Drugs / Galantamine
last change Jun 2026 re-read 8 days ago

Galantamine

Small molecule targets ACHE via inhibition

Developed for
Alzheimer disease · schizophrenia · dementia · bipolar disorder · schizoaffective disorder · cognitive disorder · depressive disorder · mental disorder
+25 more · nicotine dependence · vascular dementia · abdominal obesity-metabolic syndrome · AIDS dementia complex · attention deficit-hyperactivity disorder · autism · cocaine dependence · frontotemporal dementia · ischemic stroke · Lewy body dementia · metabolic syndrome X · obesity disorder · Parkinson disease · postural orthostatic tachycardia syndrome · stroke disorder · subarachnoid hemorrhage · tardive dyskinesia · Tourette syndrome · traumatic encephalopathy · aphasia · cocaine abuse · post-traumatic stress disorder · substance dependence · substance withdrawal syndrome · traumatic brain injury
Investigated by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Ortho-McNeil Neurologics, Inc. · National Institute of Mental Health (NIMH) · University of Maryland, Baltimore · Vanderbilt University Medical Center · Janssen Korea, Ltd., Korea
+56 more · Janssen Pharmaceutical K.K. · Massachusetts General Hospital · National Institute on Drug Abuse (NIDA) · University of Pennsylvania · Indiana University · Janssen-Cilag Farmaceutica Ltda. · Xian-Janssen Pharmaceutical Ltd. · Yale University · Agency for Healthcare Research and Quality (AHRQ) · Bronx Veterans Medical Research Foundation, Inc · Cambridge Health Alliance · Caroff, Stanley N., M.D. · Charite University, Berlin, Germany · Doris Duke Charitable Foundation · Duke University · Federal Ministry of Health, Germany · Feinstein Institute for Medical Research · Georgetown University · German Federal Ministry of Education and Research · Hannover Medical School · Icahn School of Medicine at Mount Sinai · Janssen Medical Affairs · Janssen Pharmaceutica N.V., Belgium · Janssen Research & Development, LLC · Janssen, LP · Janssen-Cilag S.p.A. · Janssen-Cilag, S.A. · Kessler Institute for Rehabilitation · Memorial Hospital of Rhode Island · National Alliance for Autism Research · National Alliance for Research on Schizophrenia and Depression · National Cancer Institute (NCI) · National Center for Research Resources (NCRR) · National Institutes of Health (NIH) · Neurological Research Center · North Suffolk Mental Health Association · Northwell Health · Northwestern University · Parkinson's Disease and Movement Disorders Center · Rapoport, Alan, M.D. · Samsung Medical Center · Seattle Institute for Biomedical and Clinical Research · Shanghai Yueyang Integrated Medicine Hospital · Sheppard Pratt Health System · Shire · Stanley Medical Research Institute · The University of Texas Health Science Center, Houston · University Hospital, Bonn · University Hospital, Bordeaux · University Hospital, Clermont-Ferrand · University of Medicine and Dentistry of New Jersey · University of Nove de Julho · University of Pittsburgh · University of Sao Paulo · VA Office of Research and Development · Washington D.C. Veterans Affairs Medical Center

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) RAZADYNE — 2001-02-28 fda.gov ↗

Trials 71 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT03124355 Sep 2017 → Jun 2027 expected postural orthostatic tachycardia syndrome Vanderbilt University Medical Center Active not recruiting No outcome recorded
Phase 1 NCT03014323 Jan 2017 → Nov 2018 — Vanderbilt University Medical Center Withdrawn No outcome recorded Stop: Business
Phase 1 NCT00750529 Nov 2008 → Sep 2013 Alzheimer disease University Hospital, Clermont-Ferrand Completed No outcome recorded
Phase 1 NCT00645554 ? → Sep 2004 — Xian-Janssen Pharmaceutical Ltd. Completed No outcome recorded
Phase 1/23 trials · 1 met primary
Phase 1/2 NCT04769206 Dec 2021 → May 2027 expected — Vanderbilt University Medical Center Recruiting No outcome recorded
Phase 1/2 NCT02872857 Sep 2016 → Jul 2019 subarachnoid hemorrhage The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 1/2 NCT02365285 Mar 2015 → Oct 2017 obesity disorder Vanderbilt University Medical Center Completed Met primary
Phase 28 trials · 1 met primary
Phase 2 NCT03384784 Oct 2017 → May 2022 AIDS dementia complex University of Pennsylvania Completed No outcome recorded
Phase 2 NCT02234752 Sep 2014 → Jul 2016 schizoaffective disorder, schizophrenia Sheppard Pratt Health System Terminated No outcome recorded Stop: Business
Phase 2 NCT01669538 Aug 2012 → Nov 2017 nicotine dependence University of Pennsylvania Completed No outcome recorded
Phase 2 NCT01548638 Feb → Aug 2012 nicotine dependence University of Pennsylvania Completed No outcome recorded
Phase 2 NCT01100775 May 2010 → Aug 2014 schizophrenia University of Maryland, Baltimore Completed Mixed
Phase 2 NCT00809835 Dec 2007 → Jan 2015 cocaine dependence Yale University Completed Met primary
Phase 2 NCT00509067 Nov 2007 → Mar 2011 schizophrenia Georgetown University Completed No outcome recorded
Phase 2 NCT00416169 May 2003 → Jul 2004 frontotemporal dementia Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT07625332 Jun 2026 → Jun 2027 expected metabolic syndrome X, spinal cord injury Northwell Health Recruiting No outcome recorded
Phase 2/3 NCT07003386 Sep 2025 → Sep 2028 expected ischemic stroke Shanghai Yueyang Integrated Medicine Hospital Recruiting No outcome recorded
Phase 2/3 NCT02248636 Jan 2015 → Oct 2019 dementia VA Office of Research and Development Completed No outcome recorded
Phase 2/3 NCT00463879 Sep 2005 → Sep 2007 schizophrenia Yale University Completed No outcome recorded
Phase 324 trials · 5 met primary
Phase 3 NCT02374567 Jan 2015 → Jun 2017 anxiety disorder, dementia, depressive disorder, schizophrenia +1 Hannover Medical School Terminated No outcome recorded
Phase 3 NCT00679627 Jun 2008 → Apr 2012 Alzheimer disease Janssen Research & Development, LLC Terminated No outcome recorded
Phase 3 NCT00814801 Feb 2007 → Sep 2008 Alzheimer disease Janssen Pharmaceutical K.K. Completed Met primary
Phase 3 NCT00082602 May 2004 → Apr 2005 Alzheimer disease Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed No outcome recorded
Phase 3 NCT00252603 Apr 2004 → Apr 2007 autism University of Medicine and Dentistry of New Jersey Completed No outcome recorded
Phase 3 NCT00645190 Mar 2004 → Feb 2005 Alzheimer disease Xian-Janssen Pharmaceutical Ltd. Completed No outcome recorded
Phase 3 NCT00216593 Dec 2003 → Sep 2007 Alzheimer disease Janssen Pharmaceutica N.V., Belgium Completed Mixed
Phase 3 NCT00240695 May 2003 → May 2004 cognitive disorder, mental disorder Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed No outcome recorded
Phase 3 NCT00077727 Mar 2003 → Feb 2005 schizophrenia Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Completed No outcome recorded
Phase 3 NCT00230997 Dec 2002 → Aug 2004 Lewy body dementia Neurological Research Center Completed No outcome recorded
Phase 421 trials · 1 met primary · 4 missed
Phase 4 NCT03454646 Jun 2024 → Apr 2027 expected Alzheimer disease University Hospital, Bordeaux Not yet recruiting No outcome recorded
Phase 4 NCT02283242 Mar 2014 → Mar 2015 abdominal obesity-metabolic syndrome University of Sao Paulo Completed Met primary
Phase 4 NCT01478633 Sep 2011 → Jun 2013 Alzheimer disease Janssen Pharmaceutical K.K. Completed No outcome recorded
Phase 4 NCT01181921 May → Jun 2011 Alzheimer disease Janssen-Cilag, S.A. Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT00741598 Sep 2008 → May 2014 bipolar disorder Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 4 NCT00814658 Jun 2008 → Oct 2009 dementia Janssen-Cilag Farmaceutica Ltda. Completed Missed primary
Phase 4 NCT00369603 Oct 2006 → Oct 2007 Alzheimer disease Duke University Terminated No outcome recorded
Phase 4 NCT01054976 Oct 2006 → Feb 2009 Alzheimer disease Janssen Korea, Ltd., Korea Completed No outcome recorded
Phase 4 NCT00226824 Sep 2005 → May 2007 Tourette syndrome Parkinson's Disease and Movement Disorders Center Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT00219869 Jul → Aug 2005 brain injury, cognitive disorder, traumatic encephalopathy Rapoport, Alan, M.D. Unknown No outcome recorded
Phase not applicable7 trials
— NCT02420327 Sep 2014 → Mar 2017 — University of Maryland, Baltimore Completed No outcome recorded
— NCT01362686 Apr 2011 → Oct 2015 Alzheimer disease Indiana University Terminated No outcome recorded Stop: Enrollment
— NCT00637442 Feb 2008 → Dec 2010 Alzheimer disease University Hospital, Bonn Unknown No outcome recorded
— NCT01029132 Apr 2007 → Oct 2009 dementia Samsung Medical Center Completed No outcome recorded
— NCT00161044 Sep 2004 → Sep 2005 schizophrenia University of Maryland, Baltimore Completed No outcome recorded
— NCT00211588 Jun 2004 → May 2007 Parkinson disease Memorial Hospital of Rhode Island Unknown No outcome recorded
— NCT00181636 ? → Oct 2006 bipolar disorder Massachusetts General Hospital Completed No outcome recorded
Comparator or background therapy23 trials
Phase 0 NCT07208344 Background Jul → Dec 2025 overdue Alzheimer disease Anhui Provincial Hospital Recruiting No outcome recorded
Phase 0 NCT03547622 Comparator May 2018 → Feb 2019 — Yale University Completed No outcome recorded
Phase 1 NCT01417429 Comparator Mar 2010 → Mar 2011 substance withdrawal syndrome Yale University Completed No outcome recorded
Phase 1 NCT01039194 Comparator Jan → Apr 2010 Alzheimer disease Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT00969696 Comparator Aug 2009 → Jun 2011 — Yale University Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2020-02-17 Upsher-Smith Laboratories Regulatory Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 15 generic drugs with 31 strengths.
2011-02-03 Sun Pharmaceutical Industries, Inc. Regulatory Sun Pharma announces USFDA approval for generic Razadyne® ER sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Razadyne® ER, galantamine hydrobromide extended-release capsules.
2007-08-30 Sun Pharmaceutical Industries, Inc. Regulatory USFDA grants tentative approval for Sun Pharma's ANDA for Galantamine tablets sunpharma.com ↗
USFDA has granted tentative approval for the company’s Abbreviated New Dr ug Application (ANDA) for generic Razadyne tm, galantamine tablets.

All press releases naming this drug 3 releases

DateIssuerRelease

Evidence & citations 39 cited values

Every value below carries the sentence it was read from. 97 sources stand behind the page.

FieldValueCited text
Known as Galantamine “The investigators will identify Veterans who have been taking a cholinesterase inhibitor (CI) (donepezil or galantamine) for at least one year.” NCT02248636 ↗
90

“stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine, as per standard practice.” NCT01872598 ↗

“with either galantamine hydrobromide (AChEI + nicotinic receptor modulation) or donepezil hydrochloride (AChEI only)” NCT00369603 ↗

“Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.” NCT05102045 ↗

“Cholinesterase inhibitors (donepezil, rivastigmine or galantamine) and/or memantine” NCT05564169 ↗

“Galantamine: 16-24 mg total daily dose, administered orally” NCT01852110 ↗

“Galantamine - 8 mg and 16 mg and 24 mg” NCT02035982 ↗

NCT07003386 ↗

NCT00741598 ↗

NCT02283242 ↗

NCT01029132 ↗

Show 80 more sources

Known as (-)-galanthamine ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Acumor xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Consion xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Elmino xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as GAL “The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life” NCT00814658 ↗
Known as Galantamina ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as galantamine HBr “Galantamine HBr, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase” NCT00181675 ↗
1

“Galantamine HBr extended-release 8mg capsules (8mg ER).” NCT07284290 ↗

Known as galantamine hydrobromide “Study medications will be given as a single dose before the Day 2 session which will produce ascending plasma drug levels (t= ½ 5/7 h) during the two hour testing session, in a...” NCT00463879 ↗
2

“The purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimer's disease.” NCT00216593 ↗

“with either galantamine hydrobromide (AChEI + nicotinic receptor modulation) or donepezil hydrochloride (AChEI only)” NCT00369603 ↗

Known as galantamine hydrobromide-ER “The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.” NCT01548638 ↗
Known as galantamine hydrochloride “The proposed study will entail a comprehensive evaluation of the effects of acute doses of the nAChR allosteric modulator galantamine hydrochloride (0, 4 and 8 mg) on...” NCT00463879 ↗
Known as Galantamine-CR “The purpose of the study is to determine whether the investigational drug galantamine-CR (Reminyl- Controlled Release capsule) is useful in improving problems with memory in...” NCT00181636 ↗
Known as Galantamine-ER “Galantamine-ER for cognitive dysfunction in bipolar disorder and correlation with hippocampal neuronal viability: a proof-of-concept study.” PMID 19889129 ↗ 2009
1

“Drug: Galantamine ER” NCT01548638 ↗

Known as Galanthamine hydrobromide ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Galsya xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Galzemic xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Gatalin xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Gazylan xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Jilkon hydrobromide ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Lotprosin xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Luventa xl ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Lycoremine hydrobromide ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Nivalin ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as Nivaline ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗
Known as NSC-100058 ChEMBL registry synonym — accepted as the source's own label CHEMBL659 ↗