MedPath

Pramipexole

Generic Name
Pramipexole
Brand Names
Mirapex, Mirapexin, Sifrol, Pramipexole Teva, Oprymea
Drug Type
Small Molecule
Chemical Formula
C10H17N3S
CAS Number
104632-26-0
Unique Ingredient Identifier
83619PEU5T

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

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

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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