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Donepezil
Adlarity, Aricept, 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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Searched
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Adlarity, Aricept (generic drugs available since 2011-05-10)
Combinations
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 Application2022-03-11
ariceptNew Drug Application2021-12-01
donepezil hydrochlorideANDA2023-05-17
namzaricNew Drug Application2019-01-22
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
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
271 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F032531162422115
DementiaD003704F033364621
Cognitive dysfunctionD060825G31.844654321
Parkinson diseaseD010300EFO_0002508G201534316
StrokeD020521EFO_0000712I63.9211216
Vascular dementiaD015140F0113116
Memory disordersD008569111115
DepressionD003863F33.91225
DeliriumD003693R41.01135
SchizophreniaD012559EFO_0000692F201124
Show 23 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Down syndromeD004314EFO_0001064Q90325
Rett syndromeD015518F84.2112
Anxiety disordersD001008EFO_0006788F41.1112
Ischemic strokeD000083242112
Brain neoplasmsD001932EFO_0003833C71112
NeoplasmsD009369C80112
Psychophysiologic disordersD011602F45.911
Traumatic brain injuriesD000070642S0611
Lung neoplasmsD008175C34.9011
Rheumatoid arthritisD001172EFO_0000685M06.911
Show 4 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Central nervous system neoplasmsD016543213
Autism spectrum disorderD000067877F84.022
Cocaine-related disordersD019970F1422
Fragile x syndromeD005600Q99.2112
Type 2 diabetes mellitusD003924EFO_0001360E1111
Post-head injury comaD02020711
Radiation injuriesD011832T6611
Subarachnoid hemorrhageD013345EFO_0000713I6011
Breast neoplasmsD001943EFO_0003869C5011
FatigueD005221HP_0012378R53.8311
Show 5 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients28129
Central nervous system diseasesD002493HP_0002011G96.922
Rh isoimmunizationD012203EFO_100115911
Urinary retentionD016055HP_0000016R3311
Sensorineural hearing lossD006319HP_0000407H90.511
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GaitD00568411
Diabetes mellitusD003920EFO_0000400E08-E1311
Neurodegenerative diseasesD019636EFO_0005772G31.911
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
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Identifiers
PDB6O4W
CAS-ID120014-06-4
RxCUI135447
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
Clinical Variant
No data
Financial
Aricept - Pfizer
$
£
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Namzaric - Allergan
$
£
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Namzaric - Warner Chilcott
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,540 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,284 adverse events reported
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