Requip Xl

(Ropinirole)

ApprovedSmall molecule

Requip Xl is a small molecule that works as a D2-Like Dopamine Receptor Agonist.[2] It is being used across 6 indications, with its most advanced program in Approved.[1]

Requip Xl is one of 134 small molecule programs targeting Restless Legs Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

133

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Restless Legs SyndromeCompleted

Parkinson DiseaseActive, not recruiting

Unverricht-Lundborg SyndromeApproved

Sexual DysfunctionCompleted

Muscle CrampActive, not recruiting

Major Depressive DisorderActive, not recruiting

Restless Legs SyndromeApproved

Completed

Parkinson DiseaseApproved

Active, not recruiting

Unverricht-Lundborg SyndromeApproved

Approved

Sexual DysfunctionApproved

Completed

Muscle CrampApproved

Active, not recruiting

Major Depressive DisorderPreclinical

Active, not recruiting

Competition

Competitive Landscape

115 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Cymbalta

Jazz Pharmaceuticals

Approved

26 2

Requip Xl

GGlaxo Dba Glaxosmithkline

Approved

42 3

Zoloft

VViatris Specialty LLC

Approved

15 4

Effexor

WWyeth-Lederle Vaccines

Approved

8 5

Ulotaront

IIntra-Cellular Therapies, Inc.

Approved

6 6

Valcyte

EEngelhard Arzneimittel GmbH & Co.KG

Approved

—7

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 8

Ketalar

Boehringer Ingelheim

Phase 3

5 9

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 10

Lithobid

SSolvay Pharmaceuticals

Phase 3

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

Clinical

Trials by Indication[1]

Restless Legs Syndrome12 trials

12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

Completed· GSK logo

GSK·Phase 4·NCT00373542·39 enrolled

Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome

Completed· GSK logo

GSK·Phase 2·NCT00530790·35 enrolled

Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

Completed· GSK logo

GSK·Phase 3·NCT00256854·135 enrolled

Show 9 more trials

A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

Completed· GSK logo

GSK·Phase 3·NCT00225862·140 enrolled

Long-term Study Of Ropinirole In Restless Legs Syndrome

Completed· GSK logo

GSK·Phase 4·NCT00329602·404 enrolled

DIalysis Symptom COntrol-Restless Legs Syndrome Trial

Completed·PPopulation Health Research Institute·Phase 3·NCT03806530·52 enrolled

Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Completed·AAxxonis Pharma AG·Phase 3·NCT00367822·300 enrolled

A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

Completed· GSK logo

GSK·Phase 3·NCT00363857·360 enrolled

Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

Completed· GSK logo

GSK·Phase 3·NCT00197080·380 enrolled

Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome

Completed· GSK logo

GSK·Phase 3·NCT00355641·450 enrolled

Ropinirole Tablets In Young Patients With Restless Legs Syndrome

Completed· GSK logo

GSK·Phase 1·NCT00140712·9 enrolled

The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome

Completed· GSK logo

GSK·Phase 3·NCT00357097·240 enrolled

Parkinson's Disease7 trials

Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease

Completed· GSK logo

GSK·Phase 3·NCT00823836·302 enrolled

An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease

Completed· GSK logo

GSK·Phase 3·NCT00632736·419 enrolled

A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease

Completed· GSK logo

GSK·Phase 4·NCT01485172·186 enrolled

Show 4 more trials

A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

Completed· Otsuka logo

Otsuka·Phase 3·NCT01628926·420 enrolled

Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.

Completed· Pfizer logo

Pfizer·Phase 3·NCT00036218·600 enrolled

Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

Completed· GSK logo

GSK·Phase 3·NCT00381472·393 enrolled

Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole

Completed· GSK logo

GSK·Phase 2·NCT00460148·28 enrolled

Prolonged2 trials

A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda

Completed· GSK logo

GSK·Phase 1·NCT01371682·50 enrolled

Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily

Completed·SSeoul National University Hospital·Phase 4·NCT00986245·82 enrolled

Bipolar Depression2 trials

Ropinirole in the Treatment of Bipolar Depression

Completed·CCambridge Health Alliance·Phase 4·NCT00314821·40 enrolled

A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.

Unknown status·SSheba Medical Center·Phase 4·NCT00335205·60 enrolled

Parkinson's2 trials

A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

Completed· GSK logo

GSK·Phase 3·NCT00331149·343 enrolled

Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole

Terminated·TTitan Pharmaceuticals·Phase 1/2·NCT03250117·6 enrolled

16 more indications

Complication1 trial

Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's

Completed· GSK logo

GSK·Phase 3·NCT00363727·209 enrolled

End-Stage Renal Disease1 trial

A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole

Completed· GSK logo

GSK·Phase 1·NCT00422994·48 enrolled

TED1 trial

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

Completed· GSK logo

GSK·Phase 3·NCT00650104·76 enrolled

Muscle Cramp1 trial

Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Completed·VVanderbilt University Medical Center·Phase 4·NCT03176966·31 enrolled

Effectiveness1 trial

Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD

Terminated·UUniversity of Alberta·Phase 2·NCT03708237·3 enrolled

Fibromyalgia1 trial

Fibromyalgia Study In Adults

Completed· GSK logo

GSK·Phase 2·NCT00256893·164 enrolled

Myoclonic Epilepsy1 trial

Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type

Unknown status·UUniversity of Turku·Phase 2·NCT00639119·16 enrolled

Hyperprolactinemia1 trial

Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Completed·—·Phase 1/2·NCT03038308·16 enrolled

Chronic Kidney Disease1 trial

Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)

Terminated· GSK logo

GSK·Phase 2·NCT00996944·34 enrolled

Sexual Dysfunction1 trial

Treating Sexual Dysfunction From Selective Serotonin Reuptake Inhibitor (SSRI) Medication: a Study Comparing Requip CR to Placebo

Completed·SSt. Luke's-Roosevelt Hospital Center·Phase 4·NCT00334048·9 enrolled

Adult1 trial

RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

Completed· GSK logo

GSK·Phase 3·NCT00314860·568 enrolled

Parkinson's Disease (PD)1 trial

Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

Completed· GSK logo

GSK·Phase 2·NCT00434304·62 enrolled

Tics1 trial

Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT01435915·24 enrolled

Absorption1 trial

Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

Completed· GSK logo

GSK·Phase 1·NCT00419692·32 enrolled

Fed1 trial

Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition

Completed·—·Phase 1·NCT01627847·48 enrolled

Unspecified2 trials

Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition

Completed·—·Phase 1·NCT01627834·48 enrolled

REQUIP RLS Post Marketing Surveillance

Completed· GSK logo

GSK··NCT01327339·755 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 19, 1997

REQUIP

NDA NDA020658

Jun 13, 2008

REQUIP XL

NDA NDA022008

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Ropinirole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ropinirole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ropinirole. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022008). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: D2-Like Dopamine Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

Requip Xl

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Restless Legs Syndrome12 trials

Parkinson's Disease7 trials

Prolonged2 trials

Bipolar Depression2 trials

Parkinson's2 trials

Complication1 trial

End-Stage Renal Disease1 trial

TED1 trial

Muscle Cramp1 trial

Effectiveness1 trial

Fibromyalgia1 trial

Myoclonic Epilepsy1 trial

Hyperprolactinemia1 trial

Chronic Kidney Disease1 trial

Sexual Dysfunction1 trial

Adult1 trial

Parkinson's Disease (PD)1 trial

Tics1 trial

Absorption1 trial

Fed1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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