Drugs / Rivastigmine
Rivastigmine
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | EXELON | — | 2006-06-27 – 2013-06-27 | fda.gov ↗ |
| Approved | US (FDA) | EXELON | — | 2000-04-21 | fda.gov ↗ |
| Approved | EU (EMA) | Exelon | — | 1998-05-11 | europa.eu ↗ |
Trials 61
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04366518 | Jul 2021 → Aug 2032 expected | psychotic disorder | Yale University | Recruiting | No outcome recorded |
| Phase 0 | NCT03915626 | Oct 2019 → May 2021 | — | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 14 trials · 1 met primary | ||||||
| Phase 1 | NCT03573050 | May → Jul 2018 | — | SocraTec R&D GmbH | Completed | Met primary |
| Phase 1 | NCT00766363 | Oct 2008 → Mar 2009 | Alzheimer disease | FORUM Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00158210 | May 2006 → Mar 2007 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00223691 | Mar 2002 → Jan 2017 | autonomic nervous system disorder, orthostatic hypotension | Vanderbilt University | Completed | Mixed |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01084135 | Nov 2009 → Feb 2014 | Down syndrome | Duke University | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06382649 | Jun 2026 → Nov 2028 expected | poisoning | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06399679 | Nov 2024 → Nov 2028 | poisoning | Washington University School of Medicine | Suspended | No outcome recorded |
| Phase 318 trials · 2 missed | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01670526 | Dec 2012 → Jun 2016 | cognitive impairment with or without cerebellar ataxia, traumatic brain injury | VA Office of Research and Development | Completed | Missed primary |
| Phase 3 | NCT01614886 | Jul 2012 → May 2014 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01399125 | Jul 2011 → May 2013 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01487317 | Jun 2011 → Aug 2015 | delirium | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT00599287 | Feb → May 2008 | delirium | UMC Utrecht | Terminated | No outcome recorded |
| Phase 3 | NCT00623103 | Jan 2008 → Nov 2010 | Parkinson disease | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00506415 | Jun 2007 → May 2011 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00428389 | Jan 2007 → Feb 2008 | Alzheimer disease | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00423085 | Jan 2007 → Mar 2009 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00257868 | Jan 2006 → Jul 2007 | delirium | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 3 | NCT00099242 | Nov 2003 → Jan 2006 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00219232 | Feb 2003 → Jul 2006 | Alzheimer disease | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00134953 | Jan 2003 → May 2004 | cognitive disorder | Novartis | Terminated | No outcome recorded |
| Phase 3 | NCT00171795 | Nov 2002 → May 2005 | traumatic brain injury | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00130338 | Feb 2002 → May 2006 | vascular dementia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00099216 | Aug 2001 → Nov 2005 | vascular dementia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00000174 | — | Alzheimer disease | Novartis | Completed | Missed primary |
| Phase 429 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07545382 | Dec 2025 → Apr 2026 | acute tricyclic antidepressant poisoning, delirium, drug-induced mental disorder | Alexandria University | Completed | No outcome recorded |
| Phase 4 | NCT03454646 | Jun 2024 → Apr 2027 expected | Alzheimer disease | University Hospital, Bordeaux | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05768126 | Sep 2021 → Dec 2025 | depressive disorder | UMC Utrecht | Unknown | No outcome recorded |
| Phase 4 | NCT03840837 | May 2019 → Apr 2020 | Parkinson disease | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT02989402 | Dec 2018 → Dec 2022 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02703636 | May 2016 → May 2018 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02444637 | Apr 2015 → Mar 2019 | Alzheimer disease, stroke disorder | National Neuroscience Institute | Completed | No outcome recorded |
| Phase 4 | NCT01948791 | Aug 2014 → Sep 2015 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01856738 | Nov 2013 → Sep 2018 | Parkinson disease | Amsterdam UMC, location VUmc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02413554 | Apr 2013 → Mar 2014 | delirium | Chung-Ang University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01585272 | Aug 2012 → Jun 2015 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01529619 | Mar 2012 → Dec 2013 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01047579 | Apr 2010 → Jan 2012 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00988117 | Apr 2010 → Apr 2011 | Parkinson disease | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT00948766 | Jul 2009 → Jan 2012 | Alzheimer disease | Novartis | Completed | Met primary |
| Phase 4 | NCT00881205 | Apr 2009 → Jan 2011 | cognitive disorder, multiple sclerosis | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00835159 | Dec 2008 → Jul 2010 | delirium | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT00704301 | Nov 2008 → Apr 2010 | delirium | UMC Utrecht | Terminated | Missed primary |
| Phase 4 | NCT00731224 | Jul 2008 → Oct 2011 | Alzheimer disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00622713 | Jan 2008 → Jan 2009 | Alzheimer disease | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00561392 | Nov 2007 → Nov 2008 | Alzheimer disease | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00549601 | Sep 2007 → Apr 2009 | Alzheimer disease | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00669344 | Feb 2006 → Apr 2007 | cognitive disorder | Singapore General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00102856 | Jan 2005 → Jun 2006 | — | University Hospital Muenster | Suspended | No outcome recorded |
| Phase 4 | NCT00102284 | Mar 2004 → Apr 2005 | — | University Hospital Muenster | Terminated | No outcome recorded |
| Phase 4 | NCT00234637 | Nov 2003 → Jun 2005 | Alzheimer disease | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00104442 | Oct 2003 → Apr 2006 | Alzheimer disease | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00219245 | Nov 2002 → Jan 2005 | traumatic brain injury | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00018278 | Oct 1998 → Sep 2001 | Alzheimer disease | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT03957174 | Jun 2019 → Jun 2020 | — | University of Oxford | Completed | No outcome recorded |
| — | NCT02063269 | Feb 2014 → Jun 2017 | Alzheimer disease | Seoul National University Hospital | Unknown | No outcome recorded |
| — | NCT01362686 | Apr 2011 → Oct 2015 | Alzheimer disease | Indiana University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00748007 | Jan 2008 → Dec 2009 | Down syndrome | National Taiwan University Hospital | Completed | No outcome recorded |
| — | NCT00627848 | Mar 2007 → Dec 2008 | Alzheimer disease | Kuopio University Hospital | Completed | No outcome recorded |
| Comparator or background therapy27 trials | ||||||
| Phase 0 | NCT07208344 Background | Jul → Dec 2025 overdue | Alzheimer disease | Anhui Provincial Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT01073319 Comparator | Jul 2009 → Jul 2010 | amphetamine abuse, methamphetamine dependence | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01030692 Comparator | Jan 2009 → Jun 2014 | cocaine abuse, cocaine dependence | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1/2 | NCT04189666 Comparator | Nov 2019 → Apr 2020 | delirium | Ain Shams University | Completed | No outcome recorded |
| Phase 2 | NCT06537076 Background | Jan 2024 → Dec 2025 overdue | Lewy body dementia | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT01852110 Background | Oct 2013 → Apr 2016 | Alzheimer disease | Merck Sharp & Dohme LLC | Terminated | Missed primary |
| Phase 2 | NCT01677754 Background | Oct 2012 → Jun 2015 | Alzheimer disease | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2 | NCT00522015 Comparator | Feb 2008 → Dec 2009 | dementia, progressive supranuclear palsy | University Hospital Tuebingen | Unknown | No outcome recorded |
| Phase 3 | NCT05564169 Background | Jun 2026 → Dec 2028 expected | Alzheimer disease | AB Science | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04226248 Comparator | Jan 2020 → May 2024 | Parkinson disease | University of Bristol | Completed | No outcome recorded |
| Phase 3 | NCT02839642 Comparator | Jul 2016 → Jun 2022 | progressive supranuclear palsy | Assistance Publique Hopitaux De Marseille | Completed | No outcome recorded |
| Phase 3 | NCT01872598 Background | Jan 2012 → Dec 2020 | Alzheimer disease | AB Science | Completed | No outcome recorded |
| Phase 3 | NCT01183806 Background | Jul 2010 → Jan 2012 | Alzheimer disease | Federal University of Bahia | Completed | No outcome recorded |
| Phase 3 | NCT02035982 Comparator | Jul 2010 → May 2014 | Alzheimer disease | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 3 | NCT00767091 Comparator | Mar 2009 → Dec 2011 | Parkinson disease, dementia | University Hospital, Lille | Completed | No outcome recorded |
| Phase 4 | NCT02670161 Comparator | May 2016 → Dec 2026 expected | Parkinson disease, brain neoplasm, cognitive impairment with or without cerebellar ataxia, epilepsy +6 | Endeavor Health | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT01519271 Comparator | Dec 2011 → Jun 2014 | Parkinson disease, cognitive impairment with or without cerebellar ataxia | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT01348282 Comparator | May 2011 → Mar 2014 | HIV infectious disease, cognitive disorder | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 4 | NCT01340885 Comparator | Jan 2011 → Jan 2013 | Parkinson disease | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 4 | NCT01025466 Comparator | Dec 2008 → Nov 2009 | Alzheimer disease | Inha University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00305903 Background | Mar 2006 → Aug 2007 | Alzheimer disease | Novartis | Completed | No outcome recorded |
| — | NCT04732182 Background | Feb → Dec 2022 | Alzheimer disease | Bright Cloud International Corp | Unknown | No outcome recorded |
| — | NCT03959124 Background | Apr → Sep 2020 | Alzheimer disease | Buddhist Tzu Chi General Hospital | Unknown | No outcome recorded |
| — | NCT05102045 Background | Sep 2016 → May 2017 | Alzheimer disease | Istanbul Medipol University Hospital | Completed | No outcome recorded |
| — | NCT01380288 Comparator | Jun 2011 → Dec 2016 | Alzheimer disease | Dong-A University | Completed | No outcome recorded |
| — | NCT01602198 Comparator | Jun 2011 → Jan 2013 | cognitive disorder, cognitive impairment with or without cerebellar ataxia | The Cleveland Clinic | Terminated | No outcome recorded |
| — | NCT00624663 Comparator | Jan → Apr 2009 | poisoning | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2020-08-18 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for 4 Generic Drugs with 13 Strengths upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 4 generic drugs with 13 strengths. |
| 2019-03-05 | Zydus Lifesciences Limited | Regulatory Zydus receives USFDA approval for its first transdermal product, Rivastigmine Transdermal System zyduslife.com ↗
Zydus Cadila has received the approval from the USFDA to market Rivastigmine Transdermal System (US RLD – EXELON® PATCH), 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, marking its first approval for a transdermal product in the US . |
| 2019-01-14 | Impax Laboratories, LLC | Regulatory Amneal Announces Approval of Rivastigmine Transdermal System amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of Exelon ® Patch (Rivastigmine Transdermal System), 4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours. |
| 2013-04-04 | Hisamitsu Pharmaceutical Co., Inc. | Regulatory Noven Pharmaceuticals,Inc.プレスリリ－ス:Noven社がEXELON®（リバスチグミン経皮システム）のジェネリック医薬品の略式新薬承認申請の提出を発表 hisamitsu.co.jp ↗
NOVEN CONFIRMS FILING OF ABBREVIATED NEW DRUG APPLICATION FOR GENERIC VERSION OF EXELON® (RIVASTIGMINE TRANSDERMAL SYSTEM) |
| 2013-04-03 | Noven Therapeutics | Regulatory Noven Confirms Filing of Abbreviated New Drug Application for Generic Version of Exelon® (Rivastigmine Transdermal System) noven.com ↗ |
| 2007-10-23 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval to market generic Exelon® Capsules sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company’s Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Exelon®, rivastigmine tartrate capsules. |
All press releases naming this drug 15 releases
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 89 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rivastigmine | “1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day.” NCT01614886 ↗81“stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine, as per standard practice.” NCT01872598 ↗ “Rivastigmine is a reversible cholinesterase inhibitor indicated for the treatment of all stages of Alzheimer's disease (AD).” PMID 35696054 ↗ Jun 2022 “Rivastigmine: 9.5 or 13.3 mg/24 hours, administered by transdermal patch; or 6-12 mg total daily dose administered orally” NCT01852110 ↗ “Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.” NCT05102045 ↗ “Cholinesterase inhibitors (donepezil, rivastigmine or galantamine) and/or memantine” NCT05564169 ↗ “mild cognitive impairment (donepezil, rivastigmine, memantine)” NCT02670161 ↗ “Rivastigmine - 1.5 mg and 3 mg” NCT02035982 ↗ |
| Known as | ENA713 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01948791 ↗ |
| Known as | ENA713D | “A 24-week, Multicenter, Parallel-group, Randomized,Double-blind Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Methods of Rivastigmine Patch...” NCT01614886 ↗ |
| Known as | Excelon | “Rivastigmine (Excelon) as a Potential Medication for Methamphetamine Abuse” NCT00158210 ↗ |
| Known as | Exelon | “This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive...” NCT01519271 ↗8“Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and memory or thinking problems...” NCT00988117 ↗ “Participant takes 10 mg of Aricept daily or wears an Exelon 9.5 mg patch and is stable on one of these medications that were prescribed for diagnostic of early Alzheimer's Disease” NCT04732182 ↗ “A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease” NCT01047579 ↗ “Alzheimer's disease patients take medications including Exelon (Rivastigmine Tartrate), Witgen (Memantine) for at least 3 months without plan of dosage adjustment” NCT03959124 ↗ “Exelon® [Rivastigmine] transdermal patch” NCT01602198 ↗ “Exelon (rivastigmine)” NCT00669344 ↗ |
| Known as | Exelon tartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Nimvastid | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | ONO-2540 | “A 24-week, Multicenter, Parallel-group, Randomized,Double-blind Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Methods of Rivastigmine Patch...” NCT01614886 ↗ |
| Known as | Prometax | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmina | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmine 1 a pharma | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmine 3m health care ltd | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmine actavis | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmine bitartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmine hexal | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmine hydrogen tartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmine sandoz | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | Rivastigmine Tartrate | “Alzheimer's disease patients take medications including Exelon (Rivastigmine Tartrate), Witgen (Memantine) for at least 3 months without plan of dosage adjustment” NCT03959124 ↗ |
| Known as | Rivastigmine teva | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | SDZ-212-713 | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Known as | SDZ-ENA-713 | ChEMBL registry synonym — accepted as the source's own label CHEMBL636 ↗ |
| Action | Inhibit | “Rivastigmine is an acetylcholinesterase inhibitor” NCT00158210 ↗ |
| Modality | Small molecule | “Rivastigmine is a carbamate” NCT00624663 ↗ |
| Route | Oral | “rivastigmine 1.5m-1.5mg-1.5mg (oral solution)” NCT00257868 ↗ |