TheraRadar
Data updated: May 26, 2026

EXELON (rivastigmine tartrate)

Cholinesterase Inhibitors Trial Activity: Declining 1 active trials
CNS Approved 2000-04-21

EXELON is indicated for the treatment of Alzheimer's Disease; Parkinson's Disease Dementia.

Source: FDA Label • Novartis • Cholinesterase Inhibitor

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

Washington University School of Medicine conducting 2 trials (11%)
28 indications explored (Broad Platform)
alzheimer's disease (3 trials)
anticholinergic toxicity (2 trials)
alzheimer disease (2 trials)
5
Indications
--
Phase 3 Trials
26
Years on Market

Details

Status
Discontinued
First Approved
2000-04-21
Routes
ORAL, TRANSDERMAL
Dosage Forms
SOLUTION, CAPSULE, FILM, EXTENDED RELEASE

Companies

Active Ingredient: RIVASTIGMINE TARTRATE

EXELON Approval History

2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
137 FDA actions from 2000 to 2024 · 3 indication expansions
May 2024 SUPPL
Label · Labeling
Dec 2018 SUPPL
Label · Labeling
Nov 2016 SUPPL
Label · Labeling

What EXELON Treats

2 indications

EXELON 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
Source: FDA Label

EXELON Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01340885 results posted PANUC - Lou 5P50NS062684-02 Ph 4 completed Cognitive Decline in Non-demented PD
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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 is indicated for the treatment of Alzheimer's Disease; Parkinson's Disease Dementia.

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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