Neupro

(Rotigotine)

ApprovedSmall molecule

Rotigotine is used to treat Parkinson's disease and restless legs syndrome by helping to restore balance of certain chemicals in the brain that control movement and sensations.[2] Neupro is currently approved and in use across 9 indications[4].[1]

Neupro is one of 268 small molecule programs targeting Stroke. It is currently in Approved.

Indications

Total Trials

Active Trials

267

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

StrokeActive, not recruiting

Restless Legs SyndromeActive, not recruiting

Alzheimer DiseaseApproved

Parkinson DiseaseActive, not recruiting

Sleep DisorderActive, not recruiting

ApathyActive, not recruiting

Drug DependenceApproved

AnxietyActive, not recruiting

FibromyalgiaActive, not recruiting

StrokePhase 2

Active, not recruiting

Restless Legs SyndromeApproved

Active, not recruiting

Alzheimer DiseaseApproved

Approved

Parkinson DiseaseApproved

Active, not recruiting

Sleep DisorderPhase 3

Active, not recruiting

ApathyApproved

Active, not recruiting

Drug DependenceApproved

Approved

AnxietyApproved

Active, not recruiting

FibromyalgiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

461 competitors in Stroke

#DrugCompanyPhaseTrials

Neupro

UCB

Approved

1 2

Activase

Roche

Preclinical

19 3

Savella

AbbVie

Preclinical

1 4

Zometa

Pfizer

Preclinical

1 5

Folvite

Eli Lilly

Preclinical

1 6

Proamatine

Repatha

Haldol

1 9

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 10

Zantac 150

CChattem

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Restless Legs Syndrome13 trials

A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

Terminated· UCB logo

UCB·Phase 3·NCT03728933·23 enrolled

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

Terminated· UCB logo

UCB·Phase 3·NCT03992196·10 enrolled

Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)

Completed· UCB logo

UCB·Phase 3·NCT01569464·150 enrolled

Show 10 more trials

Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Completed· UCB logo

UCB·Phase 3·NCT00135993·811 enrolled

Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome

Completed· UCB logo

UCB·Phase 2·NCT01498120·14 enrolled

Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome

Completed·UUniversity Hospital, Montpellier·Phase 4·NCT01823770·130 enrolled

A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

Completed· UCB logo

UCB·Phase 3·NCT01537042·30 enrolled

Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome

Completed· UCB logo

UCB·Phase 4·NCT01455012·81 enrolled

Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects

Completed· UCB logo

UCB·Phase 3·NCT00498108·341 enrolled

Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

Completed· UCB logo

UCB·Phase 2·NCT01495793·42 enrolled

A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Completed· UCB logo

UCB·Phase 3·NCT00275236·60 enrolled

Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

Completed· UCB logo

UCB·Phase 2·NCT00498186·295 enrolled

An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome

Completed· UCB logo

UCB·Phase 3·NCT00263068·279 enrolled

Parkinson's Disease11 trials

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease

Completed· UCB logo

UCB·Phase 3·NCT00599196·381 enrolled

Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease

Completed· Luye Pharma Group Ltd. logo

Luye Pharma Group Ltd.·Phase 1·NCT02728947·28 enrolled

A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery

Completed· UCB logo

UCB·Phase 4·NCT00594464·14 enrolled

Show 8 more trials

Non Motors Aspects in De Novo Parkinson's Disease

Unknown status·UUniversity Hospital, Grenoble·Phase 3·NCT02786667·199 enrolled

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

Completed· UCB logo

UCB·Phase 3·NCT00501969·395 enrolled

Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms

Completed· UCB logo

UCB·Phase 4·NCT01300819·349 enrolled

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease

Completed· UCB logo

UCB·Phase 3·NCT00594386·258 enrolled

Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

Completed· UCB logo

UCB·Phase 4·NCT01744496·68 enrolled

A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease

Completed· UCB logo

UCB·Phase 1·NCT02230904·57 enrolled

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.

Completed· UCB logo

UCB·Phase 3·NCT00594165·217 enrolled

A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease

Completed· UCB logo

UCB·Phase 3·NCT01723904·90 enrolled

Idiopathic Parkinson's Disease8 trials

A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease

Completed· UCB logo

UCB·Phase 4·NCT01711866·87 enrolled

An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

Completed· UCB logo

UCB·Phase 3·NCT00505687·186 enrolled

A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease

Completed· UCB logo

UCB·Phase 3·NCT00242008

Show 5 more trials

Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

Completed· UCB logo

UCB·Phase 3·NCT01646255·346 enrolled

Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients

Completed· UCB logo

UCB·Phase 3·NCT01646268·249 enrolled

Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

Completed· UCB logo

UCB·Phase 4·NCT01523301·380 enrolled

Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease

Terminated· UCB logo

UCB·Phase 3·NCT00519532·84 enrolled

Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease

Completed· UCB logo

UCB·Phase 1·NCT00292227·130 enrolled

Liver3 trials

Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

Completed· UCB logo

UCB·Phase 1·NCT01059903·50 enrolled

Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.

Completed· UCB logo

UCB·Phase 1·NCT00881894·52 enrolled

Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

Completed· UCB logo

UCB·Phase 1·NCT00957944·40 enrolled

Itching2 trials

Switching From Oral Dopamine Agonists to Rotigotine

Completed·—·Phase 4·NCT01976871·21 enrolled

Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine

Completed· UCB logo

UCB·Phase 3·NCT00593606·124 enrolled

18 more indications

Randomized2 trials

Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different Formulations

Completed· UCB logo

UCB·Phase 1·NCT02070796·50 enrolled

Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine

Completed· UCB logo

UCB·Phase 3·NCT00474058·287 enrolled

Treatment2 trials

Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms

Completed· UCB logo

UCB·Phase 2·NCT00296192·82 enrolled

Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

Completed· UCB logo

UCB·Phase 2·NCT00389831·44 enrolled

ESS2 trials

Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

Completed· UCB logo

UCB·Phase 1·NCT01338896·56 enrolled

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

Unknown status·—·Phase 4·NCT03098368·40 enrolled

Parkinson's Disease (PD)1 trial

Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

Completed· UCB logo

UCB·Phase 3·NCT00522379·514 enrolled

Apathy1 trial

Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy

Completed· UCB logo

UCB·Phase 4·NCT01782222·122 enrolled

Gastrointestinal Dysfunction1 trial

Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction

Terminated· UCB logo

UCB·Phase 3·NCT01536015·25 enrolled

Tics1 trial

Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Repeated Dose Transdermal Rotigotine in Japanese and Caucasian Subjects

Completed· UCB logo

UCB·Phase 1·NCT01854216·26 enrolled

Trial1 trial

Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects

Completed· UCB logo

UCB·Phase 1·NCT01964573·48 enrolled

Parkinson1 trial

Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management

Completed· UCB logo

UCB·Phase 4·NCT03103919·40 enrolled

Sleep Disorder1 trial

A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease

Completed· UCB logo

UCB·Phase 3·NCT00243945·58 enrolled

Alzheimer's Disease1 trial

Effects of Dopaminergic Therapy in Patients With Alzheimer's Disease

Completed·II.R.C.C.S. Fondazione Santa Lucia·Phase 2·NCT03250741·94 enrolled

Anxiety1 trial

Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment

Terminated·JJohns Hopkins University·Phase 4·NCT02365870·4 enrolled

Female1 trial

Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects

Completed· UCB logo

UCB·Phase 1·NCT01761526·50 enrolled

Stroke1 trial

Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke

Completed·UUniversity College, London·Phase 2·NCT00663338·20 enrolled

Restless Leg Syndrome1 trial

Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome

Completed· UCB logo

UCB·Phase 3·NCT00136045·549 enrolled

Age1 trial

MIRT and Rotigotine in the Early Stage of PD

Unknown status·OOspedale Generale Di Zona Moriggia-Pelascini··NCT02100176·40 enrolled

Fibromyalgia1 trial

The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.

Completed· UCB logo

UCB·Phase 2·NCT00464737·230 enrolled

Unspecified3 trials

Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects

Completed· UCB logo

UCB·Phase 1·NCT01565018·55 enrolled

Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease

Terminated·AAzienda Ospedaliera Cardinale G. Panico·Phase 2·NCT02103465·80 enrolled

Named Patient Program With Rotigotine Transdermal System

Completed· UCB logo

UCB··NCT01095484·520 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 2, 2012

NEUPRO

NDA NDA021829

Sources

References

[1]
ClinicalTrials.gov — 60 trial records for Rotigotine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Neupro drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rotigotine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rotigotine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021829). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Neupro. U.S. Food & Drug Administration.
[7]
SEC EDGAR — UCB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: D2-Like Dopamine Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: UCB

Patent Landscape[6]

Patent Cliff

Sep 1, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8246979Sep 1, 2027

10350174Dec 22, 2030

10130589Dec 22, 2030

9925150Mar 1, 2032

Neupro

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Restless Legs Syndrome13 trials

Parkinson's Disease11 trials

Idiopathic Parkinson's Disease8 trials

Liver3 trials

Itching2 trials

Randomized2 trials

Treatment2 trials

ESS2 trials

Parkinson's Disease (PD)1 trial

Apathy1 trial

Gastrointestinal Dysfunction1 trial

Tics1 trial

Trial1 trial

Parkinson1 trial

Sleep Disorder1 trial

Alzheimer's Disease1 trial

Anxiety1 trial

Female1 trial

Stroke1 trial

Restless Leg Syndrome1 trial

Age1 trial

Fibromyalgia1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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