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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Trade Name
FDA
EMA
Adlarity, Aricept (generic drugs available since 2011-05-10)
CombinationsNamzaric
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Donepezil hydrochloride
Donepezil hydrochloride
+
Memantine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NAMZARIC | AbbVie | N-206439 RX | 2014-12-23 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adlarity | New Drug Application | 2022-03-11 |
| aricept | New Drug Application | 2021-12-01 |
| donepezil hydrochloride | ANDA | 2023-05-17 |
| namzaric | New Drug Application | 2019-01-22 |
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 | |
| 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
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Clinical
Clinical Trials
271 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 | 25 | 31 | 16 | 24 | 22 | 115 |
| Dementia | D003704 | F03 | 3 | 3 | 6 | 4 | 6 | 21 | |
| Cognitive dysfunction | D060825 | G31.84 | 4 | 6 | 5 | 4 | 3 | 21 | |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 5 | 3 | 4 | 3 | 16 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | 1 | 1 | 2 | 1 | 6 |
| Vascular dementia | D015140 | F01 | 1 | — | 3 | 1 | 1 | 6 | |
| Memory disorders | D008569 | 1 | 1 | 1 | 1 | 1 | 5 | ||
| Depression | D003863 | F33.9 | — | 1 | 2 | 2 | — | 5 | |
| Delirium | D003693 | R41.0 | — | 1 | 1 | 3 | — | 5 | |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | 1 | 2 | — | 4 |
Show 23 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 3 | 2 | — | — | 5 |
| Rett syndrome | D015518 | F84.2 | — | — | 1 | — | 1 | 2 | |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | 1 | — | — | 2 |
| Ischemic stroke | D000083242 | — | 1 | 1 | — | — | 2 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | 1 | — | — | 2 |
| Neoplasms | D009369 | C80 | 1 | — | 1 | — | — | 2 | |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Traumatic brain injuries | D000070642 | S06 | — | — | 1 | — | — | 1 | |
| Lung neoplasms | D008175 | C34.90 | — | — | 1 | — | — | 1 | |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | 2 | 1 | — | — | — | 3 | ||
| Autism spectrum disorder | D000067877 | F84.0 | — | 2 | — | — | — | 2 | |
| Cocaine-related disorders | D019970 | F14 | — | 2 | — | — | — | 2 | |
| Fragile x syndrome | D005600 | Q99.2 | 1 | 1 | — | — | — | 2 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Post-head injury coma | D020207 | — | 1 | — | — | — | 1 | ||
| Radiation injuries | D011832 | T66 | — | 1 | — | — | — | 1 | |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 28 | — | — | — | 1 | 29 | ||
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | 2 | — | — | — | — | 2 |
| Rh isoimmunization | D012203 | EFO_1001159 | 1 | — | — | — | — | 1 | |
| Urinary retention | D016055 | HP_0000016 | R33 | 1 | — | — | — | — | 1 |
| Sensorineural hearing loss | D006319 | HP_0000407 | H90.5 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gait | D005684 | — | — | — | — | 1 | 1 | ||
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | — | — | — | 1 | 1 |
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 |
Target
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Variants
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Financial
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Safety
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Adverse Events
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3,284 adverse events reported
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