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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 2 met primary | ||||||
| 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 | Met primary |
| Phase 1 | NCT00829504 | Oct 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| 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 · 1 missed | ||||||
| Phase 2 | NCT03708237 | Feb → Nov 2019 | end stage renal failure, restless legs syndrome | University of Alberta | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00996944 | Nov 2009 → Jun 2010 | restless legs syndrome | GlaxoSmithKline | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| Phase 318 trials · 3 met primary | ||||||
| Phase 3 | NCT01929317 | Aug 2013 → Sep 2014 | Parkinson disease | GlaxoSmithKline | Terminated | Met primary |
| Phase 3 | NCT01154166 | Feb 2010 → Sep 2011 | Parkinson disease | GlaxoSmithKline | Completed | Met primary |
| 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 | Met primary |
| 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 · 2 met primary | ||||||
| Phase 4 | NCT01494532 | Apr 2012 → Nov 2014 | Parkinson disease | GlaxoSmithKline | Completed | Met primary |
| 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 | Met primary |
| 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 |
| Comparator or background therapy12 trials | ||||||
| Phase 2 | NCT01393457 Comparator | Jun 2011 → Feb 2017 | cocaine dependence | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| 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 | Met primary |
| 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 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2018-08-15 | Upsher-Smith Laboratories | Regulatory Sawai Pharmaceutical Receives Approvals for Six Compounds with 13 Strengths of Generic Drugs upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for six compounds with 13 strengths of generic drugs. |
| 2017-08-24 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals Receives FDA Clearance To Begin Clinical Study Of Parkinson's Disease Treatment titanpharm.com ↗
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its ropinirole implant intended for treatment of the signs and symptoms of Parkinson's disease. |
| 2017-02-27 | Titan Pharmaceuticals | Regulatory Titan Pharmaceuticals Receives FDA Communication On Ropinirole Implant Investigational New Drug Application titanpharm.com ↗
In a telephone communication with Titan, the FDA indicated that it will require final release test data on the ropinirole implant and the applicator used to insert the implant before clearing the IND. |
| 2015-06-17 | Titan Pharmaceuticals | Results Titan Pharmaceuticals Presents Nonclinical Data Supporting Use of ProNeura Drug Delivery Platform in Parkinson's Disease titanpharm.com ↗
The dose-escalating study in Parkinsonian monkeys showed that motor function could be significantly improved with no onset of dyskinesias (involuntary movements), following the continuous, non-fluctuating release of ropinirole with the subdermal implant. |
| 2012-08-28 | Wockhardt | Regulatory WOCKHARDT RECEIVES US FDA APPROVAL FOR GENERIC VERSION OF PARKINSONISM DRUG REQUIP XL® wockhardt.com ↗ |
| 2007-11-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Generic Requip® Tablets tevapharm.com ↗
the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline's Requip® (Ropinirole HCl) Tablets |
All press releases naming this drug 8 releases
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 ↗ |