galantamine

Trade name: reminyl

Small moleculeapproved

Approved

Feb 28, 2001

Galantamine (RAZADYNE®, galantamine hydrobromide) is a benzazepine derived from norbelladine. It is found in Galanthus and other Amaryllidaceae. It is a reversible, competitive acetylcholinesterase inhibitor that is used for the treatment of mild to moderate dementia of the Alzheimer’s type. Although the etiology of cognitive impairment in Alzheimer’s disease is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimer’s disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimer’s disease). While the precise mechanism of galantamine’s (RAZADYNE®, galantamine hydrobromide) action is unknown, it 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. If this mechanism is correct, galantamine’s (RAZADYNE®, galantamine hydrobromide) effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that galantamine (RAZADYNE®, galantamine hydrobromide) alters the course of the underlying dementing process. — NCATS

Clinical trial activity

93 trials · 78 clinical orgs · 24 marketing orgs

Phase 1
16
Phase 2
43
Phase 3
30
Phase 4
23

Earliest trial started Aug 1, 1995 (NCT00338117)

Timeline

1990s

  1. Jan 1, 1995

    Johnson and Johnson — Earliest Phase 3 Sponsor(trial)

2000s

  1. Feb 28, 2001

    Johnson and Johnson — Earliest FDA Approval

  2. Feb 28, 2001

    Johnson and Johnson — NDA Secondary Org

  3. Feb 28, 2001

    Johnson and Johnson — NDA Organization

  4. Jan 1, 2003

    Johnson and Johnson — Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 2004

    Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)

  6. Mar 30, 2007

    Watson Pharmaceuticals — Marketing Organization

  7. Aug 28, 2007

    Ranbaxy — Marketing Organization

  8. Aug 28, 2008

    Barr Laboratories — Marketing Organization

  9. Aug 28, 2008

    Mylan — Marketing Organization

  10. Aug 28, 2008

    PHARMOBEDIENT — Marketing Organization

  11. Sep 11, 2008

    Dr. Reddy's Laboratories — Marketing Organization

  12. Sep 11, 2008

    ANDA Repository — Marketing Organization

  13. Sep 11, 2008

    Senores Pharms — Marketing Organization

  14. Jan 30, 2009

    West-Ward Pharmaceutical — Marketing Organization

  15. Jan 30, 2009

    Hikma — Marketing Organization

  16. Feb 6, 2009

    Yabao Pharmaceutical Group — Marketing Organization

  17. May 27, 2009

    Impax Laboratories — Marketing Organization

  18. Jun 22, 2009

    Sandoz — Marketing Organization

  19. Jun 22, 2009

    Novartis — Marketing Organization

  20. Jul 9, 2009

    Teva — Marketing Organization

  21. Jul 9, 2009

    Heritage Pharma — Marketing Organization

  22. Jul 9, 2009

    Chartwell Pharmaceuticals — Marketing Organization

  23. Sep 15, 2009

    Actavis — Marketing Organization

2010s

  1. Feb 2, 2011

    Sun Pharmaceuticals — Marketing Organization

  2. Feb 17, 2011

    Zydus Discovery DMCC — Marketing Organization

  3. Mar 29, 2011

    Aurobindo Pharma — Marketing Organization

  4. Sep 27, 2011

    Apotex — Marketing Organization

2020s

  1. Jul 26, 2024

    ALPHA COGNITION — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedFeb 28, 2001

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc2c3c1O[C@H]1C[C@@H](O)C=C[C@@]31CCN(C)C2
Mol. weight
287.36 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • acumor xl
  • consion xl
  • elmino xl
  • galantamin
  • galantamina
  • galantamine
  • galantamine
  • galantamine
  • galantamine
  • galantamine
  • galantamine
  • galantamine
  • galantamine
  • galantamine
  • galantamine
  • (-)-galantamine
  • galantamine hydrobromide
  • galantamine hydrobromide
  • galantamine hydrobromide
  • galantamine hydrobromide
  • galantamine hydrobromide
  • galanthamine
  • galanthamine
  • galanthamine
  • galanthamine
  • (-)-galanthamine
  • (-)-galanthamine
  • (-)-galanthamine
  • galanthamine hydrobromide
  • galsya xl
  • galzemic xl
  • gatalin xl
  • gazylan xl
  • lotprosin xl
  • luventa xl
  • lycoremin
  • lycoremine
  • razadyne
  • razadyne
  • razadyne
  • razadyne
  • razadyne er
  • razadyne er
  • reminyl
  • reminyl
  • reminyl xl
  • reminyl xl
  • vp4896
  • zeebral xl

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07284290Phase 4Jan 25, 2026National Institute of Neurological Disorders and Stroke (NINDS), Virginia Commonwealth University
NCT07003386Phase 2/Phase 3 (Phase 3)Sep 15, 2025Shanghai University of Traditional Chinese Medicine
NCT07208344Early Phase 1 (Phase 1)Jul 31, 2025Anhui Medical University
NCT04769206Phase 1/Phase 2 (Phase 2)Jan 31, 2022Vanderbilt University
NCT03547622Early Phase 1 (Phase 1)May 1, 2018Yale University
NCT03454646Phase 4Mar 15, 2018University of Bordeaux
NCT03384784Phase 2Oct 30, 2017National Institute on Drug Abuse (NIDA), University of Pennsylvania
NCT03124355Phase 1May 1, 2017Vanderbilt University
NCT03014323Phase 1Jan 1, 2017Vanderbilt University
NCT02872857Phase 1/Phase 2 (Phase 2)Sep 1, 2016University of Texas at Houston
NCT02365285Phase 1/Phase 2 (Phase 2)Mar 1, 2015Doris Duke Charitable Foundation, Vanderbilt University
NCT02374567Phase 3Jan 1, 2015Gottfried Wilhelm Leibniz Universität Hannover
NCT02234752Phase 2Sep 1, 2014Sheppard Pratt Health System
NCT02420327N/ASep 1, 2014University of Maryland
NCT02283242Phase 4Mar 1, 2014Feinstein Institute for Medical Research, University of Nove de Julho, University of Sao Paulo
NCT02098824Phase 2/Phase 3 (Phase 3)Feb 1, 2014Free University of Amsterdam, University of Amsterdam
NCT01880099N/ADec 1, 2013Yale University
NCT01845961Phase 2Jan 1, 2013University of Pennsylvania
NCT01677754Phase 2Oct 24, 2012Roche
NCT01669538Phase 2Aug 1, 2012National Cancer Institute (NCI), National Center for Research Resources (NCRR), National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), University of Pennsylvania
Showing 20 of 93 trials
Page 1 / 5

Organizations

Research & Development (78)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit393051995
Janssen Pharmaceutica NVFor profit8032001
Yale UniversityAcademic/Hospital8842005
National Institute on Drug Abuse (NIDA)Government7032007
Harvard UniversityAcademic/Hospital6442002
National Institute of Mental Health (NIMH)Government5022003
University of MarylandAcademic/Hospital5532002
University of PennsylvaniaAcademic/Hospital4412012
Vanderbilt UniversityAcademic/Hospital4422015
Department of Veteran AffairsGovernment3032002
ActavisFor profit2212004
Dr. Reddy's LaboratoriesFor profit2212004
Indiana UniversityAcademic/Hospital2222003
SFBC AnapharmFor profit2012004
University of BonnAcademic/Hospital2122004
Albany Medical CollegeAcademic/Hospital1012005
Anhui Medical UniversityAcademic/Hospital1112025
Brain & Behavior Research FoundationAcademic/Hospital1012005
Bristol-Myers SquibbFor profit1112010
Brown UniversityAcademic/Hospital1112004
78 organizations
Page 1 / 4

Marketing (29)

OrganizationOrg typeRelationshipDate
ALPHA COGNITIONFor profitMKTGJul 26, 2024
ANDA RepositoryFor profitMKTGSep 11, 2008
ActavisFor profitMKTGSep 15, 2009
ApotexFor profitMKTGSep 27, 2011
Aurobindo PharmaFor profitMKTGMar 29, 2011
Aurobindo PharmaFor profitSYNAug 5, 2016
Barr LaboratoriesFor profitMKTGAug 28, 2008
Chartwell PharmaceuticalsFor profitMKTGJul 9, 2009
Dr. Reddy's LaboratoriesFor profitMKTGSep 11, 2008
Heritage PharmaFor profitMKTGJul 9, 2009
HikmaFor profitMKTGJan 30, 2009
HikmaFor profitSYNJan 30, 2009
Impax LaboratoriesFor profitMKTGMay 27, 2009
Johnson and JohnsonFor profitNDA2Feb 28, 2001
Johnson and JohnsonFor profitNDAFeb 28, 2001
MylanFor profitMKTGAug 28, 2008
NovartisFor profitMKTGJun 22, 2009
PHARMOBEDIENTFor profitMKTGAug 28, 2008
RanbaxyFor profitMKTGAug 28, 2007
SandozFor profitMKTGJun 22, 2009
Senores PharmsFor profitMKTGSep 11, 2008
Sun PharmaceuticalsFor profitMKTGFeb 2, 2011
Sun PharmaceuticalsFor profitSYNAug 28, 2007
Sun PharmaceuticalsFor profitSYNFeb 2, 2011
TevaFor profitMKTGJul 9, 2009
Watson PharmaceuticalsFor profitMKTGMar 30, 2007
West-Ward PharmaceuticalFor profitMKTGJan 30, 2009
Yabao Pharmaceutical GroupFor profitMKTGFeb 6, 2009
Zydus Discovery DMCCFor profitMKTGFeb 17, 2011