CDEK
← All drugs Report issue

donepezil

Trade name: aricept

Small moleculeapproved

Approved

Nov 25, 1996

Donepezil, marketed under the trade name Aricept, is a medication used in the palliative treatment of Alzheimer's disease. Aricept is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild to moderate Alzheimer’s Disease, as well as in patients with severe Alzheimer’s Disease. Donepezil is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. Donepezil has been tested in other cognitive disorders including Lewy body dementia and Vascular dementia, but it is not currently approved for these indications. Donepezil has also been studied in patients with Mild Cognitive Impairment, schizophrenia, attention deficit disorder, post-coronary bypass cognitive impairment, cognitive impairment associated with multiple sclerosis, and Down syndrome. — NCATS

Clinical trial activity

281 trials · 223 clinical orgs · 53 marketing orgs

Phase 1
82
Phase 2
113
Phase 3
43
Phase 4
60

Earliest trial started Jan 1, 1995 (NCT00004807)

Timeline

1990s

  1. Nov 25, 1996

    Eisai — Earliest FDA Approval

  2. Nov 25, 1996

    Eisai — NDA Organization

  3. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Jan 9, 2007

    Par Pharmaceuticals — Marketing Organization

2010s

  1. Jun 29, 2010

    Heritage Pharma — Marketing Organization

  2. Jun 29, 2010

    Teva — Marketing Organization

  3. Nov 26, 2010

    Barr Laboratories — Marketing Organization

  4. Nov 26, 2010

    Chartwell Pharmaceuticals — Marketing Organization

  5. May 10, 2011

    Sandoz — Marketing Organization

  6. May 10, 2011

    Novartis — Marketing Organization

  7. May 10, 2011

    AiPing Pharm Inc — Marketing Organization

  8. May 31, 2011

    ACI Limited — Marketing Organization

  9. May 31, 2011

    Aurobindo Pharma — Marketing Organization

  10. May 31, 2011

    Cipla — Marketing Organization

  11. May 31, 2011

    Dr. Reddy's Laboratories — Marketing Organization

  12. May 31, 2011

    Hikma — Marketing Organization

  13. May 31, 2011

    Jubilant Innovation Ltd. — Marketing Organization

  14. May 31, 2011

    Mylan — Marketing Organization

  15. May 31, 2011

    Pliva — Marketing Organization

  16. May 31, 2011

    Prinston Inc — Marketing Organization

  17. May 31, 2011

    Wockhardt — Marketing Organization

  18. May 31, 2011

    Strides Pharma Science — Marketing Organization

  19. May 31, 2011

    Sun Pharmaceuticals — Marketing Organization

  20. May 31, 2011

    Torrent Pharmaceuticals Limited — Marketing Organization

  21. May 31, 2011

    Emcure — Marketing Organization

  22. May 31, 2011

    Natco Pharma — Marketing Organization

  23. May 31, 2011

    Novitium Pharma — Marketing Organization

  24. Jun 2, 2011

    Apotex — Marketing Organization

  25. Jun 13, 2011

    Indicus Pharma — Marketing Organization

  26. Aug 29, 2011

    Accord Research — Marketing Organization

  27. Aug 17, 2012

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  28. Dec 14, 2012

    Neogen — Marketing Organization

  29. Feb 25, 2013

    Alembic — Marketing Organization

  30. Jul 5, 2013

    Graviti Pharmaceuticals — Marketing Organization

  31. Jul 5, 2013

    Shijiazhuang Pharma Group (CSPC) — Marketing Organization

  32. Jul 5, 2013

    Rising Pharmaceuticals — Marketing Organization

  33. Jul 24, 2013

    PH HEALTH — Marketing Organization

  34. Oct 29, 2014

    Sciegen Pharmaceticals — Marketing Organization

  35. Oct 29, 2014

    TWi Biotechnology, Inc. — Marketing Organization

  36. Dec 23, 2014

    Allergan — Marketing Organization

  37. Dec 23, 2014

    Allergan — NDA Secondary Org

  38. Dec 23, 2014

    AbbVie — NDA Secondary Org

  39. Jan 30, 2015

    Hetero Labs Ltd — Marketing Organization

  40. Oct 30, 2015

    Lupin — Marketing Organization

  41. Dec 17, 2015

    Actavis — Marketing Organization

  42. Dec 17, 2015

    Allergan PLC (2015) — Marketing Organization

  43. Jan 26, 2016

    Osmotica Pharmaceutical — Marketing Organization

  44. Feb 19, 2016

    Dexcel Pharma Technologies Ltd. — Marketing Organization

  45. Jun 23, 2016

    Unichem — Marketing Organization

  46. Jan 27, 2017

    Amneal Pharmaceuticals — Marketing Organization

  47. Mar 24, 2017

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

  48. Aug 31, 2017

    Zydus Discovery DMCC — Marketing Organization

  49. Sep 19, 2017

    Cadila Healthcare — Marketing Organization

2020s

  1. Mar 11, 2022

    Corium International Inc. — Marketing Organization

  2. Mar 11, 2022

    Corium International Inc. — NDA Secondary Org

  3. Apr 7, 2023

    LP Pharmaceuticals — Marketing Organization

  4. Dec 15, 2023

    Ani Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewNov 25, 1996

Chemistry & pharmacology

Loading structure…

SMILES

COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Mol. weight
379.5 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Sources

Also known as

  • 1-benzyl-4-((5,6-dimethoxy-1-indanon)-2-yl)methylpiperidine hydrochloride
  • aricept
  • aricept
  • aricept
  • aricept
  • aricept
  • aricept
  • aricept
  • aricept
  • aricept evess
  • aricept evess
  • aricept odt
  • aricept odt
  • bnag
  • bnag
  • domepezil
  • domepezil
  • donepezil
  • donepezil
  • donepezil
  • donepezil
  • donepezil
  • donepezil
  • donepezil
  • donepezil
  • donepezil
  • donepezil hcl
  • donepezil hcl
  • donepezil hcl
  • donepezil hydrochloride
  • donepezil hydrochloride
  • donepezil hydrochloride
  • donepezil hydrochloride
  • donepezil hydrochloride
  • donepezil hydrochloride
  • donepezil hydrochloride monohydrate
  • donepezilium oxalate
  • donepezilium oxalate trihydrate
  • donepezilium oxalate trihydrate
  • donepezilo
  • donepezilo
  • donepezil oxalate
  • donepezilum
  • donepezilum
  • donezepil
  • donezpil
  • donezpil hcl
  • donezpil hydrochloride
  • donzepezil
  • e2020
  • e2020
  • e2020
  • e2020
  • e2020
  • e 2020
  • e-2020
  • e-2020
  • e-2020
  • e-2020
  • eranz
  • memantine hydrochloride / donepezil hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07066826Phase 2/Phase 3 (Phase 3)Aug 1, 2025WanBangDe Pharmaceutical Group Co.,Ltd.
NCT07060391Phase 3Jul 31, 2025Jiao Tong University
NCT07208344Early Phase 1 (Phase 1)Jul 31, 2025Anhui Medical University
NCT06774261Phase 1Feb 1, 2025Helse Fonna, National Institutes of Health (NIH), Norwegian University of Science and Technology, University Hospital of North Norway, University of Exeter, University of Stavanger
NCT06518941Phase 2Dec 31, 2024Columbia University
NCT06687993Phase 2Nov 30, 2024Centre Hospitalier St Anne, Institut National de la Santé Et de la Recherche Médicale, France, University of Paris
NCT06903910Phase 2Nov 1, 2024University of Virginia
NCT06417086N/AJun 1, 2024Fudan University, Shanghai Minimally Invasive Surgery Center, Shanghai University of Traditional Chinese Medicine
NCT06373094Phase 1Jun 1, 2024Synergy Pharmaceuticals
NCT06285240Phase 1Mar 28, 2024Merck
NCT06127368Phase 1Jan 3, 2024G2GBio, Inc.
NCT06041789Phase 2Dec 4, 2023Duke University, National Institute on Aging (NIA)
NCT05709301Phase 2Oct 1, 2023University of Barcelona
NCT05345509Phase 1/Phase 2 (Phase 2)Apr 1, 2023Inventage Lab., Inc.
NCT05592678Phase 2/Phase 3 (Phase 3)Feb 28, 2023National Institute on Aging (NIA), University of Texas, Galveston, University of Texas, San Antonio
NCT05438264Early Phase 1 (Phase 1)Jan 31, 2023Vanderbilt University
NCT06393413Early Phase 1 (Phase 1)Dec 1, 2022Changchun University of Chinese Medicine
NCT05525780Phase 1Aug 26, 2022G2GBio, Inc.
NCT05540977Early Phase 1 (Phase 1)Aug 1, 2022Sun Yat-Sen University
NCT05641480N/AJun 3, 2022Shaanxi University of Chinese Medicine
Showing 20 of 281 trials
Page 1 / 15

Organizations

Research & Development (223)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
EisaiFor profit453951999
PfizerFor profit281251999
MerckFor profit9922007
National Institute of Mental Health (NIMH)Government9332000
National Institute on Aging (NIA)Government8231999
AstraZenecaFor profit7622007
GlaxoSmithKlineFor profit7652006
National Institutes of Health (NIH)Government7451995
Wake Forest UniversityAcademic/Hospital7742001
Corium International Inc.For profit6612016
Jiao Tong UniversityAcademic/Hospital6532005
CelerionFor profit5012016
National Cancer Institute (NCI)Government5132001
TevaFor profit5512006
University of LondonAcademic/Hospital5432003
AbbVieFor profit4412009
Chase Pharmaceuticals CorporationFor profit4412014
Columbia UniversityAcademic/Hospital4422011
Department of Veteran AffairsGovernment4331998
Dong-A PharmaceuticalFor profit4322013
223 organizations
Page 1 / 12

Marketing (69)

OrganizationOrg typeRelationshipDate
ACI LimitedFor profitMKTGMay 31, 2011
ACI LimitedFor profitMKTGMay 31, 2011
AbbVieFor profitNDA2Dec 23, 2014
Accord ResearchFor profitMKTGAug 29, 2011
ActavisFor profitMKTGDec 17, 2015
AiPing Pharm IncFor profitMKTGMay 10, 2011
AlembicFor profitMKTGFeb 25, 2013
AllerganFor profitMKTGDec 23, 2014
AllerganFor profitNDA2Dec 23, 2014
Allergan PLC (2015)For profitMKTGDec 17, 2015
Amneal PharmaceuticalsFor profitMKTGJan 27, 2017
Amneal PharmaceuticalsFor profitSYNJan 27, 2017
Ani PharmaceuticalsFor profitMKTGDec 15, 2023
ApotexFor profitMKTGJun 2, 2011
Aurobindo PharmaFor profitMKTGMay 31, 2011
Barr LaboratoriesFor profitMKTGNov 26, 2010
Cadila HealthcareFor profitMKTGSep 19, 2017
Cadila HealthcareFor profitSYNOct 24, 2012
Chartwell PharmaceuticalsFor profitMKTGNov 26, 2010
CiplaFor profitMKTGMay 31, 2011
Corium International Inc.For profitMKTGMar 11, 2022
Corium International Inc.For profitNDA2Mar 11, 2022
Dexcel Pharma Technologies Ltd.For profitMKTGFeb 19, 2016
Dexcel Pharma Technologies Ltd.For profitSYNFeb 19, 2016
Dr. Reddy's LaboratoriesFor profitMKTGMay 31, 2011
Dr. Reddy's LaboratoriesFor profitSYNJul 24, 2013
EisaiFor profitNDANov 25, 1996
EmcureFor profitMKTGMay 31, 2011
Graviti PharmaceuticalsFor profitMKTGJul 5, 2013
Heritage PharmaFor profitMKTGJun 29, 2010
Hetero Labs LtdFor profitMKTGJan 30, 2015
HikmaFor profitMKTGMay 31, 2011
Indicus PharmaFor profitMKTGJun 13, 2011
Jubilant Innovation Ltd.For profitMKTGMay 31, 2011
LP PharmaceuticalsFor profitMKTGApr 7, 2023
LupinFor profitMKTGOct 30, 2015
Macleods Pharmaceuticals, LtdFor profitMKTGAug 17, 2012
MylanFor profitMKTGMay 31, 2011
MylanFor profitSYNOct 22, 2015
Natco PharmaFor profitMKTGMay 31, 2011
NeogenFor profitMKTGDec 14, 2012
NovartisFor profitMKTGMay 10, 2011
Novitium PharmaFor profitMKTGMay 31, 2011
Osmotica PharmaceuticalFor profitMKTGJan 26, 2016
PH HEALTHFor profitMKTGJul 24, 2013
Par PharmaceuticalsFor profitMKTGJan 9, 2007
PlivaFor profitMKTGMay 31, 2011
Prinston IncFor profitMKTGMay 31, 2011
Rising PharmaceuticalsFor profitSYNOct 22, 2015
Rising PharmaceuticalsFor profitMKTGJul 5, 2013
SandozFor profitMKTGMay 10, 2011
Sciegen PharmaceticalsFor profitMKTGOct 29, 2014
Shijiazhuang Pharma Group (CSPC)For profitMKTGJul 5, 2013
Strides Pharma ScienceFor profitSYNMay 31, 2011
Strides Pharma ScienceFor profitMKTGMay 31, 2011
Sun PharmaceuticalsFor profitMKTGMay 31, 2011
Sun PharmaceuticalsFor profitSYNNov 26, 2010
Sun PharmaceuticalsFor profitSYNDec 11, 2009
Sun PharmaceuticalsFor profitSYNJun 5, 2015
TWi Biotechnology, Inc.For profitMKTGOct 29, 2014
TevaFor profitMKTGJun 29, 2010
Torrent Pharmaceuticals LimitedFor profitMKTGMay 31, 2011
UnichemFor profitMKTGJun 23, 2016
UnichemFor profitSYNJun 23, 2016
WockhardtFor profitMKTGMay 31, 2011
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGMar 24, 2017
Zydus Discovery DMCCFor profitMKTGAug 31, 2017
Zydus Discovery DMCCFor profitSYNMay 10, 2011
Zydus Discovery DMCCFor profitSYNOct 24, 2012