Overview
Rotigotine (Neupro) is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States. It is formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Like other dopamine agonists, rotigotine has been shown to possess antidepressant effects and may be useful in the treatment of depression as well. Rotigotine was developed by Aderis Pharmaceuticals. In 1998 Aderis licensed worldwide development and commercialization rights to Schwarz Pharma of Germany. It was approved by the European Medicines Agency in 2006 and by the FDA in 2007. However, all Neupro patches in the United States and some of Europe were recalled in 2008 due to delivery mechanism issues. Rotigotine has been authorized as a treatment for RLS since August 2008.
Indication
For use/treatment in neurologic disorders and parkinson's disease as well as moderate-to-severe primary Restless Legs Syndrome.
Associated Conditions
- Moderate restless legs syndrome (RLS)
- Parkinson's Disease (PD)
- Severe restless legs syndrome (RLS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/22 | Phase 3 | Recruiting | I.R.C.C.S. Fondazione Santa Lucia | ||
2024/02/07 | Phase 2 | Completed | SocraTec R&D GmbH | ||
2023/06/02 | Phase 2 | Recruiting | |||
2021/07/12 | N/A | UNKNOWN | |||
2021/06/24 | Phase 2 | Completed | I.R.C.C.S. Fondazione Santa Lucia | ||
2020/11/16 | Phase 1 | Completed | |||
2020/11/16 | Phase 1 | Completed | |||
2020/11/13 | Phase 1 | Completed | |||
2019/12/03 | Phase 1 | Terminated | |||
2019/06/20 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| UCB, Inc. | 50474-805 | TRANSDERMAL | 6 mg in 24 h | 7/21/2021 | |
| UCB, Inc. | 50474-804 | TRANSDERMAL | 4 mg in 24 h | 7/21/2021 | |
| UCB, Inc. | 50474-803 | TRANSDERMAL | 3 mg in 24 h | 7/21/2021 | |
| UCB, Inc. | 50474-802 | TRANSDERMAL | 2 mg in 24 h | 7/21/2021 | |
| UCB, Inc. | 50474-801 | TRANSDERMAL | 1 mg in 24 h | 7/21/2021 | |
| UCB, Inc. | 50474-806 | TRANSDERMAL | 8 mg in 24 h | 7/21/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/15/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rotigotine Microspheres for Injection | 国药准字H20240027 | 化学药品 | 注射剂 | 6/18/2024 | |
| Rotigotine Microspheres for Injection | 国药准字H20240025 | 化学药品 | 注射剂 | 6/18/2024 | |
| Rotigotine Microspheres for Injection | 国药准字H20240028 | 化学药品 | 注射剂 | 6/18/2024 | |
| Rotigotine Microspheres for Injection | 国药准字H20240026 | 化学药品 | 注射剂 | 6/18/2024 | |
| Rotigotine Patches | 国药准字HJ20180029 | 化学药品 | 贴剂 | 7/13/2023 | |
| Rotigotine Patches | 国药准字HJ20180028 | 化学药品 | 贴剂 | 7/13/2023 | |
| Rotigotine Patches | 国药准字HJ20180027 | 化学药品 | 贴剂 | 7/13/2023 | |
| Rotigotine Patches | 国药准字HJ20180026 | 化学药品 | 贴剂 | 7/13/2023 |
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 |
|---|---|---|---|---|---|
| NEUPRO rotigotine 1 mg/24 hr transdermal patch sachet | 163987 | Medicine | A | 10/19/2010 | |
| NEUPRO rotigotine 6 mg/24 hr transdermal patch sachet | 131382 | Medicine | A | 11/22/2007 | |
| NEUPRO rotigotine 3 mg/24 hr transdermal patch sachet | 163988 | Medicine | A | 10/19/2010 | |
| NEUPRO rotigotine 4 mg/24 hr transdermal patch sachet | 131381 | Medicine | A | 11/22/2007 | |
| NEUPRO rotigotine 8 mg/24 hr transdermal patch sachet | 131383 | Medicine | A | 11/22/2007 | |
| NEUPRO rotigotine 2 mg/24 hr transdermal patch sachet | 131370 | Medicine | A | 11/22/2007 |
Help Us Improve
Your feedback helps us provide better drug information and insights.