> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/donepezil-hydrochloride-3e847c97-f6d7-496b-a78e-b6a9e46fd819
> Record changed: 2026-11-04

# Donepezil hydrochloride

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

First approval year

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

## Development status

**First approval year**

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

**Drug name**

Donepezil hydrochloride

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

**Molecular weight**

415.96

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

**Structure (SMILES)**

COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2.Cl

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

### Brand names (12)

- 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

### Other names (59)

- 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.

## Identifiers

**ATC classification codes**

- N06DA02

Sources for recorded values

Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=135447)

**CAS registry numbers**

- 120011-70-3

**ChEMBL ID**

CHEMBL1678

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

**InChIKey**

XWAIAVWHZJNZQQ-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1678)

**FDA ingredient codes (UNII)**

- 3O2T2PJ89D

### PubChem compound IDs (3)

- 5741
- 10916711
- 44263804

### RxNorm IDs (RxCUI) (2)

- 135447
- 236559

## Regulatory information

### United States

**Applicant**

EISAI INC

**Approval date**

25 Nov 1996

**Application number**

NDA020690

### Other regulatory facts

**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

## Approval status

**United States (FDA)**

Approved

## Pharmacology

### Drug classification

**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

### Investigated indications (12)

- **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

### Open Targets indications (17)

- **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

### Reported adverse events (41)

- **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.

### Trial references (35)

- NCT00006349  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00006349)
- NCT00047697  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00047697)
- NCT00069550  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00069550)
- NCT00070161  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00070161)
- NCT00096473  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00096473)
- NCT00165659  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00165659)
- NCT00165724  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00165724)
- NCT00165750  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00165750)
- NCT00477659  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00477659)
- NCT00571064  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00571064)
- NCT00711204  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00711204)
- NCT01255046  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01255046)
- NCT01276353  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01276353)
- NCT01297036  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01297036)
- NCT01404169  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01404169)
- NCT01487395  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01487395)
- NCT01539031  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01539031)
- NCT01940952  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01940952)
- NCT02087865  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02087865)
- NCT02097056  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02097056)
- NCT03073876  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03073876)
- NCT03932916  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03932916)
- NCT00188812  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00188812)
- NCT00543855  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00543855)
- NCT00598650  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00598650)

And 10 more, listed on the interactive page.

## Dosing

**Dose**

7 mg/10 mg

**Route**

Oral

**How often**

Once daily

### Conditions of use (2)

- Do not divide, chew, or crush
- Take with or without food

## Chemical properties

**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

## National Drug Codes

- 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.

## Evidence counts

**Recorded assays**

1,568

**Active assays**

97

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Cholinesterase Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D002800.html)
- Nootropic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018697.html)

## Biological measurements

### Observed measurements

#### 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)

- [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md)
- [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md)

### In development for (12)

- Autism Phase 2
- Brain neoplasm Phase 1
- Central nervous system neoplasm Phase 2
- Delirium Phase 3
- [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) Phase 3
- [Down syndrome](https://trialight.com/data/condition/down-syndrome-6624b8ac-2317-5aff-9950-8c418c3c46bf.md) Phase 3
- [Lewy body dementia](https://trialight.com/data/condition/lewy-body-dementia-eaa4788b-4d65-5d2f-add5-502d935893c0.md) Phase 2
- [Migraine disorder](https://trialight.com/data/condition/migraine-disorder-0a28e77d-6415-5582-980f-2d0721f95f76.md) Phase 2
- Neuralgia Phase 2
- [Parkinson disease](https://trialight.com/data/condition/parkinson-disease-a117728d-ad75-551b-9b20-fffa9a2305ac.md) Phase 2
- Rett syndrome Phase 3
- Vascular dementia Phase 3

### Other linked conditions (1)

- Alzheimer disease type 1

### Targets (1)

- [ACHE](https://trialight.com/data/target/ache-d2ea998f-6390-5915-be6d-023f0963eeba.md) Acetylcholinesterase inhibitor

---

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