Donepezil hydrochloride
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Donepezil hydrochloride
- Molecular weight
- 415.96
- Structure (SMILES)
- COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2.Cl
- adlarity
- Adlarity
- aricept
- Aricept
- aricept evess
- Aricept evess
- aricept odt
- Aricept odt
- donepezil hydrochloride
- Donepezil hydrochloride
- donepezil hydrochloride component of namzaric
- Donepezil hydrochloride component of namzaric
- adlarity
- Adlarity
- aricept
- Aricept
- ARICEPT
- aricept 10 mg film coated tablet
- aricept 10mg tablet
- Aricept 10mg Tablet
- aricept 5 mg film coated tablet
- aricept 5mg tablet
- Aricept 5mg Tablet
- aricept clorhidrate of donepezilo
- aricept evess
- aricept tablet
- Aricept Tablet
- Aricept®
- Aricept® 10 mg film-coated tablet
- Aricept® 5 mg film-coated tablet
- Aricept® Evess
- bnag
- BNAG
- donepezil
- Donepezil
- donepezil hcl
- Donepezil hcl
And 34 more, listed on the interactive page.
- ATC classification codes
- N06DA02
Sources for recorded values
- CAS registry numbers
- 120011-70-3
- ChEMBL ID
- CHEMBL1678
- InChIKey
- XWAIAVWHZJNZQQ-UHFFFAOYSA-N
- FDA ingredient codes (UNII)
- 3O2T2PJ89D
- 5741
- 10916711
- 44263804
- 135447
- 236559
- Applicant
- EISAI INC
- Approval date
- 25 Nov 1996
- Application number
- NDA020690
- Patents
- 12
- Designations
- 1
- Earliest recorded loss of exclusivity
- 11 Aug 2038
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- United States (FDA)
- Approved
- Drug name stem
- -pezil
Administration routes
- Oral
- topical
Mechanisms of action
- Mechanism
- Acetylcholinesterase inhibitor
- Action type
- Inhibitor
- Target
- Acetylcholinesterase
- Protein identifier
- P22303
Open Targets mechanisms
- Mechanism
- Acetylcholinesterase inhibitor
- Action type
- Inhibitor
- Target
- Acetylcholinesterase
- Condition
- Down Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001064
- Subject identifier
- D004314
- Condition
- Autistic Disorder
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003758
- Subject identifier
- D001321
- Condition
- Dementia, Vascular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004718
- Subject identifier
- D015140
- Condition
- Neuralgia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005762
- Subject identifier
- D009437
- Condition
- Delirium
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009267
- Subject identifier
- D003693
- Condition
- Central Nervous System Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000158
- Subject identifier
- D016543
- Condition
- Dementia
- Highest recorded phase
- 4
- Condition identifier
- HP:0000726
- Subject identifier
- D003704
- Condition
- Cognitive Dysfunction
- Highest recorded phase
- 1
- Condition identifier
- HP:0100543
- Subject identifier
- D060825
- Condition
- Depressive Disorder
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0002050
- Subject identifier
- D003866
- Condition
- Alzheimer Disease
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004975
- Subject identifier
- D000544
- Condition
- Migraine Disorders
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005277
- Subject identifier
- D008881
- Condition
- Rett Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0010726
- Subject identifier
- D015518
- Condition identifier
- EFO_0001064
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003758
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004718
- Highest recorded phase
- 3
- Condition identifier
- EFO_0006792
- Condition identifier
- EFO_1000158
- Highest recorded phase
- 2
- Condition identifier
- HP_0100543
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0001627
- Condition identifier
- MONDO_0001627
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004975
- Condition identifier
- MONDO_0004975
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005180
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005277
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0007088
- Condition identifier
- MONDO_0007488
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008608
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0010726
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0021211
- Highest recorded phase
- 1
- Event
- abnormal behaviour
- Reports
- 169
- Reporting signal score
- 209.16
- Event
- aggression
- Reports
- 257
- Reporting signal score
- 361.629
- Event
- agitation
- Reports
- 313
- Reporting signal score
- 357.248
- Event
- application site erythema
- Reports
- 103
- Reporting signal score
- 208.738
- Event
- application site pruritus
- Reports
- 79
- Reporting signal score
- 165.396
- Event
- atrioventricular block complete
- Reports
- 70
- Reporting signal score
- 112.849
- Event
- atrioventricular block first degree
- Reports
- 74
- Reporting signal score
- 157.396
- Event
- bradycardia
- Reports
- 683
- Reporting signal score
- 1,217.27
- Event
- cholinergic syndrome
- Reports
- 63
- Reporting signal score
- 244.171
- Event
- circulatory collapse
- Reports
- 100
- Reporting signal score
- 147.191
- Event
- cognitive disorder
- Reports
- 182
- Reporting signal score
- 225.653
- Event
- confusional state
- Reports
- 583
- Reporting signal score
- 667.287
- Event
- decreased appetite
- Reports
- 259
- Reporting signal score
- 110.031
- Event
- delirium
- Reports
- 245
- Reporting signal score
- 353.456
- Event
- delusion
- Reports
- 100
- Reporting signal score
- 155.203
- Event
- dementia
- Reports
- 151
- Reporting signal score
- 271.193
- Event
- dementia alzheimer's type
- Reports
- 130
- Reporting signal score
- 384.901
- Event
- depressed level of consciousness
- Reports
- 162
- Reporting signal score
- 158.763
- Event
- disorientation
- Reports
- 179
- Reporting signal score
- 215.467
- Event
- drug interaction
- Reports
- 392
- Reporting signal score
- 207.401
- Event
- electrocardiogram qt prolonged
- Reports
- 272
- Reporting signal score
- 378.249
- Event
- extrapyramidal disorder
- Reports
- 104
- Reporting signal score
- 142.259
- Event
- fall
- Reports
- 698
- Reporting signal score
- 510.715
- Event
- hallucination
- Reports
- 274
- Reporting signal score
- 319.184
- Event
- hallucination, visual
- Reports
- 125
- Reporting signal score
- 175.979
And 16 more, listed on the interactive page.
- NCT00006349
- NCT00047697
- NCT00069550
- NCT00070161
- NCT00096473
- NCT00165659
- NCT00165724
- NCT00165750
- NCT00477659
- NCT00571064
- NCT00711204
- NCT01255046
- NCT01276353
- NCT01297036
- NCT01404169
- NCT01487395
- NCT01539031
- NCT01940952
- NCT02087865
- NCT02097056
- NCT03073876
- NCT03932916
- NCT00188812
- NCT00543855
- NCT00598650
And 10 more, listed on the interactive page.
- Dose
- 7 mg/10 mg
- Route
- Oral
- How often
- Once daily
- Do not divide, chew, or crush
- Take with or without food
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 0
- Polar surface area
- 38.77
- Calculated partition coefficient (ALogP)
- 4.36
- Prodrug
- No
- Chirality
- Racemic
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 6
- Heavy atoms
- 29
- Molecular formula
- C24H30ClNO3
- Monoisotopic mass
- 415.1914215
- Natural product
- No
- 0456-1207
- 0456-1214
- 0456-1221
- 0456-1228
- 0615-7951
- 0615-8313
- 0904-6477
- 0904-6478
- 13668-102
- 13668-103
- 16571-778
- 16571-779
- 24979-004
- 29300-248
- 29300-249
- 29300-250
- 29300-251
- 31722-737
- 31722-738
- 33342-027
- 33342-028
- 33342-029
- 33342-030
- 33342-061
- 33342-312
And 66 more, listed on the interactive page.
- Recorded assays
- 1,568
- Active assays
- 97
- Confirmatory
- Other
- Screening
- Summary
- Cholinesterase Inhibitors
- Nootropic Agents
Oral bioavailability
- Median
- 43
- Mean
- 59.6667
- Minimum
- 36
- Maximum
- 100
- Unit
- %
- Assays
- 3
- Standard deviation
- 35.1046
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Plasma protein binding
- Median
- 96
- Mean
- 96
- Minimum
- 96
- Maximum
- 96
- Unit
- %
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- PPB
Related records
Trials (81)
- 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
- 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions
- A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease
- A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
- A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
- A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
- A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®
- A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males
- A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.
- A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
- A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living.
- A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
- A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020
- A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease
- A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®
- A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
- A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
- A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI
- A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease
- A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia
Approved for (2)
In development for (12)
- Autism Phase 2
- Brain neoplasm Phase 1
- Central nervous system neoplasm Phase 2
- Delirium Phase 3
- Depressive disorder Phase 3
- Down syndrome Phase 3
- Lewy body dementia Phase 2
- Migraine disorder Phase 2
- Neuralgia Phase 2
- Parkinson disease Phase 2
- Rett syndrome Phase 3
- Vascular dementia Phase 3
Other linked conditions (1)
- Alzheimer disease type 1
Targets (1)
- ACHE Acetylcholinesterase inhibitor