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Drug

Rivastigmine

Approved · EMA
Late-stage development
Also known as (S)-3-(1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate, Exelon, m-((S)-1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate, Rivastigmina+1 more

(S)-3-(1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate, Exelon, m-((S)-1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamate, Rivastigmina, Rivastigmine Tartrate.

RxNorm183379ChEMBLCHEMBL636UNIIPKI06M3IW0
2
Active clinical trials
6
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Rivastigmine for Antimuscarinic Delirium: a Randomized, Placebo-controlled Trial

Clinical trial2026-06-04Results expected Q4 2028 · ClinicalTrials.gov

Efficacy of Rivastigmine in the Management of Toxic Anticholinergic Delirium: A Prospective Study at Alexandria Poison Center

Clinical trial2026-04-15Completed · ClinicalTrials.gov

A Randomized, Double-blind, Phase IIa Clinical Trial to Study the Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

A Prospective, 16 Week, Phase IV Study to Evaluate Safety, Tolerability and Effectiveness in Patients With Severe Dementia of the Alzheimer's Type Exposed to Rivastigmine (Exelon)15cm2 Transdermal Patch

Clinical trial2024-05-31Results posted · ClinicalTrials.gov

RIVA-PSP: Efficacy of Rivastigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy: A Randomised Double Blind Placebo-controlled Clinical Trial

Clinical trial2022-11-17Completed · ClinicalTrials.gov

Noradrenaline, Acetylcholine and Dynamic Learning in Healthy Humans

Clinical trial2020-06-01Completed · ClinicalTrials.gov

Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease

Clinical trial2019-03-01Completed · ClinicalTrials.gov

Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial.

Clinical trial2018-09-01Terminated · ClinicalTrials.gov

Approval: Rivastigmine 1 A Pharma (EMA)

Regulatory2009-12-11EMA

Approval: Rivastigmine Hexal (EMA)

Regulatory2009-12-11EMA

Approval: Rivastigmine Sandoz (EMA)

Regulatory2009-12-10EMA

Approval: Nimvastid (EMA)

Regulatory2009-05-11EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Rivastigmine
Aliases & brands
(S)-3-(1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamateExelonm-((S)-1-(Dimethylamino)ethyl)phenyl ethylmethylcarbamateRivastigminaRivastigmine Tartrate
RxNorm CUI
183379
ChEMBL ID
CHEMBL636
UNII
PKI06M3IW0
Regulatory jurisdictions
ema

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1998-05-11
Latest approval
2009-12-11
Authorities
EMA
Total events
6
emaEuropean Medicines Agency· 6 events
2009-12-11Approval
Approval: Rivastigmine 1 A Pharma (EMA)
Indication: Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's… Show full indication

Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

Evidence ↗
2009-12-11Approval
Approval: Rivastigmine Hexal (EMA)
Indication: Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's… Show full indication

Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

Evidence ↗
2009-12-10Approval
Approval: Rivastigmine Sandoz (EMA)
Indication: Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's… Show full indication

Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

39 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
39
registered trials across all phases
LATEST COMPLETION 2026
2
Active studies
2
Recruiting
27
Late-stage (III+)
26
Completed
11
Discontinued
PHASE DISTRIBUTIONn = 39
Phase 16Phase 1 / 21Phase 25Phase 312Phase 49Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy of Rivastigmine in the Management of Toxic Anticholinergic Delirium: A Prospective Study at Alexandria Poison Center

CompletedPH IVAlexandria Universityn=1002026

A Prospective, 16 Week, Phase IV Study to Evaluate Safety, Tolerability and Effectiveness in Patients With Severe Dementia of the Alzheimer's Type Exposed to Rivastigmine (Exelon)15cm2 Transdermal Patch

CompletedPH IVNovartis Pharmaceuticalsn=1002022

Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease

CompletedPH IVNational Neuroscience Instituten=1002019

Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial.

TerminatedPH IVAmsterdam UMC, location VUmcn=912018

Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial

TerminatedPH IVUMC Utrechtn=1042010

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy of Rivastigmine in the Management of Toxic Anticholinergic Delirium: A Prospective Study at Alexandria Poison Center

CompletedPH IVAlexandria Universityn=1002026

A Prospective, 16 Week, Phase IV Study to Evaluate Safety, Tolerability and Effectiveness in Patients With Severe Dementia of the Alzheimer's Type Exposed to Rivastigmine (Exelon)15cm2 Transdermal Patch

CompletedPH IVNovartis Pharmaceuticalsn=1002022

RIVA-PSP: Efficacy of Rivastigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy: A Randomised Double Blind Placebo-controlled Clinical Trial

CompletedPH IIIAssistance Publique Hopitaux De Marseillen=1062022

Noradrenaline, Acetylcholine and Dynamic Learning in Healthy Humans

CompletedN/AUniversity of Oxfordn=1072020

Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease

CompletedPH IVNational Neuroscience Instituten=1002019

A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of RO4602522 Added to Background Alzheimer's Disease Therapy in Patients With Moderate Severity Alzheimer's Disease

CompletedPH IIHoffmann-La Rochen=5422015
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.