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 diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Aricept, Donepezil (discontinued: Adlarity, Aricept, Donepezil)
CombinationsMemantine 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
+
Memantine hydrochloride
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adlarity | New Drug Application | 2023-02-17 |
| aricept | New Drug Application | 2022-11-15 |
| donepezil | ANDA | 2025-10-08 |
| donepezil donepezil hydrochloride | ANDA | 2019-10-09 |
| donepezil hydrochloride | ANDA | 2025-11-18 |
| donepezil hydrochloride donepezil hyrochloride | ANDA | 2019-01-09 |
| memantine and donepezil | ANDA | 2025-07-10 |
| memantine and donepezil hydrochlorides | ANDA | 2025-01-01 |
| memantine and donepezil hydrochlorides extended-release | ANDA | 2025-02-06 |
| memantine hydrochloride and donepezil hydrochloride | ANDA | 2025-06-20 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| alzheimer disease | EFO_0000249 | D000544 | F03 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DONEPEZIL HYDROCHLORIDE, ADLARITY, CORIUM | |||
| 2025-03-11 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Donepezil Hydrochloride, Adlarity, Corium | |||
| 10966936 | 2038-08-11 | DP | U-3334 |
| 10835499 | 2038-05-20 | DP | U-3334 |
| 11648214 | 2037-09-23 | DP | U-3334 |
| 9993466 | 2037-07-26 | DP | |
| 10016372 | 2037-07-26 | U-3334 | |
| 10300025 | 2037-07-26 | DP | |
| 10307379 | 2037-07-26 | DP | |
| 11103463 | 2037-07-26 | U-3334 | |
| 11679086 | 2037-05-26 | U-3334 | |
| Donepezil Hydrochloride / Memantine Hydrochloride, Namzaric, Abbvie | |||
| 8058291 | 2029-12-05 | U-1641 | |
| 8039009 | 2029-03-24 | U-1641 | |
| 8168209 | 2025-11-22 | DP | |
| 8173708 | 2025-11-22 | U-1641 | |
| 8283379 | 2025-11-22 | U-1641 | |
| 8293794 | 2025-11-22 | DP | |
| 8329752 | 2025-11-22 | DP | |
| 8338485 | 2025-11-22 | DP | |
| 8338486 | 2025-11-22 | U-1641 | |
| 8362085 | 2025-11-22 | U-1641 | |
| 8580858 | 2025-11-22 | U-1641 | |
| 8598233 | 2025-11-22 | DP | |
| Donepezil Hydrochloride, Aricept, Eisai Inc | |||
| 8481565 | 2026-10-04 | DP | |
HCPCS
No data
Clinical
Clinical Trials
371 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 disease | D000544 | EFO_0000249 | F03 | 38 | 50 | 32 | 39 | 46 | 200 |
| Dementia | D003704 | EFO_0003862 | F03 | 5 | 9 | 16 | 11 | 15 | 55 |
| Cognitive dysfunction | D060825 | — | G31.84 | 8 | 13 | 7 | 8 | 9 | 44 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 5 | 3 | 5 | 3 | 17 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | 2 | 3 | 3 | 2 | 11 |
| Cognition disorders | D003072 | — | — | 1 | 4 | — | 3 | 2 | 9 |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | — | 2 | 1 | 2 | 4 | 9 |
| Memory disorders | D008569 | — | — | 2 | 1 | 2 | 1 | 2 | 8 |
| Depression | D003863 | — | F33.9 | — | 2 | 2 | 2 | — | 6 |
| Vascular dementia | D015140 | — | F01 | 1 | — | 3 | 1 | 1 | 6 |
Show 41 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | 4 | 4 | — | 1 | 10 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 3 | 2 | — | — | 5 |
| Mixed dementias | D000093902 | — | — | — | — | 1 | — | 2 | 3 |
| Radiation effects | D011830 | — | — | 1 | 1 | 1 | — | — | 3 |
| Rett syndrome | D015518 | Orphanet_778 | F84.2 | — | — | 1 | — | 1 | 2 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | 1 | — | — | 2 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | 1 | — | — | 2 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 2 | 1 | — | — | 2 |
| Ischemic stroke | D000083242 | — | — | — | 1 | 1 | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | — | 1 | — | — | 2 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | — | 3 | — | — | — | 3 |
| Central nervous system neoplasms | D016543 | — | — | 2 | 1 | — | — | — | 3 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | 2 | — | — | — | 2 |
| Fragile x syndrome | D005600 | — | Q99.2 | 1 | 1 | — | — | — | 2 |
| Nervous system neoplasms | D009423 | — | — | 1 | 1 | — | — | — | 2 |
| Anorexia | D000855 | — | R63.0 | — | 2 | — | — | — | 2 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 2 | — | — | — | 2 |
| Consciousness disorders | D003244 | — | — | 1 | 1 | — | — | — | 1 |
| Pervasive child development disorders | D002659 | EFO_0003756 | F84 | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
Show 20 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 31 | — | — | — | 1 | 32 |
| Nervous system diseases | D009422 | — | G00-G99 | 2 | — | — | — | 2 | 4 |
| Central nervous system diseases | D002493 | — | G96.9 | 2 | — | — | — | 1 | 3 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | — | 3 |
| Crush injuries | D000071576 | — | T14.8 | 1 | — | — | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | — | 1 |
| Nerve degeneration | D009410 | — | — | 1 | — | — | — | — | 1 |
| Hyperalgesia | D006930 | — | — | 1 | — | — | — | — | 1 |
| Rh isoimmunization | D012203 | EFO_1001159 | — | 1 | — | — | — | — | 1 |
| Neurotoxicity syndromes | D020258 | — | G92 | 1 | — | — | — | — | 1 |
Show 7 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy aging | D000073656 | — | — | — | — | — | — | 2 | 2 |
| Brain diseases | D001927 | — | G93.40 | — | — | — | — | 2 | 2 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | — | — | — | 2 | 2 |
| Late onset disorders | D000067562 | — | — | — | — | — | — | 1 | 1 |
| Tauopathies | D024801 | — | — | — | — | — | — | 1 | 1 |
| Hypercholesterolemia | D006937 | — | — | — | — | — | — | 1 | 1 |
| Gait | D005684 | — | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Gastrointestinal motility | D005769 | — | — | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Donepezil |
| INN | donepezil |
| 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 class | acetylcholinesterase 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
| PDB | — |
| CAS-ID | 120014-06-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL502 |
| ChEBI ID | 53289 |
| PubChem CID | 3152 |
| DrugBank | DB00843 |
| UNII ID | 8SSC91326P (ChemIDplus, GSRS) |
Target
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Variants
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Namzaric – Allergan
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Namzaric – Warner Chilcott
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Aricept – Pfizer
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Estimated US medical usage
Donepezil
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Trends
PubMed Central
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Safety
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Adverse Events
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15,509 adverse events reported
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