Drugs / Rotigotine
Rotigotine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NEUPRO | — | 2012-04-02 | fda.gov ↗ |
| Approved | US (FDA) | NEUPRO | — | 2007-05-09 | fda.gov ↗ |
| Approved | EU (EMA) | Neupro | — | 2006-02-15 | europa.eu ↗ |
Trials 75 · started per year
today
EU approved 2006
US approved 2007
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT04183634 | Dec 2019 → Mar 2020 | Parkinson disease | Sandoz | Terminated | No outcome recorded |
| Phase 1 | NCT02230904 | Sep → Nov 2014 | Parkinson disease | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04044547 | Nov 2013 → Feb 2014 | Parkinson disease | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02727205 | Aug → Oct 2013 | — | Inflamax Research Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT04627155 | Mar → May 2013 | Parkinson disease | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01675024 | Aug → Sep 2012 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01338896 | Apr → May 2011 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01059903 | Jan → Feb 2010 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00957944 | Jul → Aug 2009 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00881894 | Oct → Nov 2008 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01964573 | Dec 2006 → Feb 2007 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00292227 | Jan → Sep 2006 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01854216 | Dec 2002 → Mar 2003 | — | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01761526 | Oct 2002 | — | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT06291116 | May 2026 → Jul 2030 expected | kidney disorder | University Hospital, Rouen | Recruiting | No outcome recorded |
| Phase 2 | NCT05886582 | Sep 2023 → Jun 2026 overdue | substance-related disorder | Virginia Commonwealth University | Recruiting | No outcome recorded |
| Phase 2 | NCT06247410 | Aug → Oct 2021 | Parkinson disease | SocraTec R&D GmbH | Completed | No outcome recorded |
| Phase 2 | NCT04937452 | Jun 2021 → Dec 2023 | Pick disease, TDP-43 proteinopathy, aphasia, primary progressive aphasia +1 | Santa Lucia Foundation IRCCS | Completed | No outcome recorded |
| Phase 2 | NCT02123979 | Nov 2015 → Nov 2016 | — | East Carolina University | Unknown | No outcome recorded |
| Phase 2 | NCT02103465 | Dec 2013 → Jun 2015 | Parkinson disease | Azienda Ospedaliera Cardinale G. Panico | Terminated | No outcome recorded |
| Phase 2 | NCT01498120 | Dec 2011 → Dec 2015 | restless legs syndrome | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01495793 | Dec 2011 → May 2014 | restless legs syndrome | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00663338 | Jan → Jun 2010 | — | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT01562743 | Aug 2008 → Oct 2010 | restless legs syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00666965 | Jun 2008 → Aug 2009 | restless legs syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00464737 | Mar 2007 → Nov 2008 | fibromyalgia | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01631812 | Dec 2006 → Feb 2010 | Parkinson disease | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00389831 | Aug → Nov 2006 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01628848 | Aug 2006 → Apr 2008 | Parkinson disease | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00296192 | Feb → Jun 2006 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT01634243 | Jan 2005 → May 2006 | Parkinson disease | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00498186 | Jul 2003 → Apr 2009 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00243217 | Apr 2003 → Feb 2004 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT01628965 | Jan 2008 → Oct 2010 | Parkinson disease | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2/3 | NCT00537485 | Sep 2007 → Dec 2009 | Parkinson disease | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 331 trials | ||||||
| Phase 3 | NCT06702124 | Dec 2023 → Jul 2025 overdue | Alzheimer disease | Santa Lucia Foundation IRCCS | Recruiting | No outcome recorded |
| Phase 3 | NCT03992196 | Dec 2019 → Sep 2022 | restless legs syndrome | UCB Biopharma SRL | Terminated | No outcome recorded |
| Phase 3 | NCT03728933 | Dec 2018 → Jul 2022 | restless legs syndrome | UCB Biopharma SRL | Terminated | No outcome recorded |
| Phase 3 | NCT04455555 | Aug 2018 → Feb 2019 | Parkinson disease | Peking University Third Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01723904 | Oct 2012 → Mar 2013 | Parkinson disease | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01646268 | Jul 2012 → May 2014 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01646255 | Jul 2012 → Oct 2014 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT02786667 | Jun 2012 → Oct 2017 | Parkinson disease | University Hospital, Grenoble | Unknown | No outcome recorded |
| Phase 3 | NCT01537042 | Apr 2012 → Oct 2013 | end stage renal failure, restless legs syndrome | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01536015 | Jan 2012 → Oct 2013 | Parkinson disease | UCB Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT01084551 | Feb 2010 → Sep 2011 | restless legs syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01631825 | Oct 2009 → Jun 2012 | Parkinson disease | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01628926 | Jun 2009 → May 2011 | Parkinson disease | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00522379 | Jul 2007 → Jul 2011 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00519532 | Jul 2007 → May 2009 | Parkinson disease | UCB Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT00593606 | Jul → Dec 2007 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00474058 | May 2007 → Mar 2009 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00498108 | Jan 2006 → Sep 2007 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00263068 | Dec 2005 → Dec 2007 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00275236 | Nov 2005 → Jul 2006 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00135993 | May 2005 → Nov 2006 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00136045 | May 2005 → Aug 2006 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00505687 | Feb 2005 → Dec 2008 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00243945 | Dec 2004 → Jul 2005 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00242008 | Dec 2004 → Jul 2005 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00243971 | Nov 2004 → Oct 2005 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00501969 | Aug 2004 → Dec 2008 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00244387 | Mar 2004 → Jul 2005 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00594386 | Aug 2002 → Dec 2008 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00599196 | Aug 2002 → Dec 2008 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00594165 | Jun 2002 → Nov 2008 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT03103919 | Mar 2017 → Jan 2018 | Parkinson disease | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 4 | NCT01976871 | Aug 2014 → May 2015 | restless legs syndrome | John Winkelman, MD, PhD | Completed | No outcome recorded |
| Phase 4 | NCT01782222 | Feb 2013 → Jan 2014 | Parkinson disease | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01744496 | Nov 2012 → Dec 2013 | Parkinson disease | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01711866 | Sep 2012 → Mar 2013 | Parkinson disease | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01523301 | Apr 2012 → Oct 2014 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT01455012 | Sep 2011 → May 2012 | restless legs syndrome | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01300819 | Feb 2011 → Oct 2012 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00594464 | Sep 2007 → May 2008 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03733561 Comparator | Nov → Dec 2018 | Parkinson disease | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02728947 Comparator | May → Aug 2016 | Parkinson disease | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02055274 Comparator | Oct 2013 → Aug 2015 | Parkinson disease | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03250741 Comparator | Jun 2016 → Nov 2018 | Alzheimer disease | Santa Lucia Foundation IRCCS | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01569464 Comparator | Mar 2012 → Apr 2013 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT03098368 Comparator | Sep 2016 → Dec 2017 | sleep-wake disorder | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 4 | NCT02365870 Comparator | Aug 2016 → Jul 2019 | Parkinson disease, anxiety disorder | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 4 | NCT02670161 Comparator | May 2016 → Dec 2026 expected | Parkinson disease, brain neoplasm, cognitive impairment with or without cerebellar ataxia, epilepsy +6 | Endeavor Health | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT01823770 Comparator | Nov 2012 → Jul 2016 | restless legs syndrome | University Hospital, Montpellier | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-05-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | "Neupro Patch", a Dopaminergic, Anti-Parkinsonian Drug,Will Become Available in Japan in an Additional New Dosage, "Neupro Patch 18 mg"® otsuka.co.jp ↗ |
| 2013-02-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | The First Transdermal Dopamin Agonist in Japan Neupro Patch, For Both Parkinson's Disease and Restless Legs Syndrome, To Be Launched on February 26® otsuka.co.jp ↗ |
| 2012-12-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | The World's Only Transdermal Dopamin Agonist, Neupro Patch, Approved in Japan for Both Parkinson's Disease and Restless Legs Syndrome® otsuka.co.jp ↗ |
| 2012-01-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Files New Drug Application for The Dopamine Agonist Transdermal Patch, Rotigotine Patch, in Japan otsuka.co.jp ↗ |
| 2011-10-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Confirmed Clinical Efficacy of Rotigotine Transdermal System for Restless Legs Syndrome in Phase III Clinical Study in Japan otsuka.co.jp ↗ |
| 2011-06-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical confirmed clinical efficacy of rotigotine trandermal system in Phase III clinical study in patients with advanced Parkinson's disease in Japan otsuka.co.jp ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 87 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rotigotine | “The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects...” NCT00243971 ↗70“The purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months” NCT00244387 ↗ “It is anticipated that rotigotine (SPM 936) will be more effective than placebo.” NCT00243217 ↗ “giving at the same time a drug called rotigotine ("Neupro")” NCT02123979 ↗ “Parkinson's disease (pramipexole, ropinerole, rotigotine)” NCT02670161 ↗ “Rotigotine,extended-release microspheres” NCT04627155 ↗ |
| Known as | LY03003 | “LY03003( the name of rotigotine)” NCT04455555 ↗ |
| Known as | NEUPRO | “A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO®...” NCT03733561 ↗7“Period 1: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application” NCT06247410 ↗ “A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery” NCT00594464 ↗ “Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.” NCT04183634 ↗ “Rotigotine is a marketed non-ergoline D3/D2/D1 DA agonist (RTG, Neupro®)” NCT05886582 ↗ “giving at the same time a drug called rotigotine ("Neupro")” NCT02123979 ↗ |
| Known as | PR 2.1.1 | “Rotigotine (Reference product PR 2.1.1)” NCT02230904 ↗ |
| Known as | PR 2.3.1 | “Rotigotine (Test product PR 2.3.1)” NCT02230904 ↗ |
| Known as | Rotigotine Nasal Spray | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00389831 ↗ |
| Known as | RTG | “This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal...” NCT04937452 ↗2“administration of the dopamine agonist rotigotine (RTG) could modulate cortical plasticity in AD patients” PMID 24859851 ↗ May 2014 “Rotigotine is a marketed non-ergoline D3/D2/D1 DA agonist (RTG, Neupro®)” NCT05886582 ↗ |
| Known as | SPM 936 | “The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless leg syndrome (RLS).” NCT00136045 ↗4“The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome.” NCT00135993 ↗ “The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI” NCT00275236 ↗ “It is anticipated that rotigotine (SPM 936) will be more effective than placebo.” NCT00243217 ↗ “rotigotine (SPM 936)” NCT00263068 ↗ |
| Known as | SPM 962 | “The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects...” NCT00243971 ↗12“The purpose of the study is to evaluate the effectiveness, safety and tolerability of the rotigotine patch (SPM 962) at an individual patient's optimal dose for a period of 4 months” NCT00244387 ↗ “rotigotine transdermal system (SPM 962)” NCT00242008 ↗ |
| Action | Activate | “the dopamine agonist rotigotine” PMID 17553743 ↗ Jun 2007 |
| Route | Other | “delivered by once-daily transdermal patch” PMID 20629075 ↗ Aug 2010 |