Overview
Pramipexole is a drug used to treat the symptoms of Parkinson's Disease (PD). It is a non-ergot dopamine agonist drug that is efficacious in treating various Parkinson's symptoms such as tremor, rigidity, and bradykinesia (slow movement) . It was first approved by the FDA in 1997 . Parkinson's Disease is one of the most common neurodegenerative disorders and causes a high level of disability in patients , leading to increased difficulty in performing activities of daily living due to symptoms that progress over time . The prevalence of Parkinson's Disease worldwide has increased from approximately 2.5 million in 1990 to about 6.1 million in 2016 . This increase may be attributed to an aging population along with other contributing factors . In addition to the above FDA approval for Parkinson's Disease, pramipexole was also approved by the FDA in 2006 for the treatment of Restless Legs Syndrome (RLS) . RLS is a sleep-related disorder characterized by unpleasant sensations in the lower extremities, often accompanied by an uncontrollable urge to move the legs .
Background
Pramipexole is a drug used to treat the symptoms of Parkinson's Disease (PD). It is a non-ergot dopamine agonist drug that is efficacious in treating various Parkinson's symptoms such as tremor, rigidity, and bradykinesia (slow movement) . It was first approved by the FDA in 1997 . Parkinson's Disease is one of the most common neurodegenerative disorders and causes a high level of disability in patients , leading to increased difficulty in performing activities of daily living due to symptoms that progress over time . The prevalence of Parkinson's Disease worldwide has increased from approximately 2.5 million in 1990 to about 6.1 million in 2016 . This increase may be attributed to an aging population along with other contributing factors . In addition to the above FDA approval for Parkinson's Disease, pramipexole was also approved by the FDA in 2006 for the treatment of Restless Legs Syndrome (RLS) . RLS is a sleep-related disorder characterized by unpleasant sensations in the lower extremities, often accompanied by an uncontrollable urge to move the legs .
Indication
This drug is indicated for the symptomatic treatment of Parkinson’s disease . This drug can be administered as monotherapy or in conjunction with levodopa. It is also indicated for symptomatic treatment of moderate to severe primary Restless Legs Syndrome (RLS) .
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 |
---|---|---|---|---|---|
2025/06/15 | Phase 2 | Not yet recruiting | |||
2024/11/26 | Phase 2 | Not yet recruiting | |||
2024/09/25 | Phase 2 | Recruiting | Clinical Academic Center (2CA-Braga) | ||
2024/08/30 | Phase 4 | ENROLLING_BY_INVITATION | |||
2024/06/13 | Phase 1 | Completed | |||
2024/02/21 | Phase 2 | Recruiting | |||
2023/04/24 | Phase 3 | Recruiting | |||
2022/06/02 | Phase 2 | Not yet recruiting | Clinical Academic Center (2CA-Braga) | ||
2022/05/02 | Phase 3 | Active, not recruiting | |||
2021/08/12 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
ScieGen Pharmaceuticals Inc | 50228-129 | ORAL | 0.75 mg in 1 1 | 1/7/2023 | |
Zydus Lifesciences Limited | 65841-735 | ORAL | 0.25 mg in 1 1 | 12/16/2022 | |
Alembic Pharmaceuticals Limited | 46708-612 | ORAL | 0.25 mg in 1 1 | 12/8/2023 | |
Torrent Pharmaceuticals Limited | 13668-092 | ORAL | 0.25 mg in 1 1 | 4/5/2022 | |
Physicians Total Care, Inc. | 54868-6237 | ORAL | 0.125 mg in 1 1 | 1/3/2012 | |
Alembic Pharmaceuticals Limited | 46708-579 | ORAL | 3.75 mg in 1 1 | 4/3/2019 | |
ScieGen Pharmaceuticals Inc | 50228-130 | ORAL | 1 mg in 1 1 | 1/7/2023 | |
Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0286 | ORAL | 2.25 mg in 1 1 | 11/8/2023 | |
A-S Medication Solutions | 50090-2217 | ORAL | 0.5 mg in 1 1 | 3/31/2021 | |
Alembic Pharmaceuticals Limited | 46708-004 | ORAL | 0.25 mg in 1 1 | 11/20/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 9/12/2008 | ||
Authorised | 10/13/1997 | ||
Authorised | 12/18/2008 | ||
Authorised | 2/23/1998 | ||
Authorised | 12/18/2008 | ||
Authorised | 10/13/1997 | ||
Authorised | 2/23/1998 | ||
Authorised | 9/12/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Sifrol Extended Release Tablet 0.375 mg | SIN13928P | TABLET, EXTENDED RELEASE | 0.375mg | 3/9/2011 | |
Sifrol Extended Release Tablet 1.5mg | SIN13930P | TABLET, EXTENDED RELEASE | 1.500mg | 3/9/2011 | |
SIFROL TABLET 0.125 mg | SIN11253P | TABLET | 0.125mg | 1/4/2000 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Pramipexole Dihydrochloride Tablets | 国药准字HJ20140917 | 化学药品 | 片剂 | 8/15/2024 | |
Pramipexole Dihydrochloride Tablets | 国药准字HJ20140916 | 化学药品 | 片剂 | 8/15/2024 | |
Pramipexole Dihydrochloride Tablets | 国药准字H20213911 | 化学药品 | 片剂 | 11/30/2021 | |
Pramipexole Dihydrochloride Tablets | 国药准字HJ20140918 | 化学药品 | 片剂 | 8/15/2024 | |
Pramipexole Dihydrochloride Tablets | 国药准字H20203723 | 化学药品 | 片剂 | 12/29/2020 | |
Pramipexole Dihydrochloride Tablets | 国药准字H20203724 | 化学药品 | 片剂 | 12/29/2020 | |
Pramipexole Dihydrochloride Tablets | 国药准字H20193412 | 化学药品 | 片剂 | 12/26/2019 | |
Pramipexole Dihydrochloride Tablets | 国药准字H20213573 | 化学药品 | 片剂 | 7/12/2021 | |
Pramipexole Dihydrochloride Tablets | 国药准字H20213572 | 化学药品 | 片剂 | 7/12/2021 | |
Pramipexole Dihydrochloride Tablets | 国药准字J20180038 | 化学药品 | 片剂 | 12/23/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
PMS-PRAMIPEXOLE TABLETS 1MG | N/A | N/A | N/A | 1/31/2013 |