galantamine
Trade name: reminyl
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
Earliest trial started Aug 1, 1995 (NCT00338117)
Timeline
1990s
- Jan 1, 1995
Johnson and Johnson — Earliest Phase 3 Sponsor(trial)
2000s
- Feb 28, 2001
Johnson and Johnson — Earliest FDA Approval
- Feb 28, 2001
Johnson and Johnson — NDA Secondary Org
- Feb 28, 2001
Johnson and Johnson — NDA Organization
- Jan 1, 2003
Johnson and Johnson — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2004
Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)
- Mar 30, 2007
Watson Pharmaceuticals — Marketing Organization
- Aug 28, 2007
Ranbaxy — Marketing Organization
- Aug 28, 2008
Barr Laboratories — Marketing Organization
- Aug 28, 2008
Mylan — Marketing Organization
- Aug 28, 2008
PHARMOBEDIENT — Marketing Organization
- Sep 11, 2008
Dr. Reddy's Laboratories — Marketing Organization
- Sep 11, 2008
ANDA Repository — Marketing Organization
- Sep 11, 2008
Senores Pharms — Marketing Organization
- Jan 30, 2009
West-Ward Pharmaceutical — Marketing Organization
- Jan 30, 2009
Hikma — Marketing Organization
- Feb 6, 2009
Yabao Pharmaceutical Group — Marketing Organization
- May 27, 2009
Impax Laboratories — Marketing Organization
- Jun 22, 2009
Sandoz — Marketing Organization
- Jun 22, 2009
Novartis — Marketing Organization
- Jul 9, 2009
Teva — Marketing Organization
- Jul 9, 2009
Heritage Pharma — Marketing Organization
- Jul 9, 2009
Chartwell Pharmaceuticals — Marketing Organization
- Sep 15, 2009
Actavis — Marketing Organization
2010s
- Feb 2, 2011
Sun Pharmaceuticals — Marketing Organization
- Feb 17, 2011
Zydus Discovery DMCC — Marketing Organization
- Mar 29, 2011
Aurobindo Pharma — Marketing Organization
- Sep 27, 2011
Apotex — Marketing Organization
2020s
- Jul 26, 2024
ALPHA COGNITION — Marketing Organization
Indications
Studied for
- AIDS Dementia Complex · Phase 2
- Alzheimer Disease · Phase 4
- Anxiety Disorders · Phase 3
- Attention Deficit Disorder with Hyperactivity · Phase 4
- Autism Spectrum Disorder · Phase 3
- Autistic Disorder · Phase 3
- Bipolar Disorder · Phase 4
- Brain Diseases · Phase 3
- Brain Injuries, Traumatic · Phase 2
- Buprenorphine · Early Phase 1
- Cholinesterase Inhibitors · Phase 4
- Cocaine-Related Disorders · Phase 2
- Cognition Disorders · Phase 3
- Cognitive Dysfunction · Phase 2
- Dementia · Phase 4
- Dementia, Vascular · Phase 3
- Depression · Phase 4
- Endothelial Cells · Phase 1/Phase 2
- Fasting · Phase 1
- Frontotemporal Dementia · Phase 2
- Galantamine · Phase 4
- Genetic Diseases, Inborn · Phase 2
- Head Injuries, Closed · Phase 4
- Healthy Volunteers · Phase 1
- Hypertension · Phase 4
- Insulin Resistance · Phase 1
- Ischemic Stroke · Phase 2/Phase 3
- Lewy Body Disease · Phase 3
- Memory · Phase 1
- Memory Disorders · Phase 4
- Mental Disorders · Phase 3
- Nervous System Diseases · Phase 3
- Obesity · Phase 1/Phase 2
- Oxidative Stress · Phase 1
- Pharmacokinetics · Phase 1
- Post-Traumatic Headache · Phase 4
- Postural Orthostatic Tachycardia Syndrome · Phase 1
- Psychophysiologic Disorders · Phase 3
- Psychotic Disorders · Phase 4
- Schizophrenia · Phase 4
- Smoking · Phase 1
- Stress Disorders, Post-Traumatic · Phase 2
- Stroke · Phase 4
- Subarachnoid Hemorrhage · Phase 1/Phase 2
- Substance Withdrawal Syndrome · Phase 1
- Tardive Dyskinesia · Phase 4
- Tic Disorders · Phase 4
- Tobacco Use Disorder · Phase 2
- Tourette Syndrome · Phase 4
Mechanism of action
- AcetylcholinesteraseINHIBITOR
ACHE inhibitor
Approval history
- approvedFeb 28, 2001
Chemistry & pharmacology
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
- ChEMBLCHEMBL659 ↗
- WikipediaGalantamine ↗
- NCATS0D3Q044KCA ↗
- ChEMBLCHEMBL6068431 ↗
- ChEMBLCHEMBL1555 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07284290 | Phase 4 | Jan 25, 2026 | National Institute of Neurological Disorders and Stroke (NINDS), Virginia Commonwealth University |
| NCT07003386 | Phase 2/Phase 3 (Phase 3) | Sep 15, 2025 | Shanghai University of Traditional Chinese Medicine |
| NCT07208344 | Early Phase 1 (Phase 1) | Jul 31, 2025 | Anhui Medical University |
| NCT04769206 | Phase 1/Phase 2 (Phase 2) | Jan 31, 2022 | Vanderbilt University |
| NCT03547622 | Early Phase 1 (Phase 1) | May 1, 2018 | Yale University |
| NCT03454646 | Phase 4 | Mar 15, 2018 | University of Bordeaux |
| NCT03384784 | Phase 2 | Oct 30, 2017 | National Institute on Drug Abuse (NIDA), University of Pennsylvania |
| NCT03124355 | Phase 1 | May 1, 2017 | Vanderbilt University |
| NCT03014323 | Phase 1 | Jan 1, 2017 | Vanderbilt University |
| NCT02872857 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2016 | University of Texas at Houston |
| NCT02365285 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2015 | Doris Duke Charitable Foundation, Vanderbilt University |
| NCT02374567 | Phase 3 | Jan 1, 2015 | Gottfried Wilhelm Leibniz Universität Hannover |
| NCT02234752 | Phase 2 | Sep 1, 2014 | Sheppard Pratt Health System |
| NCT02420327 | N/A | Sep 1, 2014 | University of Maryland |
| NCT02283242 | Phase 4 | Mar 1, 2014 | Feinstein Institute for Medical Research, University of Nove de Julho, University of Sao Paulo |
| NCT02098824 | Phase 2/Phase 3 (Phase 3) | Feb 1, 2014 | Free University of Amsterdam, University of Amsterdam |
| NCT01880099 | N/A | Dec 1, 2013 | Yale University |
| NCT01845961 | Phase 2 | Jan 1, 2013 | University of Pennsylvania |
| NCT01677754 | Phase 2 | Oct 24, 2012 | Roche |
| NCT01669538 | Phase 2 | Aug 1, 2012 | National Cancer Institute (NCI), National Center for Research Resources (NCRR), National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), University of Pennsylvania |
Organizations
Research & Development (78)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Johnson and Johnson | For profit | 39 | 30 | 5 | 1995 |
| Janssen Pharmaceutica NV | For profit | 8 | 0 | 3 | 2001 |
| Yale University | Academic/Hospital | 8 | 8 | 4 | 2005 |
| National Institute on Drug Abuse (NIDA) | Government | 7 | 0 | 3 | 2007 |
| Harvard University | Academic/Hospital | 6 | 4 | 4 | 2002 |
| National Institute of Mental Health (NIMH) | Government | 5 | 0 | 2 | 2003 |
| University of Maryland | Academic/Hospital | 5 | 5 | 3 | 2002 |
| University of Pennsylvania | Academic/Hospital | 4 | 4 | 1 | 2012 |
| Vanderbilt University | Academic/Hospital | 4 | 4 | 2 | 2015 |
| Department of Veteran Affairs | Government | 3 | 0 | 3 | 2002 |
| Actavis | For profit | 2 | 2 | 1 | 2004 |
| Dr. Reddy's Laboratories | For profit | 2 | 2 | 1 | 2004 |
| Indiana University | Academic/Hospital | 2 | 2 | 2 | 2003 |
| SFBC Anapharm | For profit | 2 | 0 | 1 | 2004 |
| University of Bonn | Academic/Hospital | 2 | 1 | 2 | 2004 |
| Albany Medical College | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Anhui Medical University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Brain & Behavior Research Foundation | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Bristol-Myers Squibb | For profit | 1 | 1 | 1 | 2010 |
| Brown University | Academic/Hospital | 1 | 1 | 1 | 2004 |
Marketing (29)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ALPHA COGNITION | For profit | MKTG | Jul 26, 2024 |
| ANDA Repository | For profit | MKTG | Sep 11, 2008 |
| Actavis | For profit | MKTG | Sep 15, 2009 |
| Apotex | For profit | MKTG | Sep 27, 2011 |
| Aurobindo Pharma | For profit | MKTG | Mar 29, 2011 |
| Aurobindo Pharma | For profit | SYN | Aug 5, 2016 |
| Barr Laboratories | For profit | MKTG | Aug 28, 2008 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 9, 2009 |
| Dr. Reddy's Laboratories | For profit | MKTG | Sep 11, 2008 |
| Heritage Pharma | For profit | MKTG | Jul 9, 2009 |
| Hikma | For profit | MKTG | Jan 30, 2009 |
| Hikma | For profit | SYN | Jan 30, 2009 |
| Impax Laboratories | For profit | MKTG | May 27, 2009 |
| Johnson and Johnson | For profit | NDA2 | Feb 28, 2001 |
| Johnson and Johnson | For profit | NDA | Feb 28, 2001 |
| Mylan | For profit | MKTG | Aug 28, 2008 |
| Novartis | For profit | MKTG | Jun 22, 2009 |
| PHARMOBEDIENT | For profit | MKTG | Aug 28, 2008 |
| Ranbaxy | For profit | MKTG | Aug 28, 2007 |
| Sandoz | For profit | MKTG | Jun 22, 2009 |
| Senores Pharms | For profit | MKTG | Sep 11, 2008 |
| Sun Pharmaceuticals | For profit | MKTG | Feb 2, 2011 |
| Sun Pharmaceuticals | For profit | SYN | Aug 28, 2007 |
| Sun Pharmaceuticals | For profit | SYN | Feb 2, 2011 |
| Teva | For profit | MKTG | Jul 9, 2009 |
| Watson Pharmaceuticals | For profit | MKTG | Mar 30, 2007 |
| West-Ward Pharmaceutical | For profit | MKTG | Jan 30, 2009 |
| Yabao Pharmaceutical Group | For profit | MKTG | Feb 6, 2009 |
| Zydus Discovery DMCC | For profit | MKTG | Feb 17, 2011 |