RIVASTIGMINE (rivastigmine tartrate)
Rivastigmine transdermal system 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). Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. Parkinson’s disease (PDD).
Development Insights
Details
- Status
- None (Tentative Approval)
- First Approved
- 2015-08-31
- Routes
- ORAL, TRANSDERMAL
- Dosage Forms
- SOLUTION, FILM, EXTENDED RELEASE
RIVASTIGMINE Approval History
What RIVASTIGMINE Treats
7 FDA approvalsOriginally approved for its first indication in 2015 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Aug 2015)Letter
- • Approved indication (Sep 2015)
- • Approved indication (Jun 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Mar 2019)
- • Approved indication (Nov 2019)
- • Approved indication (Sep 2025) New
Clinical Trial Registry
17 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 | suspended | Rivastigmine for Antimuscarinic Delirium |
| NCT06399679 RIVA-AP | 202403052 | Ph 2 | recruiting | 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 |
| 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.
RIVASTIGMINE FDA Label Details
Indications & Usage
Rivastigmine transdermal system 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 Rivastigmine transdermal system 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 Rivastigmine transdermal system is indicated for the treatment of mild-to-moderate dementia associated with...
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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