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 .
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 | 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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PRAMIPEXOLE | sanis health inc | 02367602 | Tablet - Oral | 0.25 MG | 7/21/2011 |
ACT PRAMIPEXOLE | teva canada limited | 02297329 | Tablet - Oral | 1 MG | 4/15/2009 |
DOM-PRAMIPEXOLE | dominion pharmacal | 02309033 | Tablet - Oral | 1.0 MG | N/A |
MYLAN-PRAMIPEXOLE | Mylan Pharmaceuticals ULC | 02376350 | Tablet - Oral | 0.25 MG | 11/23/2011 |
PRAMIPEXOLE | sivem pharmaceuticals ulc | 02309130 | Tablet - Oral | 0.5 MG | 4/9/2009 |
SANDOZ PRAMIPEXOLE | 02315270 | Tablet - Oral | 0.5 MG | 8/14/2008 | |
PRAMIPEXOLE | PRO DOC LIMITEE | 02325837 | Tablet - Oral | 1.5 MG | 6/15/2009 |
PRAMIPEXOLE | sivem pharmaceuticals ulc | 02309122 | Tablet - Oral | 0.25 MG | 4/9/2009 |
PRAMIPEXOLE | sanis health inc | 02367610 | Tablet - Oral | 0.5 MG | 7/21/2011 |
NTP-PRAMIPEXOLE | nt pharma canada ltd | 02362287 | Tablet - Oral | 0.25 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
PRAMIPEXOL TEVA 0,088 mg COMPRIMIDOS EFG | 08490001 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
PRAMIPEXOL SANDOZ FARMACEUTICA 0,26 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Sandoz Farmaceutica S.A. | 78130 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
PRAMIPEXOL NORMON 0,18 mg COMPRIMIDOS EFG | Laboratorios Normon S.A. | 72079 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
PRAMIPEXOL SANDOZ FARMACEUTICA 2,1 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Sandoz Farmaceutica S.A. | 78132 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
MIRAPEXIN 0,18 mg COMPRIMIDOS | 97051004 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
PRAMIPEXOL SANDOZ 0,7 mg COMPRIMIDOS EFG | Sandoz Farmaceutica S.A. | 71039 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Oprymea 0,70 mg comprimidos EFG | Krka D.D. Novo Mesto | 108469017 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Oprymea 0,70 mg comprimidos EFG | Krka D.D. Novo Mesto | 108469020 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
PRAMIPEXOL ARISTO 0,18 MG. COMPRIMIDOS EFG | Aristo Pharma Iberia S.L. | 74930 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
PRAMIPEXOL PENSA 0,18 mg COMPRIMIDOS EFG | Towa Pharmaceutical S.A. | 72072 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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