Drug

Rotigotine

Approved · EMA

Emerging researchLate-stage developmentCooling momentum

Also known as Neupro, Rotigotina, (6S)-6-(propyl(2-(2-thienyl)ethyl)amino)-5,6,7,8-tetrahydro-1-naphthalenol.

RxNorm616739 ChEMBLCHEMBL1303UNII87T4T8BO2E

Research papers

Regulatory events

Latest activity

beta

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

An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.

Clinical trial2020-03-16Terminated · ClinicalTrials.gov

A Multicenter, Open-Label, Two-Arm Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management

Clinical trial2019-02-19Results posted · ClinicalTrials.gov

A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood

Clinical trial2018-08-31Results posted · ClinicalTrials.gov

A Multicenter, Open-Label, 2-Group, Dose Escalation Study of Monotherapy Administration of Rotigotine in Pediatric Subjects With Idiopathic Restless Legs Syndrome

Clinical trial2018-04-04Results posted · ClinicalTrials.gov

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On Levodopa

Clinical trial2018-04-04Results posted · ClinicalTrials.gov

Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors

Clinical trial2017-12-01Primary completion · ClinicalTrials.gov

Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.

Clinical trial2017-10-15Primary completion · ClinicalTrials.gov

Pharmacokinetics of rotigotine transdermal system in adolescents with idiopathic restless legs syndrome (Willis-Ekbom disease).

Research2016-06-08Sleep medicine

Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study.

Research2012-02-10Parkinsonism & related disorders

Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease.

Research2011-08-10BMC neurology

Effect of rotigotine on sleep and quality of life in Parkinson's disease patients: post hoc analysis of RECOVER patients who were symptomatic at baseline.

Research2011-07-27Expert opinion on pharmacotherapy

Approval: Neupro (EMA)

Regulatory2006-02-15EMA

Profile

Identifiers & mechanism

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

Canonical name

Rotigotine

Aliases & brands

NeuproRotigotina(6S)-6-(propyl(2-(2-thienyl)ethyl)amino)-5,6,7,8-tetrahydro-1-naphthalenol

RxNorm CUI

616739

ChEMBL ID

CHEMBL1303

UNII

87T4T8BO2E

Regulatory jurisdictions

ema

Regulatory timeline

1 event

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

2006-02-15

Latest approval

2006-02-15

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2006-02-15Approval

Approval: Neupro (EMA)

Indication: Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in… Show full indication

Parkinson's disease: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or 'on-off' fluctuations). Restless-legs syndrome: Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults.

Evidence ↗

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