EXELON (rivastigmine) · Novartis
Exelon (rivastigmine) is a cholinesterase inhibitor indicated for the treatment of dementia. It is approved for use in patients with mild, moderate, and severe Alzheimer’s disease, as well as those with mild-to-moderate dementia associated with Parkinson’s disease. While the medication is used to manage symptoms, there is no evidence that it alters the course of the underlying dementing process.
How EXELON Works
Rivastigmine is thought to exert its therapeutic effect by enhancing cholinergic function. It increases the concentration of acetylcholine by reversibly inhibiting cholinesterase, the enzyme responsible for breaking it down. By preventing this hydrolysis, the drug facilitates improved communication between neurons. The effectiveness of this mechanism may diminish as the disease advances and fewer cholinergic neurons remain intact.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-04-21
- Routes
- TRANSDERMAL, ORAL
- Dosage Forms
- FILM, EXTENDED RELEASE, CAPSULE, SOLUTION
EXELON Approval History
What EXELON Treats
2 indicationsEXELON is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alzheimer's Disease
- Parkinson's Disease Dementia
EXELON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to EXELON
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07545382 | 0202283 | Ph 4 | completed | Rivastigmine as an Antidote for Clozapine and Other Anticholinergic-Induced CNS Depression and Delirium: A Study of 100 Cases |
| NCT06382649 RIVA-AM | 202403051 | Ph 2 | recruiting | Rivastigmine for Antimuscarinic Delirium |
| NCT06399679 RIVA-AP | 202403052 | Ph 2 | suspended | Rivastigmine to Prevent Recurrence of Antimuscarinic Delirium |
| NCT02989402 results posted | CENA713DIN01 | Ph 4 | completed | A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type. |
| NCT02839642 RIVA-PSP | 2015-11 2016-001319-19 | Ph 3 | completed | Efficacy of RIVAstigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy |
| NCT02444637 | RACE_1.0 | Ph 4 | completed | Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD |
| NCT01340885 results posted | PANUC - Lou 5P50NS062684-02 | Ph 4 | completed | Cognitive Decline in Non-demented PD |
| NCT01856738 CHEVAL | NL44622.029.13 2013-001722-25 | Ph 4 | terminated | Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease |
| NCT00599287 | ICHYPDEL/002 METC-UMCU 07/236 | Ph 3 | terminated | Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01677754 MAyflOwer RoAD | BP28248 2012-000943-29 | Ph 2 | completed | A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy |
| NCT01084135 DS-Riv results posted | Pro00013682 | Ph 1, Ph 2 | completed | Rivastigmine Study in Adolescents With Down Syndrome |
| NCT01348282 | TRIANT-TE | Ph 4 | completed | Efficacy and Safety of Two Pharmacologic Strategies on Neurocognitive Impairment in HIV Infection. The TRIANT-TE Study |
| NCT01073319 | H-23064 R01DA023964, DPMC | Ph 1 | completed | Rivastigmine as a Treatment for Methamphetamine Dependence |
| NCT00767091 CHoPA-I | 2008-002578-36 2008/0817 | Ph 3 | completed | Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia |
| NCT00766363 results posted | EVP-6124-007 | Ph 1 | completed | Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease |
| NCT01183806 | PA-01 | Ph 3 | completed | Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients |
| NCT00704301 | IC-DEL/009 | Ph 4 | terminated | Rivastigmine for Intensive Care Unit (ICU) Delirium |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EXELON FDA Label Details
Indications & Usage
FDA Label (PDF)EXELON PATCH is an acetylcholinesterase inhibitor indicated for treatment of: • Mild, moderate, and severe dementia of the Alzheimer’s type (AD). • Mild-to-moderate dementia associated with Parkinson’s disease (PD). 1.1 Alzheimer’s Disease EXELON PATCH is indicated for the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. 1.2 Parkinson’s Disease Dementia EXELON PATCH is indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PDD).
Explore on TheraRadar
Alzheimer's Disease Drug Landscape 2026
Disease-modifying therapies, symptomatic treatments, and clinical trial intelligence
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment