02-06
namzaricNew Drug Application2024-05-13
tradenameNew Drug Application2014-12-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
alzheimer diseaseEFO_0000249D000544F03
Agency Specific
FDA
EMA
Expiration
Code
DONEPEZIL HYDROCHLORIDE, ADLARITY, CORIUM
2025-03-11NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Donepezil Hydrochloride, Adlarity, Corium
109669362038-08-11DPU-3334
108354992038-05-20DPU-3334
116482142037-09-23DPU-3334
99934662037-07-26DP
100163722037-07-26U-3334
103000252037-07-26DP
103073792037-07-26DP
111034632037-07-26U-3334
116790862037-05-26U-3334
Donepezil Hydrochloride / Memantine Hydrochloride, Namzaric, Abbvie
80582912029-12-05U-1641
80390092029-03-24U-1641
81682092025-11-22DP
81737082025-11-22U-1641
82833792025-11-22U-1641
82937942025-11-22DP
83297522025-11-22DP
83384852025-11-22DP
83384862025-11-22U-1641
83620852025-11-22U-1641
85808582025-11-22U-1641
85982332025-11-22DP
Donepezil Hydrochloride, Aricept, Eisai Inc
84815652026-10-04DP
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06D: Anti-dementia drugs
— N06DA: Anticholinesterase anti-dementia drugs
— N06DA02: Donepezil
— N06DA52: Donepezil and memantine
— N06DA53: Donepezil, memantine and ginkgo folium
HCPCS
No data
Clinical
Clinical Trials
361 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F03—4610828
DementiaD003704EFO_0003862F03—483318
Cognitive dysfunctionD060825—G31.84—322—7
Lewy body diseaseD020961EFO_0006792G31.83—21115
Cerebrovascular disordersD002561EFO_0003763I60-I69——21—3
Vascular dementiaD015140—F01——11—2
Chronic kidney failureD007676EFO_0003884N18.6———1—1
Kidney diseasesD007674EFO_0003086N08———1—1
Memory disordersD008569—————1—1
AmnesiaD000647EFO_1001454F44.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Down syndromeD004314EFO_0001064Q90—32——5
SyndromeD013577———32——5
Parkinson diseaseD010300EFO_0002508G20——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine disordersD008881EFO_0003821G43—1———1
HeadacheD006261—R51—1———1
CadasilD046589Orphanet_136I67.850—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mixed dementiasD000093902——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDonepezil
INNdonepezil
Description
Donepezil is a racemate comprising equimolar amounts of (R)- and (S)-donepezil. A centrally acting reversible acetylcholinesterase inhibitor, its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine. It has a role as an EC 3.1.1.7 (acetylcholinesterase) inhibitor, a nootropic agent and an EC 3.1.1.8 (cholinesterase) inhibitor. It contains a (R)-donepezil and a (S)-donepezil. It is a conjugate base of a donepezil (1+).
Classification
Small molecule
Drug classacetylcholinesterase inhibitors used in the treatment of Alzheimer's disease
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Structure (InChI/SMILES or Protein Sequence)
COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Identifiers
PDB—
CAS-ID120014-06-4
RxCUI—
ChEMBL IDCHEMBL502
ChEBI ID53289
PubChem CID3152
DrugBankDB00843
UNII ID8SSC91326P (ChemIDplus, GSRS)
Target
Agency Approved
ACHE
ACHE
Organism
Homo sapiens
Gene name
ACHE
Gene synonyms
NCBI Gene ID
Protein name
acetylcholinesterase
Protein synonyms
acetylcholinesterase (Yt blood group), apoptosis-related acetylcholinesterase, Yt blood group
Uniprot ID
Mouse ortholog
Ache (11423)
acetylcholinesterase (P21836)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Namzaric – Allergan
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Namzaric – Warner Chilcott
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Aricept – Pfizer
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Estimated US medical usage
Donepezil
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,519 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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14,821 adverse events reported
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