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Exelon

(Rivastigmine)

ApprovedSmall molecule

Rivastigmine is used to treat memory loss and thinking problems in people with Alzheimer's disease or Parkinson's disease by helping to preserve a chemical in the brain that is important for memory and learning.[2] Exelon is currently approved and in use across 13 indications[4].[1]

Exelon is one of 299 small molecule programs targeting Delirium. It is currently in Approved.

13

Indications

63

Total Trials

3

Active Trials

298

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

DeliriumCompleted

Lewy Body DementiaApproved

Substance AbuseApproved

Neurobehavioral ManifestationsApproved

Drug DependenceApproved

DementiaCompleted

Parkinson DiseaseCompleted

Brain InjuryCompleted

Cognitive ImpairmentTerminated

CognitionCompleted

DeliriumApproved

Completed

Lewy Body DementiaApproved

Approved

Substance AbuseApproved

Approved

Neurobehavioral ManifestationsApproved

Approved

Drug DependenceApproved

Approved

DementiaApproved

Completed

Parkinson DiseaseApproved

Completed

Brain InjuryApproved

Completed

Cognitive ImpairmentApproved

Terminated

CognitionApproved

Completed

Showing 10 of 13 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Exelon

Dexilant

Niclocide

Alfenta

Jazz Pharmaceuticals

Hivid

CConrado Roberto Hoffmann Filho

Valium

Akero Therapeutics

Barhemsys

Tibotec Pharmaceuticals, Ireland

Norpramin

VValidus Pharmaceuticals

Lotemax

Clomid

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Delirium

NCT06399679

Clinical

Trials by Indication[1]

Alzheimer's Disease15 trials

Study of the Effects of Current Drug Treatments on Levels of Certain Brain Chemicals in Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 4·NCT00104442·80 enrolled

Comparative Research of Alzheimer's Disease Drugs

Terminated·IIndiana University·N/A·NCT01362686·200 enrolled

Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00428389·262 enrolled

Show 12 more trials

Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 4·NCT00561392·208 enrolled

Rivastigmine in Mild Alzheimer's Disease, FMRI Study

Completed·KKuopio University Hospital·N/A·NCT00627848·20 enrolled

Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients

Completed·FFederal University of Bahia·Phase 3·NCT01183806·40 enrolled

A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 3·NCT01399125·501 enrolled

Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.

Completed· Novartis logo

Novartis·Phase 4·NCT00731224·380 enrolled

A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)

Completed· Novartis logo

Novartis·Phase 4·NCT00622713·228 enrolled

An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00219232·868 enrolled

Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00099242·1,040 enrolled

Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine

Completed·—·N/A·NCT01380288·300 enrolled

A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 4·NCT01047579·51 enrolled

Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)

Completed· Novartis logo

Novartis·Phase 3·NCT00000174

Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease

Completed·FFORUM Pharmaceuticals Inc·Phase 1·NCT00766363·49 enrolled

Delirium6 trials

Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients

Terminated·UUMC Utrecht·Phase 3·NCT00599287·80 enrolled

Rivastigmine for Intensive Care Unit (ICU) Delirium

Terminated·UUMC Utrecht·Phase 4·NCT00704301·104 enrolled

Rivastigmine in the Management of Delirium

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT01487317·23 enrolled

Show 3 more trials

Rivastigmine in the Treatment of Postoperative Delirium: a Pilot Clinical Trial

Completed·NNYU Langone Health·Phase 4·NCT00835159·30 enrolled

Rivastigmine for Antimuscarinic Delirium

Suspended·WWashington University School of Medicine·Phase 2·NCT06382649·42 enrolled

Rivastigmine to Prevent Recurrence of Antimuscarinic Delirium

Recruiting·WWashington University School of Medicine·Phase 2·NCT06399679·42 enrolled

Cognitive impairment5 trials

Efficacy and Safety of Two Pharmacologic Strategies on Neurocognitive Impairment in HIV Infection. The TRIANT-TE Study

Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 4·NCT01348282·33 enrolled

Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment

Terminated· Novartis logo

Novartis·Phase 3·NCT00134953·24 enrolled

Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment

Terminated· Novartis logo

Novartis·Phase 4·NCT00881205·86 enrolled

Show 2 more trials

Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI

Completed·VVA Office of Research and Development·Phase 3·NCT01670526·94 enrolled

Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment

Completed· Novartis logo

Novartis·Phase 3·NCT00171795·67 enrolled

Dementia3 trials

A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.

Completed· Novartis logo

Novartis·Phase 4·NCT02989402·100 enrolled

Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia

Completed·UUniversity Hospital, Lille·Phase 3·NCT00767091·40 enrolled

Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

Completed· Novartis logo

Novartis·Phase 3·NCT00623103·583 enrolled

Mild to Moderate Alzheimer's Disease3 trials

Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 4·NCT00549601·142 enrolled

Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00423085·859 enrolled

Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors

Completed· Novartis logo

Novartis·Phase 4·NCT01529619·52 enrolled

24 more indications

Vascular Dementia2 trials

Rivastigmine Capsules in Patients With Probable Vascular Dementia

Completed· Novartis logo

Novartis·Phase 3·NCT00130338·521 enrolled

Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia

Completed· Novartis logo

Novartis·Phase 3·NCT00099216·708 enrolled

Down syndrome2 trials

Efficacy of Rivastigmine in Patients With Down Syndrome

Completed·NNational Taiwan University Hospital·N/A·NCT00748007·14 enrolled

Rivastigmine Study in Adolescents With Down Syndrome

Completed·—·Phase 1/2·NCT01084135·42 enrolled

Neuromodulation2 trials

Neuromodulation and Language Acquisition (Project Stage Ia)

Terminated·UUniversity Hospital Muenster·Phase 4·NCT00102284·100 enrolled

Neuromodulation and Language Acquisition (Stage Ib)

Suspended·UUniversity Hospital Muenster·Phase 4·NCT00102856·60 enrolled

Progressive Supranuclear Palsy2 trials

Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy

Unknown status·UUniversity Hospital Tuebingen·Phase 2·NCT00522015·20 enrolled

Efficacy of RIVAstigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy

Completed·AAssistance Publique Hopitaux De Marseille·Phase 3·NCT02839642·106 enrolled

Alzheimer's Disease (AD)2 trials

Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

Completed· Novartis logo

Novartis·Phase 3·NCT00506415·1,584 enrolled

Study for the Tolerability of Exelon Patch (Rivastigmine) for Alzheimer's Disease (AD) Patients

Completed·SSeoul National University Hospital··NCT01312363·300 enrolled

Trial2 trials

Exelon Patch and Combination With Memantine Comparative Trial

Completed·IInha University Hospital·Phase 4·NCT01025466·206 enrolled

Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD

Completed·NNational Neuroscience Institute·Phase 4·NCT02444637·100 enrolled

Brain Injury1 trial

An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits

Completed· Novartis logo

Novartis·Phase 4·NCT00219245·157 enrolled

Hallucinations1 trial

Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease

Terminated·AAmsterdam UMC, location VUmc·Phase 4·NCT01856738·91 enrolled

Humans1 trial

Noradrenaline, Acetylcholine and Dynamic Learning in Healthy Humans

Completed·UUniversity of Oxford·N/A·NCT03957174·107 enrolled

Cognition1 trial

Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44

Completed· Novartis logo

Novartis·Phase 4·NCT00948766·716 enrolled

Methamphetamine Dependence1 trial

Rivastigmine as a Treatment for Methamphetamine Dependence

Completed·—·Phase 1·NCT01073319·17 enrolled

Double-blind1 trial

A Double-Blind, Placebo-controlled Crossover Study of Repeat Rivastigmine Administration in Healthy Male Volunteers

Completed·TTel-Aviv Sourasky Medical Center·N/A·NCT00624663·15 enrolled

Alzheimer disease1 trial

A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy

Completed· Roche logo

Roche·Phase 2·NCT01677754·542 enrolled

LCH1 trial

Brain Changes by Rivastigmine According to Butyrylcholinesterase Alleles

Unknown status·SSeoul National University Hospital·N/A·NCT02063269·70 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

Recruiting·YYonsei University·Phase 2·NCT06537076·60 enrolled

Cocaine Dependence1 trial

Rivastigmine and Huperzine A as Treatments for Cocaine Dependence

Completed·—·Phase 1·NCT01030692·72 enrolled

Parkinson disease1 trial

Cholinergic Neurotransmission in Mobility and Cognition in Parkinson Disease

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT03840837·31 enrolled

Post-Operative Delirium1 trial

Rivastigmine Patch Effect on the Post-operative Delirium in Patients at Risk of Dementia.

Completed·—·Phase 4·NCT02413554·62 enrolled

Treatment1 trial

Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine

Recruiting·UUMC Utrecht·Phase 4·NCT05768126·100 enrolled

Efficacy1 trial

NextStep:Study to Evaluate Safety,Efficacy & Tolerability of Rivastigmine Patch in Mild to Moderate Alzheimer's Patients.

Completed· Novartis logo

Novartis·Phase 4·NCT02703636·118 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Rivastigmine 1.5 mg Capsules Under Fasting Conditions

Completed·—·Phase 1·NCT01146067·44 enrolled

Methamphetamine1 trial

Rivastigmine For Methamphetamine Dependent Individuals

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00158210·18 enrolled

Fed1 trial

Bioequivalence Study of Rivastigmine Capsules 1.5 mg of Dr.Reddy's Under Fed Conditions

Completed·—·Phase 1·NCT01146041·44 enrolled

Unspecified2 trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Effect of Heat on Rivastigmine TDS Products

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT03915626·7 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 21, 2000

EXELON

NDA NDA020823

Apr 21, 2000

EXELON

NDA NDA021025

Jul 6, 2007

EXELON

NDA NDA022083

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for Rivastigmine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Exelon drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rivastigmine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rivastigmine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022083). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cholinesterases; ACHE & BCHE Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

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