Drugs / Ropinirole
Ropinirole
also known as
Requip · Ropinirole Hydrochloride · Ropinirole HCl · Ropinirole XL · SKF-101468 · Adartrel · Aimpart xl · Clevor · +26 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | REQUIP XL | — | 2017-03-23 | fda.gov ↗ |
| Label expansion | US (FDA) | REQUIP | — | 2005-05-04 | fda.gov ↗ |
| Approved | US (FDA) | REQUIP | — | 1997-09-19 | fda.gov ↗ |
Trials 44 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT01435915 | Jun → Aug 2010 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01712568 | Sep 2008 | — | Lupin Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00419692 | Aug → Dec 2006 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00422994 | Apr → Dec 2006 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00140712 | Jun 2005 → Feb 2008 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00830219 | Nov 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00829504 | Oct 2004 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03250117 | Oct 2017 → May 2018 | Parkinson disease | Titan Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/2 | NCT03038308 | Sep 2016 → Nov 2020 | hyperprolactinemia, prolactin-producing pituitary gland adenoma | Columbia University | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT03708237 | Feb → Nov 2019 | end stage renal failure, restless legs syndrome | University of Alberta | Terminated | No outcome recorded |
| Phase 2 | NCT00996944 | Nov 2009 → Jun 2010 | restless legs syndrome | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT00530790 | Aug 2007 → Feb 2008 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00639119 | Aug 2007 → Aug 2008 | Unverricht-Lundborg syndrome | University of Turku | Unknown | No outcome recorded |
| Phase 2 | NCT00434304 | Apr 2007 → Mar 2009 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00460148 | Apr → Aug 2007 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00256893 | Nov 2004 → Jul 2005 | fibromyalgia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00221390 | Oct 2003 → Feb 2007 | hemiplegia, stroke disorder | University of California, Irvine | Completed | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT01929317 | Aug 2013 → Sep 2014 | Parkinson disease | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT01154166 | Feb 2010 → Sep 2011 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00823836 | Mar 2009 → Dec 2010 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00465452 | Jan 2007 → Mar 2009 | Parkinson disease | University of Toledo | Completed | No outcome recorded |
| Phase 3 | NCT00331149 | Jun 2006 → Aug 2007 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00357097 | Jun 2006 → Dec 2007 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00314860 | Feb → Dec 2006 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00275275 | Jan 2006 → May 2008 | Parkinson disease | Rajesh Pahwa, MD | Completed | No outcome recorded |
| Phase 3 | NCT00256854 | Nov 2005 → Sep 2006 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00260793 | Nov 2005 → ? | Parkinson disease | Agarwal, Pinky, M.D. | Unknown | No outcome recorded |
| Phase 3 | NCT00355641 | Oct 2005 → Oct 2007 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00197080 | Jun 2005 → Jan 2006 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00225862 | Jan → Dec 2005 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00363727 | Dec 2003 → Jan 2006 | Parkinson disease, movement disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00363857 | Aug 2003 → May 2004 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00381472 | Jun 2003 → Dec 2004 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00036218 | Dec 2001 → Apr 2003 | Parkinson disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00367822 | — | restless legs syndrome | Axxonis Pharma AG | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT01494532 | Apr 2012 → Nov 2014 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01485172 | Jan 2012 → Apr 2014 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00485069 | Jun 2007 → Dec 2009 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00373542 | Oct 2006 → Jun 2007 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00334048 | Jun 2006 → Sep 2007 | sexual disorder | St. Luke's-Roosevelt Hospital Center | Completed | No outcome recorded |
| Phase 4 | NCT00329602 | Mar 2006 → Sep 2008 | restless legs syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00314821 | Sep 2005 → Jun 2007 | bipolar disorder | Cambridge Health Alliance | Completed | No outcome recorded |
| Phase 4 | NCT00335205 | Apr 2003 → ? | bipolar disorder, major depressive disorder | Sheba Medical Center | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00285727 | Jan 2006 → Oct 2007 | major depressive disorder | Stanford University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01393457 Comparator | Jun 2011 → Feb 2017 | cocaine dependence | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT03806530 Comparator | May 2019 → Dec 2021 | end stage renal failure, restless legs syndrome | Population Health Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT01007864 Comparator | Jan 2010 → Dec 2011 | Parkinson disease | Desitin Arzneimittel GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01628926 Comparator | Jun 2009 → May 2011 | Parkinson disease | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00632736 Comparator | Feb 2004 → Mar 2010 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00650104 Comparator | May 2002 → Mar 2009 | Parkinson disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT03176966 Comparator | Sep 2016 → Oct 2021 | cirrhosis of liver | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00986245 Comparator | Sep 2009 → Dec 2010 | Parkinson disease | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00399477 Background | Oct 2006 → Jul 2007 | Parkinson disease | Teva Neuroscience, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00144300 Comparator | Jan 2005 → Sep 2010 | Parkinson disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06468371 Comparator | Jan 2022 → Dec 2023 | end stage renal failure, restless legs syndrome | Lahore General Hospital | Completed | No outcome recorded |
| — | NCT00282152 Background | Mar 2006 → Jan 2012 | Parkinson disease | Vanderbilt University Medical Center | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2007-11-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Generic Requip® Tablets tevapharm.com ↗ |
Evidence & citations 38 cited values
Every value below carries the sentence it was read from. 60 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ropinirole | “This is a phase III, multicenter, randomized, double-blind, parallel group, placebo-controlled study to compare the efficacy of 6-months therapy of ropinirole Prolonged Release...” NCT01154166 ↗54“A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio...” NCT00275275 ↗ “The purpose of this proposal is to determine if switching PD patients treated with pramipexole to ropinirole CR reduces the non-motor side effects frequently experienced by...” NCT00465452 ↗ “Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006.” NCT00485069 ↗ “Patients received labeled IR regimens of pramipexole (n = 121) or ropinirole (n = 125) for 2 years.” PMID 28078162 ↗ Dec 2016 “Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.” NCT00282152 ↗ |
| Known as | Adartrel | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Aimpart xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Clevor | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | CR-RLS | “ropinirole CR-RLS” NCT00373542 ↗ |
| Known as | Ipinnia xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | NSC-758917 | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Ralnea xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Raponer xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Repinex xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Requip | “The objective of this study was to compare the relative bioavailability of the test formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of...” NCT00829504 ↗6“A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio...” NCT00275275 ↗ “The purpose of this study is to investigate the effect of dopaminergic medication (ropinirole hydrochloride, Requip ®) on relieving the symptoms of ULD patients.” NCT00639119 ↗ “An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169” NCT00632736 ↗ “Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease” NCT00260793 ↗ “Requip® (ropinirole hydrochloride) 0.25 mg tablets” NCT00830219 ↗ |
| Known as | REQUIP CR | “ropinirole controlled-release (REQUIP CR) for RLS” NCT00363727 ↗ |
| Known as | REQUIP IR | “Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468)” NCT00331149 ↗ |
| Known as | Requip xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | ROP | “Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006.” NCT00485069 ↗ |
| Known as | Ropilynz xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Ropinirol | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Ropinirole (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | Ropinirole CR | “Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164” NCT00650104 ↗ |
| Known as | Ropinirole CR-RLS (SK&F101468) | “Ropinirole CR-RLS (SK&F101468)” NCT00530790 ↗ |
| Known as | Ropinirole HCl | “Ropinirole HCl 0.25 mg Tablets” NCT00829504 ↗1“Ropinirole HCl 0.25 mg Tablets” NCT00830219 ↗ |
| Known as | Ropinirole Hydrochloride | “The purpose of this study is to investigate the effect of dopaminergic medication (ropinirole hydrochloride, Requip ®) on relieving the symptoms of ULD patients.” NCT00639119 ↗2“Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006.” NCT00485069 ↗ “test formulation of ropinirole hydrochloride 0.25 mg tablets” NCT00830219 ↗ |
| Known as | ropinirole immediate release (IR) | “To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa...” NCT00823836 ↗ |
| Known as | ropinirole IR | “to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks” NCT00996944 ↗ |
| Known as | ropinirole PR | “receive once daily doses of ropinirole PR or identical appearing placebo tablets.” NCT01154166 ↗ |
| Known as | ropinirole PR/XR | “To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa...” NCT00823836 ↗ |
| Known as | Ropinirole Prolonged Release | “A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment” NCT01494532 ↗ |
| Known as | Ropinirole XL | “Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164” NCT00650104 ↗1“Ropinirole XL (formerly CR)” NCT00632736 ↗ |
| Known as | Ropinirole XL (formerly CR) | “Ropinirole XL (formerly CR)” NCT00632736 ↗ |
| Known as | ropinirole XL/PR | “Long-term safety of once-daily ropinirole extended/prolonged release (ropinirole XL/PR) was evaluated in subjects with early and advanced Parkinson's disease (PD) in this...” PMID 25495896 ↗ Dec 2014 |
| Known as | Ropinirole XR | “Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome” NCT00355641 ↗ |
| Known as | Ropitor | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | SK&F 101468-A | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Known as | SKF-101468 | “Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole...” NCT00256854 ↗1“Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468)” NCT00331149 ↗ |
| Known as | Spiroco xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL589 ↗ |
| Action | Activate | “increased dopaminergic tone via the dopamine agonist ropinirole” PMID 19520987 ↗ Jun 2009 |
| Modality | Small molecule | — CHEMBL589 ↗ |
| Route | Oral | “Requip tablets three times daily (TID) dosing according to manufacturer's guidelines” NCT00144300 ↗ |