ropinirole

Trade name: Requip

Small moleculeapproved

Approved

Sep 19, 1997

Ropinirole (INN; trade names Requip, Repreve, Ronirol, Adartrel) is a dopamine agonist of the non-ergoline class of medications, used in the treatment of Parkinson's disease and restless legs syndrome. Although the precise mechanism of action of ropinirole as a treatment for Parkinson's disease is unknown, it is believed to be related to its ability to stimulate dopamine receptors in the striatum. This conclusion is supported by electrophysiologic studies in animals that have demonstrated that ropinirole influences striatal neuronal firing rates via activation of dopamine receptors in the striatum and the substantia nigra, the site of neurons that send projections to the striatum. Ropinirole is a nonergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D2 subfamily of dopamine receptors, binding with higher affinity to D3 than to D2 or D4 receptor subtypes. The relevance of D3 receptor binding in Parkinson's disease is unknown. The mechanism of ropinirole-induced postural hypotension is presumed to be due to a D2 -mediated blunting of the noradrenergic response to standing and subsequent decrease in peripheral vascular resistance. Ropinirole can cause nausea, dizziness, hallucinations, orthostatic hypotension, and sudden sleep attacks during the daytime. Unusual side effects specific to D3 agonists such as ropinirole and pramipexole can include hypersexuality, punding, and compulsive gambling, even in patients without a history of these behaviors. — NCATS

Clinical trial activity

63 trials · 42 clinical orgs · 29 marketing orgs

Phase 1
15
Phase 2
35
Phase 3
23
Phase 4
11

Earliest trial started Dec 1, 2001 (NCT00036218)

Timeline

1990s

  1. Sep 19, 1997

    Earliest FDA Approval

  2. Sep 19, 1997

    GlaxoSmithKline — NDA Secondary Org

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  4. May 5, 2008

    Cosette — Marketing Organization

  5. May 5, 2008

    G & W Laboratories Inc. — Marketing Organization

  6. May 5, 2008

    Prinston Inc — Marketing Organization

  7. May 5, 2008

    West-Ward Pharmaceutical — Marketing Organization

  8. May 5, 2008

    ACP Nimble — Marketing Organization

  9. May 5, 2008

    Hikma — Marketing Organization

  10. May 5, 2008

    PHARMOBEDIENT — Marketing Organization

  11. May 20, 2008

    Epic Pharma Llc — Marketing Organization

  12. May 29, 2008

    Celltrion — Marketing Organization

  13. May 29, 2008

    Chartwell Pharmaceuticals — Marketing Organization

  14. Jun 1, 2009

    Cadila Healthcare — Marketing Organization

  15. Jun 1, 2009

    Zydus Discovery DMCC — Marketing Organization

2010s

  1. Feb 25, 2010

    Glenmark Pharmaceuticals — Marketing Organization

  2. Mar 24, 2010

    Alembic — Marketing Organization

  3. Feb 7, 2012

    Apotex — Marketing Organization

  4. May 17, 2012

    Actavis — Marketing Organization

  5. Jun 6, 2012

    Dr. Reddy's Laboratories — Marketing Organization

  6. Jun 6, 2012

    Sandoz — Marketing Organization

  7. Jun 6, 2012

    Watson Pharmaceuticals — Marketing Organization

  8. Jun 6, 2012

    Novartis — Marketing Organization

  9. Aug 27, 2012

    Wockhardt — Marketing Organization

  10. Oct 15, 2012

    Mylan — Marketing Organization

  11. Oct 15, 2012

    Aurobindo Pharma — Marketing Organization

  12. Nov 28, 2012

    Orbion Pharms — Marketing Organization

  13. Nov 28, 2012

    Orchid Pharma — Marketing Organization

  14. Feb 28, 2017

    Accord Research — Marketing Organization

2020s

  1. Nov 10, 2025

    Elite Laboratories, Inc — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedSep 19, 1997

Chemistry & pharmacology

Loading structure…

SMILES

CCCN(CCC)CCc1cccc2c1CC(=O)N2
Mol. weight
260.38 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 4-(2-(di-n-propylamino)ethyl)-2(3h)-indolone
  • adartrel
  • adartrel
  • aimpart xl
  • glaxosmithkline brand of ropinirole hydrochloride
  • ipinnia xl
  • ralnea xl
  • raponer xl
  • repinex xl
  • requip
  • requip
  • requip
  • requip
  • requip
  • requip
  • requip xl
  • requip xl
  • ropilynz xl
  • ropinirol
  • ropinirol
  • ropinirol
  • ropinirol
  • ropinirol
  • ropinirol
  • ropinirole
  • ropinirole
  • ropinirole
  • ropinirole
  • ropinirole
  • ropinirole
  • ropinirole
  • ropinirole
  • ropinirole
  • ropinirole hcl
  • ropinirole hcl
  • ropinirole hcl
  • ropinirole hydrochloride
  • ropinirole hydrochloride
  • ropinirole hydrochloride
  • ropinirole hydrochloride
  • ropinirole hydrochloride
  • ropinirolum
  • ropinirolum
  • ropinrole
  • ropirinole
  • sk&f 101468
  • sk&f-101468
  • sk&f-101468
  • sk&f-101,468
  • skf 101468
  • sk&f-101468a
  • sk&f-101468a
  • sk&f-101468-a
  • sk&f-101468-a
  • smithkline beecham brand of ropinirole hydrochloride
  • spiroco xl

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06681389Phase 1Nov 25, 2024CMAX Clinical Research, NIBEC Co., Ltd.
NCT06468371N/AJan 2, 2022Post-Graduate Medical Institute, Lahore
NCT03806530Phase 3Apr 30, 2019McMaster University
NCT03708237Phase 2Feb 19, 2019University of Alberta
NCT03250117Phase 1/Phase 2 (Phase 2)Oct 10, 2017Titan Pharmaceuticals
NCT03038308Phase 1/Phase 2 (Phase 2)Sep 16, 2016Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT03176966Phase 4Sep 2, 2016Vanderbilt University
NCT02347059Phase 2Jan 1, 2015Michael J. Fox Foundation for Parkinson's Research, University of Toronto
NCT01929317Phase 3Aug 1, 2013GlaxoSmithKline
NCT01494532Phase 4Apr 1, 2012GlaxoSmithKline
NCT01485172Phase 4Jan 1, 2012GlaxoSmithKline
NCT01393457Phase 2Jun 1, 2011University of Texas at Houston
NCT01536574Phase 3Sep 1, 2010GlaxoSmithKline
NCT01435915Phase 1Jun 1, 2010GlaxoSmithKline
NCT01154166Phase 3Feb 1, 2010GlaxoSmithKline
NCT01007864Phase 3Jan 1, 2010Desitin Arzneimittel GmbH, FGK Clinical Research GmbH
NCT00996944Phase 2Nov 1, 2009GlaxoSmithKline
NCT01627847Phase 1Oct 1, 2009Dr. Reddy's Laboratories, GVK Biosciences Pvt. Ltd
NCT01627834Phase 1Oct 1, 2009Dr. Reddy's Laboratories, GVK Biosciences Pvt. Ltd
NCT01371682Phase 1Sep 18, 2009GlaxoSmithKline
Showing 20 of 63 trials
Page 1 / 4

Organizations

Research & Development (42)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit373152002
LupinFor profit3312008
Sipra Labs LimitedFor profit3012008
Dr. Reddy's LaboratoriesFor profit2212009
GVK Biosciences Pvt. LtdFor profit2012009
Novum Pharmaceutical Research ServicesFor profit2012004
Roxane LaboratoriesFor profit2212004
SFBC AnapharmFor profit2012004
TevaFor profit2212004
Axxonis Pharma AGFor profit1112006
Boehringer IngelheimFor profit1112005
CMAX Clinical ResearchFor profit1012024
Colorado Neurology, P.C.Academic/Hospital1012005
Columbia UniversityAcademic/Hospital1112016
Desitin Arzneimittel GmbHFor profit1112010
Duke UniversityAcademic/Hospital1012006
Emory UniversityAcademic/Hospital1012005
EvergreenHealthAcademic/Hospital1112005
FGK Clinical Research GmbHFor profit1012010
Harvard UniversityAcademic/Hospital1112005
42 organizations
Page 1 / 3

Marketing (36)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGMay 5, 2008
Accord ResearchFor profitMKTGFeb 28, 2017
ActavisFor profitMKTGMay 17, 2012
AlembicFor profitMKTGMar 24, 2010
AlembicFor profitSYNApr 22, 2013
AlembicFor profitSYNApr 22, 2013
ApotexFor profitMKTGFeb 7, 2012
Aurobindo PharmaFor profitMKTGOct 15, 2012
Cadila HealthcareFor profitMKTGJun 1, 2009
CelltrionFor profitMKTGMay 29, 2008
Chartwell PharmaceuticalsFor profitMKTGMay 29, 2008
CosetteFor profitMKTGMay 5, 2008
Dr. Reddy's LaboratoriesFor profitMKTGJun 6, 2012
Elite Laboratories, IncFor profitMKTGNov 10, 2025
Epic Pharma LlcFor profitMKTGMay 20, 2008
G & W Laboratories Inc.For profitMKTGMay 5, 2008
GlaxoSmithKlineFor profitNDA2Sep 19, 1997
Glenmark PharmaceuticalsFor profitMKTGFeb 25, 2010
Glenmark PharmaceuticalsFor profitSYNFeb 25, 2010
HikmaFor profitMKTGMay 5, 2008
HikmaFor profitSYNMay 5, 2008
MylanFor profitSYNMay 5, 2008
MylanFor profitMKTGOct 15, 2012
MylanFor profitSYNFeb 7, 2012
NovartisFor profitMKTGJun 6, 2012
Orbion PharmsFor profitMKTGNov 28, 2012
Orchid PharmaFor profitMKTGNov 28, 2012
PHARMOBEDIENTFor profitMKTGMay 5, 2008
Prinston IncFor profitMKTGMay 5, 2008
SandozFor profitMKTGJun 6, 2012
SmithKline BeechamFor profitNDA
Watson PharmaceuticalsFor profitMKTGJun 6, 2012
West-Ward PharmaceuticalFor profitMKTGMay 5, 2008
WockhardtFor profitSYNMay 29, 2008
WockhardtFor profitMKTGAug 27, 2012
Zydus Discovery DMCCFor profitMKTGJun 1, 2009