Donepezil
As of the edition of 20 October 2026, Donepezil is a small molecule: marketed, first approved in 1996 (US); acts on ACHE; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Aricept
- First approved
- 25 November 1996 (US)
- Approvals on record
- 21 in 6 regions
- Holder of the most recent approval
- Teikoku Seiyaku; 6 holders in all
- Registered trials
- 209, 23 stopped early
- Disease areas
- Nervous system; Mental health; Heart and blood vessels; Cancer; Chemically induced; Inherited and neonatal
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Corium holds a later exclusivity on its own new formulation or combination product, ending 2036; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Donepezil.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ACHE | Acetylcholinesterase | P22303 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 34 | 24 | 5 | 2 |
| Phase 1 | 56 | 44 | 2 | 7 |
| Phase 2 | 45 | 27 | 4 | 6 |
| Phase 3 | 28 | 18 | 1 | 4 |
| Phase 4 | 46 | 36 | 1 | 4 |
| All trials | 209 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eisai | Originator and Lead sponsor of trials | 1996 to now |
| Pfizer | Applicant and Lead sponsor of trials | 1997 to now |
| Corium | Later holder and Lead sponsor of trials | 2016 to now |
| Teikoku Seiyaku | Applicant | 2022 to now |