Overview
Ropinirole, also known as ReQuip, is a non-ergoline dopamine agonist used in Parkinson's disease and restless legs syndrome , . It is manufactured by GlaxoSmithKline Pharmaceuticals. Ropinirole was initially approved in 1997 by the FDA for the management of Parkinson's disease. In 2005, it was the first drug approved in the US for the management of primary moderate to severe restless legs syndrome . In 2008, the extended-release capsules of ropinirole were approved, allowing for less frequent dosing, therefore increased compliance, and offering a similar side effect profile and efficacy to previous formulations of ropinirole .
Background
Ropinirole, also known as ReQuip, is a non-ergoline dopamine agonist used in Parkinson's disease and restless legs syndrome , . It is manufactured by GlaxoSmithKline Pharmaceuticals. Ropinirole was initially approved in 1997 by the FDA for the management of Parkinson's disease. In 2005, it was the first drug approved in the US for the management of primary moderate to severe restless legs syndrome . In 2008, the extended-release capsules of ropinirole were approved, allowing for less frequent dosing, therefore increased compliance, and offering a similar side effect profile and efficacy to previous formulations of ropinirole .
Indication
For the treatment of the signs and symptoms of Parkinson's disease and for the treatment of primary moderate-severe restless legs syndrome .
Associated Conditions
- Idiopathic Parkinson's Disease
- Moderate restless legs syndrome (RLS)
- Parkinson's Disease (PD)
- Severe restless legs syndrome (RLS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/01/16 | Phase 3 | Completed | |||
2018/10/17 | Phase 2 | Terminated | |||
2017/08/15 | Phase 1 | Terminated | |||
2017/06/06 | Phase 4 | Completed | |||
2017/01/31 | Phase 1 | Completed | |||
2013/08/27 | Phase 3 | Terminated | |||
2012/10/30 | Phase 1 | Completed | |||
2012/10/26 | Phase 1 | Completed | |||
2012/06/27 | Phase 3 | Completed | |||
2012/06/26 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvPAK | 50268-742 | ORAL | 0.5 mg in 1 1 | 8/19/2022 | |
| Marlex Pharmaceuticals Inc | 10135-677 | ORAL | 3 mg in 1 1 | 11/15/2023 | |
| Zydus Lifesciences Limited | 65841-716 | ORAL | 3 mg in 1 1 | 11/5/2022 | |
| DIRECT RX | 72189-222 | ORAL | 1 mg in 1 1 | 11/22/2021 | |
| Dr. Reddys Laboratories Limited | 55111-662 | ORAL | 8 mg in 1 1 | 2/28/2023 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-911 | ORAL | 2 mg in 1 1 | 6/10/2014 | |
| Carilion Materials Management | 68151-4073 | ORAL | 1 mg in 1 1 | 2/25/2013 | |
| SOLCO HEALTHCARE US, LLC | 43547-595 | ORAL | 0.25 mg in 1 1 | 8/31/2020 | |
| Bryant Ranch Prepack | 63629-4798 | ORAL | 0.5 mg in 1 1 | 5/4/2022 | |
| Alembic Pharmaceuticals Inc. | 62332-032 | ORAL | 1 mg in 1 1 | 8/10/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| REQUIP TABLET 0.25 mg | SIN10976P | TABLET, FILM COATED | 0.25 mg | 6/11/1999 | |
| Requip PD 24 Hour Prolonged Release Tablets (2mg) | SIN13763P | TABLET, FILM COATED, EXTENDED RELEASE | 2 mg | 2/11/2010 | |
| Requip PD 24 Hour Prolonged Release Tablets (4mg) | SIN13764P | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | 2/11/2010 | |
| REQUIP TABLET 2 mg | SIN10975P | TABLET, FILM COATED | 2 mg | 6/11/1999 | |
| REQUIP TABLET 1 mg | SIN11018P | TABLET, FILM COATED | 1 mg | 7/13/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ropinirole Hydrochloride Sustained-release Tablets | 国药准字H20253817 | 化学药品 | 片剂 | 4/8/2025 | |
| Ropinirole Hydrochloride Sustained-release Tablets | 国药准字HJ20150415 | 化学药品 | 片剂 | 8/10/2020 | |
| Ropinirole Hydrochloride Sustained-release Tablets | 国药准字HJ20150414 | 化学药品 | 片剂 | 8/10/2020 | |
| Ropinirole Hydrochloride Sustained-release Tablets | 国药准字H20249538 | 化学药品 | 片剂 | 12/1/2024 | |
| Ropinirole Hydrochloride Sustained-release Tablets | 国药准字HJ20150424 | 化学药品 | 片剂 | 8/10/2020 | |
| Ropinirole Hydrochloride Sustained-release Tablets | 国药准字H20244677 | 化学药品 | 片剂 | 8/20/2024 | |
| Ropinirole Hydrochloride Tablets | 国药准字H20130045 | 化学药品 | 片剂 | 4/12/2023 | |
| Ropinirole Hydrochloride Tablets | 国药准字H20130044 | 化学药品 | 片剂 | 4/12/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| APPESE 0.5 ropinirole (as hydrochloride) 0.5 mg tablet blister pack | 140833 | Medicine | A | 8/4/2008 | |
| REPREVE ropinirole (as hydrochloride) 0.25 mg tablet blister pack | 295481 | Medicine | A | 11/7/2017 | |
| ROPINIROLE ARW ropinirole (as hydrochloride) 0.25mg tablet blister pack | 96866 | Medicine | A | 10/5/2004 | |
| APPESE 0.25 ropinirole (as hydrochloride) 0.25 mg tablet blister pack | 140830 | Medicine | A | 8/4/2008 | |
| APPESE 1 ropinirole (as hydrochloride) 1 mg tablet blister pack | 140834 | Medicine | A | 8/4/2008 | |
| ROPINIROLE ARW ropinirole (as hydrochloride) 2mg tablet blister pack | 96870 | Medicine | A | 10/5/2004 | |
| APPESE 2 ropinirole (as hydrochloride) 2 mg tablet blister pack | 140835 | Medicine | A | 8/4/2008 | |
| REPREVE ropinirole (as hydrochloride) 2 mg tablet blister pack | 295484 | Medicine | A | 11/7/2017 | |
| ROPINIROLE ARW ropinirole (as hydrochloride) 1mg tablet blister pack | 96869 | Medicine | A | 10/5/2004 | |
| ROPINIROLE ARW ropinirole (as hydrochloride) 0.5 mg tablet blister pack | 96868 | Medicine | A | 10/5/2004 |