Drugs / Rotigotine
Rotigotine
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Parkinson disease, mitochondrial 1 milestone | |||||
| Filed | Japan (PMDA) | — | Parkinson disease, mitochondrial | — | “In December 2011, Otsuka Pharmaceutical filed rotigotine for marketing authorisation in Japan with the MHLW for the treatment of Parkinson's disease and restless legs syndrome.” otsuka.co.jp ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 74 · started per year
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US approved 2007
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials · 3 met primary | ||||||
| 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 | Met primary |
| Phase 1 | NCT00957944 | Jul → Aug 2009 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00881894 | Oct → Nov 2008 | — | UCB Pharma | Completed | Met primary |
| 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 | Met primary |
| 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 218 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06291116 | May 2026 → Jul 2030 expected | kidney disorder | University Hospital, Rouen | Recruiting | No outcome recorded |
| Phase 2 | NCT05886582 | Sep 2023 → Aug 2026 | substance-related disorder | Virginia Commonwealth University | Completed | 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 | Missed primary |
| 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 Stop: Enrollment |
| Phase 2 | NCT01495793 | Dec 2011 → May 2014 | restless legs syndrome | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01498120 | Dec 2011 → Dec 2015 | 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 | 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 | Met primary |
| Phase 2/32 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 331 trials · 9 met primary | ||||||
| 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 Stop: Business |
| Phase 3 | NCT03728933 | Dec 2018 → Jul 2022 | restless legs syndrome | UCB Biopharma SRL | Terminated | No outcome recorded Stop: Business |
| 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 | NCT01646255 | Jul 2012 → Oct 2014 | Parkinson disease | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT01646268 | Jul 2012 → May 2014 | Parkinson disease | UCB Pharma | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01536015 | Jan 2012 → Oct 2013 | Parkinson disease | UCB Pharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01084551 | Feb 2010 → Sep 2011 | restless legs syndrome | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00593606 | Jul → Dec 2007 | Parkinson disease | UCB Pharma | 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 | NCT00474058 | May 2007 → Mar 2009 | Parkinson disease | UCB Pharma | Completed | Met primary |
| 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 | NCT00136045 | May 2005 → Aug 2006 | restless legs syndrome | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00135993 | May 2005 → Nov 2006 | restless legs syndrome | UCB Pharma | Completed | Met primary |
| 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 | Met primary |
| 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 · 1 met primary · 4 missed | ||||||
| Phase 4 | NCT03103919 | Mar 2017 → Jan 2018 | Parkinson disease | UCB Biopharma S.P.R.L. | Completed | Missed primary |
| 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 | Mixed |
| Phase 4 | NCT01744496 | Nov 2012 → Dec 2013 | Parkinson disease | UCB BIOSCIENCES, Inc. | Completed | Missed primary |
| 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 | Missed primary |
| Phase 4 | NCT01455012 | Sep 2011 → May 2012 | restless legs syndrome | UCB BIOSCIENCES, Inc. | Completed | Met primary |
| Phase 4 | NCT01300819 | Feb 2011 → Oct 2012 | Parkinson disease | UCB Pharma | Completed | Missed primary |
| Phase 4 | NCT00594464 | Sep 2007 → May 2008 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Comparator or background therapy9 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 2 | NCT03250741 Comparator | Jun 2016 → Nov 2018 | Alzheimer disease | Santa Lucia Foundation IRCCS | Completed | No outcome recorded |
| Phase 3 | NCT01569464 Comparator | Mar 2012 → Apr 2013 | restless legs syndrome | UCB Pharma | Completed | No outcome recorded |
| 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 Stop: Business |
| 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 |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-08-02 | Luye Pharma Group Ltd. | Regulatory 绿叶制药罗替高汀微球在华上市申请获得受理并纳入优先审评审批 luye.com ↗ |
| 2022-07-20 | Luye Pharma Group Ltd. | Results 绿叶制药创新制剂罗替戈汀微球治疗帕金森病Ⅲ期临床达预设终点 luye.com ↗
试 验 结 果 显 示：与 安 慰 剂 组 相 比，LY03003组 统 一 帕 金 森 病 评 分 量 表（UPDRS）Ⅱ+Ⅲ评 分 较 基 线 显 著 改 善，两 组 差 异 具 有 统 计 学 意 义（P＜0.001）. |
| 2018-12-11 | Luye Pharma Group Ltd. | Regulatory 罗替戈汀缓释微球将在日本开展临床试验，绿叶制药加速全球中枢神经战略布局 luye.com ↗
绿 叶 制 药 集 团 宣 布，其 治 疗 帕 金 森 病 的 在 研 新 药——注 射 用 罗 替 戈 汀 缓 释 微 球（LY03003）已 向 日 本 独 立 行 政 法 人 医 药 品 及 医 疗 器 械 综 合 管 理 机 构(PMDA)申 报 临 床 试 验 批 件，即 将 在 日 本 开 展 临 床 试 验. |
| 2012-12-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory The World's Only Transdermal Dopamin Agonist, Neupro Patch, Approved in Japan for Both Parkinson's Disease and Restless Legs Syndrome® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) has received regulatory approvals today in Japan for Neupro Patch (chemical name is rotigotine), indicated for both Parkinson's disease and Restless Legs Syndrome. |
| 2012-01-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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. | Results Otsuka Pharmaceutical Confirmed Clinical Efficacy of Rotigotine Transdermal System for Restless Legs Syndrome in Phase III Clinical Study in Japan otsuka.co.jp ↗
As for safety, with the exception of some minor localized reactions seen in the rotigotine group, such as redness where the skin patch was applied, Japanese RLS patients were able to use the drug safely. |
| 2011-06-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
Over the 16-week dosing period, the response of patients treated with rotigotine showed statistically significant superiority compared to placebo and non-inferiority to ropinirole. |
All press releases naming this drug 9 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 86 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 | 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 |