ropinirole
Trade name: Requip
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
Earliest trial started Dec 1, 2001 (NCT00036218)
Timeline
1990s
- Sep 19, 1997
Earliest FDA Approval
- Sep 19, 1997
GlaxoSmithKline — NDA Secondary Org
2000s
- Jan 1, 2001
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2003
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2004
Earliest Phase 1 Sponsor(trial)
- May 5, 2008
Cosette — Marketing Organization
- May 5, 2008
G & W Laboratories Inc. — Marketing Organization
- May 5, 2008
Prinston Inc — Marketing Organization
- May 5, 2008
West-Ward Pharmaceutical — Marketing Organization
- May 5, 2008
ACP Nimble — Marketing Organization
- May 5, 2008
Hikma — Marketing Organization
- May 5, 2008
PHARMOBEDIENT — Marketing Organization
- May 20, 2008
Epic Pharma Llc — Marketing Organization
- May 29, 2008
Celltrion — Marketing Organization
- May 29, 2008
Chartwell Pharmaceuticals — Marketing Organization
- Jun 1, 2009
Cadila Healthcare — Marketing Organization
- Jun 1, 2009
Zydus Discovery DMCC — Marketing Organization
2010s
- Feb 25, 2010
Glenmark Pharmaceuticals — Marketing Organization
- Mar 24, 2010
Alembic — Marketing Organization
- Feb 7, 2012
Apotex — Marketing Organization
- May 17, 2012
Actavis — Marketing Organization
- Jun 6, 2012
Dr. Reddy's Laboratories — Marketing Organization
- Jun 6, 2012
Sandoz — Marketing Organization
- Jun 6, 2012
Watson Pharmaceuticals — Marketing Organization
- Jun 6, 2012
Novartis — Marketing Organization
- Aug 27, 2012
Wockhardt — Marketing Organization
- Oct 15, 2012
Mylan — Marketing Organization
- Oct 15, 2012
Aurobindo Pharma — Marketing Organization
- Nov 28, 2012
Orbion Pharms — Marketing Organization
- Nov 28, 2012
Orchid Pharma — Marketing Organization
- Feb 28, 2017
Accord Research — Marketing Organization
2020s
- Nov 10, 2025
Elite Laboratories, Inc — Marketing Organization
Indications
Studied for
- Bipolar Disorder · Phase 4
- Cocaine-Related Disorders · Phase 2
- Colitis, Ulcerative · Phase 1
- Dyskinesias · Phase 3
- Fibromyalgia · Phase 2
- Fibrosis · Phase 4
- Healthy Volunteers · Phase 1
- Hyperprolactinemia · Phase 1/Phase 2
- Kidney Failure, Chronic · Phase 3
- Major Depressive Disorder · Phase 4
- Muscle Cramp · Phase 4
- Paresis · Phase 2
- Pharmacokinetics · Phase 1
- Prolactinoma · Phase 1/Phase 2
- Restless Legs Syndrome · Phase 4
- Sexual Dysfunction, Physiological · Phase 4
- Stroke · Phase 2
- Ulcer · Phase 1
- Unverricht-Lundborg Syndrome · Phase 2
Mechanism of action
Approval history
- approvedSep 19, 1997
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL589 ↗
- WikipediaRopinirole ↗
- NCATS030PYR8953 ↗
- ChEMBLCHEMBL1200411 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06681389 | Phase 1 | Nov 25, 2024 | CMAX Clinical Research, NIBEC Co., Ltd. |
| NCT06468371 | N/A | Jan 2, 2022 | Post-Graduate Medical Institute, Lahore |
| NCT03806530 | Phase 3 | Apr 30, 2019 | McMaster University |
| NCT03708237 | Phase 2 | Feb 19, 2019 | University of Alberta |
| NCT03250117 | Phase 1/Phase 2 (Phase 2) | Oct 10, 2017 | Titan Pharmaceuticals |
| NCT03038308 | Phase 1/Phase 2 (Phase 2) | Sep 16, 2016 | Columbia University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT03176966 | Phase 4 | Sep 2, 2016 | Vanderbilt University |
| NCT02347059 | Phase 2 | Jan 1, 2015 | Michael J. Fox Foundation for Parkinson's Research, University of Toronto |
| NCT01929317 | Phase 3 | Aug 1, 2013 | GlaxoSmithKline |
| NCT01494532 | Phase 4 | Apr 1, 2012 | GlaxoSmithKline |
| NCT01485172 | Phase 4 | Jan 1, 2012 | GlaxoSmithKline |
| NCT01393457 | Phase 2 | Jun 1, 2011 | University of Texas at Houston |
| NCT01536574 | Phase 3 | Sep 1, 2010 | GlaxoSmithKline |
| NCT01435915 | Phase 1 | Jun 1, 2010 | GlaxoSmithKline |
| NCT01154166 | Phase 3 | Feb 1, 2010 | GlaxoSmithKline |
| NCT01007864 | Phase 3 | Jan 1, 2010 | Desitin Arzneimittel GmbH, FGK Clinical Research GmbH |
| NCT00996944 | Phase 2 | Nov 1, 2009 | GlaxoSmithKline |
| NCT01627847 | Phase 1 | Oct 1, 2009 | Dr. Reddy's Laboratories, GVK Biosciences Pvt. Ltd |
| NCT01627834 | Phase 1 | Oct 1, 2009 | Dr. Reddy's Laboratories, GVK Biosciences Pvt. Ltd |
| NCT01371682 | Phase 1 | Sep 18, 2009 | GlaxoSmithKline |
Organizations
Research & Development (42)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 37 | 31 | 5 | 2002 |
| Lupin | For profit | 3 | 3 | 1 | 2008 |
| Sipra Labs Limited | For profit | 3 | 0 | 1 | 2008 |
| Dr. Reddy's Laboratories | For profit | 2 | 2 | 1 | 2009 |
| GVK Biosciences Pvt. Ltd | For profit | 2 | 0 | 1 | 2009 |
| Novum Pharmaceutical Research Services | For profit | 2 | 0 | 1 | 2004 |
| Roxane Laboratories | For profit | 2 | 2 | 1 | 2004 |
| SFBC Anapharm | For profit | 2 | 0 | 1 | 2004 |
| Teva | For profit | 2 | 2 | 1 | 2004 |
| Axxonis Pharma AG | For profit | 1 | 1 | 1 | 2006 |
| Boehringer Ingelheim | For profit | 1 | 1 | 1 | 2005 |
| CMAX Clinical Research | For profit | 1 | 0 | 1 | 2024 |
| Colorado Neurology, P.C. | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Desitin Arzneimittel GmbH | For profit | 1 | 1 | 1 | 2010 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2006 |
| Emory University | Academic/Hospital | 1 | 0 | 1 | 2005 |
| EvergreenHealth | Academic/Hospital | 1 | 1 | 1 | 2005 |
| FGK Clinical Research GmbH | For profit | 1 | 0 | 1 | 2010 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2005 |
Marketing (36)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACP Nimble | For profit | MKTG | May 5, 2008 |
| Accord Research | For profit | MKTG | Feb 28, 2017 |
| Actavis | For profit | MKTG | May 17, 2012 |
| Alembic | For profit | MKTG | Mar 24, 2010 |
| Alembic | For profit | SYN | Apr 22, 2013 |
| Alembic | For profit | SYN | Apr 22, 2013 |
| Apotex | For profit | MKTG | Feb 7, 2012 |
| Aurobindo Pharma | For profit | MKTG | Oct 15, 2012 |
| Cadila Healthcare | For profit | MKTG | Jun 1, 2009 |
| Celltrion | For profit | MKTG | May 29, 2008 |
| Chartwell Pharmaceuticals | For profit | MKTG | May 29, 2008 |
| Cosette | For profit | MKTG | May 5, 2008 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jun 6, 2012 |
| Elite Laboratories, Inc | For profit | MKTG | Nov 10, 2025 |
| Epic Pharma Llc | For profit | MKTG | May 20, 2008 |
| G & W Laboratories Inc. | For profit | MKTG | May 5, 2008 |
| GlaxoSmithKline | For profit | NDA2 | Sep 19, 1997 |
| Glenmark Pharmaceuticals | For profit | MKTG | Feb 25, 2010 |
| Glenmark Pharmaceuticals | For profit | SYN | Feb 25, 2010 |
| Hikma | For profit | MKTG | May 5, 2008 |
| Hikma | For profit | SYN | May 5, 2008 |
| Mylan | For profit | SYN | May 5, 2008 |
| Mylan | For profit | MKTG | Oct 15, 2012 |
| Mylan | For profit | SYN | Feb 7, 2012 |
| Novartis | For profit | MKTG | Jun 6, 2012 |
| Orbion Pharms | For profit | MKTG | Nov 28, 2012 |
| Orchid Pharma | For profit | MKTG | Nov 28, 2012 |
| PHARMOBEDIENT | For profit | MKTG | May 5, 2008 |
| Prinston Inc | For profit | MKTG | May 5, 2008 |
| Sandoz | For profit | MKTG | Jun 6, 2012 |
| SmithKline Beecham | For profit | NDA | — |
| Watson Pharmaceuticals | For profit | MKTG | Jun 6, 2012 |
| West-Ward Pharmaceutical | For profit | MKTG | May 5, 2008 |
| Wockhardt | For profit | SYN | May 29, 2008 |
| Wockhardt | For profit | MKTG | Aug 27, 2012 |
| Zydus Discovery DMCC | For profit | MKTG | Jun 1, 2009 |